Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis Services for Cisgender Women

NCT07318532 | Completed

• 2 other identifiers: MedstarRIR34MH128046
• Study Type: interventional
• Target: 745
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Prevention Program

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adoption

  Two-month intervention training period

• Intervention characteristics: organizational and patient perspectives

  6 months (four month intervention and two months of follow-up)

Study Arms (1)

PrEP CGW Pilot: W-PrEP intervention arm

EXPERIMENTAL

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)

Interventions

The women's PrEP Project (W-PrEP) BEHAVIORAL

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.

Also known as: W-PrEP

PrEP CGW Pilot: W-PrEP intervention arm

Eligibility Criteria

• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving care at the study-site clinic

You may not qualify if:

• N/A

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• 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.

  PMID: 41337677 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Note, this is a clinic-level intervention. Thus the "participant" is the clinic.

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 6, 2026
• Study Start: January 2, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

US (1)