Purpose of This Guideline
Reviewed and updated: Maria Teresa (Tess) Timoney, MS, RN, CNM; September 9, 2022
Writing group: Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa Radix, MD, MPH, PhD; Jessica Rodrigues; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: July 2020
This guideline was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) to provide clinicians in NYS with evidence-based recommendations for HIV testing of all pregnant patients, including those in labor.
The purpose is to promote universal HIV screening in pregnancy to ensure timely diagnosis of HIV and rapid initiation of antiretroviral therapy, which can prevent perinatal transmission and protect the health of patients and their infants. To meet these goals, this guideline emphasizes the following:
- In each pregnancy, HIV testing is recommended as early as possible and again during the third trimester.
- Expedited HIV testing during labor is required for patients without documented negative HIV status and is recommended for patients with risk factors for HIV infection.
- Third-trimester syphilis testing is recommended for all patients, to be performed at the same time as third-trimester HIV testing.
- HIV testing is recommended for any patient who presents with signs or symptoms of acute HIV infection during pregnancy or postpartum as well as for those with newly diagnosed sexually transmitted infections.
- Pre-exposure prophylaxis and post-exposure prophylaxis are available and recommended for pregnant and postpartum patients with negative HIV test results who are at high risk of acquiring HIV.
Universal HIV Screening in Pregnancy
Reviewed and updated: Maria Teresa (Tess) Timoney, MS, RN, CNM, with the Medical Care Criteria Committee; September 9, 2022
RECOMMENDATIONS |
Universal HIV Screening in Pregnancy
Testing for Acute HIV
Third Trimester HIV and Syphilis Testing
PrEP to Prevent HIV
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NEW YORK STATE LAW |
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To help ensure timely diagnosis of HIV and implementation of effective measures to prevent perinatal transmission of HIV, New York State public health law mandates that all prenatal care settings regulated by the NYSDOH—including hospitals, diagnostic and treatment centers, health maintenance organizations, and birthing centers—provide information about HIV and recommend HIV testing, preferably at the first prenatal visit, to all individuals who present for care. Settings not regulated by the NYSDOH, such as some private offices, should also provide information about HIV and recommend voluntary HIV testing in accordance with NYSDOH, U.S. Department of Health and Human Services, and American College of Obstetrics and Gynecology (ACOG) standards of care for all pregnant individuals [DHHS 2021; ACOG 2018].
Diagnosing HIV and initiating ART at the time of diagnosis are crucial to reducing the risk of perinatal HIV transmission and maintaining the health of pregnant patients. HIV screening at the first prenatal visit increases the likelihood that HIV will be diagnosed, ART will be initiated early during pregnancy, and viral suppression can be attained.
For pregnant patients who are diagnosed with HIV, clinicians can provide assistance with partner notification through direct referral to:
- New York State and County Health Department What Health Care Providers Need to Know about Partner Services
- New York City Department of Health Contact Notification Assistance Program
More information on partner notification assistance and resources is also available at HIV/AIDS Laws and Regulations.
Testing for Acute HIV
Repeat HIV testing in patients who have a negative HIV test result early in pregnancy and assessment for acute HIV during pregnancy are important for reducing the risk of perinatal HIV transmission. Between 2007 and 2018, 11 of 45 (24.4%) perinatal transmissions to infants in New York State were associated with acute HIV infection acquired during pregnancy or the postpartum period through breastfeeding [NYSDOH 2019].
When a pregnant patient presents with symptoms suggestive of acute HIV, a plasma HIV RNA assay should be performed in conjunction with an HIV serologic screening test to diagnose acute HIV. An HIV-1/2 Ag/Ab combination immunoassay is the recommended serologic test.
For specific recommendations and expanded guidance on diagnosing and managing acute HIV, see the NYSDOH AI guideline Diagnosis and Management of Acute HIV Infection.
Third Trimester HIV and Syphilis Testing
Throughout New York State, clinicians who provide perinatal care should perform additional HIV testing in the third trimester for all pregnant patients with an initial negative HIV test result or no prior documented HIV test result. Approximately 80% of perinatal HIV transmissions occur after week 36 [Kourtis, et al. 2001]; therefore, this committee recommends HIV testing be performed between weeks 28 and 32 so that HIV testing can be performed concurrently with syphilis testing. See discussion of syphilis testing, below.
The Centers for Disease Control and Prevention (CDC) and ACOG recommend repeat HIV testing in the third trimester (before week 36) in areas with high incidence or prevalence of HIV; New York State is an area of high HIV prevalence [Workowski, et al. 2021; ACOG 2018], and some experts have argued that third-trimester testing should be universal [Cassimatis, et al. 2021]. Additionally, the CDC and ACOG recommend repeat testing for chlamydia, gonorrhea, and syphilis in the third trimester if the patient is at risk [Workowski, et al. 2021; ACOG 2018]. Assessment for acute HIV is strongly recommended in patients who present with compatible symptoms at any time during pregnancy.
