Just4Us: Acceptability & Feasibility of a Woman-focused Pre-Exposure Prophylaxis (PrEP) Intervention: A Randomized Controlled Trial

Background Women comprise 19% of new HIV infections in the U.S. Many women, particularly women of color, are unaware of pre-exposure prophylaxis (PrEP) as an HIV prevention option. We conducted a pilot randomized controlled trial (RCT) to assess feasibility and acceptability of a theory-based, contextually-relevant behavioral intervention, Just4Us, to promote PrEP initiation and adherence among women in New York City and Philadelphia.

Eligibility criteria included: cisgender women, aged 18-55, not living with HIV, not currently taking PrEP, and meeting PrEP eligibility guidelines. Participants were randomized 3:1 to the Just4Us Education and Activities (E&A) arm or to the Information arm (Info); all were provided with PrEP information and a referral list. E&A arm participants received an individually-delivered session with a counselor-navigator, who provided information, motivation enhancement, skills-building, problem-solving, and referrals. Between baseline and 3-month follow-up, E&A arm participants received phone calls to support linkage to care and text-messages to promote adherence. Feasibility and acceptability were assessed.

Eighty-three women were enrolled (61 intervention; 22 Info); 79% were Black, 26% Latina, exceeding diversity and enrollment targets. Attendance rate for the initial E&A and Info intervention session was 100%. Three-month retention rate was high at 90%. E&A arm participants reported feeling “very satisfied/satisfied with the following: overall session, 95%; discussion with counselor-navigator, 97%; tablet activities, 95%; text-messaging set-up, 93%.; and video, 90%. Among Info and E&A arms, 78% felt the session length was just right, and 95% stated that they would recommend/strongly recommend Just4Us to others.

The pilot RCT demonstrated feasibility and acceptability of the Just4Us E&A intervention, a promising intervention to increase uptake of PrEP among cisgender women. The team was able to recruit, implement the interventions with a high degree of fidelity, and retain the target number of PrEP-eligible socially disadvantaged women. Overall, participant feedback indicated they were generally very satisfied with their intervention. Competing Interest Statement The authors have declared no competing interest. Clinical Trial NCT03699722 Funding Statement This study was funded by the National Institute of Mental Health (R34 #1R34MH108437-01A1; PI: Anne Teitelman) and the National Institute of Allergy and Infectious Disease (P30AI045008; PI: Anne Teitelman). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The institutional review boards at the University of Pennsylvania gave ethical approvals for this work. The institutional review boards at the New York Blood Center gave ethical approvals for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present study are available upon reasonable request to the authors.