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Updates, Authorship, and Related Guidelines
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Developer and funding source
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New York State Department of Health AIDS Institute (NYSDOH AI)
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Intended users
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NYS clinicians who provide care to pregnant individuals who are at risk of acquiring HIV
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Development
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See Supplement: Guideline Development and Recommendation Ratings
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Updates
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September 09, 2022
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Recommendation in Universal HIV Screening in Pregnancy updated: Using an FDA-approved HIV-1/2 Ag/Ab combination immunoassay and following the standard HIV testing algorithm, clinicians should screen all patients early in pregnancy, regardless of reported exposure, risk, or symptoms. (A2) Recommendation in Testing for Acute HIV updated: If a patient’s plasma HIV RNA test result indicates a viral load ≥5,000 copies/mL (or ≥200 copies/mL for patients taking PrEP or PEP), the clinician should make a presumptive diagnosis of acute HIV, even if the results of screening and HIV-1/HIV-2 Ab differentiation immunoassays are nonreactive or indeterminate. (A2) New recommendation in Testing for Acute HIV: If a patient’s viral load is detectable but lower than the levels stated above, to rule out acute HIV infection, the clinician should repeat the plasma HIV RNA test 2 weeks after the first test, preferably with a repeat HIV-1/2 Ag/Ab combination immunoassay. (A3) Recommendations in Third Trimester HIV and Syphilis Testing updated:
Before 36 weeks’ gestation (preferably between weeks 28 and 32), clinicians should repeat HIV testing for all patients with either a negative HIV test result or no documented HIV test result early in pregnancy. (A2) Clinicians should repeat HIV testing in all pregnant patients who have engaged in behaviors that put them at risk of HIV acquisition during pregnancy or have acquired other STIs. (A2)
New recommendation in Third Trimester HIV and Syphilis Testing: Clinicians should repeat syphilis testing along with HIV testing in the third trimester in all pregnant patients. (A2) Recommendation in PrEP to Prevent HIV updated: If a patient with a negative HIV test result requests PrEP or reports being at risk of HIV acquisition, clinicians should provide or promptly refer the patient for PrEP services. (A1) PrEP with TDF/FTC is not contraindicated during pregnancy or while breastfeeding an infant.
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Author and writing group conflict of interest disclosures
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See Conflict of Interest statement*
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Related NYSDOH AI guidelines
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Purpose of This Guideline
Date of current publication: September 9, 2022
Lead author: Maria Teresa (Tess) Timoney, MS, RN, CNM
Writing group: Steven M. Fine, MD, PhD; Rona Vail, MD; Joseph P. McGowan, MD, FACP, FIDSA; Samuel T. Merrick, MD; Asa Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee:
Medical Care Criteria Committee
Date of original publication: July 21, 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.
Note on “experienced” and “expert” HIV care providers: Throughout this guideline, when reference is made to “experienced HIV care provider” or “expert HIV care provider,” those terms are referring to the following 2017 NYSDOH AI definitions:
Experienced HIV care provider: Practitioners who have been accorded HIV Experienced Provider status by the American Academy of HIV Medicine or have met the HIV Medicine Association’s definition of an experienced provider are eligible for designation as an HIV Experienced Provider in New York State. Nurse practitioners and licensed midwives who provide clinical care to individuals with HIV in collaboration with a physician may be considered HIV Experienced Providers as long as all other practice agreements are met (8 NYCRR 79-5:1; 10 NYCRR 85.36; 8 NYCRR 139-6900). Physician assistants who provide clinical care to individuals with HIV under the supervision of an HIV Specialist physician may also be considered HIV Experienced Providers (10 NYCRR 94.2)
Expert HIV care provider: A provider with extensive experience in the management of complex patients with HIV.
