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  • Guideline Summary
  • NGC:010577
  • 2014 Jul

Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations.

World Health Organization (WHO). Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. Geneva (Switzerland): World Health Organization (WHO); 2014 Jul. 160 p. [313 references]

View the original guideline documentation External Web Site Policy

This is the current release of the guideline.

This guideline meets NGC's 2013 (revised) inclusion criteria.

Age Group

UMLS Concepts (what is this?)

PDQ
SNOMEDCT_US
Behavioral therapy (166001), Circumcision (72310004), Condom (706506000), Contraception (13197004), Highly active anti-retroviral therapy (416234007), HIV prevention education (313208007), HIV screening (171121004), Human immunodeficiency virus counseling (313077009), Human immunodeficiency virus infection (86406008), Lubricant (312438007), Lubricant (350100009), Lubricant (706774004), Mixed infectious disease (4559000), Neoplasm of anus (126849006), Neoplasm of uterine cervix (123841004), Nutrition therapy (386373004), Post-exposure prophylaxis (409516001), Screening for cancer (15886004), Vaginal lubricants (326646000), Vaginal lubricants (464890009), Venereal disease screening (171128005)
UMD
Condoms, Male (18-080)

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • March 22, 2016 – Opioid pain medicines External Web Site Policy: The U.S. Food and Drug Administration (FDA) is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. They are requiring changes to the labels of all opioid drugs to warn about these risks.

Major Recommendations

The rating schemes for the quality of the evidence (High, Moderate, Low, Very Low) and the strength of the recommendations (Strong, Conditional) are defined at the end of the "Major Recommendations" field.

Prevention

Comprehensive Condom and Lubricant Programming

Recommendations and Guidance

All Key Population Groups

The correct and consistent use of condoms with condom-compatible lubricants is recommended for all key populations to prevent sexual transmission of human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) (Strong recommendation, Moderate quality of evidence) ("Guidelines: prevention and treatment," 2011; "WHO, UNODC, UNAIDS technical guide," 2012; "Interventions to address HIV," 2007; "Prevention and treatment," 2012).

Related Recommendations and Contextual Issues for Specific Key Population Groups

Men Who Have Sex with Men

  • Condoms and condom-compatible lubricants are recommended for anal sex ("Guidelines: prevention and treatment," 2011).
  • Adequate provision of lubricants needs to be emphasized.

People in Prisons and Other Closed Settings

Sexual activity takes place in prisons and other closed settings, but general access to condoms there is limited. It is important to introduce, and expand to scale, condom and lubricant distribution programmes in prisons and other closed settings, without quantity restriction, with anonymity and in an easily accessible manner (e.g., condom vending machines) ("Interventions to address HIV," 2007; "HIV prevention," 2013).

Sex Workers (and Clients of Sex Workers)

  • Correct and consistent use of condoms and condom-compatible lubricants is recommended for sex workers and their clients ("Prevention and treatment," 2012).
  • Sex workers, female or male, often face power imbalances that limit their ability to use condoms with clients. (See Chapter 5 in the original guideline document on critical enablers.) Female sex workers who inject drugs may be particularly vulnerable to these power imbalances. The female condom has the advantages over the male condom that the woman can initiate its use and it can be inserted up to several hours before intercourse ("WHO information update," 2002). Peer-led and outreach approaches may help to increase knowledge, develop skills and empower sex workers to use condoms and lubricants consistently.

Transgender People

  • Condoms and condom-compatible lubricants are recommended for anal sex ("Guidelines: prevention and treatment," 2011).
  • Adequate provision of lubricants for transgender women and transgender men who have sex with men needs emphasis.

Adolescents from Key Populations

Adolescents' emotional, intellectual and social capacities are continuously evolving. Young people from key populations, perhaps more so than their peers in the general population, experience power imbalances in sexual relationships that limit their ability to use condoms (Goldenberg et al., 2012; Balthasar, Jeannin, & Dubois-Arber, 2009; Pettifor et al., 2004). Peer-led and outreach approaches may help to distribute condoms and lubricants, increase knowledge, develop skills and empower adolescents from key populations to use condoms and lubricants correctly and consistently ("Condom programming," 2005).

Harm Reduction for People Who Inject Drugs

Needle and Syringe Programmes

Recommendations and Guidance

All Key Population Groups

  • All individuals from key populations who inject drugs should have access to sterile injecting equipment through needle and syringe programmes (Strong recommendation, Low quality of evidence) ("WHO, UNDOC, UNAIDS technical guide," 2012; "Tool," Forthcoming; "Effectiveness," 2004; "mhGAP intervention guide," 2011).
  • Additional remarks
    • It is suggested that needle and syringe programmes also provide low dead-space syringes (LDSS) along with information about their preventive advantage over conventional syringes ("Guidance on prevention," 2012).
    • Injecting equipment should be appropriate to the local context, taking into account such factors as the type and preparation of drugs that are commonly injected ("WHO, UNDOC, UNAIDS technical guide," 2012; "Guide to starting," 2007).

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

  • It is important to provide people in prisons and other closed settings with prevention measures, such as condoms and clean injecting equipment, and not just with information about avoiding risks. People in prisons and other closed settings should have easy, confidential access to needle and syringe programmes (NSPs) ("Interventions to address HIV," 2007).
  • Prison systems should pilot-test and evaluate safer tattooing initiatives to assess whether they reduce the sharing and re-use of tattooing equipment and, thereby, reduce infections ("Interventions to address HIV," 2007; "HIV prevention," 2013).

Transgender People

Transgender people who inject substances for gender affirmation should use sterile injecting equipment and practice safe injecting practices to reduce the risk of infection with bloodborne pathogens such as HIV, hepatitis B and hepatitis C ("Guidelines: prevention and treatment," 2011).

Adolescents from Key Populations

World Health Organization (WHO) guidance does not specify age restrictions for needle and syringe programmes.

Opioid Substitution Therapy

Recommendations and Guidance

All Key Population Groups

  • All people from key populations who are dependent on opioids should be offered opioid substitution therapy in keeping with WHO guidance (Strong recommendation, Low quality of evidence) ("WHO, UNDOC, UNAIDS technical guide," 2012; "Tool," Forthcoming; "Guidelines for the psychosocially," 2009), including those in prison and other closed settings ("Interventions to address HIV," 2007).
  • Additional remarks
    • To maximize the safety and effectiveness of opioid substitution therapy (OST) programmes, policies and regulations should encourage flexible dosing structures, without restricting dose levels or duration of treatment ("Guidelines for the psychosocially," 2009). Usual methadone maintenance doses should be in the range of a minimum of 60–120 mg per day, and average buprenorphine maintenance doses should be at least 8 mg per day ("Guidelines for the psychosocially," 2009). Take-home doses can be offered when the dose and social situation are stable and when there is little risk of diversion for illegitimate purposes ("Guidelines for the psychosocially," 2009). OST is most effective as a maintenance treatment for longer periods of time (treatment for years may be necessary). Detoxification or opioid withdrawal (rather than maintenance treatment) results in poor outcomes in the long term. However, patients should be helped to withdraw from opioids if it is their informed choice to do so ("Guidelines for the psychosocially," 2009).
    • OST should be used for the treatment of opioid dependence in pregnancy rather than attempt opioid detoxification ("Guidelines for the psychosocially," 2009; "Guidelines for identification," 2014).
    • Psychosocial support should be available to all opioid-dependent people, in association with pharmacological treatments of opioid dependence. At a minimum this support should include assessment of psychosocial needs, supportive counselling and links to family and community services ("Guidelines for the psychosocially," 2009).
    • For opioid-dependent people with tuberculosis (TB), viral hepatitis B or C or HIV, opioid agonists should be administered in conjunction with medical treatment. There is no need to wait for abstinence from opioids to start treatment for these conditions ("Guidelines for the psychosocially," 2009).
    • Treatment services should offer hepatitis B vaccination to all opioid-dependent patients (whether or not they are participating in OST programmes) ("Guidelines for the psychosocially," 2009).
    • Care settings that provide OST should initiate and maintain antiretroviral therapy (ART) for eligible people living with HIV ("Consolidated guidelines," 2013).

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

  • Prison authorities in countries where OST is available in the community should urgently introduce OST programmes and expand them to scale as soon as possible ("Interventions to address HIV," 2007).
  • Countries should affirm and strengthen the principle of providing treatment, education and rehabilitation as an alternative to conviction and punishment for drug-related offences ("WHO, UNODC, UNAIDS technical guide," 2012).
  • Care should be taken to see that people on OST before entering prisons or other closed settings can continue OST without interruption while imprisoned and when transferred between settings ("Interventions to address HIV," 2007; "Guidelines for the psychosocially," 2009) and can be linked to community-based OST upon release ("Rolling out," 2013).
  • Provision of OST before release can help reduce overdose-related mortality (Degenhardt et al., 2014).

Transgender People

There is no evidence of drug interactions between opioid substitution therapy and medications used for gender affirmation; however, research is very limited.

Adolescents from Key Populations

WHO guidance does not specify age restrictions for opioid substitution therapy.

Other Drug Dependence Treatment

Recommendations and Guidance

All Key Population Groups

All key populations with harmful alcohol or other substance use should have access to evidence-based interventions, including brief psychosocial interventions involving assessment, specific feedback and advice (Conditional recommendation, Very low quality of evidence) ("Guidelines: prevention and treatment," 2011; "mhGAP interventions guide," 2011).

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

  • People in prisons should have access to the same evidence-based treatment options for substance dependence as people in the community ("Interventions to address HIV," 2007; "Rolling out," 2013).
  • To reduce over-incarceration and prison over-crowding, which increase the risk of HIV infection, it is important that countries review their laws and policies that criminalize people for their consumption of alcohol or drugs ("Interventions to address HIV," 2007; "Rolling out," 2013).

Adolescents from Key Populations

Treatment should be provided in the best interests of the adolescent concerned and in consultation with her or him.

Opioid Overdose Prevention and Management

Recommendations and Guidance

All Key Population Groups

  • People likely to witness an opioid overdose should have access to naloxone and be instructed in its use for emergency management of suspected opioid overdose (Strong recommendation, Very low quality of evidence) ("Guidelines on the management," Forthcoming).
  • Naloxone is effective when delivered by intramuscular, intranasal, intravenous and subcutaneous routes. Persons administering naloxone should select the route based on formulation available, skills in administration, setting and local context (Conditional recommendation, Very low quality of evidence) ("Guidelines on the management," Forthcoming).
  • In suspected opioid overdose, first-responders should focus on maintaining an airway, assisting ventilation and giving naloxone (Strong recommendation, Very low quality of evidence) ("Guidelines on the management," Forthcoming).
  • After successful resuscitation following administration of naloxone, the affected person's level of consciousness and breathing should be closely observed – where possible, until the person has fully recovered (Strong recommendation, Very low quality of evidence) ("Guidelines on the management," Forthcoming).

Related Recommendations and Contextual Issues for Specific Key Population Groups

Adolescents from Key Populations

WHO guidance does not specify age restrictions for overdose management.

Behavioural Interventions

Recommendations and Guidance

All Key Population Groups

A range of behavioural interventions can provide information and skills that support risk reduction, prevent HIV transmission and increase uptake of services among all key populations. There is insufficient evidence to make general recommendations for all key populations. However, specific behavioural approaches for particular key population groups have been assessed and can be recommended.

