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

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: HIV Prevention Program
• Intervention / Treatment: Behavioral: The women's PrEP Project (W-PrEP)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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

• Sponsor: Medstar Health Research Institute
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Scott R, Hull SJ, Kerrigan D, Wang Y, Pratt-Chapman M, Mathias-Prabhu T, Unwala N, Sadauskas M, Hose BZ, Smith M, Moriarty P, Hanson T, Tedla A, Lotke P, Ye P, Arem H. "The Women's PrEP Project," a Clinic-Based, Socio-Structural Intervention to Improve the Provision of Preexposure Prophylaxis for Cisgender Women: Interrupted Time Series Pilot. JMIR Form Res. 2025 Dec 3;9:e80653. doi: 10.2196/80653.

Study record dates

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: Women; HIV prevention; HIV pre-exposure prophylaxis (PrEP)
• 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