This is the current release of the guideline.

To provide guidelines for human immunodeficiency virus (HIV) testing during pregnancy and at delivery

Some areas of this guideline are based on New York State regulation and public health law. For recommendations formulated based on evidence rather than regulation or law, MEDLINE was searched up to January 2011 with use of appropriate key words. New York State laboratory data and epidemiologic data were also used. Human immunodeficiency virus (HIV) perinatal transmission guidelines from the Public Health Service Task Force and American College of Obstetrics and Gynecology were reviewed, as well as HIV testing guidelines from the Centers for Disease Control and Prevention.

Not stated

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

Not stated

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

Strength of Recommendation

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

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

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.

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

Clinicians should:

• 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.

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

None provided

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

Appropriate human immunodeficiency (HIV) testing during pregnancy and at delivery and timely prophylaxis in women identified as HIV-infected, thus preventing mother-to-child HIV transmission

Human immunodeficiency virus (HIV) testing could render false-positive results.

Breastfeeding is contraindicated, even while receiving antiretroviral (ARV) prophylaxis, until there is definitive evidence that the mother is not infected with human immunodeficiency virus (HIV).

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.

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.

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

New York State Department of Health

Perinatal Transmission Committee

Committee 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

Not stated

This is the current release of the guideline.

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

None available

None available

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

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  for terms of use.