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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06684613
Status
Recruiting
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Conditions

  • Reproductive Health
  • Sexual Risk Behavior for HIV-infection

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PrEP Decision Aid — DEVICE
    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.
  • Generic Information — OTHER
    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.

Study Details

This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.

Key Dates

Start date
Mar 11, 2026
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Sep 5, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

PrEP initiation (prescribing) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Clinical and Community ResearchNew HavenConnecticut06519
Carolina Price, MPA
[email protected]
203-499-8075
Jaimie P Meyer, MD
[email protected]
2037376233
Jaimie P Meyer, MD (PRINCIPAL_INVESTIGATOR)
Sangini S Sheth, MD (PRINCIPAL_INVESTIGATOR)

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Yale Clinical and Community Research· New Haven, CT

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