Syphilis testing: The NYSDOH highly recommends that clinicians obtain serologic screening for syphilis for all pregnant patients at the first prenatal visit, during the third trimester (28 to 32 weeks of gestation), and at delivery. See also the CDC 2021 STI Treatment Guidelines and Recommended Clinician Timeline for Screening for Syphilis, HIV, HBV, HCV, Chlamydia, and Gonorrhea.
PrEP to Prevent HIV
In addition to HIV screening as part of routine antenatal care, other prevention strategies should be available to pregnant and breastfeeding patients who are at high risk of acquiring HIV, including assessment for PrEP candidacy. PrEP significantly decreases the risk of HIV transmission in heterosexual serodifferent couples [Baeten, et al. 2012].
Although available data suggest that the use of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; brand name Truvada) as PrEP does not increase the risk of congenital anomalies, studies of bone mineral density (BMD) in infants born to women taking TDF-containing antiretroviral regimens have provided conflicting results [Mofenson, et al. 2017; Siberry, et al. 2015; Vigano, et al. 2011]. One study suggested a decrease in BMD of up to 15% in infants exposed to TDF in utero compared with infants who were not exposed to TDF [Siberry, et al. 2015], whereas another study found no association between in utero TDF exposure and infant BMD [Vigano, et al. 2011].
KEY POINTS |
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References
ACOG. Committee opinion no. 752 summary: Prenatal and perinatal human immunodeficiency virus testing. Obstet Gynecol 2018;132(3):805-806. [PMID: 30134421]
Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367(5):399-410. [PMID: 22784037]
Cassimatis IR, Ayala LD, Miller ES, et al. Third-trimester repeat HIV testing: it is time we make it universal. Am J Obstet Gynecol 2021;225(5):494-499. [PMID: 33932342]
DHHS. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. 2021 Dec 30. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/antiretroviral-management-newborns-perinatal-hiv-exposure-or-hiv-infection?view=full [accessed 2022 May 23]
Kourtis AP, Bulterys M, Nesheim SR, et al. Understanding the timing of HIV transmission from mother to infant. JAMA 2001;285(6):709-712. [PMID: 11176886]
Mofenson LM, Baggaley RC, Mameletzis I. Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding. AIDS 2017;31(2):213-232. [PMID: 27831952]
NYSDOH. 2019. Unpublished data.
Siberry GK, Jacobson DL, Kalkwarf HJ, et al. Lower newborn bone mineral content associated with maternal use of tenofovir disoproxil fumarate during pregnancy. Clin Infect Dis 2015;61(6):996-1003. [PMID: 26060285]
Vigano A, Mora S, Giacomet V, et al. In utero exposure to tenofovir disoproxil fumarate does not impair growth and bone health in HIV-uninfected children born to HIV-infected mothers. Antivir Ther 2011;16(8):1259-1266. [PMID: 22155907]
Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep 2021;70(4):1-187. [PMID: 34292926]
HIV Testing During Labor and in Newborns
Reviewed and updated: Maria Teresa (Tess) Timoney, MS, RN, CNM, with the Medical Care Criteria Committee; September 9, 2022
RECOMMENDATIONS |
HIV Testing and Prophylaxis During Labor and in Newborns
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U.S. Food and Drug Administration (FDA)-approved HIV-1/2 antigen/antibody combination immunoassays are recommended for expedited HIV testing during labor and delivery. These tests screen for HIV-1 and HIV-2 antibodies and the HIV-1 p24 antigen. Because the p24 antigens produced by the virus may be detectable before an individual produces antibodies, combination immunoassays are capable of detecting acute HIV-1.
HIV testing of pregnant patients and their infants in the peripartum period functions as a safety net, ensuring screening for the small number of individuals not tested earlier in pregnancy or who seroconverted during pregnancy after the initial negative HIV test result.
Preliminary positive HIV test results: Although not diagnostic of HIV, most preliminary positive HIV test results are true-positive results; the precise ratio of true-positive to false-positive test results will depend on the test used and the local prevalence of HIV. When a preliminary positive result from a rapid HIV test occurs during labor and delivery, a second rapid test may be performed using a different FDA-approved rapid test device to obtain quick verification of the initial result. If both rapid HIV test results are reactive, the likelihood of infection is high. Regardless of whether 1 or 2 rapid HIV tests are performed, supplemental testing after a preliminary positive result is required to establish a diagnosis of HIV (see the standard HIV laboratory testing algorithm for maternal testing). Clinicians should collect a plasma sample from infants with a preliminary positive result and should obtain an HIV-1 NAT.
