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About
This study addresses the need for HIV prevention to be integrated into contraceptive counseling visits at family planning clinics.
Full 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.
Enrollment
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Inclusion and exclusion criteria
Patients (inclusion):
Patients (exclusion):
Sexual and Reproductive Health (SRH) clinicians will be included if they provide SRH patient care at any of the participating sites. SRH clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
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Central trial contact
Carolina Price, MPA; Jaimie P Meyer, MD
Data sourced from clinicaltrials.gov
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