The quality of evidence (I-III) and strength of recommendation (A-C) are defined at the end of the "Major Recommendations" field.
New York State Public Health Regulations
The following are mandated in New York State (NYS) and must be performed in accordance with State Law:
All prenatal care settings regulated by the New York State Department of Health (NYSDoH), including hospitals, diagnostic and treatment centers, health maintenance organizations, and birthing centers, must provide human immunodeficiency virus (HIV) information and recommend HIV testing, preferably at the first prenatal visit for all women who present for care.
Diagnostic HIV tests must be performed in full compliance with the NYS Law .
If a woman presents for delivery without documentation of a negative HIV test during the current pregnancy and is not known to be HIV-infected, HIV expedited testing must be conducted on the mother with her consent:
- If the woman declines expedited testing, the newborn must be tested using the infant's blood specimen collected at birth. Maternal consent is not required.
- Results of expedited testing must be available as soon as possible, preferably within 1 hour, and no longer than 12 hours after the mother's consent or the infant's birth if the mother declines testing.
Preliminary positive expedited HIV test results obtained using HIV rapid testing or a laboratory-based screening test must be confirmed according to currently recommended procedures for diagnosing HIV infection.
- Confirmatory test results should be available as soon as possible and no later than 4 days after the preliminary positive HIV test result.
- Positive maternal confirmatory test results must be reported in accordance with NYS Law, which necessitates name reporting and partner notification.
HIV Testing During Third Trimester of Pregnancy
- Routinely recommend repeat testing in the third trimester, preferably between 34 and 36 weeks, for all women who test negative for HIV early in pregnancy. Repeat testing is strongly recommended for women who have continued high-risk behaviors during pregnancy or who acquire any other sexually transmitted infections during pregnancy.
- Offer testing during labor and delivery for any woman who does not have documented third trimester HIV test results. (AIII)
Clinicians should maintain a high level of suspicion for acute HIV infection in all pregnant women who present with a compatible clinical syndrome. Women who present with symptoms suggestive of acute HIV infection should be tested immediately, even if a previous HIV antibody test during current pregnancy was negative. Screening for acute infection can be performed 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 (see the National Guideline Clearinghouse [NGC] summary of the NYSDoH guideline Acute HIV Infection in Pregnancy for more information.
NYS Law requires clinicians to discuss partner notification with patients who have been recently diagnosed with HIV infection. Assistance with partner notification can be provided through direct referral to the NYS and County Health Department Partner Services (PS) Programs, and the New York City Department of Health Contact Notification Assistance Program (CNAP) . The partner notification discussion must be documented in the medical record and on the Medical Provider Reporting Form (DOH Form # 4189) as required by Public Health Law, Article 21, Title III, Section 213. (More information on partner notification assistance and resources can be found at: Partner Services outside of NYC or Contact Notification Assistance Program [CNAP]).
Evaluation and Management of Women Presenting in Labor Without Documentation of a Negative HIV Test During the Current Pregnancy and Who Are Not Known to Be HIV-Infected
All birth facilities should adopt point-of-care rapid HIV testing in labor and delivery settings for women who present in labor without documentation of a negative HIV test result during the current pregnancy and who are not already known to be HIV-infected. As per NYS Regulations, these women must receive expedited HIV testing or the infant must be tested at birth if the mother declines testing.
Facilities should perform expedited HIV testing using a U.S. Food and Drug Administration (FDA)-approved HIV rapid test; however, a conventional, laboratory-based screening test, such as an enzyme immunoassay (EIA) or chemiluminescent immunoassay (CIA), may be used if results can be returned rapidly, preferably within 1 hour, and no longer than 12 hours. The most sensitive screening test available should be used to allow for detection of early or acute HIV infection.
Facilities should strive to have expedited HIV test results available prior to delivery to allow maximum benefits of intrapartum antiretroviral (ARV) prophylaxis for the fetus.
