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Society for Maternal-Fetal Medicine Special Statement: Updated checklists for pregnancy management in persons with HIV

Published:August 27, 2020DOI:https://doi.org/10.1016/j.ajog.2020.08.064
      Optimal management of HIV-positive pregnant individuals involves many specific interventions made by many healthcare professionals at specific time-points before, during, and after pregnancy. Errors of omission are likely unless those professionals use a cognitive aid such as a checklist as a reminder of critical steps. In this document, SMFM presents updated and expanded checklists to help ensure that all relevant elements are considered for every person with HIV during prepregnancy, antepartum, intrapartum, and postpartum periods. The checklists are intended to be used as tools to facilitate the care of individuals with HIV during all phases of pregnancy care. Their use should improve the safety of HIV-positive patients by ensuring that appropriate treatment is given and relevant information is shared with consultative services. Routine use should also facilitate improved documentation, communication, and continuity of care before, during, and after pregnancy.

      Key words

      Introduction

      The Centers for Disease Control and Prevention (CDC) estimates that more than 1.1 million people in the United States are living with HIV infection, and 1 of 7 individuals is unaware of their infection.
      Center for Disease Control and Prevention
      HIV Surveillance Report: Diagnosis of HIV infection in the United States and dependent areas, 2018 [Updated].
      In 2018, 24% of new cases were attributed to heterosexual contact and 7% to intravenous drug use.
      Center for Disease Control and Prevention
      HIV Surveillance Report: Diagnosis of HIV infection in the United States and dependent areas, 2018 [Updated].
      The burden of the disease is higher in some populations, with 42% of new cases occurring in those of African American race and 26% in those of Hispanic ethnicity.
      Center for Disease Control and Prevention
      HIV Surveillance Report: Diagnosis of HIV infection in the United States and dependent areas, 2018 [Updated].
      As the available treatment options have improved, more patients are living with their infection rather than dying from its complications. With treatment, the rate of perinatal transmission from mother to child is <2%.
      Centers for Disease Control and Prevention
      HIV and pregnant women, infants, and children.
      Because many people may not know their HIV status and may be at risk for both HIV and unintended pregnancy through sexual contact, obstetrician-gynecologists are often the first healthcare professionals to offer testing and provide a new HIV diagnosis.
      American College of Obstetrics and Gynecology
      ACOG Committee Opinion no. 389, Human immunodeficiency virus.
      Because of the significant benefits offered by treatment and risk reduction for perinatal transmission, universal testing is recommended at least once during one’s lifetime and during each prenatal episode.
      American College of Obstetricians and Gynecologists
      ACOG Committee Opinion no. 752: prenatal and perinatal human immunodeficiency virus testing.
      Once a patient is known to be HIV positive, appropriate counseling, treatment, and multidisciplinary care are recommended. Ideally, this care begins in the prepregnancy period to allow time for appropriate management of medications to suppress the virus.
      American College of Obstetricians and Gynecologists
      ACOG Committee Opinion no. 762: prepregnancy counseling.
      ,
      • Bhatt S.J.
      • Douglas N.
      Undetectable equals untransmittable (U = U): implications for preconception counseling for human immunodeficiency virus serodiscordant couples.
      In serodiscordant couples, preconception counseling should include a discussion of preexposure prophylaxis treatment for a partner.
      American College of Obstetricians and Gynecologists
      ACOG Committee Opinion no 595: Committee on Gynecologic Practice: preexposure prophylaxis for the prevention of human immunodeficiency virus.
      During pregnancy, the patient must be carefully monitored to ensure adherence with medication recommendations and to avoid the development of viral resistance and potentially teratogenic side effects.
      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 [Updated].
      Many resources are available to assist with medication selection and treatment, including a national 24-hour hotline for questions.
      UCSF National Clinician Consultation Center
      Clinician consultation.
      When planning for delivery, a multidisciplinary team, including the obstetrician, infectious disease specialist, and pediatrician, should determine the safest mode of delivery on the basis of the viral load and obstetrical condition and also determine a plan for neonatal treatment.
      American College of Obstetricians and Gynecologists
      ACOG Committee Opinion no. 751: labor and delivery management of women with human immunodeficiency virus infection.
      Optimal management of pregnant individuals who are HIV positive, therefore, involves many specific interventions made by various healthcare professionals at specific time points before, during, and after pregnancy. Errors of omission are likely unless those professionals use a cognitive aid, such as a checklist, as a reminder of critical steps to be taken at particular times.
      • Bernstein P.S.
      • Combs C.A.
      • et al.
      Society for Maternal-Fetal Medicine (SMFM)
      The development and implementation of checklists in obstetrics.
      Since 2016, the Society for Maternal-Fetal Medicine (SMFM) has posted a checklist for preconception and antepartum management of persons with HIV on its website.
      Society for Maternal-Fetal Medicine
      SMFM patient safety checklists.
      Here, SMFM presents updated and expanded checklists to help ensure that all relevant elements are considered for every person with HIV during prepregnancy, antepartum, intrapartum, and postpartum periods. Practical tips to help facilities adapt the checklist for their own circumstances and implement it at their sites are also included.

