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Guideline Summary
Guideline Title
Acute HIV infection in pregnancy.
Bibliographic Source(s)
New York State Department of Health. Acute HIV infection in pregnancy. New York (NY): New York State Department of Health; 2011 Sep. 7 p. [14 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Acute human immunodeficiency virus (HIV) infection in pregnancy

Guideline Category
Counseling
Diagnosis
Management
Prevention
Screening
Clinical Specialty
Allergy and Immunology
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Pediatrics
Preventive Medicine
Intended Users
Advanced Practice Nurses
Health Care Providers
Nurses
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)

To provide guidelines for the diagnosis and management of acute human immunodeficiency virus (HIV) infection in pregnancy

Target Population

Pregnant women with acute human immunodeficiency virus (HIV) infection

Interventions and Practices Considered
  1. Counseling patients during pregnancy about the increased risk of transmitting human immunodeficiency virus (HIV) during acute HIV infection
  2. Evaluating pregnant patients for potential HIV infection when they present with symptoms of acute infection
  3. Continued vigilance for signs and symptoms of acute HIV infection during the postpartum period for all breastfeeding women
  4. Immediate HIV serologic screening test in conjunction with a plasma HIV ribonucleic acid [RNA] assay when acute infection is suspected
  5. Repeated HIV serologic testing 2 to 3 weeks after diagnosis by HIV RNA testing to confirm infection
  6. Prompt initiation of antiretroviral therapy
  7. Use of a multidisciplinary care team (including a pediatrician) for managing pregnant women with HIV
  8. Obtaining baseline genotypic testing in the setting of acute infection
Major Outcomes Considered

Rates of human immunodeficiency virus (HIV) mother-to-child transmission

Methodology

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

MEDLINE was searched up to December 2010 with use of appropriate key words. Where possible, studies were limited to acute human immunodeficiency virus (HIV) infection in pregnancy and during breastfeeding. Guidelines from the Department of Health and Human Services were reviewed.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence for Recommendation

  1. One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
  2. One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes
  3. Expert opinion
Methods Used to Analyze the Evidence
Review
Review of Published Meta-Analyses
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

AIDS Institute clinical guidelines are developed by distinguished committees of clinicians and others with extensive experience providing care to people with human immunodeficiency virus (HIV) infection. Committees* meet regularly to assess current recommendations and to write and update guidelines in accordance with newly emerging clinical and research developments.

The Committees* rely on evidence to the extent possible in formulating recommendations. When data from randomized clinical trials are not available, Committees rely on developing guidelines based on consensus, balancing the use of new information with sound clinical judgment that results in recommendations that are in the best interest of patients.

*Current committees include:

  • Medical Care Criteria Committee
  • Committee for the Care of Children and Adolescents with HIV Infection
  • Dental Standards of Care Committee
  • Mental Health Guidelines Committee
  • Committee for the Care of Women with HIV Infection
  • Committee for the Care of Substance Users with HIV Infection
  • Physicians' Prevention Advisory Committee
  • Pharmacy Advisory Committee
Rating Scheme for the Strength of the Recommendations

Strength of Recommendation

  1. Strong recommendation for the statement
  2. Moderate recommendation for the statement
  3. Optional recommendation
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Description of Method of Guideline Validation

All guidelines developed by the Committee are externally peer reviewed by at least two experts in that particular area of patient care, which ensures depth and quality of the guidelines.

Recommendations

Major Recommendations

The quality of evidence (I-III) and strength of recommendation (A-C) are defined at the end of the "Major Recommendations" field.

Introduction

Clinicians should counsel patients during pregnancy about the increased risk of transmitting human immunodeficiency virus (HIV) during acute HIV infection.

Key Point:

In addition to previously identified factors, such as breastfeeding and lack of antiretroviral medications, New York State (NYS) found that the factors of inadequate prenatal care, substance use during pregnancy, and low neonatal birth weight also increased the risk for mother-to-child transmission (MTCT).

