Recruiting
Phase 2

HIV Prevention

Sponsor:

Yale University

Code:

NCT06684613

Conditions

Sexual Risk Behavior for HIV-infection

Reproductive Health

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

PrEP Decision Aid

Generic Information

Study Details

Brief summary:

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

Study ID

NCT06684613

Start date

Mar 11, 2026

Status verified date

Sep, 2026

Completion date

Sep 5, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

PrEP Decision Aid

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

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.

Primary outcome measure

  • PrEP initiation (prescribing) [ Time Frame: 6 months ]
  • Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy [ Time Frame: 6 months ]
  • Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy) [ Time Frame: 6 months ]
  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [ Time Frame: 6 months ]
  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [ Time Frame: 6 months ]
  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [ Time Frame: 6 months ]
  • Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Carolina Price, MPA

2034998075carolina.price@yale.edu

Jaimie P Meyer, MD

2037376233jaimie.meyer@yale.edu

Locations

Yale Clinical and Community Research

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Carolina Price, MPA

203-499-8075carolina.price@yale.edu

Jaimie P Meyer, MD

2037376233jaimie.meyer@yale.edu

Principal Investigator:

Jaimie P Meyer, MD

More Information

Sponsor

Yale University

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • HIV Prevention
  • PrEP
  • sexual reproductive health
  • woman

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-04.