      Checklists for HIV Care

      Box 1 presents a checklist for prepregnancy management, Box 2 for antepartum management, and Box 3 for intrapartum and postpartum management. The checklists are intended to be used as tools to facilitate the care of individuals with HIV during all phases of pregnancy care. Their use should improve the safety of patients who are HIV positive by ensuring that appropriate treatment is given and relevant information is shared with consultative services. Routine use should also facilitate improved documentation, communication, and continuity of care before, during, and after pregnancy.
      Sample checklist for prepregnancy management of persons with HIV
      Checklist for Prepregnancy Management of Persons With HIV
      This checklist is a sample and should be modified as needed to fit local circumstances
      • Discuss ways to safely become pregnant.
      • Ensure an undetectable HIV viral load prior to attempting pregnancy.
      • Ensure combined antiretroviral therapy (cART) agents are appropriate for use during pregnancy.
      • Laboratory testing:
      • HIV viral load
      • CD4 T-lymphocyte cell count
      • Antiretroviral drug resistance (genotype) panel
      • G6PD and HLA-B∗ 5701
      • Toxoplasmosis immunity
      • Hepatitis B surface antigen, hepatitis B surface antibody
      • Hepatitis A total antibody
      • Hepatitis C antibody
      • Tuberculosis screening (PPD skin test or quantiferon)
      • Ensure vaccines are up to date (pneumococcal, hepatitis B, hepatitis A, flu, MMR, varicella, HPV, tDAP). Consult CDC for HIV-specific vaccine recommendations: cdc.gov/vaccines/adults/rec-vac/health-conditions/hiv.html
      • Optimize comorbidities (smoking cessation, treatment for opiate use disorders, treatment for viral hepatitis [B or C], management of diabetes, hypertension, cervical HPV).
      • Discuss disclosure of patient’s HIV status to partner(s).
        • Offer partner(s) testing and referral to infectious disease specialist if indicated.
        • Discuss PrEP.
        • Ensure partner’s vaccines are up to date.
      Version: September 23, 2020.
      CD4, T-lymphocyte cluster of differentiation 4; CDC, Centers for Disease Control and Prevention; G6PD, glucose-6-phosphate dehydrogenase; HPV, human papillomavirus, MMR, measles, mumps, rubella vaccine; PPD, purified protein derivative; PrEP, preexposure prophylaxis; tDAP, tetanus, diphtheria, acellular pertussis vaccine.
      Gibson. SMFM Special Statement: Updated checklists for pregnancy management in persons with human immunodeficiency virus. Am J Obstet Gynecol 2020.
      Sample checklist for antepartum management of gravidas with HIV
      Checklist for Antepartum Management of Gravidas With HIV
      This checklist is a sample and should be modified as needed to fit local circumstances.
      First Prenatal Visit
      • Laboratory testing:
        • Order any tests listed in prepregnancy checklist that are not already completed.
        • Update:
          • HIV viral load
          • CD4 T-lymphocyte cell count
      • Begin cART regimen that contains three active medications based on perinatal guidelines recommendations and/or consult with specialist.
        • Do not wait for genotype results to start treatment.
        • If HLA-B∗ 5701-positive, do not use abacavir.
        • If G6PD deficiency is present, do not use trimethoprim/sulfamethoxazole for Pneumocystis jirovecii prophylaxis or treatment.
      • If currently on effective cART, continue the same treatment during pregnancy unless contraindicated.
      First and Second Trimesters
      • Recheck CD4 T-lymphocyte cell count every 3 months.
        • Every 6 months for patients with undetectable viral load and CD4 count >200 copies/mL
      • Recheck viral load monthly until RNA levels are undetectable, then every 1-3 months thereafter.
        • Recheck viral load 2-4 weeks after initiating (or changing) cART.
        • If failure of viral suppression is found:
        • Assess viral resistance if viral load remains >500 copies/mL with HIV genotype testing
        • Assess adherence.
        • Consult an HIV treatment expert.
      • Assess adherence and tolerance to cART at every patient visit.
      • Address nausea or other barriers to adherence.
      • Give vaccines if needed (pneumococcal, hepatitis A and B, influenza).
      • If on protease inhibitor-based regimen, consider early glucose screening.
      Third Trimester
      • Repeat screening for syphilis, gonorrhea, and chlamydia at 28-34 weeks.
      • Reassess viral load at 34-36 weeks for delivery planning.
        • If viral load is not suppressed, assess adherence and viral resistance.
      • Make a postpartum plan for cART.
      • Determine plan for contraception after delivery.
      • Discuss infant plan of care and availability of pediatric infectious disease team for prophylaxis.
      • Make delivery plan including whether zidovudine will be used and route of delivery.
        • If viral load is ≥1000 copies/mL at 37-38 weeks, schedule cesarean delivery at 38 weeks.
      Version: September 23, 2020.
      cART, combined antiretroviral therapy; CD4 T-lymphocyte, cluster of differentiation 4; CDC, Centers for Disease Control and Prevention; G6PD, glucose-6-phosphate dehydrogenase.
      Gibson. SMFM Special Statement: Updated checklists for pregnancy management in persons with HIV. Am J Obstet Gynecol 2020.
      Sample checklist for intrapartum and postpartum management of persons with HIV
      Checklist for Intrapartum and Postpartum Management of Persons With HIV
      This checklist is a sample and should be modified as needed to fit local circumstances.
      Labor or Preoperatively for Cesarean
      • Treat with zidovudine (ZDV) for at least 3 hours prior to delivery [1-hour intravenous loading dose (2 mg/kg), followed by continuous infusion (1 mg/kg/hr) until delivery] if viral load ≥1000 copies/ml (treatment can be considered if viral load is <1000 copies/ml).
      • Avoid scalp electrodes or internal fetal monitors.
      • Ensure appropriate staff personal protective equipment is available and worn by all staff.
      • Continue cART regimen.
      Immediately After Delivery
      • Establish pathway for neonatal treatment within 12 hours of delivery.
      • Avoid use of methergine or other ergotamines with protease inhibitors or cobicistat to avoid exaggerated vasoconstrictive responses.
      • Continue cART regimen.
      Postpartum
      • Support formula feeding.
      • Support neonatal follow-up medication and testing plan.
      • Ensure reliable contraception with condoms.
      • Discuss PrEP.
      • Continue cART regimen.
      • Ensure cervical cytology (Pap test) and HPV screening are up to date; refer to colposcopy if needed.
      • Ensure transition to long-term follow-up with infectious disease specialist.
      • Ensure transition to long-term follow-up with primary care provider.
      Version: September 23, 2020.
      cART, combined antiretroviral therapy; HPV, human papillomavirus; Pap, Papanicolaou; PrEP, preexposure prophylaxis; ZDV, zidovudine.
      Gibson. SMFM Special Statement: Updated checklists for pregnancy management in persons with HIV. Am J Obstet Gynecol 2020.
      Key differences between the current checklists and the 2016 versions are as follows:
      For checklist design, we followed the guidance of Ariadne Labs’ A Checklist for Checklists.
      Ariadne Labs
      A checklist for checklists. 2010.
      For example, each checklist is presented in a simple uncluttered format on a single page, uses a sans-serif font, avoids the use of color; and includes a version date.
      The checklists should be considered examples because each institution will likely need to modify them to fit its unique circumstances.