Related Recommendations and Contextual Issues for Specific Key Population Groups

Men Who Have Sex with Men

  • The following strategies are recommended to increase safer sexual behaviours and increase uptake of HIV testing and counselling among men who have sex with men:
    • Targeted Internet-based information
    • Social marketing strategies
    • Sex venue-based outreach ("Guidelines: prevention and treatment," 2011; "Tool," Forthcoming)
  • Implementing both individual-level behavioural interventions and community-level behavioural interventions is suggested ("Guidelines: prevention and treatment," 2011; "Tool," Forthcoming).

People in Prisons and Other Closed Settings

  • A peer-based, comprehensive approach increases the effectiveness of prison-based HIV education efforts ("Interventions to address HIV," 2007).
  • Information and education programmes about HIV and other infectious diseases are important for both prisoners and prison staff. Special attention should be paid to the needs of prisoners after release.

People Who Inject Drugs

  • People who inject drugs and relevant community networks should participate in developing and delivering messages.
  • Behavioural interventions for people who inject drugs need to address risk related to both drug use and sexual behaviour ("Guide to starting and managing," 2007).
  • For people who inject drugs, peer interventions are particularly effective for the prevention of HIV and viral hepatitis ("Guidance on prevention," 2012).
  • Information and education about safe injecting and overdose prevention are also important.

Sex Workers

Condom promotion programmes, including community-led programmes, can increase condom use by sex workers and their clients. Through peer- and community-led interventions, these programmes can provide information and skills-building for condom use and information and create demand for HIV testing, STI screening, and HIV treatment and care ("Implementing comprehensive," 2013).

Transgender People

  • The following strategies are recommended to increase safer sexual behaviours and increase uptake of HIV testing and counselling among transgender people:
    • Targeted Internet-based information
    • Social marketing strategies
    • Sex venue-based outreach ("Guidelines: prevention and treatment," 2011; "Tool," Forthcoming)
  • Implementing both individual-level behavioural interventions and community-level behavioural interventions is suggested ("Guidelines: prevention and treatment," 2011; "Tool," Forthcoming).

Adolescents from Key Populations

Skills-based interactive and participatory approaches for adolescents from key populations, including online, mobile health, peer and outreach approaches, have proved acceptable to adolescents and have shown promise in some contexts ("Guidance brief," 2007; Interagency Youth Working Group, 2010).

Antiretroviral (ARV)-Related Prevention

Pre-exposure Prophylaxis (PrEP)

Recommendations and Guidance

All Key Population Groups

Where serodiscordant couples can be identified and where additional HIV prevention choices for them are needed, daily oral PrEP (specifically tenofovir or the combination of tenofovir and emtricitabine) may be considered as a possible additional intervention for the uninfected partner (Conditional recommendation, High quality of evidence) ("Guidance on oral pre-exposure prophylaxis," 2012).

Related Recommendations and Contextual Issues for Specific Key Population Groups

Men Who Have Sex with Men

Among men who have sex with men, PrEP is recommended as an additional HIV prevention choice within a comprehensive HIV prevention package (Strong recommendation, High quality of evidence).

People Who Inject Drugs

  • No new recommendation was made for use of oral PrEP for people who inject drugs.
  • The existing recommendation to offer daily oral PrEP as an additional HIV prevention choice for the negative partner in a serodiscordant relationship remains relevant for people who inject drugs and are in a serodiscordant relationship (Conditional recommendation, High quality of evidence) ("Guidance on oral pre-exposure prophylaxis," 2012).

Sex Workers

The existing recommendation to offer daily oral PrEP as an additional HIV prevention choice for the HIV-negative partner in a serodiscordant couple remains relevant for sex workers who are in serodiscordant couple relationships (Conditional recommendation, High quality of evidence) ("Guidance on oral pre-exposure prophylaxis," 2012).

Transgender People

Where HIV transmission occurs among transgender women who have sex with men and additional HIV prevention choices for them are needed, daily oral PrEP (specifically the combination of tenofovir and emtricitabine) may be considered as a possible additional intervention (Conditional recommendation, High quality of evidence) ("Guidance on oral pre-exposure prophylaxis," 2012).

Post-exposure Prophylaxis (PEP)

Recommendations and Guidance

All Key Population Groups

HIV PEP prophylaxis should be considered for people presenting within 72 hours of a sexual assault. Use shared decision-making with the survivor to determine whether HIV post-exposure prophylaxis is appropriate (Strong recommendation, Very Low quality of evidence) ("Responding," 2013).

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

PEP should be made accessible to all people in prisons and other closed settings who have possibly been exposed to HIV, just as in non-prison settings. Clear guidelines need to be developed and communicated to prisoners, health-care staff and other employees ("Interventions to address HIV," 2007; "HIV Prevention," 2013).

Early Initiation of ART/ART Regardless of CD4 Count

Recommendations and Guidance

All Key Population Groups

ART should be initiated in all individuals with HIV regardless of WHO clinical stage or CD4 count in the following situations:

  • Individuals with HIV and active TB disease (Strong recommendation, Low quality of evidence).
  • Individuals co-infected with HIV and hepatitis B virus (HBV) with evidence of severe chronic liver disease (Strong recommendation, Low quality of evidence).
  • For programmatic and operational reasons, particularly in generalized epidemics, all pregnant and breastfeeding women with HIV should initiate ART as lifelong treatment (Conditional recommendation, Low quality of evidence) ("Consolidated guidelines," 2013).
  • Partners with HIV in serodiscordant couples should be offered ART to reduce HIV transmission to uninfected partners (Strong recommendation, High quality of evidence) ("Consolidated guidelines," 2013).

Voluntary Medical Male Circumcision (VMMC) for HIV Prevention

Recommendations and Guidance

All Key Population Groups

  • VMMC is recommended as an additional, important strategy for the prevention of heterosexually acquired HIV infection in men, particularly in settings with hyperendemic and generalized HIV epidemics and low prevalence of male circumcision ("Technical consultation," 2007).
  • VMMC service provision should serve as an opportunity to address the sexual health needs of men; such services should actively counsel and promote safer sexual behaviour ("Technical consultation," 2007).

Related Recommendations and Contextual Issues for Specific Key Population Groups

Men Who Have Sex with Men

  • VMMC is not recommended to prevent HIV transmission in sex between men, as evidence is lacking that VMMC is protective during receptive anal intercourse ("Guidelines: prevention and treatment," 2011).
  • Men who have sex with men may still benefit from VMMC if they also engage in vaginal sex. Men who have sex with men should not be excluded from VMMC services in countries in eastern and southern Africa where VMMC is offered for HIV prevention.

People in Prisons and Other Closed Settings

VMMC is not one of the recommended interventions in the prison package. If VMMC is offered to men in prisons in priority countries in eastern and southern Africa with generalized epidemics and low rates of male circumcision, it is crucial that it is provided with full adherence to medical ethics and human rights principles. Informed consent, confidentiality and absence of coercion should be assured.

Sex Workers (and Clients of Sex Workers)

  • Health messages and counselling should emphasize that resuming sexual relations before complete wound healing may increase the risk of HIV acquisition among recently circumcised HIV-negative men and may increase the risk of HIV transmission to female partners of recently circumcised HIV-positive men ("Technical consultation," 2007).
  • "Men's health services" offering VMMC to clients of sex workers or other men at higher risk (such as in serodiscordant couples) may be a promising approach in the high-priority countries of eastern and southern Africa to reach men at greater risk of HIV infection. This approach has not been systematically reviewed and evaluated, however.

Transgender People

VMMC is not recommended for HIV prevention among transgender women ("Guidelines: prevention and treatment," 2011).

Adolescents from Key Populations

Countries with hyperendemic and generalized HIV epidemics and low prevalence of male circumcision should increase access to male circumcision services as a priority for adolescents and young men ("Technical consultation," 2007).

HIV Testing and Counselling

Recommendations and Guidance

All Key Population Groups

  • Voluntary HIV testing and counselling (HTC) should be routinely offered to all key populations in both the community and clinical settings ("Guidelines: prevention and treatment," 2011; "Consolidated guidelines," 2013; "WHO, UNODC, UNAIDS technical guide," 2012; "Prevention and treatment," 2012; "HIV and adolescents," 2013; "Guidance on provider," 2007).
  • Community-based HIV testing and counselling for key populations, with linkage to prevention, care and treatment services, is recommended, in addition to provider-initiated testing and counselling (Strong recommendation, Low quality of evidence) ("Consolidated guidelines," 2013).
  • Additional remark
    • Couples and partners should be offered voluntary HTC with support for mutual disclosure ("Guidance on couples," 2012).

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

It is important to guard against negative consequences of testing in prisons – for example, segregation of prisoners – and to respect confidentiality. It is also important that people who test positive have access and are linked to HIV care and treatment services ("Interventions to address HIV," 2007; "HIV testing and counselling," 2009).

  • HIV testing and counselling should be voluntary ("HIV testing and counseling," 2009).
  • The use of HIV rapid testing can increase the likelihood of prisoners receiving their results ("HIV testing and counselling," 2009).
  • Testing in conjunction with other risk-reduction services such as the provision of condoms with lubricants and STI screening can increase the benefits of testing and counselling ("HIV testing and counselling," 2009).

Adolescents from Key Populations

In all epidemic settings accessible and acceptable HTC services must be available to adolescents and provided in ways that do not put them at risk ("HIV and adolescents," 2013). Countries are encouraged to examine their current consent policies and consider revising them to reduce age-related barriers to access and uptake of HTC and to linkages to prevention, treatment and care following testing ("HIV and adolescents," 2013). Young people should be able to obtain HTC without required parental or guardian consent or presence.

  • HIV testing and counselling, with linkages to prevention, treatment and care, is recommended for adolescents from key populations in all settings (generalized, low and concentrated epidemics) (Strong recommendation, Very low quality of evidence) ("Consolidated guidelines," 2013; "HIV and adolescents," 2013).
  • Adolescents should be counselled about the potential benefits and risks of disclosure of their HIV status and empowered and supported to determine when, how and to whom to disclose (Conditional recommendation, Very low quality of evidence) ("HIV and adolescents," 2013).
  • Children of school age should be told their HIV-positive status (Strong recommendation, Low quality of evidence) ("HIV and adolescents," 2013).

HIV Treatment and Care

Antiretroviral Therapy

Recommendations and Guidance

All Key Population Groups

ART Initiation

  • As a priority ART should be initiated in all individuals with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and individuals with CD4 counts of ≤350 cells/mm3 (Strong recommendation, Moderate quality of evidence) ("Consolidated guidelines," 2013).
  • ART should be initiated in all individuals with HIV with CD4 counts between 350 and 500 cells/mm3 regardless of WHO clinical stage (Strong recommendation, Moderate quality of evidence) ("Consolidated guidelines," 2013).
  • ART should be initiated in all individuals with HIV, regardless of WHO clinical stage or CD4 count, in the following situations ("Consolidated guidelines," 2013):
    • Individuals with HIV and active TB disease (Strong recommendation, Low quality of evidence)
    • Individuals co-infected with HIV and HBV with evidence of severe chronic liver disease (Strong recommendation, Low quality of evidence)
    • Partners with HIV in serodiscordant couples, to reduce HIV transmission to uninfected partners (Strong recommendation, High quality of evidence)
    • Pregnant and breastfeeding women (Strong recommendation, Moderate quality of evidence)
  • Additional remark
    • There are no special clinical ART recommendations specific to any key population. However, because of stigma, discrimination and marginalization, they frequently present late for treatment.