Antiretroviral prophylaxis for pregnant patients is more likely to benefit the infant when started as soon as a patient tests positive for HIV; the benefit of infant prophylaxis decreases when initiation is delayed [Fiscus, et al. 1999; Wade, et al. 1998]. These factors underscore the importance of initiating antiretroviral prophylaxis in pregnant patients and their infants as soon as possible and highlight the need for ongoing assessment of risk and HIV screening for patients who breastfeed. For specific prophylaxis regimens, see U.S. Department of Health and Human Services Recommendations for Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
KEY POINTS |
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SELECTED GOOD PRACTICE REMINDERS |
HIV Testing and Prophylaxis During Labor and in Newborns
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References
Fiscus SA, Schoenbach VJ, Wilfert C. Short courses of zidovudine and perinatal transmission of HIV. N Engl J Med 1999;340(13):1040-1041; author reply 1042-1043. [PMID: 10189281]
NYSDOH. 2019. Unpublished data.
Wade NA, Birkhead GS, Warren BL, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med 1998;339(20):1409-1414. [PMID: 9811915]
HIV Testing and Management Checklist
Reviewed and updated: Maria Teresa (Tess) Timoney, MS, RN, CNM, with the Medical Care Criteria Committee; September 9, 2022
All Recommendations
Reviewed and updated: Maria Teresa (Tess) Timoney, MS, RN, CNM, with the Medical Care Criteria Committee; September 9, 2022
ALL RECOMMENDATIONS: HIV TESTING DURING PREGNANCY, AT DELIVERY, AND POSTPARTUM |
Universal HIV Screening in Pregnancy
Testing for Acute HIV
Third Trimester HIV and Syphilis Testing
PrEP to Prevent HIV
HIV Testing and Prophylaxis During Labor and in Newborns
——— Notes:
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Guideline Information and Updates
Guideline Information | |
Intended users |
NYS clinicians who provide care to pregnant individuals who are at risk of acquiring HIV |
Reviewed and updated |
Maria Teresa (Tess) Timoney, MS, RN, CNM; September 9, 2022 |
Original publication |
July 2020 |
Writing group |
Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa Radix, MD, MPH, PhD; Jessica Rodrigues; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD |
Committee | |
Developer and funding |
New York State Department of Health AIDS Institute (NYSDOH AI) |
Development |
See Guideline Development and Recommendation Ratings Scheme, below |
Updates | |
September 9, 2022 |
Maria Teresa (Tess) Timoney, MS, RN, CNM, with the MCCC:
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August 19, 2021 |
Rodney L. Wright, MD, MS, with the MCCC: Recommendation in Third Trimester Testing updated: Before 36 weeks’ gestation (preferably between weeks 28 and 32), clinicians should perform HIV testing for all patients with an initial negative HIV antibody test result or no prior documented HIV test result. (A2) |
July 2020 |
Rodney L. Wright, MD, MS, with the MCCC:
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Guideline Development: New York State Department of Health AIDS Institute Clinical Guidelines Program | |
Developer | New York State Department of Health AIDS Institute (NYSDOH AI) Clinical Guidelines Program |
Funding Source | NYSDOH AI |
Program Manager |
Clinical Guidelines Program, Johns Hopkins University School of Medicine, Division of Infectious Diseases. See Program Leadership and Staff. |
Mission | To produce and disseminate evidence-based, state-of-the-art clinical practice guidelines that establish uniform standards of care for practitioners who provide prevention or treatment of HIV, viral hepatitis, other sexually transmitted infections, and substance use disorders for adults throughout New York State in the wide array of settings in which those services are delivered. |
Expert Committees |
The NYSDOH AI Medical Director invites and appoints committees of clinical and public health experts from throughout NYS to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of NYS, all relevant clinical practice settings, key NYS agencies, and community service organizations. |
Committee Structure |
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Conflicts of Interest Disclosure and Management |
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Evidence Collection and Review |
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Recommendation Development |
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Review and Approval Process |
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External Reviewers |
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Update Process |
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Recommendation Ratings Scheme | |||
Strength | Quality of Evidence | ||
Rating | Definition | Rating | Definition |
A | Strong | 1 | Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints. |
B | Moderate | * | Based on either a self-evident conclusion; conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial. |
C | Optional | 2 | Based on published results of at least 1 well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes. |
2† | Extrapolated from published results of well-designed studies (including nonrandomized clinical trials) conducted in populations other than those specifically addressed by a recommendation. The source(s) of the extrapolated evidence and the rationale for the extrapolation are provided in the guideline text. One example would be results of studies conducted predominantly in a subpopulation (e.g., one gender) that the committee determines to be generalizable to the population under consideration in the guideline. | ||
3 | Based on committee expert opinion, with rationale provided in the guideline text. |