      Suggestions for Implementation

      These checklists have many intended users located at various sites in the healthcare system, including the prenatal clinic, the infectious disease specialist office, the inpatient obstetrical and pediatric units, the postpartum clinic, and the pediatrician office. If all of these users are part of an integrated system sharing a common electronic health record (EHR), then the checklists should ideally be incorporated into the EHR. However, if the various users do not share a common EHR platform, a paper format may be needed, but there are significant challenges in determining how to ensure that all users have access to the current version of each patient’s checklist in progress during encounters at various sites.
      One purpose of the checklists is to encourage teamwork and communication. Therefore, it is anticipated that a team of relevant stakeholders will be needed for effective implementation of the checklists. Potential members of a workgroup for the adoption-implementation process may include the following:
      • 1.
        Physicians who care for individuals with HIV (obstetrical, maternal-fetal medicine, infectious disease) and their children (pediatrics, neonatology)
      • 2.
        Outpatient nursing staff and advanced practitioners
      • 3.
        Social workers and community outreach workers
      • 4.
        Inpatient nursing staff and administration (labor and delivery, antepartum, postpartum)
      • 5.
        Specialists in the EHR, if an electronic implementation is planned
      • 6.
        Patient advocates
      Such a team could be formed at the maternity hospital level and involve relevant members of community practices, but other models are possible.
      The implementation team leader or leaders should set actionable goals and a projected timetable for the rollout of the checklists. The team should meet to discuss several key issues that will need to be solved during implementation:
      • 1.
        Should each patient have an individual working copy of the checklists, either in the EHR or on paper, with items literally checked off as they are completed? Alternatively, should healthcare professionals simply refer to the relevant section of the checklists when providing care at various phases to double-check that all items have been done?
      • 2.
        Does the checklist content need to be modified to reflect actual current local practice? Alternatively, is there a need to encourage a change in local practice to bring it in line with the guidance on the checklists?
      • 3.
        Should the 3 checklists be introduced all at once, or should they be implemented 1 at a time?
      • 4.
        Are there other ways that the checklists need to be adapted or amended to fit the unique circumstances of local facilities?
      • 5.
        Where and in what format will the checklists be kept? If they will be EHR templates, significant resources will need to be allocated for the development of dedicated EHR modules and for training of staff regarding their use. If they will be paper forms, where is the best place to keep master copies, and how will updated copies be distributed to other team members when items are updated over time? One possible solution would be to have the patient keep the master copy and bring it with them when attending various facilities for care. Another would be to have the documents in a shared, Health Insurance Portability and Accountability Act of 1996–compliant Internet (cloud) document-sharing platform.
      • 6.
        Will use of the checklists be mandatory or voluntary?
      • 7.
        How will the staff be informed and educated about the availability of the checklists and expectations for use? Before rollout, the checklists should be reviewed at department meetings, grand rounds, and nursing in-service teaching sessions to engage a broad spectrum of physicians and nurses so that all have a stake in the project.
      • 8.
        Who will be responsible for initiating the checklists (physician or nurse), and how will the team members be held accountable for adherence?

