Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
Overview
- Phase
- N/A
- Intervention
- PrEP Decision Aid
- Conditions
- Sexual Risk Behavior for HIV-infection
- Sponsor
- Yale University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- PrEP initiation (prescribing)
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients (inclusion):
- •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)
Exclusion Criteria
- Not provided
Arms & Interventions
PrEP Decision Aid
Participants randomized to the decision aid (active intervention arm), will interact with the enhanced PrEP decision aid in REDCap. This is an individualized, patient-facing decision aid that supports informed patient choice and is interactive. In contrast to shared decision aids that guide a clinical encounter, the participants uses the individualized decision aid prior to the clinical encounter to discretely assess HIV risk and build awareness before discussing with their clinician
Intervention: PrEP Decision Aid
Generic Information
Participants randomized to this arm will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis)" (available online free of charge through CDC website) that will serve as a time- and attention-based control.
Intervention: Generic Information
Outcomes
Primary Outcomes
PrEP initiation (prescribing)
Time Frame: 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
Time Frame: 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)
Time Frame: 6 months
Acceptability is defined as the user perception that the enhanced PrEP decision aid is acceptable in SRH settings.
Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)
Time Frame: 6 months
Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no)
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
Time Frame: 6 months
Penetration (reach) of the intervention, measured by recruitment rate (number of participants enrolled per month)
Secondary Outcomes
- PrEP initiation (dispensing)(6 months)
- PrEP initiation (first use)(6 months)
- PrEP persistence(6 months)
- PrEP adherence(6 months)