Universal HIV Screening in Pregnancy
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| RECOMMENDATIONS |
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Universal HIV Screening in Pregnancy
Using an FDA-approved HIV-1/2 Ag/Ab combination immunoassay and following the standard HIV laboratory testing algorithm, clinicians should screen all patients early in pregnancy, regardless of reported exposure, risk, or symptoms. (A2) Clinicians should refer patients who test positive for HIV to an experienced HIV care provider [a] who can manage ART initiation, ideally within 3 days. (A3)
Testing for Acute HIV
When a patient presents with symptoms suggestive of acute HIV infection, the clinician should perform an HIV test immediately, even if a previous HIV screening test result during the current pregnancy was nonreactive. (A2) Clinicians should maintain a high level of suspicion for acute HIV in all pregnant patients who present with a compatible clinical syndrome. (A3) When screening for acute HIV, clinicians should obtain plasma HIV RNA testing in conjunction with HIV serologic testing, preferably with an HIV-1/2 Ag/Ab combination immunoassay; the plasma HIV RNA test should be performed even if the HIV serologic screening test result is nonreactive or indeterminate. (A2) If a patient’s plasma HIV RNA test result indicates a viral load ≥5,000 copies/mL (or ≥200 copies/mL for patients taking PrEP or PEP), the clinician should make a presumptive diagnosis of acute HIV, even if the results of screening and HIV-1/HIV-2 Ab differentiation immunoassays are nonreactive or indeterminate. (A2) If a patient’s viral load is detectable but lower than the levels stated above, to rule out acute HIV infection, the clinician should repeat the plasma HIV RNA test 2 weeks after the first test, preferably with a repeat HIV-1/2 Ag/Ab combination immunoassay. (A3)
Third Trimester HIV and Syphilis Testing
Before 36 weeks’ gestation (preferably between weeks 28 and 32), clinicians should repeat HIV testing for all patients with either a negative HIV test result or no documented HIV test result early in pregnancy. (A2) Clinicians should repeat HIV testing in all pregnant patients who have engaged in behaviors that put them at risk of HIV acquisition during pregnancy or have acquired other STIs. (A2) Clinicians should repeat syphilis testing along with HIV testing in the third trimester in all pregnant patients. (A2)
PrEP to Prevent HIV
If a patient with a negative HIV test result requests PrEP or reports being at risk of HIV acquisition, clinicians should provide or promptly refer the patient for PrEP services. (A1) PrEP with TDF/FTC is not contraindicated during pregnancy or while breastfeeding an infant.
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Abbreviations: Ab, antibody; Ag, antigen; ART, antiretroviral therapy; CEI, Clinical Education Initiative; FDA, U.S. Food and Drug Administration; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection; TDF/FTC, tenofovir disoproxil fumarate/emtricitabine.
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CEI Line for expert consultation: Clinicians in New York State can speak with an experienced HIV care provider 24/7 regarding maternal or fetal HIV exposure by calling the CEI Line: 1-866-637-2342, option 2.
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| New York State Law |
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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. 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.
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).
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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:
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 recommends repeat testing for chlamydia, gonorrhea, and syphilis in the third trimester if the patient is at risk [Workowski, et al. 2021]; in light of increasing rates of congenital syphilis, the ACOG recommends repeat syphilis testing for all pregnant individuals in the third trimester regardless of risk [ACOG 2024]. 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 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].
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| Key Points |
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Routine STI screening in pregnancy: Routine screening for chlamydia, gonorrhea, and syphilis can be combined with HIV testing at the initial visit and at 28 to 32 weeks gestation. Sex partner STI testing: This Committee encourages healthcare providers to recommend HIV testing for sex partner(s) of pregnant patients. During the first prenatal visit, when a clinician provides counseling about HIV and other health conditions, the care provider can suggest that a patient’s sex partner(s) undergo testing for HIV. The same suggestion can be made if a patient is diagnosed with a new STI or reports having new sex partners during pregnancy. Whenever possible, the clinician should offer direct linkage to HIV testing and prevention services for partners. Universal hepatitis C virus (HCV) screening: The NYSDOH AI currently recommends universal HCV screening during each pregnancy. PrEP: For patients who report behavior that places them at risk for HIV acquisition, a negative HIV test result is an opportunity to encourage PrEP use. When used as prescribed, PrEP effectively prevents HIV acquisition.
TDF/FTC is the preferred PrEP regimen during pregnancy and while breastfeeding. When indicated, PrEP is an effective component of a comprehensive HIV prevention plan that includes counseling and education about adherence to PrEP medications, ongoing monitoring with laboratory tests, and discussion of risk-reduction strategies.
CEI Line for expert consultation: Clinicians in New York State can speak with an experienced HIV care provider 24/7 regarding maternal or fetal HIV exposure by calling the CEI Line: 1-866-637-2342, option 2.
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HIV Testing During Labor and in Newborns
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| RECOMMENDATIONS |
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HIV Testing and Prophylaxis During Labor and in Newborns
When a patient in labor is not known to have HIV, does not have a documented third-trimester negative HIV test result, has been diagnosed with a sexually transmitted infection during pregnancy, or reports exposure risk for themselves or sex partners, the clinician should perform expedited HIV testing with consent and discuss the use of antiretroviral prophylaxis for the patient and the newborn [a]. (A2) If the result of the expedited HIV screening test for a patient in labor is reactive, the clinician should:
If supplemental diagnostic testing confirms that a patient in labor has HIV, the clinician should:
Make arrangements for the patient with newly diagnosed HIV to see an experienced HIV care provider and, if indicated, provide referrals for case management and support services [c]. (A3) Ensure that the HIV-exposed infant is discharged from care with antiretroviral medications in hand, not just a prescription. (B3) Make arrangements for the infant’s medical follow-up with an experienced pediatric HIV care provider. (A3)
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Clinical Education Initiative (CEI) Line for expert consultation: Clinicians in New York State can speak with an experienced HIV care provider 24/7 regarding maternal or fetal HIV exposure by calling the CEI Line: 1-866-637-2342, option 2.
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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.
