Actively Recruiting
Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
Led by Yale University · Updated on 2026-03-19
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve HIV prevention by integrating a decision aid for pre-exposure prophylaxis (PrEP) into counseling visits at sexual and reproductive health clinics, focusing on women at risk of HIV. The study evaluates how well the enhanced decision aid supports informed choice and its implementation within clinical settings, examining factors like innovation, clinical encounters, recipient experiences, and context. Participants will be randomized to one of two groups: one using an individualized, interactive PrEP decision aid before their clinical visit to assess HIV risk and build awareness, and the other watching a CDC-produced video about PrEP as a control. The study includes an initial phase of interviews with patients, clinicians, and staff to refine the decision aid and prepare clinics for its use. During the study, participants will be followed up immediately after the clinical visit and at 3 and 6 months to assess outcomes such as PrEP initiation, feasibility, acceptability, reach, and adoption of the decision aid in clinics. The study involves interviews, questionnaires, and monitoring of PrEP use and adherence over six months to evaluate both clinical and implementation outcomes.
CONDITIONS
Brief Title
Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- People who cannot become pregnant (e.g., hysterectomy or tubal ligation)
- People who wish to become pregnant
- Have a scheduled visit with a member of the investigative team
- Participants of Aim 1 cannot participate in Aim 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session before clinical visit
Participants interact with either the enhanced PrEP decision aid or watch a CDC-produced PrEP information video prior to their clinical visit to support informed decision making about PrEP.
1 visit (in-person)
Duration - 6 months
Participants complete follow-up interviews immediately after their clinical visit and at 3 and 6 months to evaluate PrEP initiation, adherence, and implementation outcomes.
3 follow-up visits (in-person or remote) over 6 months
Trial Site Locations
Total: 1 location
1
Yale Clinical and Community Research
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
C
Carolina Price, MPA
J
Jaimie P Meyer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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