Presentation of Acute HIV Infection

When pregnant or breastfeeding women present with a febrile, "flu"- or "mono"-like illness, or rash that is not otherwise explained, clinicians should evaluate the potential for acute HIV infection by inquiring about the following (AII):

  • Sexual exposures with a known HIV-infected partner or a partner of unknown HIV serostatus in the past 2 to 6 weeks
  • Acquisition of any other sexually transmitted infection
  • Needle-sharing practices with a known HIV-infected partner or a partner of unknown HIV serostatus in the past 2 to 6 weeks (see the New York State Department of Health [NYSDoH] guideline Diagnosis and Management of Acute HIV Infection)

Clinicians should continue to be vigilant for signs and symptoms of acute HIV infection during the postpartum period for all breastfeeding women.

See Appendix A of the original guideline document for an extensive list of signs and symptoms of acute HIV infection.

Diagnosis of Acute HIV Infection

When acute HIV infection is suspected, clinicians should immediately screen for acute infection by obtaining the following (AIII):

  • An HIV serologic screening test in conjunction with a plasma HIV ribonucleic acid (RNA) assay. The plasma RNA test should be performed even if the serologic screening test is negative. If available, a fourth-generation HIV antigen/antibody combination test is the preferred serologic screening test.

Detection of HIV RNA or antigen in the absence of HIV antibody should be considered a preliminary positive result; HIV RNA testing from a new specimen should be repeated immediately to confirm the presence of HIV RNA.

To exclude a false-positive result, clinicians should repeat both serologic and RNA testing when low-level quantitative results (<5,000 copies/mL) from an HIV RNA assay are reported in the absence of serologic evidence of HIV infection. (AII)

HIV serologic testing should be repeated 2 to 3 weeks after diagnosis by HIV RNA testing to confirm infection. (AII) However, clinicians should not wait for HIV serologic confirmatory test results to initiate antiretroviral therapy (ART) when pregnant women are diagnosed with acute HIV infection by HIV RNA testing. Initiation of ART is strongly recommended for pregnant women. (AII)

Key Points:

  • Clinicians should not wait for HIV serologic confirmatory test results to initiate ART when pregnant women are diagnosed with acute HIV infection by HIV RNA testing.
  • If acute HIV infection is suspected, immediate consultation with a provider who has expertise in the diagnosis and evaluation of acute HIV infection can result in earlier diagnosis and treatment to reduce the risk of MTCT. Clinicians who need support from a provider with experience in acute HIV infection may call the Clinical Education Initiative (CEI) Line at 1-866-637-2342.
  • Testing for acute HIV infection during pregnancy may be accessed by contacting:
    • In New York City: New York City Department of Health & Mental Hygiene, HIV Surveillance and Epidemiology Program, Provider Line (212) 442-3388.
    • Outside New York City: New York State Department of Health, Wadsworth Center, Bloodborne Viruses Laboratory (518) 474-2163.
  • To aid in the diagnosis of acute HIV infection, providers should specifically indicate when contacting testing sites that acute HIV infection is suspected in the pregnant woman.

For more information about acute HIV infection, see the NYSDoH guideline Diagnosis and Management of Acute HIV Infection.

Management of Pregnant Women with Acute HIV Infection

Pregnant women with acute HIV infection should receive health care from a multidisciplinary team including providers who have experience with HIV management and obstetrical care providers. A pediatric care provider with HIV expertise also should be part of the care team. (AIII)

Clinicians should obtain baseline genotypic testing in the setting of acute infection, even if the woman declines treatment. Initiation of prophylaxis should not be delayed while awaiting results of resistance testing. When results are available, treatment choice can be changed based on the results of genotypic testing and implemented with the goal of suppressing plasma HIV RNA levels to below detectable levels. (AII)

Definitions:

Quality of Evidence for Recommendation

  1. One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
  2. One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes
  3. Expert opinion

Strength of Recommendation

  1. Strong recommendation for the statement
  2. Moderate recommendation for the statement
  3. Optional recommendation
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

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

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Early diagnosis and initiation of antiretroviral therapy (ART) in pregnancy may reduce the mother-to-child transmission of human immunodeficiency virus (HIV) infection.

Potential Harms

Side effects of medication

Qualifying Statements

Qualifying Statements

When formulating guidelines for a disease as complex and fluid as human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), it is impossible to anticipate every scenario. It is expected that in specific situations, there will be valid exceptions to the approaches offered in these guidelines and sound reason to deviate from the recommendations provided within.

