Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
Purpose
This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.
Conditions
- Sexual Risk Behavior for HIV-infection
- Reproductive Health
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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 .
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- We will use health-focused implementation frameworks to develop a semi-structured interview guide for the formative work in Aim 1. Domains will be measured in Aim 2 to examine implementation determinants. In Aim 2, we will randomize participants 1:1 to receive either a) the enhanced decision aid developed in Aim 1, or b) generic information on PrEP provided by a CDC-produced video, PrEP (Pre-Exposure Prophylaxis).
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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 |
|
|
Other 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. |
|
Recruiting Locations
New Haven 4839366, Connecticut 4831725 06519
More Details
- Status
- Recruiting
- Sponsor
- Yale University
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.