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

  • HIV treatment adherence can be increased by addressing HIV stigma and discrimination, ensuring the confidentiality of a prisoner's HIV status, and allowing people in prisons and other closed settings access to care and treatment without discrimination by prison officials.
  • If they are being transferred, people in prisons and other closed settings should be given a supply of ART to last until health care can be established at the new prison location or, if they are being released, until linkage can be made to community-based HIV care ("Rolling out," 2013; Roberson, White & Fogel, 2009; Small et al., 2009; Shalihu et al., 2014; Catz et al., 2011; Fontana & Beckerman, 2007; Wohl et al., 2011; Nunn et al., 2010; Zaller, 2008).

People Who Inject Drugs

  • Current WHO guidance on the use of ART for treatment of HIV infection in adults and adolescents applies to people living with HIV who inject drugs ("Consolidated guidelines," 2013).
  • When ART is provided in a supportive environment, people who inject drugs have treatment outcomes similar to others' outcomes (Wolfe, Carrieri, & Shepard, 2010).

Adolescents from Key Populations

  • Community-based approaches can improve treatment adherence and retention in care of adolescents living with HIV ("HIV and adolescents," 2013).
  • Training of health-care workers can contribute to treatment adherence and retention in care of adolescents living with HIV ("HIV and adolescents," 2013).
  • Health-care providers can support adherence among adolescents by:
    • Assisting them in exploring factors influencing their adherence
    • Improving their understanding of HIV, ART and adherence
    • Recognizing developmental needs while supporting their emerging independence
    • Assisting them in integrating ART into daily life
    • Offering simplified ART regimes
    • Encouraging participation in peer support groups and community-based interventions ("IMAI," 2010; "Adolescent HIV care," 2012; "Toolkit," 2013)

Prevention of Mother-to-Child Transmission

Recommendations and Guidance

All Pregnant Women* in Key Population Groups

  • All pregnant and breastfeeding women living with HIV should initiate triple ARVs, which should be maintained at least for the duration of risk of mother-to-child transmission. Women meeting treatment eligibility criteria should continue ART for life (CD4 <500 cells/mm3) (Strong recommendation, Moderate quality of evidence) ("Consolidated guidelines," 2013).
  • For programmatic and operational reasons, particularly in generalized epidemics, all pregnant and breastfeeding women living with HIV should initiate ART and maintain it as lifelong treatment (option B+) (Conditional recommendation, Low quality of evidence) ("Consolidated guidelines" 2013).

*This includes pregnant transgender men.

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

Special consideration should be given to ensuring that pregnant female prisoners have ready access to prevention of mother-to-child transmission of HIV (PMTCT) services, as women often face greater barriers to HIV testing, counselling, care, and treatment in prison than outside prison.

People Who Inject Drugs

All pregnant women and their families affected by substance use disorders should have access to affordable prevention and treatment services and interventions delivered with a special attention to confidentiality, national legislation and international human rights standards; women should not be excluded from health care because of their substance use ("Guidelines for the identification and management" 2014).

Prevention and Management of Co-infections and Co-morbidities

Tuberculosis

Recommendations and Guidance

All Key Population Groups

  • Routine HIV testing should be offered to all people with presumptive and diagnosed TB (Strong recommendation, Low quality of evidence) ("WHO policy," 2012).
  • ART should be initiated in all individuals with HIV and active TB disease regardless of WHO clinical stage or CD4 cell count (Strong recommendation, Low quality of evidence) ("Consolidated guidelines," 2013).
  • Additional remarks
    • ART should be initiated as soon as possible, no later than eight weeks after initiation of TB treatment ("Consolidated guidelines," 2013).
    • Alcohol dependence, active drug use and mental health disorders should not be used as reasons to withhold TB treatment ("Policy guidelines for collaborative TB," 2008).

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

  • Systematic screening for active TB should be considered in prisons and other closed settings ("Global tuberculosis report," 2013). It should be a priority where the prevalence of TB is high in the general population or in the prison population; where the incarceration rate is high; where the prevalence of HIV or multidrug-resistant (MDR)-TB is high; or where living conditions are poor.
  • Medical examination, including TB screening, upon entry and any time thereafter, conforming to internationally accepted standards of medical confidentiality and care, should be conducted for all prisoners ("Policy guidelines," 2008).
  • Prisoners should obtain care equivalent to that provided for the general population ("Policy guidelines," 2008).
  • Given the high risk for transmission of TB and high rates of HIV-TB co-morbidity in closed settings, all prisons should engage in intensified case-finding, provide isoniazid preventive therapy for people living with HIV, and introduce effective tuberculosis control measures ("Policy guidelines," 2008).
  • Essential for TB prevention in prisons is the improvement of living conditions by limiting the number of prisoners per cell and providing adequate ventilation and nutrition ("Policy guidelines," 2008).
  • People in prisons or other closed settings known or suspected to have infectious TB should be separated (in a clinical setting) from other people until adequately treated and shown to be non-infectious ("Policy guidelines," 2008).
  • Education activities for all prisoners should cover coughing etiquette and respiratory hygiene ("HIV prevention," 2013).
  • Continuity of TB treatment in prisons and other closed settings is essential to prevent the development of resistance and must be ensured at all stages of detention, including during prison transfer, and following release. This requires close collaboration between health services providing care for the general population and those caring for detainees, prisoners and the like ("HIV prevention," 2013).

People Who Inject Drugs

  • People with TB who inject drugs should have equitable access to TB treatment ("Guidelines for the psychosocially," 2009).
  • Co-morbidity, including viral hepatitis infection, should not contraindicate TB treatment for people who inject drugs and should be properly managed ("Policy guidelines," 2008).
  • For patients with TB, OST should be administered in conjunction with medical treatment; there is no need to wait for abstinence from opioids to commence either anti-TB medication or ARV medication ("Guidelines for the psychosocially," 2009).
  • Rifampicin, one of the first-line drugs used to treat TB, can significantly reduce the concentration and effect of both methadone and buprenorphine, resulting in opioid withdrawal (McCance-Katz et al., 2011; "Protocol 4," 2013; Friedland, 2010).

Sex Workers

Clinical programmes or community outreach services for sex workers can carry out TB screening and can support sex workers throughout the cycle of care, from TB prevention through diagnosis and treatment. They can teach sex workers to recognize TB symptoms and understand TB transmission, as well as to appreciate the importance of infection control and cough etiquette. They also can inform their clients of nearby health facilities for TB diagnosis and treatment ("Implementing comprehensive," 2013).

Viral Hepatitis

Recommendations and Guidance

All Key Population Groups

Hepatitis B

  • Catch-up hepatitis B immunization strategies should be instituted in settings where infant immunization has not reached full coverage ("Guidelines: prevention and treatment," 2011; "Prevention and treatment," 2012; "Tool," Forthcoming).
  • People from key populations with HIV and HBV co-infection who have severe chronic liver disease should be offered ART with a tenofovir (TDF) and lamivudine (3TC) (or emtricitabine [FTC])-based regimen irrespective of CD4 count or WHO clinical stage (Strong recommendation, Low quality of evidence) ("Consolidated guidelines," 2013).*

Hepatitis C

  • Hepatitis C virus (HCV) serology testing should be offered to individuals from populations with high HCV prevalence or who have a personal history of HCV risk exposure/behaviour (Strong recommendation, Moderate quality of evidence) ("Guidelines for the screening," 2014).
  • An alcohol intake assessment is recommended for all persons with HCV infection, followed by the offer of a behavioural alcohol reduction intervention for persons with moderate-to-high alcohol intake (Strong recommendation, Moderate quality of evidence) ("Guidelines for the screening," 2014).
  • Assessment for antiviral treatment of all adults and children with chronic HCV infection is recommended, including for people who inject drugs (strong recommendation, moderate quality of evidence) ("Guidelines for the screening," 2014).
  • In addition, a number of recommendations on diagnosis and antiviral treatment regimens for HCV are available ("Guidelines for the screening," 2014).
  • Additional remarks
    • WHO is developing clinical guidance on hepatitis B treatment and screening strategies for hepatitis B and C. This guidance should be available in early 2015.
    • WHO HCV guidelines provide detailed guidance on treatment and care ("Guidelines for the screening," 2014).
    • There are challenges in diagnosing and treating active HCV infection in certain populations such as people who inject drugs, particularly in settings with limited access to HCV antibody and ribonucleic acid (RNA) assays, diagnostic tools for staging of liver disease and HCV therapy. People receiving ART and HCV drugs require close monitoring for possible drug interactions ("Guidelines for the screening," 2014; Walsh et al., 2011).

*There is insufficient evidence or favourable risk-benefit profile to support initiating ART in everyone co-infected with HIV and HBV with a CD4 count >500 cells/mm3 or regardless of CD4 cell count or WHO clinical stage. Initiating ART regardless of CD4 count is, therefore, recommended only for people with evidence of severe chronic liver disease, who are those at greatest risk of progression and mortality from liver disease. For people without evidence of severe chronic liver disease, ART initiation should follow the same principles and recommendations as for other adults.

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

  • It is important that prisons offer hepatitis B vaccination ("Guidelines for the psychosocially," 2009; "Rolling out," 2013).
  • It is important to offer voluntary HCV/HBV testing, treatment and care for people living with HIV soon after entry to prison, with assessment for and provision of treatment in accord with current WHO recommendations. Harm reduction measures should also be offered to prisoners.

People Who Inject Drugs

  • In addition to the comprehensive harm reduction package of nine interventions for people who inject drugs ("WHO, UNODC, UNAIDS technical guide," 2012), which include most importantly NSP and OST, specific recommendations include:
    • Offering the rapid hepatitis B vaccination regimen to people who inject drugs ("Guidance on prevention," 2012).
    • Needle and syringe programmes should also offer low dead-space syringes ("Guidance on prevention," 2012).
    • Offering peer interventions to reduce transmission of viral hepatitis among people who inject drugs ("Guidance on prevention," 2012).
  • It is important also to consider the following:
    • A higher-dose HBV vaccine should be used with the rapid regimen.*
    • When the rapid vaccine regimen is not available, the standard regimen should be offered.
    • For both the standard and rapid regimens, delivery of the first dose is the priority.
    • To reduce transmission of viral hepatitis, needle and syringe programmes should offer all types of syringes and other equipment used for the preparation of injecting drugs, including cookers, sterile water, alcohol swabs, filters and tourniquets, as appropriate to local needs.

*The standard vaccination schedule for infants and unvaccinated adults is 0, 1, and 6 months, while the rapid schedule is 1, 7 and 21 days ("Guidance on prevention," 2012).

Mental Health

Recommendations and Guidance

All Key Population Groups

Routine screening and management for mental health disorders (particularly depression and psychosocial stress) should be provided for people from key populations living with HIV in order to optimize health outcomes and improve adherence to ART. Management can range from co-counselling for HIV and depression to appropriate medical therapies ("Consolidated guidelines," 2013).

Related Recommendations and Contextual Issues for Specific Key Population Groups

Adolescents from Key Populations

Peer support groups and safe spaces can help improve self-esteem and address self-stigma. Additionally, individual and family counselling can address adolescents' mental health co-morbidities. The involvement of supportive parents or guardians can be beneficial, especially for those requiring ongoing treatment and care. It is important, however, to have the adolescent's express permission before contacting parents or care-givers ("HIV and adolescents," 2013).