      Quality Indicators

      Once the checklists have been put into practice, it is essential to have follow-up so that revisions can be made and outcomes evaluated to look for areas of future improvement. The implementation team should consider ways to encourage feedback and to collate suggestions for modifications to the checklists.
      Clinical quality indicators can be used to assess whether the checklists are being used effectively. Some suggested quality indicators include the percentage of gravidas who are HIV positive and who had the following:
      • 1.
        Measurement of HIV viral load within 2 to 4 weeks after initiating antiretroviral therapy
      • 2.
        Repeat screening for syphilis, gonorrhea, and chlamydia at 28 to 34 weeks of gestation
      • 3.
        A documented delivery plan in the antepartum record, including timing and route of delivery, peripartum use of zidovudine or other anti-HIV agents, and newborn plan of care
      To address racial and ethnic disparities in the incidence of HIV and rates of maternal and perinatal morbidity and mortality, these indicators should all be stratified by race and ethnicity. Individual facilities can consider other relevant quality metrics.

      References

        • Center for Disease Control and Prevention
        HIV Surveillance Report: Diagnosis of HIV infection in the United States and dependent areas, 2018 [Updated].
        (Available at:)
        • Centers for Disease Control and Prevention
        HIV and pregnant women, infants, and children.
        (Available at:)
        • American College of Obstetrics and Gynecology
        ACOG Committee Opinion no. 389, Human immunodeficiency virus.
        Obstet Gynecol. 2007; 110: 1473-1478
        • American College of Obstetricians and Gynecologists
        ACOG Committee Opinion no. 752: prenatal and perinatal human immunodeficiency virus testing.
        Obstet Gynecol. 2018; 132: e138-e142
        • American College of Obstetricians and Gynecologists
        ACOG Committee Opinion no. 762: prepregnancy counseling.
        Obstet Gynecol. 2019; 133: e78-e89
        • Bhatt S.J.
        • Douglas N.
        Undetectable equals untransmittable (U = U): implications for preconception counseling for human immunodeficiency virus serodiscordant couples.
        Am J Obstet Gynecol. 2020; 222: 53e1-53e4
        • American College of Obstetricians and Gynecologists
        ACOG Committee Opinion no 595: Committee on Gynecologic Practice: preexposure prophylaxis for the prevention of human immunodeficiency virus.
        Obstet Gynecol. 2014; 123: 1133-1136
        • 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 [Updated].
        (Available at:)
        • UCSF National Clinician Consultation Center
        Clinician consultation.
        (Available at:)
        http://nccc.ucsf.edu/clinician-consultation
        Date: 2020
        Date accessed: September 14, 2020
        • American College of Obstetricians and Gynecologists
        ACOG Committee Opinion no. 751: labor and delivery management of women with human immunodeficiency virus infection.
        Obstet Gynecol. 2018; 132: e131-e137
        • Bernstein P.S.
        • Combs C.A.
        • et al.
        • Society for Maternal-Fetal Medicine (SMFM)
        The development and implementation of checklists in obstetrics.
        Am J Obstet Gynecol. 2017; 217: B2-B6
        • Society for Maternal-Fetal Medicine
        SMFM patient safety checklists.
        (Available at:)
        • Ariadne Labs
        A checklist for checklists. 2010.
        (Available at:)