Current US Guidelines for Prescribing HIV Pre-exposure Prophylaxis (PrEP) Disqualify Many Women Who Are at Risk and Motivated to Use PrEP

Abstract

Background: US Centers for Disease Control and Prevention clinical guidelines for HIV pre-exposure prophylaxis (PrEP) are widely used to assess patients' PrEP eligibility. The guidelines include 2 versions of criteria-guidance summary criteria and recommended indications criteria-that diverge in a potentially critical way for heterosexually active women: Both require women's knowledge of their own risk behavior, but the recommended indications also require women's knowledge of their partners' HIV risk or recognition of a potentially asymptomatic sexually transmitted infection. This study examined women's PrEP eligibility according to these 2 different versions of criteria across risk and motivation categories.

Setting/methods: HIV-negative women (n = 679) recently engaged in care at Connecticut Planned Parenthood centers were surveyed online in 2017. The survey assessed PrEP eligibility by both versions of Centers for Disease Control and Prevention criteria, HIV risk indicators, PrEP motivation indicators, and sociodemographic characteristics.

Results: Participants were mostly non-Hispanic white (33.9%) or black (35.8%) and had low income (<$30,000/year; 58.3%). Overall, 82.3% were eligible for PrEP by guidance summary criteria vs. 1.5% by recommended indications criteria. Women disqualified by recommended indications criteria included those reporting condomless sex with HIV-positive or serostatus-unknown male partners (n = 27, 11.1% eligible); 1 or more recent sexually transmitted infection(s) (n = 53, 3.8% eligible); multiple sex partners (n = 168, 3.0% eligible); intended PrEP use (n = 211, 2.8% eligible); and high self-perceived risk (n = 5, 0.0% eligible).

Conclusion: Current guidelines disqualify many women who could benefit from PrEP and may lead to discrepant assessments of eligibility. Guideline reform is needed to improve clarity and increase women's PrEP access and consequent HIV protection.

Figures

Figure 1.

Summary of Participant Enrollment and Inclusion within Analytic Sample. aOur enrollment maximum was established as 1,000 participants. To avoid exceeding this maximum, we closed the survey to new participants when 973 had enrolled because additional patients had clicked on the survey link but not yet consented and we were uncertain whether they would continue on to enroll. bParticipant self-reported being 18 or older on screening item and subsequently reported being 17 in demographic survey question cEligiblity assessable by all 4 sets Df CDC guideline criteria: (a) 2017 recommended indications criteria, (b) 2017 guidance summary criteria, (c) 2014 recommended indications criteria, and (d) guidance summary criteria

Figure 2.

PrEP Eligibility According to 2017 CDC Criteria Among Subgroups of Women in Reporting Various Risk Indicators. aEligibility assessment assumed all participants were NOT in a high-prevalence area or network. If all participants were assumed to be in a high-prevalence area or network, 100% would be eligible based on guidance summary criteria for all risk indicators. bA total of 349 participants responded to survey items corresponding to the "experienced intimate partner violence" risk indicator because only participants who reported having sex with men (or both men and women) and having a current sexual/romantic relationship for 1+ year (n = 357) were gated to those items (and 8 responses were missing). For ail risk indicators besides the "experienced intimate partner violence" risk indicator, the total number of participants who responded to corresponding survey items ranged from 651-679 due to survey gating/display logic, missing responses, and exclusion of "prefer not to say" responses. (See Appendix 1 for description of gating/display logic and Appendix 2:eTable 1 for total n per risk indicator). cPotentially viremic = not virally suppressed or viral suppression status unknown to participant

Figure 3.

Schematic Representation of PrEP Eligibility According to 2017 CDC Criteria Among Women At Risk for HIV, Motivated to Use PrEP, or Both. RI eligible = % eligible according to CDC recommended indications criteria. GS eligible = % eligible according to CDC guidance summary criteria.