General Care

Nutrition

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

Inadequate nutrition is a major problem for many people in prisons and can have a significant impact on people with HIV or TB, jeopardizing treatment outcomes and adherence. Protecting and promoting the health of people in prisons and other closed settings should include provision of adequate nutrition, including access to safe drinking water and nutritional supplements ("HIV prevention," 2013).

Sexual and Reproductive Health Interventions

Sexually Transmitted Infection Prevention, Screening and Treatment

Recommendations and Guidance

All Key Population Groups

  • Screening, diagnosis and treatment of STIs are crucial parts of a comprehensive response to HIV; this includes services for key populations ("Consolidated guidelines," 2013). STI management should accord with existing WHO guidance and be adapted to the national context ("Sexually transmitted," 2005). Also, it should be confidential and free from coercion, and patients must give informed consent for treatment ("Tool," Forthcoming; "Sexually transmitted," 2005).
  • Periodic screening of people from key populations for asymptomatic STIs is recommended (Conditional recommendation, Low quality of evidence) ("Consolidated guidelines," 2013; "Prevention and treatment," 2012).
  • In the absence of laboratory tests, symptomatic people from key populations should be managed syndromically in line with national STI management guidelines ("Sexually transmitted," 2005).

Related Recommendations and Contextual Issues for Specific Key Population Groups

People Who Inject Drugs

Health-care providers need to be alert to provide STI control and management for people who inject drugs. People who inject drugs may also engage in sex work, and men who inject drugs may have sex with other men, and thus they face higher STI risks (Des Jarlais & Semaan, 2005; Donoghoe, 1992).

Sex Workers

  • The authors suggest offering periodic presumptive treatment (PPT) for asymptomatic STIs to female sex workers in settings with high prevalence and limited clinical services (Conditional recommendation, Moderate to high quality of evidence).
  • PPT should be implemented only as a free, voluntary, confidential, short-term measure as part of comprehensive sexual health services and while HIV/STI services are being further developed in settings where STI prevalence is high, e.g., >15% prevalence of Neisseria gonorrhoea and/or Chlamydia trachomatis infection ("Prevention and treatment," 2012).

Transgender People

Health-care providers should be sensitive to and knowledgeable about the specific health needs of transgender people. In particular, genital examination and specimen collection can be uncomfortable or upsetting whether or not the person has undergone genital reconstructive surgery ("Tool," Forthcoming).

Contraceptive Services

Recommendations and Guidance

All Key Population Groups

  • It is important that contraceptive services are free, voluntary and non-coercive for all people from key populations.

Related Recommendations and Contextual Issues for Specific Key Population Groups

People in Prisons and Other Closed Settings

It is important that prison health services offer contraception to women in closed settings ("Interventions to address HIV," 2007; La Vigne et al., 2011; Yap et al., 2011; Ravi, Blankenship, & Altice, 2007; Kerbs & Jolley, 2007).

People Who Inject Drugs

It is important that health-care providers in contact with women who use drugs offer contraception, including hormonal contraceptives, as part of a standard package of care.

Sex Workers

  • Women at higher risk of HIV, including sex workers, initiating or using hormonal contraceptives should be strongly advised always to use condoms, male or female, and other HIV prevention measures because of evidence, albeit inconclusive, of possibly increased risk of HIV acquisition among women using progestogen-only injectable contraception ("Consolidated guidelines," 2013; Polis & Curtis, 2013).
  • Additional remark
    • Female sex workers should be offered contraceptive counselling to explore pregnancy intention and offered a range of contraceptive options including dual protection.

Transgender People

  • It is important to counsel transgender women who use oral contraceptive pills for feminization about the higher risk of thrombotic events with ethinyl estradiol than with 17-beta estradiol.
  • Consideration should be given to offering transgender men who have sex with men appropriate contraceptive options that do not lead to unwanted systemic feminization.

Adolescents from Key Populations

  • In order to meet the educational and service needs of adolescents, it is recommended that sexual and reproductive health services, including contraceptive information and services, be provided for adolescents without mandatory parental and guardian authorization/notification ("Ensuring human rights," 2014).
  • To act in the best interest of adolescents, health services may need to prioritize their immediate health needs, while being attentive to signs of vulnerability, abuse and exploitation. Appropriate and confidential referral, if and when requested by the adolescent, can provide linkage to other services and sectors for support (Interagency Youth Working Group, 2010).

Safe Abortion and Post-abortion Care

Related Recommendations and Contextual Issues for Specific Key Population Groups

All Women from Key Populations

  • Where abortion is legal, it is important to establish linkages to safe abortion services.
  • Where abortion is illegal, unsafe abortion may be common and present serious health risks. Women from key populations should be informed about these risks ("Safe abortion," 2013).
  • Access to appropriate post-abortion care is essential to reduce morbidity and mortality.

Adolescents from Key Populations

Adolescents may be deterred from accessing health services if they think they will be required to obtain permission from their parents or guardians; this can increase the likelihood that they will go to providers of unsafe abortion ("Safe abortion," 2013).

Cervical Cancer Screening and Treatment

Related Recommendations and Contextual Issues for Specific Key Population Groups

All Women from Key Populations

It is important in areas with high rates of endemic HIV infection to offer cervical cancer screening to sexually active girls and women as soon as they have tested positive for HIV ("WHO guidelines for screening," 2013).

Transgender People

Specific considerations are needed for transgender men ("WHO guidelines for screening," 2013):

  • Transgender men who retain their female genitalia often miss out on cervical screening and other sexual health services, as they may not seek out or may be excluded from those services. As a result, they face increased risk of ovarian, uterine and cervical disease.
  • Following total hysterectomy, if there is a history of high-grade cervical dysplasia and/or cervical cancer, a Papanicolaou test of the vaginal cuff can be performed annually until three normal tests are documented, and then every two to three years.
  • Following removal of ovaries, but where the uterus and cervix remain intact, WHO cervical screening guidelines for natal females can be followed. This may be deferred if there is no history of genital sexual activity. It is important to inform the pathologist of current or prior testosterone use, as cervical atrophy can mimic dysplasia.

Adolescents from Key Populations

  • Human papillomavirus (HPV) vaccination does not replace cervical cancer screening. In countries where the HPV vaccine is introduced, screening programmes may need to be developed or strengthened ("Comprehensive cervical cancer," 2013).
  • The WHO recommended target group for HPV vaccination is girls ages 9–13 years who have not yet become sexually active, including those living with HIV ("Comprehensive cervical cancer," 2013).

Conception and Pregnancy

Related Recommendations and Contextual Issues for Specific Key Population Groups

All Women from Key Populations

  • All adult and adolescent women from key populations who are living with HIV and are pregnant should receive appropriate HIV treatment and care, in line with WHO guidance, to prevent HIV transmission from mother to child ("Consolidated guidelines," 2013).
  • Women living with HIV and those in serodiscordant couples who wish to have children should be provided information and support to help them to conceive as safely as possible.
  • Many women from key populations, in particular adolescents, have inadequate access to antenatal care, attend late in pregnancy and have less access to PMTCT services (see "Prevention of Mother-to-Child Transmission" above).

Recommendations regarding critical enablers of HIV interventions and service delivery can be found in Sections 5 and 6 in the original guideline document.

Definitions:

Significance of the Four Grading of Recommendations Assessment, Development and Evaluation (GRADE) Levels of Evidence

Quality of Evidence Rationale
High Further research is very unlikely to change confidence in the estimate of effect.
Moderate Further research is likely to have an important impact on confidence in the effect.
Low Further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate.
Very Low Any estimate of effect is very uncertain.

Strength of Recommendations

A strong recommendation (for or against) is one for which there is confidence that the desirable effects of adherence to the recommendation clearly outweigh the undesirable effects.

A conditional recommendation (for or against) is one for which the quality of evidence may be low or may apply only to specific groups or settings; or the panel concludes that the desirable effects of adherence to the recommendation probably outweigh the undesirable effects or are closely balanced, but the panel is not confident about these trade-offs in all situations.

If implemented, a conditional recommendation should be monitored closely and evaluated rigorously. Further research will be required to address the uncertainties and is likely to provide new evidence that may change the calculation of the balance of trade-offs.

The values and preferences of the end users (key populations), feasibility and cost as well as consideration of potential benefits and harms contribute to determining the strength of a recommendation.

Clinical Algorithm(s)

None provided

Disease/Condition(s)

Human immunodeficiency virus (HIV) infection

Guideline Category

Counseling

Diagnosis

Management

Prevention

Screening

Treatment

Clinical Specialty

Family Practice

Infectious Diseases

Internal Medicine

Obstetrics and Gynecology

Pediatrics

Preventive Medicine

Intended Users

Advanced Practice Nurses

Allied Health Personnel

Health Care Providers

Nurses

Other

Pharmacists

Physician Assistants

Physicians

Psychologists/Non-physician Behavioral Health Clinicians

Public Health Departments

Social Workers

Substance Use Disorders Treatment Providers

Guideline Objective(s)

  • To provide a comprehensive package of evidence-based human immunodeficiency virus (HIV)-related recommendations for all key populations; increase awareness of the needs of and issues important to key populations; improve access, coverage and uptake of effective and acceptable services; and catalyze greater national and global commitment to adequate funding and services
  • To provide consolidated guidance to inform the development and implementation of HIV policies, programmes and services for key populations
  • To consolidate guidance for health sector interventions for HIV for each key population
  • To outline common HIV and related health service packages that are beneficial and acceptable for all key populations and additional services needed for specific key population groups
  • To update guidance for planning, delivering, monitoring and evaluating HIV prevention, diagnosis, care and treatment interventions for each key population
  • To provide gender- and age-specific guidance for HIV interventions for members of key populations, including adolescents

Target Population

Five key population groups, including adolescents and young people from each key population, which in almost all settings are disproportionately affected by human immunodeficiency virus (HIV):

  • Men who have sex with men
  • People in prisons and other closed settings
  • People who inject drugs
  • Sex workers
  • Transgender people

Interventions and Practices Considered

Prevention

  1. Comprehensive condom and lubricant programming
  2. Harm reduction for people who inject drugs (e.g., needle and syringe program [NSP], opioid substitution therapy [OST])
  3. Behavioural interventions
  4. Antiretroviral (ARV)-related prevention (pre-exposure and post-exposure prophylaxis, early initiation of antiretroviral therapy [ART])
  5. Voluntary medical male circumcision (VMMC) for human immunodeficiency virus (HIV) prevention

Management/Treatment

  1. HIV testing and counselling (HTC)
  2. Linkage and enrolment in care
  3. HIV treatment and care
    • ART
    • Prevention of mother-to-child transmission
    • Recognizing ART drug interactions
  4. Prevention and management of co-infections and co-morbidities (tuberculosis [TB], viral hepatitis, mental health disorders)
  5. General care
    • Nutrition
    • Sexual and reproductive health interventions (sexually transmitted infection [STI] prevention, screening, and treatment; contraception services; safe abortion and post-abortion care; cervical cancer screening and treatment; screening for anal cancer)

Major Outcomes Considered

  • Human immunodeficiency virus (HIV) infection
  • Any adverse event
  • Any stage 3 or 4 adverse event
  • Condom use
  • Number of sexual partners
  • Injection frequency
  • Needle/syringe sharing

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Primary Sources)

Hand-searches of Published Literature (Secondary Sources)

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

Information on Prisons and Other Closed Settings

In 2007 an extensive literature review was conducted to inform the development of the World Health Organization (WHO) publication Effectiveness of interventions to address HIV in prisons. In 2014 this work was updated for these guidelines, using an abbreviated literature review focusing on materials developed between 2007 and 2014. Results supported the 2007 review; no new evidence was found that would change the recommendations made in the 2007 guidelines. The Guideline Development Group and United Nations Office on Drugs and Crime (UNODC) reviewed, confirmed and accepted this conclusion. See the "Health Information for Prisoners" review (see the "Availability of Companion Documents" field) for additional information.

