Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.

The purpose of this study is to 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 settings during counseling visits, where PrEP can be provided to all women who are interested. Rooted in health implementation frameworks, this study evaluates health and implementation determinants simultaneously along: 1) innovation characteristics; 2) clinical encounter; 3) recipients; and 4) context.

In Aim 1, patients (n=15-20), clinicians (n=10), and staff (n=10) at sexual and reproductive health clinics across Greater New Haven, CT will be engaged for semi-structured interviews to expand and enhance an existing PrEP decision aid to include all available formulations and optimize its integration into sexual and reproductive health clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in sexual and reproductive health clinics.

In Aim 2 (a hybrid Type 2 effectiveness-implementation study), patients will be randomized (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.

Patients (inclusion):

• Woman
• Aged 18 years or older
• Have a uterus
• Do not have HIV (by self-report)
• Not currently on PrEP
• Comfortable conversing in English or Spanish
• Able to participate in informed consent procedures

Patients (exclusion):

• People who cannot become pregnant (i.e., have had a hysterectomy or tubal ligation)
• People who wish to become pregnant (will not qualify for pregnancy prevention counseling)
• Have a scheduled visit with a member of the investigative team (to minimize risk of potential ascertainment bias)
• Participants of Aim 1 cannot participate in Aim 2.

Sexual and Reproductive Health clinicians will be included if they provide sexual and reproductive health patient care at any of the participating sites. Clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles .