NCT06684613

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

October 30, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 11, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

October 30, 2024

Last Update Submit

March 17, 2026

Conditions

Reproductive HealthSexual Risk Behavior for HIV-infection

Keywords

HIV PreventionPrEPsexual reproductive healthwoman

Outcome Measures

Primary Outcomes (7)

  • PrEP initiation (prescribing)

    Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame

    6 months

  • Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy

    Feasibility is defined as the extent to which the enhanced PrEP decision aid can be successfully used in SRH clinic settings (qualitative).

    6 months

  • Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)

    Acceptability is defined as the user perception that the enhanced PrEP decision aid is acceptable in SRH settings.

    6 months

  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)

    Penetration (reach) of the intervention, measured by recruitment rate (number of participants enrolled per month)

    6 months

  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)

    Penetration (reach) of the intervention, measured by completion rate (percentage of participants completing 6-month interviews out of those enrolled)

    6 months

  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)

    Penetration (reach) of the intervention, measured by reasons for not meeting inclusion criteria

    6 months

  • Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)

    Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no)

    6 months

Secondary Outcomes (6)

  • PrEP initiation (dispensing)

    6 months

  • PrEP initiation (first use)

    6 months

  • PrEP adherence

    6 months

  • PrEP adherence

    6 months

  • PrEP adherence

    6 months

  • +1 more secondary outcomes

Study Arms (2)

PrEP Decision Aid

EXPERIMENTAL

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

Device: PrEP Decision Aid

Generic Information

OTHER

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.

Other: Generic Information

Interventions

PrEP Decision AidDEVICE

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.

PrEP Decision Aid
Generic InformationOTHER

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.

Generic Information

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWoman
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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 .

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Yale Clinical and Community Research

New Haven, Connecticut, 06519, United States

RECRUITING

Related Links

Study Officials

  • Jaimie P Meyer, MD

    Yale Clinical and Community Research, Yale School of Medicine

    PRINCIPAL INVESTIGATOR

  • Sangini S Sheth, MD

    Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Price, MPA

CONTACT

2034998075carolina.price@yale.edu

Jaimie P Meyer, MD

CONTACT

2037376233jaimie.meyer@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: We will use health-focused implementation frameworks to develop a semi-structured interview guide for the formative work in Aim 1. Domains will be measured in Aim 2 to examine implementation determinants. In Aim 2, we will randomize participants 1:1 to receive either a) the enhanced decision aid developed in Aim 1, or b) generic information on PrEP provided by a CDC-produced video, PrEP (Pre-Exposure Prophylaxis).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 12, 2024

Study Start

March 11, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 5, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)