Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PrEP Decision Aid, Generic Information.
- Who it may be relevant to
- Registry conditions: Sexual Risk Behavior for HIV-infection, Reproductive Health. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
Overview
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.
Interventions
- 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.
Primary outcome measures
- PrEP initiation (prescribing) [Time frame: 6 months]
- Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy [Time frame: 6 months]
- Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy) [Time frame: 6 months]
- Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [Time frame: 6 months]
- Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [Time frame: 6 months]
- Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [Time frame: 6 months]
- Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy) [Time frame: 6 months]
Secondary outcome measures (6)
- PrEP initiation (dispensing) [Time frame: 6 months]
- PrEP initiation (first use) [Time frame: 6 months]
- PrEP adherence [Time frame: 6 months]
- PrEP adherence [Time frame: 6 months]
- PrEP adherence [Time frame: 6 months]
- PrEP persistence [Time frame: 6 months]
Eligibility criteria
Patients (inclusion):
- Woman
- 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)
- Have a scheduled visit with a member of the investigative team (to minimize risk of potential ascertainment bias)
- Participants of Aim 1 cannot participate in Aim 2.
Sexual and Reproductive Health clinicians will be included if they provide sexual and reproductive health patient care at any of the participating sites. Clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Yale Clinical and Community Research — New Haven
Identifiers
NCT: NCT06684613 · 2000038555 · 1R34MH137756-01