Adding a PrEP decision aid to counseling at sexual and reproductive health clinics

Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

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: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Yale University (other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06684613 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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 .

Where this trial is running

New Haven, Connecticut

• 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

Conditions: Sexual Risk Behavior for HIV-infection, Reproductive Health, HIV Prevention, PrEP, sexual reproductive health, woman