Pre-exposure Prophylaxis (PrEP) Recommendations

To inform recommendations on PrEP, evidence questions were framed in the PICO format: Population, Intervention, Comparator, Outcome. External researchers used the PICO questions to develop search protocols and perform systematic reviews of the scientific evidence (see the "Availability of Companion Documents" field).

Pre-exposure Prophylaxis for Men Who Have Sex with Men (MSM)

Background

In 2012, WHO developed guidelines for PrEP for serodiscordant couples, MSM, and transgender people at high risk of human immunodeficiency virus (HIV). This systematic review updates the review of PrEP for MSM that was completed for those guidelines. A few minor changes were made to the PICO question from the earlier guidelines. First, the new PICO question includes only MSM, not transgender people. Second, the new PICO question covers all oral PrEP containing tenofovir, as opposed to the previous PICO question which focused specifically on the combination of emtricitabine (FTC 200mg) and tenofovir (TDF 300 mg) used in the iPrEx study.

In addition, in 2011, a review of values and preferences of MSM about PrEP was conducted through a review of published literature. However, most of the studies available at that time were based on data collected before the iPrEx trial results were available. Values and preferences may have changed now that MSM are aware of the partial effectiveness of PrEP. This values and preferences literature review was also updated to capture literature through the end of 2013, with a focus on studies that collected data after iPrEx study results were released.

Methods

PICO Question

PICO 1: Should oral PrEP (containing tenofovir [TDF]) be used for HIV prevention among men who have sex with men?

P: Men who have sex with men

I: Oral PrEP (containing TDF)

C: Placebo

O: (1) HIV infection, (2) any adverse event, (3) any stage 3 or 4 adverse event, (4) condom use, and (5) number of sexual partners

Inclusion Criteria

To be included in the review, an article had to meet the following criteria:

  1. Randomized controlled trial evaluating the use of oral PrEP (containing TDF) to prevent HIV infection among MSM participants.
  2. Measured one or more of the following key outcomes: (1) HIV infection, (2) any adverse event, (3) any stage 3 or 4 adverse event, (4) condom use, and (5) number of sexual partners.
  3. Published in a peer-reviewed journal, or presented as an abstract at a scientific conference, between January 1, 1990 and January 1, 2014.

No restrictions were placed based on location of the intervention. No language restrictions were used on the search. Articles in languages other than English were translated where necessary.

Following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, if direct evidence from MSM populations was limited for one or more of the key outcomes, indirect evidence from other populations (e.g., heterosexual men) would have been instead, but downgraded for indirectness. If evidence from other populations was limited, evidence from non-randomized but controlled studies would have been used instead, but also downgraded for directness.

Search Strategy

The following electronic databases were searched using the date ranges January 1, 1990 to January 1, 2014: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and EMBASE. Secondary reference searching was conducted on all studies included in the review. Further, selected experts in the field were contacted to identify additional articles not identified through other search methods.

Abstracts from the following conferences were searched from January 1, 1990 to January 1, 2014: International AIDS Conference (IAC) and IAS Conference on HIV Pathogenesis, Treatment, and Prevention (IAS). Reviewers had planned to search the Conference on Retroviruses and Opportunistic Infections (CROI) as well, but abstracts from this conference were no longer available online to the public at the time the search was conducted.

Search Terms

The following terms were entered into all computer databases:

("men who have sex with men" or MSM or transgender or TG or "gay men") AND ("pre-exposure prophylaxis" or PrEP or emtricitabine or tenofovir or Truvada or FTC or TDF) AND (HIV OR AIDS)

The search for abstracts was more difficult given the search engines available on conference websites. For each conference, a search was first conducted for all abstracts including the word "PrEP". These search results were then further searched for keywords regarding MSM.

Screening Abstracts

Titles, abstracts, citation information, and descriptor terms of citations identified through the search strategy were screened by two reviewers. Full text articles were obtained for all selected abstracts and both reviewers independently assessed all full-text articles for eligibility to determine final study selection. Differences were resolved through consensus.

Articles not meeting the inclusion criteria for the review, but presenting potentially interesting background information relevant to PrEP among MSM, including review articles, qualitative studies, cost or cost-effectiveness analyses, or descriptions of interventions without an evaluation component, were included in an annotated bibliography of additional articles.

Pre-exposure Prophylaxis for People Who Inject Drugs

Methods

PICO Question

PICO 1: Should oral PrEP (containing TDF) be used for HIV prevention among people who inject drugs (PWID)?

P: People who inject drugs

I: Oral PrEP (containing tenofovir (TDF))

C: Placebo

O: (1) HIV infection, (2) any adverse event, (3) any stage 3 or 4 adverse event, (4) condom use, (5) number of sexual partners, (6) injection frequency, (7) needle/syringe sharing

Inclusion Criteria

To be included in the review, an article had to meet the following criteria:

  1. Randomized controlled trial evaluating the use of oral PrEP (containing TDF) to prevent HIV infection among PWID.
  2. Measured one or more of the following key outcomes: (1) HIV infection, (2) any adverse event, (3) any stage 3 or 4 adverse event, (4) condom use, (5) number of sexual partners, (6) injection frequency, (7) needle/syringe sharing.
  3. Published in a peer-reviewed journal, or presented as an abstract at a scientific conference, between January 1, 1990 and January 1, 2014.

Only studies among people who inject drugs were included; studies among people who use, but do not inject, drugs were excluded, as HIV risk and transmission modalities differ between these groups. However, both terms were used in the search.

No restrictions were placed based on location of the intervention. No language restrictions were used on the search. Articles in languages other than English were translated where necessary.

Following the GRADE approach, if direct evidence from PWID populations was limited for one or more of the key outcomes, indirect evidence from other populations (men who have sex with men, or heterosexual men or women) would be used instead, but downgraded for indirectness. If evidence from other populations was limited, evidence from non-randomized but controlled studies would be used instead, but also downgraded for directness.

Search Strategy

The following electronic databases were searched using the date ranges January 1, 1990 to January 1, 2014: PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and EMBASE. Secondary reference searching was conducted on all studies included in the review. Further, selected experts in the field were contacted to identify additional articles not identified through other search methods.

Abstracts from the following conferences were searched from January 1, 1990 to January 1, 2014: International AIDS Conference (IAC) and IAS Conference on HIV Pathogenesis, Treatment, and Prevention (IAS). Reviewers had planned to search the Conference on Retroviruses and Opportunistic Infections (CROI) as well, but abstracts from this conference were no longer available online to the public at the time the search was conducted.

Search Terms

The following terms were entered into all computer databases:

("people who use drugs" or PWUD or "people who inject drugs" or PWID or "drug users" or IDU or IDUs) AND ("pre-exposure prophylaxis" or PrEP or tenofovir or TDF) AND (HIV OR AIDS)

These search terms were used both for the main systematic review (PICO question) and for the values and preferences review.

The search for abstracts was more difficult given the search engines available on conference websites. For each conference, a search was first conducted for all abstracts including the word "PrEP". These search results were then further searched for keywords regarding PWID.

Screening Abstracts

Titles, abstracts, citation information, and descriptor terms of citations identified through the search strategy were screened by two reviewers. Full text articles were obtained for all selected abstracts and both reviewers independently assessed all full-text articles for eligibility to determine final study selection. Differences were resolved through consensus.

Articles not meeting the inclusion criteria for the review, but presenting potentially interesting background information relevant to PrEP among PWID, including review articles, qualitative studies, cost or cost-effectiveness analyses, or descriptions of interventions without an evaluation component, were included in an annotated bibliography of additional articles.

Number of Source Documents

Pre-exposure Prophylaxis for Men Who Have Sex with Men

Combining search results from both the 2011 and 2014 searches, initial database searching yielded 764 citations and 139 conference abstracts; one additional study was identified through other means, such as searching through the reference lists of relevant articles (see Figure 1 in the systematic review [see the "Availability of Companion Documents" field]). Once all duplicates were removed, 609 records were reviewed and 348 article citations and 119 abstracts were excluded for being unrelated to the study topic. After thoroughly reviewing the remaining 142 articles and abstracts, 3 were excluded for being unrelated to the study topic, 4 did not meet the study design criteria, and 128 were coded as background or values and preferences; an additional 3 conference abstracts presented preliminary data and were used in the 2011 review, although all 3 were later published as peer-reviewed articles and thus were duplicative of other included articles. Ultimately, 4 studies reported in 5 articles were deemed eligible for inclusion in the review.

Pre-exposure Prophylaxis for People Who Inject Drugs

The initial database search yielded 183 citations and 243 conference abstracts; no additional studies were identified through other means (see Figure 1 in the systematic review [see the "Availability of Companion Documents" field]). Once duplicates were removed, 392 records were reviewed and 131 article citations and 236 abstracts were excluded for being unrelated to the study topic. After review of the remaining 17 articles and 7 abstracts by two independent screeners, 16 articles were excluded for not meeting the study design criteria and were coded as background or values and preferences, while 6 abstracts were excluded for providing additional information on the included trial, but without reporting key outcomes. The remaining study (with data for outcomes reported in one article and one conference abstract) was deemed eligible for inclusion in the review. The one study that met all inclusion criteria was the Bangkok Tenofovir Study.

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Significance of the Four Grading of Recommendations Assessment, Development and Evaluation (GRADE) Levels of Evidence

Quality of Evidence Rationale
High Further research is very unlikely to change confidence in the estimate of effect.
Moderate Further research is likely to have an important impact on confidence in the effect.
Low Further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate.
Very Low Any estimate of effect is very uncertain.

Methods Used to Analyze the Evidence

Review of Published Meta-Analyses

Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

To inform recommendations on PrEP, evidence questions were framed in the PICO format: Population, Intervention, Comparator, Outcome. External researchers used the PICO questions to develop search protocols and perform two systematic reviews of the scientific evidence (see the "Availability of Companion Documents" field).

Data Extraction and Management

Data were extracted independently by two reviewers using standardized data extraction forms. Differences in data extraction were resolved through consensus and referral to a senior team member from WHO when necessary. Study authors were contacted when additional information or data were needed.

The following information was gathered from each included study:

  • Study identification: Author(s); type of citation; year of publication
  • Study description: Study objectives; location; population characteristics; description of the intervention; study design; sample size; follow-up periods and loss to follow-up
  • Outcomes: Analytic approach; outcome measures; comparison groups; effect sizes; confidence intervals; significance levels; conclusions; limitations

Risk of bias was assessed using the Cochrane Collaboration's tool for assessing risk of bias (Cochrane Handbook, chapter 8.5 – Higgins & Green, 2011). This tool assesses random sequence generation (selection bias), allocation concealment (selection bias), blinding of participants and personnel (performance bias), blinding of outcome assessment (detection bias) incomplete outcome data (attrition bias), and selective reporting (reporting bias). Methodological components of the studies were assessed and classified as high, low, or uncertain risk of bias.

Data Analysis

Data were analyzed according to coding categories and outcomes. If multiple studies reported the same outcome, meta-analysis would have been conducted using random-effects models to combine effect sizes with the program Comprehensive Meta-Analysis (CMA). Data were summarized in Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tables, summary of finding tables, and risk/benefit tables.

