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

Not Applicable

Not yet recruiting

• Conditions: Sexual Risk Behavior for HIV-infection; Reproductive Health

• Registration Number: NCT06684613
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-23
• Study Start: 2025-10-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-09-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PrEP initiation (prescribing)	6 months	Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame
Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy	6 months	Feasibility is defined as the extent to which the enhanced PrEP decision aid can be successfully used in SRH clinic settings (qualitative).
Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)	6 months	Acceptability is defined as the user perception that the enhanced PrEP decision aid is acceptable in SRH settings.
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)	6 months	Penetration (reach) of the intervention, measured by reasons for not meeting inclusion criteria
Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)	6 months	Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no)

Secondary Outcome Measures

Name	Time	Method
PrEP initiation (dispensing)	6 months	Whether PrEP was dispensed (yes/no) in the EHR within the 6-month time frame
PrEP initiation (first use)	6 months	Whether PrEP was started by the patient within the 6 months' time frame (yes/no)
PrEP adherence	6 months	Pharmacokinetic: (objective) urine tenofovir levels (units detected/ not detected)
PrEP persistence	6 months	Dates of completed PrEP encounters in EHR (i.e., clinic dates)

Trial Locations

Locations (1)

Yale Clinical and Community Research; 🇺🇸 New Haven, Connecticut, United States