Integrating PrEP Decision Making Into Contraceptive Counseling in Family Planning Clinics
- Conditions
- Sexual Risk Behavior for HIV-infectionReproductive Health
- Registration Number
- NCT06684613
- Lead Sponsor
- Yale University
- Brief Summary
This study addresses the need for HIV prevention to be integrated into contraceptive counseling visits at family planning 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 (SRH) settings during contraceptive counseling visits, where PrEP can be provided to all women who are interested. Rooted in the Health Equity Implementation Framework, this study evaluates health equity 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 SRH 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 SRH clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in SRH 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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)
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
- 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