Evidence Assessment

How to Interpret the Quality of Evidence

The higher the quality of scientific evidence, the more likely that a strong recommendation can be made. The GRADE approach to recommendation development, which WHO has adopted, defines the quality of evidence as the extent to which one can be confident that the reported estimates of effect (desirable or undesirable) available from the evidence are close to the actual effects of interest. The GRADE approach specifies four levels of quality of evidence (see the "Rating Scheme for the Strength of the Evidence" field).

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Overview

The World Health Organization (WHO) Department of HIV led development of these WHO consolidated key populations guidelines, following the WHO procedures and reporting standards laid out in the WHO handbook for guideline development, 2012 (see the "Availability of Companion Documents" field).

These guidelines combine existing WHO recommendations, new recommendations and guidance published by WHO together with United Nations (UN) partners. Key recommendations from the WHO 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection are included, with specific considerations for each of the key population groups highlighted.

Establishing Guideline Groups

The WHO HIV Department set up four groups to perform specific guideline development functions. Members of the groups were selected so as to ensure a range of expertise and experience, including appropriate geographical, gender and key population representation and expertise. The four groups and their functions were:

  • The WHO Guideline Steering Group on HIV and Key Populations, chaired by the WHO Department of HIV, led the guideline development process. It included participants from the WHO Department of Maternal, Newborn, Child and Adolescent Heath, the Department of Mental Health and Substance Abuse, the Department of Reproductive Health and Research, the Global Hepatitis Programme, and the Global TB Programme.
  • The External Steering Group, composed of a geographically and gender-balanced group of 25 academics, researchers, programme managers, implementers and people from key population networks and organizations, provided WHO with guidance on scope, content and new areas to be addressed.
  • The 26-member Guidelines Development Group consisted of the majority of the External Steering Group along with some additional expert members. This group was responsible for formulating new WHO recommendations, good practice guidance and consensus on the final content.
  • The External Peer Review Group was selected in consultation with the WHO regional offices to assure geographical and gender balance. In total over 70 peer reviewers from academia, policy and research, implementing programmes and key population networks and organizations reviewed the guidelines. In general, reviewers made suggestions to improve the clarity of the document and provided minor additions and corrections to the narrative.

Involvement of Key Population Groups and Networks

Crucial to development of these guidelines has been the partnership with, and the engagement of, key population groups and networks at all stages of the process, both as members of the guidelines and peer review groups and as partners in developing the values and preferences investigation methodology and assessment.

Defining the Scope of the Guidelines

To develop these guidelines, the WHO Guideline Steering Group mapped all existing WHO human immunodeficiency (HIV) guidance specifically concerned with the five key population groups; then it reviewed these and other materials to identify gaps, overlaps, inconsistencies and determine relevance. The outcome of the mapping exercise was presented to the External Steering Group at a scoping meeting in October 2013. The group reviewed the mapping and made recommendations on the scope of the guidelines (populations and range of interventions to be covered) and noted two areas needing new guidance: 1) pre-exposure prophylaxis (PrEP) and 2) opioid overdose prevention and management.

Review of the Evidence

These guidelines include both relevant existing recommendations and new recommendations. Development of the new recommendations began with systematic reviews of the evidence. The Guidelines Development Group recommended the commissioning of new literature reviews and appraisal of existing reviews and surveys investigating values and preferences, along with reviews of the costs and feasibility of implementation. Also, WHO commissioned new studies and reviewed existing studies of values and preferences related to existing recommendations to help ensure that the guidance appropriately reflects the concerns of key populations.

Development of the Pre-exposure Prophylaxis (PrEP) Recommendations

WHO convened the guideline development meeting in March 2014 to update recommendations regarding PrEP use among men who have sex with men and to look at the evidence for formulating a new recommendation on PrEP use among people who inject drugs, as well as to review all sections of the consolidated guidelines. Individuals representing a broad range of stakeholders participated in the guideline development meeting as either Guideline Development Group members or expert observers.

Participants at this meeting assessed the evidence for both PICO (population, intervention, comparator, outcome) questions concerning PrEP, along with the risks and benefits, values and preferences and cost-benefits/feasibility associated with each possible intervention and made recommendations (see Section 4.1.5.1 in the original guideline document).

Evidence Assessment

Under the WHO guideline development process, the guideline development group formulates the recommendations guided by the quality of available evidence. Other factors – values and preferences, costs and feasibility – are also taken into consideration when determining the strength of the recommendation.

Determining the Strength of a Recommendation

The strength of a recommendation reflects the degree of confidence of the guidelines group that the desirable effects of the recommendation outweigh the undesirable effects (see Table 2.2 in the original guideline document). Desirable effects (potential benefits) may include beneficial health outcomes (e.g., reduced incidence of HIV and reduced morbidity and mortality); reduction of burden on the individual and/or health services; and potential cost-savings for the individual, communities, programme and/or health system. Undesirable effects (potential harms) include those affecting individuals, families, communities or health services. Additional burdens considered include the resource use and cost implications of implementing the recommendations that programmes, care providers or patients would have to bear; adverse clinical outcomes (e.g., drug resistance, drug toxicities); and legal ramifications where certain practices are criminalized.

The strength of a recommendation can be either strong or conditional.

Surveys, qualitative studies and literature reviews were commissioned and other available material was appraised to investigate the values and preferences of key populations and service providers and benefits, harms, cost and feasibility concerning new areas of guidance, existing recommendations and service provision issues. Specific attention was paid to the values and preferences of adolescents in key populations. Evidence on values and preferences included findings developed at workshops with members of key populations in a range of countries; a multi-regional, anonymous e-survey of men who have sex with men; in-depth key informant interviews with selected service providers and people who inject drugs; in-depth interviews with men who have sex with men; and a literature review of values and preference of key populations concerning PrEP.

Review of Service Delivery, Implementation Approaches and Case Studies

A large-scale call for examples of good practices was undertaken to identify effective and acceptable delivery approaches for key populations. These case studies, presented in Chapters 5 and 6 in the original guideline document, offer insights into successful implementation of services for key population groups.

Rating Scheme for the Strength of the Recommendations

Strength of Recommendations

A strong recommendation (for or against) is one for which there is confidence that the desirable effects of adherence to the recommendation clearly outweigh the undesirable effects.

A conditional recommendation (for or against) is one for which the quality of evidence may be low or may apply only to specific groups or settings; or the panel concludes that the desirable effects of adherence to the recommendation probably outweigh the undesirable effects or are closely balanced, but the panel is not confident about these trade-offs in all situations.

If implemented, a conditional recommendation should be monitored closely and evaluated rigorously. Further research will be required to address the uncertainties and is likely to provide new evidence that may change the calculation of the balance of trade-offs.

The values and preferences of the end users (key populations), feasibility and cost as well as consideration of potential benefits and harms contribute to determining the strength of a recommendation.

Cost Analysis

Cost or cost-effectiveness analyses did not meet the inclusion criteria for the review.

Method of Guideline Validation

External Peer Review

Internal Peer Review

Description of Method of Guideline Validation

Following the Guideline Development Group consultation, the full draft guidelines were revised and circulated electronically to both the Guidelines Development Group and the External Peer Review Group for comments and feedback. All responses were considered and, as appropriate, addressed in the final draft.

References Supporting the Recommendations

Adolescent HIV care and treatment: a training curriculum for health workers. New York: International Center for AIDS Care and Treatment Programs; 2012.

Balthasar H, Jeannin A, Dubois-Arber F. First anal intercourse and condom use among men who have sex with men in Switzerland. Arch Sex Behav. 2009 Dec;38(6):1000-8. PubMed External Web Site Policy

Catz SL, et al. Prevention needs of HIV-positive men and women awaiting release from prison. AIDS Behav. 2011;16(1):108-20.

Comprehensive cervical cancer prevention and control - a healthier future for girls and women: WHO guidance note. [Internet]. Geneva: World Health Organization (WHO); 2013 [accessed 2014 Mar 07].

Condom programming for HIV prevention: an operations manual for programme managers. [internet]. New York: United Nations Population Fund; 2005 [accessed 2014 Feb 25].

Consolidated guidelines on general HIV care and the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. [internet]. Geneva: World Health Organization (WHO); 2013 [accessed 2014 Feb 25].

Degenhardt L, Mathers BM, Wirtz AL, Wolfe D, Kamarulzaman A, Carrieri MP, Strathdee SA, Malinowska-Sempruch K, Kazatchkine M, Beyrer C. What has been achieved in HIV prevention, treatment and care for people who inject drugs, 2010-2012? A review of the six highest burden countries. Int J Drug Policy. 2014 Jan;25(1):53-60. PubMed External Web Site Policy

Des Jarlais DC, Semaan S. Interventions to reduce the sexual risk behavior of injecting drug users. Int J Drug Policy. 2005;16(1):S58-S66.

Donoghoe MC. Sex, HIV and the injecting drug user. Br J Addict. 1992 Mar;87(3):405-16. PubMed External Web Site Policy

Effectiveness of sterile needle and syringe programming in reducing HIV/AIDS among injecting drug users. (Evidence for Action Technical Papers). [internet]. Geneva: World Health Organization (WHO); 2004 [accessed 2014 Feb 28].

Ensuring human rights in the provision of contraceptive information and services Guidance and recommendations. [internet]. Geneva: World Health Organization (WHO); 2014 [accessed 2014 May 22].

Fontana L, Beckerman A. Recently released with HIV/AIDS: primary care treatment needs and experiences. J Health Care Poor Underserved. 2007 Aug;18(3):699-714. PubMed External Web Site Policy

Friedland G. Infectious disease comorbidities adversely affecting substance users with HIV: hepatitis C and tuberculosis. J Acquir Immune Defic Syndr. 2010 Dec;55(Suppl 1):S37-42. PubMed External Web Site Policy

Global tuberculosis report 2013. [internet]. Geneva: World Health Organization (WHO); 2013 [accessed 2014 Feb 28].

Goldenberg SM, Rangel G, Vera A, Patterson TL, Abramovitz D, Silverman JG, Raj A, Strathdee SA. Exploring the impact of underage sex work among female sex workers in two Mexico-US border cities. AIDS Behav. 2012 May;16(4):969-81. PubMed External Web Site Policy

Guidance brief: HIV interventions for most-at-risk young people. New York: Inter-Agency Task Team on HIV and Young People; 2007.

Guidance on couples HIV testing and counselling including antiretroviral therapy for treatment and prevention in serodiscordant couples: recommendations for a public health approach. [internet]. Geneva: World Health Organization (WHO); 2012 [accessed 2014 Feb 27].

Guidance on oral pre-exposure prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: recommendations for use in the context of demonstration projects. [internet]. Geneva: World Health Organization (WHO); 2012 [accessed 2014 Feb 27].

Guidance on prevention of viral hepatitis B and C among people who inject drugs. [internet]. Geneva: World Health Organization (WHO); 2012 [accessed 2014 Feb 25].

Guidance on provider-initiated HIV testing and counselling in health facilities. [internet]. Geneva: World Health Organization (WHO); 2007 [accessed 2014 Feb 27].

Guide to starting and managing needle and syringe programmes. [internet]. Geneva: World Health Organization (WHO); 2007 [accessed 2014 Feb 27].

Guidelines for identification and management of substance use and substance use disorders in pregnancy. [internet]. Geneva: World Health Organization (WHO); 2014 [accessed 2014 Mar 11].

Guidelines for the identification and management of substance use and substance use disorders in pregnancy. [internet]. Geneva: World Health Organization (WHO); 2014 [accessed 2014 Jun 09].

Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. [internet]. Geneva: World Health Organization (WHO); 2009 [accessed 2014 Feb 27].

Guidelines for the screening, care and treatment of persons with hepatitis C infection. [internet]. Geneva: World Health Organization (WHO); 2014 [accessed 2014 Jun 02].

Guidelines on the management of opioid overdose in the community setting [Forthcoming]. Geneva: World Health Organization (WHO);

Guidelines: prevention and treatment of HIV and other sexually transmitted infections among men who have sex with men and transgender people: recommendations for a public health approach 2011. [internet]. Geneva: World Health Organization (WHO); 2011 [accessed 2014 Feb 25].

HIV and adolescents: guidance for HIV testing and counselling and care for adolescents living with HIV: recommendations for a public health approach and considerations for policy-makers and managers. Geneva: World Health Organization (WHO); 2013.

HIV prevention, treatment and care in prisons and other closed settings: a comprehensive package of interventions: policy brief. [internet]. Vienna: United Nations Office on Drugs and Crime; 2013 [accessed 2014 Feb 25].

HIV testing and counselling in prisons and other closed settings, technical paper. [internet]. New York: United Nations; 2009 [accessed 2014 Feb 27].

IMAI one-day orientation on adolescents living with HIV: participants manual and facilitator guide. Geneva: World Health Organization (WHO); 2010.

Implementing comprehensive HIV/STI programmes with sex workers: practical approaches from collaborative interventions. [internet]. Geneva: World Health Organization (WHO); 2013 [accessed 2014 May 23].

Interagency Youth Working Group. Young people most at risk of HIV: a meeting report and discussion paper from the Interagency Youth Working Group, United States Agency for International Development, Joint United Nations Programme on HIV/AIDS Inter-Agency Task Team on HIV and Young People, and FHI. Research Triangle Park (NC): FHI; 2010.

Interventions to address HIV in prisons: prevention of sexual transmission (Evidence for Action Technical Papers). [internet]. Geneva: World Health Organization (WHO); 2007 [accessed 2014 Jun 06].

Kerbs JJ, Jolley JM. Inmate-on-inmate victimization among older male prisoners. Crime Delinq. 2007;31(5):385-93.

La Vigne NG, et al. Preventing violence and sexual assault in jail: a situational crime prevention approach. Justice Policy Center Brief; 2011.

McCance-Katz EF, Moody DE, Prathikanti S, Friedland G, Rainey PM. Rifampin, but not rifabutin, may produce opiate withdrawal in buprenorphine-maintained patients. Drug Alcohol Depend. 2011 Nov 1;118(2-3):326-34. PubMed External Web Site Policy

mhGAP intervention guide for mental, neurological and substance use disorders in nonspecialized health settings. [internet]. Geneva: World Health Organization (WHO); 2011 [accessed 2014 Feb 27].

Nuun A, Cornwall A, et al. Linking HIV-positive jail inmates to treatment, care, and social services after release: results from a qualitative assessment of the COMPASS program. J Urban Health. 2010;87(6):954-68.

Pettifor AE, Measham DM, Rees HV, Padian NS. Sexual power and HIV risk, South Africa. Emerg Infect Dis. 2004 Nov;10(11):1996-2004. PubMed External Web Site Policy

Policy guidelines for collaborative TB and HIV services for injecting and other drug users: an integrated approach. (Evidence for Action Technical Papers). [internet]. Geneva: World Health Organization (WHO); 2008 [accessed 2014 Feb 25].

Polis CB, Curtis KM. Use of hormonal contraceptives and HIV acquisition in women: a systematic review of the epidemiological evidence. Lancet Infect Dis. 2013 Sep;13(9):797-808. PubMed External Web Site Policy

Prevention and treatment of HIV and other sexually transmitted infections for sex workers in low- and middle-income countries: recommendations for a public health approach. [internet]. Geneva: World Health Organization (WHO); 2012 [accessed 2014 Feb 25].

Protocol 4. Management of tuberculosis and HIV coinfection, 2013 revision. Copenhagen: WHO Regional Office for Europe; 2013.

Ravi A, Blankenship KM, Altice FL. The association between history of violence and HIV risk: a cross-sectional study of HIV-negative incarcerated women in Connecticut. Womens Health Issues. 2007 Jul-Aug;17(4):210-6. PubMed External Web Site Policy

Responding to intimate partner violence and sexual violence against women: WHO clinical and policy guidelines. [internet]. Geneva: World Health Organization (WHO); 2013 [accessed 2014 Feb 27].

Roberson DW, White BL, Fogel CI. Factors influencing adherence to antiretroviral therapy for HIV-infected female inmates. J Assoc Nurses AIDS Care. 2009 Jan-Feb;20(1):50-61. PubMed External Web Site Policy

Rolling out of opioid substitution treatment (OST) in Tihar prisons, India: scientific report. Vienna: United Nations Office on Drugs and Crime; 2013.

Safe abortion: technical and policy guidance for health systems, 2nd ed. [internet]. Geneva: World Health Organization (WHO); 2012 [accessed 2014 May 22].

Sexually transmitted and other reproductive tract infections. [internet]. Geneva: World Health Organization (WHO); 2005 [accessed 2014 Feb 27].

Shalihu N, Pretorius L, van Dyk A, Vander Stoep A, Hagopian A. Namibian prisoners describe barriers to HIV antiretroviral therapy adherence. AIDS Care. 2014;26(8):968-75. PubMed External Web Site Policy

Small W, Wood E, Betteridge G, Montaner J, Kerr T. The impact of incarceration upon adherence to HIV treatment among HIV-positive injection drug users: a qualitative study. AIDS Care. 2009 Jun;21(6):708-14. PubMed External Web Site Policy

Technical Consultation on Male Circumcision and HIV Prevention: research implications for policy and programming. [internet]. Geneva: World Health Organization (WHO); 2007 [accessed 2014 Feb 27].

Tool for setting and monitoring targets for prevention, treatment and care for HIV among men who have sex with men, sex workers and transgender people. [Forthcoming]. Geneva: World Health Organization (WHO);

Toolkit for transition of care and other services for adolescents living with HIV. Arlington (VA): AIDSTAR-One; 2013.

Walsh N, et al. The silent epidemic: responding to viral hepatitis among people who inject drugs. In: Cook C, ed. Global state of harm reduction 2010. [internet]. London: International Harm Reduction Association; 2011 [accessed 2014 Feb 28].

WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. [internet]. Geneva: World Health Organization (WHO); 2013 [accessed 2014 Feb 27].

WHO information update: considerations regarding reuse of the female condom. [internet]. Geneva: World Health Organization (WHO); 2002 [accessed 2014 Feb 25].

WHO Policy on collaborative TB/HIV activities: guidelines for national programmes and other stakeholders. [internet]. Geneva: World Health Organization (WHO); 2012 [accessed 2014 May 22].

WHO, UNODC, UNAIDS technical guide for countries to set targets for universal access to HIV prevention, treatment and care for injecting drug users – 2012 revision. [internet]. Geneva: World Health Organization (WHO); 2012 [accessed 2014 May 31].

Wohl DA, Scheyett A, Golin CE, White B, Matuszewski J, Bowling M, Smith P, Duffin F, Rosen D, Kaplan A, Earp J. Intensive case management before and after prison release is no more effective than comprehensive pre-release discharge planning in linking HIV-infected prisoners to care: a randomized trial. AIDS Behav. 2011 Feb;15(2):356-64. PubMed External Web Site Policy

Wolfe D, Carrieri MP, Shepard D. Treatment and care for injecting drug users with HIV infection: a review of barriers and ways forward. Lancet. 2010 Jul 31;376(9738):355-66. PubMed External Web Site Policy

Yap L, Richters J, Butler T, Schneider K, Grant L, Donovan B. The decline in sexual assaults in men's prisons in New South Wales: a "systems" approach. J Interpers Violence. 2011 Oct;26(15):3157-81. PubMed External Web Site Policy

Zaller ND, Holmes L, Dyl AC, Mitty JA, Beckwith CG, Flanigan TP, Rich JD. Linkage to treatment and supportive services among HIV-positive ex-offenders in Project Bridge. J Health Care Poor Underserved. 2008 May;19(2):522-31. PubMed External Web Site Policy

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for selected recommendations (see the "Major Recommendations" field).

Potential Benefits

  • Appropriate human immunodeficiency virus (HIV) prevention, diagnosis, treatment, and care for key populations
  • Public health benefits of decreasing HIV transmission
  • Health services in low-resource settings will benefit most from the guidance presented here, as they face the greatest challenges in providing services tailored to key populations.

Potential Harms

  • Side effects of antiretroviral therapy (ART)
  • Drug interactions with ART, including interactions with recreational drugs, drugs for co-infections and co-morbidities, and hormones used for contraception or in the transgender population

Contraindications

A key contraindicated drug combination is rifampicin and protease inhibitors (PIs).

Qualifying Statements

  • The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization (WHO) concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
  • The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
  • All reasonable precautions have been taken by the WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the WHO be liable for damages arising from its use.

Description of Implementation Strategy

Plans for Dissemination

The guidelines are being disseminated as a printed publication and electronically on the World Health Organization (WHO) web site including all Annexes.

Implementation Considerations

Refer to the "Implementation Considerations" sections of the original guideline document for suggestions for approaches to service implementation of specific recommendations.

Refer to Chapter 5 in the original guideline document (Critical Enablers) for strategies, activities and approaches that aim to improve the accessibility, acceptability, uptake, equitable coverage, quality, effectiveness and efficiency of human immunodeficiency virus (HIV) interventions and services. Enablers operate at many levels – individual, community, institutional, societal and national, regional and global. They are crucial to implementing comprehensive HIV programmes for key populations in all epidemic contexts. Critical enablers aim to overcome major barriers to service uptake, including social exclusion and marginalization, criminalization, stigma and inequity. If left unaddressed, such barriers will undermine the provision of HIV services, especially for key populations. Chapter 5 includes sections on law and policy, stigma and discrimination, community empowerment, and violence.

Refer to Chapter 6 in the original guideline document for information on service delivery elements important to the comprehensive package of health interventions for key populations.

Refer to Chapter 7 in the original guideline document for information on decision-making, planning, and monitoring guideline implementation.

Implementation Tools

Quick Reference Guides/Physician Guides

Resources

Staff Training/Competency Material

For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

IOM Care Need

Living with Illness

Staying Healthy

IOM Domain

Effectiveness

Patient-centeredness

Bibliographic Source(s)

World Health Organization (WHO). Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. Geneva (Switzerland): World Health Organization (WHO); 2014 Jul. 160 p. [313 references]

Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released

2014 Jul

Guideline Developer(s)

World Health Organization - International Agency

Source(s) of Funding

The Unified Budget, Results and Accountability Framework of the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) provided the funding to support this work, including the systematic reviews of evidence, evidence compilation, convening of the expert meeting, and development, editing, and printing of the guidelines. The Global Fund to Fight AIDS, Tuberculosis and Malaria provided funding for the background work on transgender populations.

