Integrating PrEP Decision-Making into Contraceptive Counseling in Family Planning Clinics

Problem: There is high unmet need for PrEP among cis-gender women in the U.S. Even where resources are available to support PrEP, it remains inaccessible to women because too few clinical settings provide it. Purpose: To support women’s choice, we will expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its

delivery into sexual and reproductive health (SRH) settings during contraceptive counseling visits, where PrEP can be provided to all women who are interested. Methods: Project Carmenta is guided by the Health Equity Implementation Framework, critical ongoing input from our Community Advisory Board and the cumulative expertise of the study team in HIV

prevention, sexual and reproductive health, decision science, implementation science, and family planning epidemiology. We will engage patients (n=15-20), clinicians (n=10), and staff (n=10) at SRH clinics across Greater New Haven, CT for semi-structured interviews to expand and enhance an existing PrEP decision aid to include all available formulations and optimize its

integration into SRH clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in SRH clinics. In a hybrid Type 2 effectiveness-implementation study, we will then randomize patients (n=50) to receive either the PrEP decision aid or generic PrEP information prior to a clinician visit. In follow-up interviews immediately post-visit, and at Months

3 and 6, primary outcomes are clinical efficacy (PrEP initiation) and implementation (using Proctor definitions for feasibility, acceptability, penetration, and adoption) that are important for future planned scale-up. Aims: The Aims of the project are: 1) To expand and enhance an existing decision aid on PrEP, and assess innovation, clinical encounter, recipients, and context-

level factors affecting its integration into contraceptive counseling visits in SRH clinics; and 2) To integrate the expanded patient-facing individual PrEP decision aid into contraceptive counseling visits and evaluate clinical and implementation outcomes. Significance: The proposed research directly addresses the key objectives of RFA-MH-24-332 and priorities of the NIH Office of AIDS

Research by using a decision aid to support women’s choice of PrEP product and providing new insights on how women weigh each option. Significance is high because integration of PrEP into SRH reduces barriers to access for women. Innovation is high because of the use of a gender- and trauma-responsive PrEP decision aid for women within a SRH setting. Public health impact

is high because of a focus on achieving health equity in a rapidly changing SRH landscape and supporting women’s choice of PrEP.