NCT06684613

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Sexual Risk Behavior for HIV-infection
• Reproductive Health

Interventions

Type	Name	Description
DEVICE	PrEP Decision Aid	Patient-facing decision-aid on PrEP that will be enhanced to include various formulations of available PrEP. Can be integrated into sexual and reproductive health clinics as part of counseling.
OTHER	Generic Information	Participants will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis" (available online free of charge through the CDC web site). The video will serve as a time- and attention- based control to the decision aid.

Timeline

• Start date: 2026-03-11
• Primary completion: 2027-03-01
• Completion: 2027-09-05
• First posted: 2024-11-12
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States