Implementation of the Guideline

Description of Implementation Strategy

The AIDS Institute's Office of the Medical Director directly oversees the development, publication, dissemination and implementation of clinical practice guidelines, in collaboration with The Johns Hopkins University, Division of Infectious Diseases. These guidelines address the medical management of adults, adolescents and children with human immunodeficiency virus (HIV) infection; primary and secondary prevention in medical settings; and include informational brochures for care providers and the public.

Guidelines Dissemination

Guidelines are disseminated to clinicians, support service providers and consumers through mass mailings and numerous AIDS Institute-sponsored educational programs. Distribution methods include the HIV Clinical Resource website, the Clinical Education Initiative (CEI), the AIDS Educational Training Centers (AETC) and the HIV/AIDS Materials Initiative. Printed copies of clinical guidelines are available for order from the New York State Department of Health (NYSDoH) Distribution Center.

Guidelines Implementation

The HIV Clinical Guidelines Program works with other programs in the AIDS Institute to promote adoption of guidelines. Clinicians, for example, are targeted through the CEI and the AETC. The CEI provides tailored educational programming on site for health care providers on important topics in HIV care, including those addressed by the HIV Clinical Guidelines Program. The AETC provides conferences, grand rounds and other programs that cover topics contained in AIDS Institute guidelines.

Support service providers are targeted through the HIV Education and Training initiative which provides training on important HIV topics to non-physician health and human services providers. Education is carried out across the State as well as through video conferencing and audio conferencing.

The HIV Clinical Guidelines Program also works in a coordinated manner with the HIV Quality of Care Program to promote implementation of HIV guidelines in New York State. By developing quality indicators based on the guidelines, the AIDS Institute has created a mechanism for measurement of performance that allows providers and consumers to know to what extent specific guidelines have been implemented.

Finally, best practices booklets are developed through the HIV Clinical Guidelines Program. These contain practical solutions to common problems related to access, delivery or coordination of care, in an effort to ensure that HIV guidelines are implemented and that patients receive the highest level of HIV care possible.

Implementation Tools
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
New York State Department of Health. Acute HIV infection in pregnancy. New York (NY): New York State Department of Health; 2011 Sep. 7 p. [14 references]
Adaptation

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

Date Released
2011 Sep
Guideline Developer(s)
New York State Department of Health - State/Local Government Agency [U.S.]
Source(s) of Funding

New York State Department of Health

Guideline Committee

Perinatal Transmission Committee

Composition of Group That Authored the Guideline

Members: Elaine J Abrams, MD, Columbia University College of Physicians and Surgeons, New York, New York; Mark D Foca, MD, Children's Hospital of New York, New York, New York; Sreedhar Gaddipati, MD, Columbia Medical Center, New York, New York; Howard Minkoff, MD, Maimonides Medical Center, Brooklyn, New York; Renee Samelson, MD, MPH, Albany Medical Center, Albany, New York; Geoffrey A Weinberg, MD, University of Rochester School of Medicine and Dentistry, Rochester, New York; Andrew A Wiznia, MD, Jacobi Medical Center, Bronx, New York; Rodney L Wright, MD, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, New York

AIDS Institute Staff: Barbara L Warren, BSN, MPH, PNP, New York State Department of Health AIDS Institute, Albany, New York

AIDS Institute Staff Liaison: Gina M Brown, MD, National Institutes of Health, Bethesda, Maryland

AIDS Institute Staff Physician: Charles J Gonzalez, MD, New York State Department of Health AIDS Institute, New York, New York

Principal Contributors: Gina Brown, MD, National Institutes of Health, Office of AIDS Research, Bethesda, Maryland; Monica M Parker, PhD, Laboratory of Bloodborne Diseases, Wadsworth Center, New York State Department of Health, Albany; Barbara Warren, BSN, MPH, PNP, Bureau of HIV Ambulatory Care Services, New York State Department of Health AIDS Institute, Albany

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the New York State Department of Health AIDS Institute Web site External Web Site Policy.

Availability of Companion Documents

The following is available:

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on January 30, 2012.

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the guideline developer. See the New York State Department of Health AIDS Institute Web site External Web Site Policy for terms of use.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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