Purpose of This Guideline
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
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 who are at high risk of HIV acquisition during pregnancy and postpartum.
KEY POINT |
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Guideline development: This guideline was developed by the NYSDOH AI Clinical Guidelines Program, which is a collaborative effort between the NYSDOH AI Office of the Medical Director and the Johns Hopkins University School of Medicine, Division of Infectious Diseases.
Established in 1986, the goal of the Clinical Guidelines Program is to develop and disseminate evidence-based, state-of-the-art clinical practice guidelines to improve the quality of care throughout NYS for people who have HIV, hepatitis C virus, or sexually transmitted infections; people with substance use issues; and members of the LGBTQ community. NYSDOH AI guidelines are developed by committees of clinical experts through a consensus-driven process.
The NYSDOH AI charged the Medical Care Criteria Committee with developing evidence-based clinical recommendations for HIV testing during labor and delivery. The resulting recommendations are based on an extensive review of the medical literature and reflect consensus among this panel of experts. Each recommendation is rated for strength and for quality of the evidence (see below). If recommendations are based on expert opinion, the rationale for the opinion is included.
AIDS Institute Clinical Guidelines Program: Recommendations Ratings (updated June 2019 [a]) |
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Strength of Recommendation Ratings | |
A | Strong recommendation |
B | Moderate recommendation |
C | Optional |
Quality of Supporting Evidence Ratings | |
1 | Evidence is derived from published results of at least one randomized trial with clinical outcomes or validated laboratory endpoints. |
* | Evidence is strong because it is based on a self-evident conclusion(s); conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial. |
2 | Evidence is derived from published results of at least one well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes. |
2† | Evidence has been extrapolated from published results of well-designed studies (including non-randomized 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 | Recommendation is based on the expert opinion of the committee members, with rationale provided in the guideline text. |
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NYS Public Health Law
Updated July 2020
NEW YORK STATE PUBLIC HEALTH LAW |
Partner Notification
Universal HIV Screening
HIV Testing
Antiretroviral Prophylaxis
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Partner Notification
Updated July 2020
Clinicians can provide assistance with partner notification through direct referral to:
- The New York State and County Health Department Partner Services (PS) Programs.
- The 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 & Regulations.
Universal Screening and Testing in Pregnancy
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
RECOMMENDATIONS |
Universal Screening and Testing in Pregnancy
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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; AIDSinfo 2020].
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]
AIDSinfo. 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 https://aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0/ [accessed 2020 Mar 5]
PrEP to Prevent HIV
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
RECOMMENDATION |
PrEP to Prevent HIV
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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].
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References
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]
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]
Testing for Acute HIV
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
RECOMMENDATIONS |
Testing for Acute HIV
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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. A 4th-generation 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.
Reference
NYSDOH. 2017. Unpublished data.
Third Trimester Testing
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
RECOMMENDATIONS |
Third Trimester Testing
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The NYSDOH recommends that all prenatal care providers routinely recommend repeat HIV testing in the third trimester, preferably between weeks 34 and 36, for all pregnant individuals in New York State, regardless of location, who tested negative for HIV early in prenatal care [NYSDOH 2007]. The Centers for Disease Control and Prevention (CDC) and American College of Obstetrics and Gynecology (ACOG) recommend repeat HIV testing in the third trimester in areas with high incidence or prevalence of HIV; New York State is listed as an area of high HIV prevalence [Branson, et al. 2006; ACOG 2018]. The CDC and ACOG recommend repeat testing for chlamydia, gonorrhea, and syphilis in the third trimester if the patient is at risk [Workowski 2015; ACOG 2018]. Assessment for acute HIV is strongly recommended in patients who present with compatible symptoms.
Syphilis testing: The NYSDOH recommends that clinicians obtain serologic screening for syphilis for pregnant patients with HIV at the first prenatal visit, during the third trimester (28 to 32 weeks of gestation), and at delivery. See the NYSDOH guideline Management of Syphilis in Patients with HIV > Screening.
References
ACOG. Committee Opinion No. 752 Summary: Prenatal and Perinatal Human Immunodeficiency Virus Testing. Obstet Gynecol 2018;132(3):805-806. [PMID: 30134421]
Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006;55(RR-14):1-17; quiz CE11-14. [PMID: 16988643]
NYSDOH. Health alert: Steps to further reduce mother-to-child HIV transmission in New York State. 2007 https://www.health.ny.gov/diseases/aids/providers/testing/docs/healthalert.pdf [accessed 2019 Jun 10]
Workowski KA. Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines. Clin Infect Dis 2015;61 Suppl 8:S759-762. [PMID: 26602614]
HIV Testing and Management Checklist
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
Patients Who Present in Labor and Newborns
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
RECOMMENDATIONS |
Patients Who Present in Labor and Newborns
a. See Department of Health and Human Services (DHHS) Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States > Management of Infants Born to Women with HIV Infection. |
SELECTED GOOD PRACTICE REMINDERS |
Patients Who Present in Labor and Newborns
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U.S. Food and Drug Administration (FDA)-approved 4th-generation 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, 4th-generation 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 NYSDOH AI guideline HIV Testing > Steps in the HIV Diagnostic 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 in Pregnant HIV-1-Infected Women for Maternal Health 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]
All Recommendations
Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated July 2020
ALL RECOMMENDATIONS: HIV TESTING DURING PREGNANCY, AT DELIVERY, AND POSTPARTUM |
Universal Screening and Testing in Pregnancy
PrEP to Prevent HIV
Testing for Acute HIV
Third Trimester Testing
Patients Who Present in Labor and Newborns
a. See Department of Health and Human Services (DHHS) Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States > Management of Infants Born to Women with HIV Infection. |
Updates to This Guideline
July 2020
- New recommendation: Universal Screening and Testing in Pregnancy
- Clinicians should refer patients who test positive for HIV to an experienced HIV care provider who can manage antiretroviral therapy (ART) initiation (ideally within 3 days). (A3)
- New recommendations: Third Trimester Testing
- Clinicians should perform repeat HIV testing in the third trimester of pregnancy, preferably between weeks 34 and 36, for all patients with a negative HIV test result early in pregnancy. (A2)
- Clinicians should repeat HIV testing in the third trimester in patients who have engaged in behaviors that put them at risk of HIV acquisition during pregnancy or have acquired other sexually transmitted infections. (A2)
- New resources: