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. Methods: 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. Results: 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. Conclusions: 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.