Guideline Committee

WHO Guideline Steering Group on HIV and Key Populations

External Steering Group

Guidelines Development Group

External Peer Review Group

Composition of Group That Authored the Guideline

Guideline Development Group and Steering Group Members: Chris Beyrer (Co-chair), Johns Hopkins Bloomberg School of Public Health, USA; Adeeba Kamarulzaman (Co-chair), University of Malaya, Malaysia; Elie Aaraj#, Middle East & North Africa Harm Reduction Association (MENAHRA), Lebanon; Eliot Albers*, The International Network of People who Use Drugs (INPUD), United Kingdom; George Ayala, The Global Forum on MSM and HIV (MSMGF), USA; Carlos F. Cáceres, Sexuality and Human Development, Cayetano Heredia University, Peru; Kate Montecarlo Cordova#, Association of Transgender People in the Philippines (A.T.P), Philippines; Tetiana Deshko#, International HIV/AIDS Alliance in Ukraine; Daouda Diouf#, Enda Santé, Senegal; Zoë Dodd#, The International Network of People who Use Drugs (INPUD), Canada; Frits van Griensven, Thai Red Cross Society, Chulalongkorn University, Thailand; Mengjie Han, National Center for AIDS/STD Control and Prevention, China CDC, People's Republic of China; Ralf Jürgens, Open Society Foundations, USA; Mehdi Karkouri#, Centre Hospitalier Universitaire Ibn Rochd, Morocco; JoAnne Keatley, Center of Excellence for Transgender Health, USA; Anita Krug#, Youth RISE, Australia; Joep Lange*, University of Amsterdam, Netherlands; Keletso Makofane#, The Global Forum on MSM and HIV, South Africa; Jessie Mbwambo#, Muhimbili University of Health and Allied Sciences, Tanzania; Fabio Mesquita, Ministry of Health, Brazil; Noah Metheny*, The Global Forum on MSM and HIV (MSMGF), USA; Ruth Morgan Thomas, Global Network of Sex Work Projects (NSWP), United Kingdom; Debbie Muirhead, Department of Foreign Affairs and Trade (DFAT), Indonesia; Patrick Mutua Mburugu, Ministry of Public Health & Sanitation, Kenya; Ed Ngoksin, Global Network of People Living with HIV/AIDS (GNP+), South Africa; Sam Nugraha#, Community Based Treatment (Rumah Singgah PEKA), Indonesia; Tonia Poteat, Office of the U.S. Global AIDS Coordinator (OGAC), USA; Ganesh Ramakrishnan, Bill and Melinda Gates Foundation, India; Sushena Reza-Paul#, University of Manitoba, Canada; Ashodaya Samithi, India

#Guidelines Development Group only
*Steering group only

Contributors to the GRADE Systematic Reviews: Caitlin Kennedy and Virginia Fonner, Johns Hopkins Bloomberg School of Public Health, USA; Nandi Siegfried, independent clinical epidemiologist, South Africa

Contributors to Supporting Evidence: Sonya Arreola; George Ayala; Jack Beck; Keletso Makofane, The Global Forum on MSM and HIV (MSMGF), USA; Margaret Harris, WHO consultant; Mary Henderson, WHO consultant; Mira Schneiders, WHO consultant; Amee Schwitters, Centers for Disease Control and Prevention, USA; Kate Welch, WHO consultant

External Peer Reviewers: Peter Aggleton, Centre for Social Research in Health, University of New South Wales, Australia; Eliot Albers, The International Network of People who Use Drugs (INPUD), United Kingdom; George Ayala, The Global Forum on MSM and HIV (MSMGF), USA; Sylvia Ayon, Kenya AIDS NGOs Consortium, Kenya; Stef Baral, Center for Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health, USA; Taib Basheeib, Reachout Center Trust, Kenya; Nicholas Bates, The Albion Centre, Australia; Parinita Bhattacharjee, University of Manitoba, Kenya, and National AIDS and STI Control Programme Technical Support Unit (NASCOP TSU), Kenya; Sha'ari bin Ngadiman, Ministry of Health, Malaysia; Jamie Bridge, International Drug Policy Consortium, United Kingdom; Jude Byrne, International Network of People who Use Drugs (INPUD), Australia; Gabriela Calazans, School of Medicine of the University of São Paulo, Brazil; Mohamed Chakroun, Faculty of Medicine, University of Monastir, Tunisia; Xiang-Sheng Chen, National Center for Sexually Transmitted Disease Control, People's Republic of China; Mauro Cabral, GATE - Global Action for Trans* Equality, Argentina; Mean Chhi Vun, National Centre for HIV and STI prevention and Control, Cambodia; Joy Cunningham, FHI360, USA; Louisa Degenhardt, National Drug and Alcohol Research Centre (NDARC), University of New South Wales, Australia; Justus Eisfeld, GATE – Global Action for Trans* Equality, USA; Benham Farhoudi, Islamic Azad University, Tehran Medical Branch, Iran; Naomi Fontanos, Gender and Development Advocates (GANDA) Filipinas, Philippines; Le Minh Giang, Center for Research and Training on HIV/AIDS, Viet Nam; George Githuka, Ministry of Health, Kenya; Kimberly Green, FHI360, Ghana; Bikash Gurung, Youth RISE, Nepal; Wisal Hassan, Health Alliance International, Sudan; Lee Hertel, The International Network of People who Use Drugs (INPUD), USA; Chad Hughes, Centre for International Health, Burnet Institute, Australia; Smarajit Jana, Sonagachi Research and Training Institute, India; Manhong Jia, Yunnan AIDS/STI Centre, People's Republic of China; Jeremiah Johnson, Treatment Action Group, USA; Kianoush Kamali, National AIDS Control Programme, Iran; John Kashiha, Tanzania Sisi Kwa Sisi Foundation, Tanzania; Deanna Kerrigan, Johns Hopkins Bloomberg School of Public Health, USA; Nduku Kilonzo, Liverpool VCT, Care and Treatment (LVCT), Kenya; Nataliia Kitsenko, The Way Home NGO, Ukraine; Kelika A. Konda, University of California, Los Angeles, USA, Universidad Peruana Cayetano Heredia, Peru; Bram Langen, COC Nederland, Netherlands; Biangtung Langkham, Project ORCHID, Emmanuel Hospital Association, India; Joseph Tak Fai Lau, The Chinese University of Hong Kong, People's Republic of China; Anthony Lisle, UNAIDS Regional Support Team for Asia and the Pacific, Thailand; Lisa Maher, Kirby Institute for Infection and Immunity in Society, University of New South Wales, Australia; Samuel Matsikure, Gays and Lesbians of Zimbabwe (GALZ), Zimbabwe; Marden Marques Soares Filho, Ministério da Saúde, Brazil; Susie McLean, International HIV/AIDS Alliance, United Kingdom; Ellen Mitchell, KNCV Tuberculosis Foundation, The Netherlands; Jason Mitchell, Oceania Society for Sexual Health and HIV Medicine, Fiji; Joseph Ngua Mombo, Sex Worker Outreach Programme (SWOP), Kenya; Jules Mugabo, WHO Rwanda; Lillian Mworeko, International Community of Women Living with HIV (ICW Eastern Africa), Uganda; Isidore Obot, University of Uyo, Nigeria; Dédé Oetomo, Asia Pacific Coalition on Male Sexual Health (APCOM), Indonesia; Nittaya Phanuphak, Thai Red Cross AIDS Research Centre, Thailand; Midnight Poonkasetwattana, Asia Pacific Coalition on Male Sexual Health (APCOM), Thailand; Made Yogi Oktavian Prasetia, Bali Medika Clinic, Indonesia; Anita Radix, Callen Lorde Community Health Center, USA; Kevin Rebe, ANOVA Health Institute, South Africa; Helen Rees, Wits Reproductive and HIV Research Institute, South Africa; Gary Reid, independent consultant, India; Kirill Sabir, FtM Phoenix Group, Russia; Bettina Schunter, independent consultant, Pakistan; Sopheap Seng, National Center for HIV/AIDS, Cambodia; Maninder Singh Setia, consultant dermatologist and epidemiologist, India; Sally Shackleton, Sex Workers Education and Advocacy Taskforce (SWEAT), South Africa; Kate Shannon, British Columbia Centre for Excellence in HIV/AIDS, Canada; Oscar Ozmund Simooya, The Copper Belt University, Zambia; Tim Sladden, United Nations Population Fund, Turkey; Mat Southwell, Coact, United Kingdom; Rosario Jessica Tactacan-Abrenica, San Lazaro Hospital, Philippines; Siti Nadia Tarmizi, Ministry of Health, Indonesia; Pham Thi Minh, Viet Nam Network of People who Use Drugs (VNPUD), Viet Nam; Marguerite Thiam-Niangoin, Ministère de la santé et de la lutte contre le SIDA, Côte d'Ivoire; Tengiz Tsertsvadze, AIDS and Clinical Immunology Research Center, Georgia; Bea Vuylsteke, Institute of Tropical Medicine, Belgium; Darshana Vyas, Pathfinder International, India; Daniel Wolfe, Open Society Foundations, USA; William Chi Wai Wong, The University of Hong Kong, China; Tariq Zafar, Nai Zindagi, Pakistan

Financial Disclosures/Conflicts of Interest

All External Steering Group participants, Guidelines Development Group participants and External Peer Review Group members submitted Declarations of Interest (DOI) to the World Health Organization (WHO) secretariat. The WHO secretariat and the Guidelines Development Group reviewed all declarations and found no conflicts of interest sufficient to preclude anyone from participating in the development of the guidelines. A full compilation of the declarations is available on request.

Guideline Status

This is the current release of the guideline.

This guideline meets NGC's 2013 (revised) inclusion criteria.

Guideline Availability

Electronic copies: Available from the World Health Organization (WHO) Web site External Web Site Policy.

Print copies: Available from the WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland; Phone: +41 22 791 3264; Fax: +41 22 791 4857; E-mail: bookorders@who.int.

Availability of Companion Documents

The following are available:

  • Kennedy C, Fonner V. Pre-exposure prophylaxis for people who inject drugs: a systematic review. Geneva (Switzerland): World Health Organization (WHO); 2014 Mar. 24 p. Electronic copies: Available from the World Health Organization (WHO) Web site External Web Site Policy.
  • Kennedy C, Fonner V. Pre-exposure prophylaxis for men who have sex with men: a systematic review. Geneva (Switzerland): World Health Organization (WHO); 2014 Mar. 83 p. Electronic copies: Available from the WHO Web site External Web Site Policy.
  • Schwitters A. Health interventions for prisoners. Update of the literature since 2007. Geneva (Switzerland): World Health Organization (WHO); 2014. 17 p. Electronic copies: Available from the WHO Web site External Web Site Policy.
  • Policy brief: Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations, 2014. Geneva (Switzerland): World Health Organization (WHO); 2014 Jul. 8 p. Electronic copies: Available from the WHO Web site External Web Site Policy.
  • Questions and answers on pre-exposure prophylaxis for men who have sex with men. Geneva (Switzerland): World Health Organization; 2014 Dec 2. Electronic copies: Available from the WHO Web site External Web Site Policy.
  • WHO handbook for guideline development. Geneva (Switzerland): World Health Organization; 2012. Electronic copies: Available from the WHO Web site External Web Site Policy.

In addition, case studies are available in the original guideline document and in Annex 5 on the WHO Web site External Web Site Policy. Values and preferences reports and inter-agency technical briefs are available from the WHO Web site External Web Site Policy.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on December 19, 2014. This summary was updated by ECRI Institute on June 2, 2016 following the U.S. Food and Drug Administration advisory on Opioid pain medicines.

Copyright Statement

This NGC summary is based on the original guideline, which may be subject to the guideline developer's copyright restrictions.

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