Adding a PrEP decision aid to counseling at sexual and reproductive health clinics
Official title: Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
Run by Yale University · NCT06684613 · Data updated 2026-11-12
This project will test whether giving a PrEP decision aid to women at sexual and reproductive health clinic visits helps them choose and start the best HIV prevention option.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | September 5, 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT06684613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who have a uterus, do not have HIV, are not currently on PrEP, can consent in English or Spanish, and are attending participating sexual and reproductive health clinics are ideal candidates.
✕Probably not a fit
People who already take PrEP, have HIV, cannot become pregnant (e.g., hysterectomy or tubal ligation), or who wish to become pregnant are unlikely to benefit from this decision aid in this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project first expands and refines an existing PrEP decision aid through interviews with patients (15–20), clinicians (10), and clinic staff (10) in Greater New Haven to include all available PrEP formulations and optimize clinic integration. It then conducts a hybrid Type 2 randomized test in which 50 patients are assigned to receive either the decision aid or generic PrEP information before a clinician visit. Primary outcomes include PrEP initiation (clinical efficacy) and implementation outcomes—feasibility, acceptability, penetration, and adoption—measured immediately post-visit and at 3 and 6 months. The work is rooted in implementation science frameworks to inform scalable delivery in sexual and reproductive health settings.
Why it matters
Potential benefit: If successful, this approach could increase PrEP uptake among women by making prevention options clearer and easier to access during routine reproductive health visits.
How similar studies have gone: Prior clinic-based PrEP programs and decision aids have shown promise for increasing uptake, but integrating a comprehensive formulation-inclusive decision aid into sexual and reproductive health visits for women is relatively new.
Who can join: the full rules
Show full inclusion / exclusion 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 .
Where it's running
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Yale Clinical and Community Research
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Jaimie P Meyer, MD — Yale Clinical and Community Research, Yale School of Medicine
- Study coordinator: Carolina Price, MPA
- Email: carolina.price@yale.edu
- Phone: 2034998075
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.