HIV Testing During Pregnancy, at Delivery, and Postpartum

HIV Testing During Pregnancy, at Delivery, and Postpartum

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
  • Clinicians in NYS can call the Clinical Education Initiative (CEI Line) to speak with an experienced HIV care provider regarding maternal/fetal exposure. The CEI Line is available 24/7.
    • Call 1-866-637-2342, press “2.”

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 New York Codes, Rules and Regulations (NYCRR) Title 10, Section 405.21.

Partner Notification

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 & 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
  • Clinicians should maintain a high level of suspicion for acute HIV in all pregnant patients who present with a compatible clinical syndrome. (A3)
  • 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)
  • When screening for acute HIV, clinicians should obtain plasma HIV RNA testing in conjunction with HIV serologic testing, preferably with a 4th-generation HIV antigen/antibody 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, the clinician should make a presumptive diagnosis of acute HIV, even if the results of screening and antibody differentiation tests are nonreactive or indeterminate. (A2)
Third Trimester Testing
  • 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)
  • 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)
PrEP to Prevent HIV
  • If a patient requests pre-exposure prophylaxis (PrEP) or reports engaging in behaviors that confer risk of HIV acquisition, clinicians should assess for PrEP candidacy or refer the patient for assessment. (A1) PrEP is not contraindicated during pregnancy or while breastfeeding an infant.

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
  • 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.
  • Additional HIV testing during the third trimester is prudent when:
    • A patient reports behavior that confers high risk of HIV acquisition, such as substance use or involvement with a new sex partner whose HIV status is not known.
    • A sexually transmitted infection is diagnosed, which increases the likelihood that recent HIV infection will be identified.
  • Routine screening for chlamydia, gonorrhea, and syphilis can be combined with HIV testing at the initial visit and at 28 to 32 weeks gestation.
  • Hepatitis C virus screening should be performed in all patients who are pregnant or planning to get pregnant; screening should be repeated during each pregnancy. (See the NYSDOH guideline Treatment of Chronic HCV With Direct-Acting Antivirals > Pregnancy and HCV.)
  • 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 reports having new sex partners during pregnancy.

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. A 4th-generation HIV antigen/antibody combination immunoassay is the recommended serologic test.

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 antibody 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 NYSDOH guideline Management of Syphilis in Patients with HIV > Screening.

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
  • 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].
  • When used as prescribed, PrEP effectively prevents HIV acquisition.
  • When indicated, PrEP should be prescribed as part of a comprehensive prevention plan that includes counseling and education about adherence to PrEP medications, ongoing monitoring with laboratory tests, and discussion of risk-reduction strategies (for more information regarding PrEP, see the NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health).
  • Repeat screening for HIV and other sexually transmitted infections (chlamydia, gonorrhea, and syphilis) is part of routine PrEP management.
  • The use of antiretroviral medications during pregnancy is monitored through the Antiretroviral Pregnancy Registry.
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
  • Clinicians should offer and recommend repeat HIV testing during labor and delivery and counsel regarding the use of antiretroviral prophylaxis in the birth parent and the infant, for any patient in labor who (A2):
    • Is not known to have HIV and who does not have documented third-trimester HIV test results.
    • Has engaged in or whose partners have engaged in behaviors that confer risk of HIV acquisition or who has acquired sexually transmitted infections during the current pregnancy.
  • If the result of the expedited HIV test for a patient in labor is reactive, the clinician should:
  • If supplemental diagnostic testing confirms that a patient who is in labor has HIV, the clinician should:

 

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
  • If the result of the expedited HIV test for a patient in labor is reactive:
    • Discuss the meaning of a preliminary positive HIV test result.
    • Do not delay prophylaxis while awaiting results of confirmatory serologic testing.
    • Inform the birth parent that HIV can be transmitted through breast milk and that breastfeeding is contraindicated until they are confirmed to be HIV negative. Refer the birth parent to a lactation specialist to assist with education and support for maintenance of breast milk supply, if so desired, so breastfeeding may be initiated if HIV infection is excluded.
  • Provide education about the benefits of antiretroviral prophylaxis for any patient with HIV who declines it for themselves or their newborn.

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
  • 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.
  • Providing information about HIV and recommending HIV testing as early as possible in pregnancy is ideal.