When maternal expedited HIV testing yields a preliminary positive result, the clinician should:
- Discuss the meaning of a preliminary positive HIV test result with the mother. (AIII)
- Recommend immediate initiation of ARV prophylaxis during labor for the mother and for the infant in the immediate postnatal period, preferably within the first 6 to 12 hours, until HIV infection is definitively excluded. (AIII) (In this instance, the benefits of HIV prophylaxis given for a short period of time outweigh the risks of the medications). If a woman chooses to decline ARV prophylaxis for herself or her newborn, she should be educated about the benefits that ARV prophylaxis provides.
- Inform the mother about the risk of postpartum mother-to-child transmission (MTCT) via breast milk and that breastfeeding is contraindicated, even while receiving ARV prophylaxis, until there is definitive evidence that the mother is not infected with HIV. (Rousseau et al., 2003) (AII) Safe formula alternatives are available in the US; however, for women who wish to breastfeed, pumping and discarding or saving breast milk can be recommended to prevent breast engorgement and to continue milk production if HIV infection is definitively excluded by diagnostic tests that are capable of detecting early infection.
- Discontinue maternal ARV prophylaxis after delivery. If definitive test results indicate HIV infection, follow-up evaluation should occur by a provider who has experience with HIV management to discuss initiation of antiretroviral therapy.
NYS Regulations require that providers must obtain a confirmatory test for all preliminary positive HIV test results. Current recommendations require that a Western blot be obtained if the screening test produces a preliminary positive result, regardless of the type of screening test performed (rapid or EIA/CIA). If the Western blot is negative or indeterminate, a nucleic acid test (NAT) should be performed as soon as possible to distinguish between early HIV infection and a false-positive screening test result.*
When the definitive test results indicate HIV infection is present:
- ARV prophylaxis with at least zidovudine for the infant should be continued for 6 weeks. (AI) The infant should be discharged from the birth facility with the full 6-week supply of ARV prophylaxis.
- The importance of not breastfeeding should be emphasized. The infant should be discharged with a supply of formula.
- Arrangements should be made prior to discharge for the infant to receive HIV-related follow-up care from, or in consultation with, a pediatric provider who has experience with HIV management. This includes making arrangements for diagnostic testing to determine the infant's HIV status. The first diagnostic specimen should be sent within 48 hours of birth to the Pediatric HIV Testing Service at the Wadsworth Center, NYSDoH (see the NGC summary of the NYSDoH guideline Diagnosis of Pediatric HIV Infection in HIV-Exposed Infants).
- Arrangements should be made prior to discharge, if possible, for the mother to receive follow-up evaluation by a provider who has experience with HIV management to discuss maternal health and future antiretroviral therapy (ART); referral should be made for subsequent HIV primary care. (AIII)
- Referral should be made for HIV-specific case management and supportive services.
- It should be explained to the mother that a confirmed positive antibody test result obtained from the infant is not reported unless the infant's HIV virologic assay (i.e., NAT, a general term which includes deoxyribonucleic acid polymerase chain reaction [DNA PCR] and RNA virologic assays) is positive (see the NGC summary of the NYSDoH guideline Diagnosis of Pediatric HIV Infection in HIV-Exposed Infants).
After HIV infection has been definitively excluded in the mother:
- Infant ARV prophylaxis should be discontinued. (AI)
- Maternal ARV prophylaxis should be discontinued after delivery. (AI)
- Mothers may initiate breastfeeding if desired. (AII)
*An alternative diagnostic strategy that uses a combination of FDA-approved immunoassays and NAT to determine HIV infection status without Western blot testing has been proposed (Pandori & Branson, 2010) and may provide a more definitive result in less time; however, formal recommendations are required before laboratories can implement this alternative strategy for expedited maternal testing.
The ideal time for providing HIV information and testing in pregnancy is as early as possible. The peripartum period is the final opportunity to provide ARV prophylaxis and decrease the risk for MTCT to HIV-exposed infants in mothers who have not been previously identified as HIV-infected.
Quality of Evidence for Recommendation
- One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
- One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes
- Expert opinion
Strength of Recommendation
- Strong recommendation for the statement
- Moderate recommendation for the statement
- Optional recommendation