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Maternal HIV acquisition and acute infection confer a significant risk of HIV transmission to an infant who is being breastfed. Of maternal seroconversion-associated transmissions that occurred between 2007 and 2018, 4 of 11 were attributed to breastfeeding among women who acquired HIV early postpartum [ NYSDOH 2019]. The peripartum period is the final opportunity to provide antiretroviral prophylaxis and decrease the risk for perinatal HIV transmission to exposed infants of individuals who have not been previously identified as having HIV. As in the prenatal and peripartum periods, when a breastfeeding patient presents with symptoms suggestive of acute HIV infection, the clinician should perform an HIV test in conjunction with a plasma HIV RNA test immediately, even if previous HIV screening tests were nonreactive. Providing information about HIV and recommending HIV testing as early as possible in pregnancy is ideal. Per New York State Law, 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.
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| SELECTED GOOD PRACTICE REMINDERS |
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HIV Testing and Prophylaxis During Labor and in Newborns
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HIV Testing and Management Checklist
All Recommendations
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| RECOMMENDATIONS |
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Universal HIV Screening in Pregnancy
Using an FDA-approved HIV-1/2 Ag/Ab combination immunoassay and following the standard HIV laboratory testing algorithm, clinicians should screen all patients early in pregnancy, regardless of reported exposure, risk, or symptoms. (A2) Clinicians should refer patients who test positive for HIV to an experienced HIV care provider [a] who can manage ART initiation, ideally within 3 days. (A3)
Testing for Acute HIV
When a patient presents with symptoms suggestive of acute HIV infection, the clinician should perform an HIV test immediately, even if a previous HIV screening test result during the current pregnancy was nonreactive. (A2) Clinicians should maintain a high level of suspicion for acute HIV in all pregnant patients who present with a compatible clinical syndrome. (A3) When screening for acute HIV, clinicians should obtain plasma HIV RNA testing in conjunction with HIV serologic testing, preferably with an HIV-1/2 Ag/Ab combination immunoassay; the plasma HIV RNA test should be performed even if the HIV serologic screening test result is nonreactive or indeterminate. (A2) If a patient’s plasma HIV RNA test result indicates a viral load ≥5,000 copies/mL (or ≥200 copies/mL for patients taking PrEP or PEP), the clinician should make a presumptive diagnosis of acute HIV, even if the results of screening and HIV-1/HIV-2 Ab differentiation immunoassays are nonreactive or indeterminate. (A2) If a patient’s viral load is detectable but lower than the levels stated above, to rule out acute HIV infection, the clinician should repeat the plasma HIV RNA test 2 weeks after the first test, preferably with a repeat HIV-1/2 Ag/Ab combination immunoassay. (A3)
Third Trimester HIV and Syphilis Testing
Before 36 weeks’ gestation (preferably between weeks 28 and 32), clinicians should repeat HIV testing for all patients with either a negative HIV test result or no documented HIV test result early in pregnancy. (A2) Clinicians should repeat HIV testing in all pregnant patients who have engaged in behaviors that put them at risk of HIV acquisition during pregnancy or have acquired other STIs. (A2) Clinicians should repeat syphilis testing along with HIV testing in the third trimester in all pregnant patients. (A2)
PrEP to Prevent HIV
If a patient with a negative HIV test result requests PrEP or reports being at risk of HIV acquisition, clinicians should provide or promptly refer the patient for PrEP services. (A1) PrEP with TDF/FTC is not contraindicated during pregnancy or while breastfeeding an infant.
HIV Testing and Prophylaxis During Labor and in Newborns
When a patient in labor is not known to have HIV, does not have a documented third-trimester negative HIV test result, has been diagnosed with a sexually transmitted infection during pregnancy, or reports exposure risk for themselves or sex partners, the clinician should perform expedited HIV testing with consent and discuss the use of antiretroviral prophylaxis for the patient and the newborn [a]. (A2) If the result of the expedited HIV screening test for a patient in labor is reactive, the clinician should:
If supplemental diagnostic testing confirms that a patient in labor has HIV, the clinician should:
Make arrangements for the patient with newly diagnosed HIV to see an experienced HIV care provider and, if indicated, provide referrals for case management and support services [c]. (A3) Ensure that the HIV-exposed infant is discharged from care with antiretroviral medications in hand, not just a prescription. (B3) Make arrangements for the infant’s medical follow-up with an experienced pediatric HIV care provider. (A3)
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Abbreviations: Ab, antibody; Ag, antigen; ART, antiretroviral therapy; CEI, Clinical Education Initiative; FDA, U.S. Food and Drug Administration; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection; TDF/FTC, tenofovir disoproxil fumarate/emtricitabine.
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CEI Line for expert consultation: Clinicians in New York State can speak with an experienced HIV care provider 24/7 regarding maternal or fetal HIV exposure by calling the CEI Line: 1-866-637-2342, option 2.
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Conflict of Interest: Joseph P. McGowan: Institutional Pharma grant recipient/support, clinical trial; Gilead
Created: July 2020; Last Update: September 2022.