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

HIV Testing and Management Checklist

Lead author: Rodney L. Wright, MD, MS, with the Medical Care Criteria Committee; updated August 19, 2021

Download PDF

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
  • Clinicians should maintain a high level of suspicion for acute HIV in all pregnant patients who present with a compatible clinical syndrome. (A3)
  • 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)
  • When screening for acute HIV, clinicians should obtain plasma HIV RNA testing in conjunction with HIV serologic testing, preferably with a 4th-generation HIV antigen/antibody 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, the clinician should make a presumptive diagnosis of acute HIV, even if the results of screening and antibody differentiation tests are nonreactive or indeterminate. (A2)
Third Trimester Testing
  • 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)
  • 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)
PrEP to Prevent HIV
  • If a patient requests pre-exposure prophylaxis (PrEP) or reports engaging in behaviors that confer risk of HIV acquisition, clinicians should assess for PrEP candidacy or refer the patient for assessment. (A1) PrEP is not contraindicated during pregnancy or while breastfeeding an infant.
Patients Who Present in Labor and Newborns
  • Clinicians should offer and recommend repeat HIV testing during labor and delivery and counsel regarding the use of antiretroviral prophylaxis in the birth parent and the infant, for any patient in labor who (A2):
    • Is not known to have HIV and who does not have documented third-trimester HIV test results.
    • Has engaged in or whose partners have engaged in behaviors that confer risk of HIV acquisition or who has acquired sexually transmitted infections during the current pregnancy.
  • If the result of the expedited HIV test for a patient in labor is reactive, the clinician should:
  • If supplemental diagnostic testing confirms that a patient who is in labor has HIV, the clinician should:

 

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.

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

  • New recommendation in 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 in 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)
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
  • Leadership: AI-appointed chair, vice chair(s), chair emeritus, clinical specialist(s), JHU Guidelines Program Director, AI Medical Director, AI Clinical Consultant, AVAC community advisor
  • Contributing members
  • Guideline writing groups: Lead author, coauthors if applicable, and all committee leaders
Conflicts of Interest Disclosure and Management
  • Annual disclosure of financial relationships with commercial entities for the 12 months prior and upcoming is required of all individuals who work with the guidelines program, and includes disclosure for partners or spouses and primary professional affiliation.
  • The NYSDOH AI assesses all reported financial relationships to determine the potential for undue influence on guideline recommendations and, when indicated, denies participation in the program or formulates a plan to manage potential conflicts.
  • Disclosures are listed for each committee member.
Evidence Collection and Review
  • Literature search and review strategy is defined by the guideline lead author based on the defined scope of a new guideline or update.
  • A comprehensive literature search and review is conducted for a new guideline or an extensive update using PubMed, other pertinent databases of peer-reviewed literature, and relevant conference abstracts to establish the evidence base for guideline recommendations.
  • A targeted search and review to identify recently published evidence is conducted for guidelines published within the previous 3 years.
  • Title, abstract, and article reviews are performed by the lead author. The JHU editorial team collates evidence and creates and maintains an evidence table for each guideline.
Recommendation Development
  • The lead author drafts recommendations to address the defined scope of the guideline based on available published data.
  • Writing group members review the draft recommendations and evidence and deliberate to revise, refine, and reach consensus on all recommendations.
  • When published data are not available, support for a recommendation may be based on the committee’s expert opinion.
  • The writing group assigns a 2-part rating to each recommendation to indicate the strength of the recommendation and quality of the supporting evidence. The group reviews the evidence, deliberates, and may revise recommendations when required to reach consensus. 
Review and Approval Process
  • Following writing group approval, draft guidelines are reviewed by all contributors, program liaisons, and a volunteer reviewer from the AI Community Advisory Committee.
  • Recommendations must be approved by two-thirds of the full committee. If necessary to achieve consensus, the full committee is invited to deliberate, review the evidence, and revise recommendations when required.
  • Final approval by the committee chair and the NYSDOH AI Medical Director is required for publication.
External Reviewers
  • External peer reviewers recognized for their experience and expertise review guidelines for accuracy, balance, clarity, and practicality and provide feedback.
  • Peer reviewers may include nationally known experts from outside of New York State.
Update Process
  • JHU editorial staff ensure that each guideline is reviewed and determined to be current upon the 3-year anniversary of publication; guidelines that provide clinical recommendations in rapidly changing areas of practice may be reviewed annually. Published literature is surveilled to identify new evidence that may prompt changes to existing recommendations or development of new recommendations.
  • If changes in the standard of care, newly published studies, new drug approval, new drug-related warning, or a public health emergency indicate the need for immediate change to published guidelines, committee leadership will make recommendations and immediate updates.
  • All contributing committee members review and approve substantive changes to, additions to, or deletions of recommendations; JHU editorial staff track, summarize, and publish ongoing guideline changes.
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.