Purpose of This Guideline
Lead author: Rodney L. Wright, MD, MS
Publication date: August 19, 2021
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
Timely diagnosis of HIV and rapid initiation of antiretroviral therapy are crucial to reducing the risk of perinatal HIV transmission and maintaining the health of pregnant patients and their infants. This guideline was developed by the New York State (NYS) Department of Health (DOH) AIDS Institute (AI) to provide evidence-based recommendations regarding HIV testing during pregnancy and at delivery and to promote universal HIV screening for all pregnant patients to achieve the following:
- Ensure universal HIV screening early in pregnancy, during the third trimester, and during labor for individuals who do not have a documented negative HIV status.
- Encourage third-trimester testing for syphilis and HIV testing.
- Encourage HIV testing for pregnant and postpartum patients who exhibit symptoms of acute HIV.
- Increase uptake of pre-exposure prophylaxis among pregnant patients who do not test positive for HIV but are at high risk of HIV acquisition during pregnancy and postpartum.
KEY POINT |
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NYS Public Health Law
Partner notification: Clinicians must discuss partner notification with patients who have been recently diagnosed with HIV, and the discussion must be documented in the medical record and on the Medical Provider Reporting Form (DOH-4189), as required by Public Health Law, Article 21, Title III, Section 2130.
Universal HIV screening: Clinicians in prenatal care settings must provide HIV-related information and recommend HIV testing for all pregnant patients, including those who present in labor if their HIV status is not documented.
Immediately arrange an expedited HIV test, with consent, for patients in labor when no HIV test result is documented for the current pregnancy, with results available as soon as possible.
HIV testing: Any patient who does not have a documented HIV test result during the current pregnancy and who is not known to have HIV must, with their consent, receive expedited HIV testing during labor; results must be available within 12 hours of consent and preferably within 60 minutes. All birth facilities must have the capacity to provide and perform expedited HIV testing.
- Facilities should use a U.S. Food and Drug Administration–approved HIV screening test, with results available 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.
- Ensure that expedited HIV test results are available prior to delivery to allow maximum benefits of intrapartum antiretroviral prophylaxis for the fetus.
- Supplemental diagnostic testing must be obtained for all preliminary positive HIV test results in pregnant patients.
- If a patient who presents in labor declines an HIV test, the infant is required to have an expedited HIV antibody screen at birth, with or without consent, with results available as soon as possible but no later than 12 hours after birth.
- If the infant HIV test is reactive for HIV antibodies, a plasma sample should be collected from the infant for HIV-1 nucleic acid testing. See New York Codes, Rules and Regulations (NYCRR) Title 10, Section 69-1.3.
- The DOH-4068 Maternal-Pediatric HIV Prevention and Care Program Test History and Assessment form must be completed for every pregnant individual presenting for delivery.
Antiretroviral prophylaxis: The hospital shall determine the need for, and ensure provision of, HIV prophylaxis and/or treatment per standard of care to prevent transmission to the infant, and shall record such in both the birth parent’s and newborn’s health records. See NYCRR Title 10, Section 405.21.
Partner Notification
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 (CNAP)
More information on partner notification assistance and resources is also available at HIV/AIDS Laws and Regulations.
Universal Screening and Testing in Pregnancy
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated August 19, 2021
RECOMMENDATIONS |
Universal Screening and Testing in Pregnancy
Testing for Acute HIV
Third Trimester Testing
PrEP to Prevent HIV
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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 standards of care for all pregnant individuals [ACOG 2018; DHHS 2020].
KEY POINTS |
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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 during the postpartum period through breastfeeding [NYSDOH 2017].
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 antigen/antibody 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.
Third Trimester Testing
In all locations 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 American College of Obstetrics and Gynecology (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 [ACOG 2018; Workowski, et al. 2021], 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 [ACOG 2018; Workowski, et al. 2021]. 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 the CDC > Sexually Transmitted Infections Treatment Guidelines, 2021.
- See also CDC 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 use of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; brand name Truvada) as PrEP does not increase the risk of birth defects, studies of bone mineral density (BMD) in infants born to women taking TDF-containing antiretroviral regimens have provided conflicting results [Vigano, et al. 2011; Siberry, et al. 2015]. 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]
DHHS. Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs in pregnant women with HIV infection and interventions to reduce perinatal HIV transmission in the United States. 2020 Dec 29. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/antiretroviral-management-newborns-perinatal-hiv-exposure-or-hiv-infection?view=full [accessed 2021 Aug 19]
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. [PMID: 33932342]
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]
NYSDOH. 2017. Unpublished data.
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]
Patients Who Present in Labor and Newborns
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated August 19, 2021
RECOMMENDATIONS |
Patients Who Present in Labor and Newborns
a. See Department of Health and Human Services (DHHS) Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States > Management of Infants Born to Women with HIV Infection. |
SELECTED GOOD PRACTICE REMINDERS |
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U.S. Food and Drug Administration (FDA)-approved HIV 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 for 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.
KEY POINTS |
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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 testing algorithm for maternal testing). Clinicians should collect a plasma sample from infants with a preliminary positive result and should obtain HIV-1 nucleic acid testing.
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 [Wade, et al. 1998; Fiscus, et al. 1999]. 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 DHHS Recommendations for Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
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]
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
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated August 19, 2021
All Recommendations
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated August 19, 2021
ALL RECOMMENDATIONS: HIV TESTING DURING PREGNANCY, AT DELIVERY, AND POSTPARTUM |
Universal Screening and Testing in Pregnancy
Testing for Acute HIV
Third Trimester Testing
PrEP to Prevent HIV
Patients Who Present in Labor and Newborns
a. See Department of Health and Human Services (DHHS) Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States > Management of Infants Born to Women with HIV Infection. |
Guideline Updates, Development, and Ratings
Guideline Information | |
Publication Date |
August 19, 2021 |
Intended Users |
Clinicians in New York State who provide prenatal and perinatal care to pregnant individuals who are at risk of acquiring HIV. |
Development Process |
See Guideline Development and Recommendation Ratings Scheme, below. |
Updates (date, lead author, summary) | |
August 19, 2021; MCCC, with Rodney L. Wright, MD, MS |
Recommendation ins 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; MCCC, with Rodney L. Wright, MD, MS |
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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 (NYS DOH 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. |