Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis Services for Cisgender Women (PrEP CGW)

January 2, 2026 updated by: Medstar Health Research Institute

Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis (PrEP) Services for Cisgender Women (CGW) (PrEP-CGW)

The goal of the "PrEP CGW" pilot study is evaluate the feasibility and acceptability of a clinic-level intervention to improve HIV prevention and Pre-exposure Prophylaxis (PrEP) services for women. The intervention includes clinic wide trainings, provider and clinic staff tool kits, PrEP navigation, and patient-facing educational resources. The overarching goal of the program is to determine if the intervention improves PrEP uptake among women.

Patients who attend the study-site clinic will be exposed to the intervention. Patients will be invited to participate in post-visit questionnaires; approximately 20 patients will be invited to participate in interviews.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of the "PrEP CGW" pilot study is evaluate the feasibility and acceptability of a clinic-level intervention to improve HIV prevention and Pre-exposure Prophylaxis (PrEP) services for women. Feasibility testing additionally includes assessing the appropriateness of the study measures (e.g., questionnaires, interviews, collection of electronic health record data) to assess the outcomes of interest in the planned full scale trial. The intervention includes clinic wide trainings, provider and clinic staff tool kits, PrEP navigation, and patient-facing educational resources developed and/or collated as part of the R34 award. The overarching goal of the program is to determine if the intervention improves PrEP uptake among women.

Patients who attend the study-site clinic will be exposed to the clinic level intervention. Patients will be invited to participate in post-visit questionnaires; approximately 20 patients will be invited to participate in interviews. Electronic health data from the intervention period will be compared with a historical control period.

Study Type

Interventional

Enrollment (Actual)

745

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Receiving care at the study-site clinic

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PrEP CGW Pilot: W-PrEP intervention arm

W-PrEP intervention arm included exposure to trained providers and clinic staff, PrEP navigation, and patient-facing educational resources such as videos, pamphlets, posters, and an educational website.

This arm was compared to historical controls from the same calendar year.
Behavioral: The women's PrEP Project (W-PrEP)
W-PrEP intervention included exposure to trained providers and clinic staff, PrEP navigation, and patient-facing educational resources such as videos, pamphlets, posters, and an educational website.
Other Names:
  • W-PrEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach
Time Frame: Each study visit within the 4 month intervention period
  • Percentage of eligible patients who received introduction to pre-exposure prophylaxis (PrEP) by navigators (by comparison of the navigators counseling log to the electronic health record (EHR)
  • Percentage of eligible patients counseled about PrEP by providers (by EHR review)
  • Percentage of eligible patients counseled by either the PrEP navigator or a provider
Each study visit within the 4 month intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adoption
Time Frame: Two-month intervention training period
  • Percentage of clinic-team members who participated in training (by attendance log)
  • Percentage of change in PrEP knowledge and PrEP best practices (pre-/post-clinic-wide training questionnaire)
Two-month intervention training period
Intervention characteristics: organizational and patient perspectives
Time Frame: 6 months (four month intervention and two months of follow-up)
  • Perceived feasibility of implementing the intervention and identified barriers (by in depth interviews (IDI) with the clinic team and navigators)
  • Satisfaction with training and intervention usability/complexity among clinic team and navigators (by IDIs with the clinic team and navigators)
  • Acceptability of the provider or navigator PrEP education/counseling, focusing on burden and addressing patient barriers (by IDI with patients)
6 months (four month intervention and two months of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MedstarRI
  • R34MH128046 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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