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Completed

NCT Number: NCT07318532

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

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.

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Key information

Conditions

HIV Prevention Program

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receiving care at the study-site clinic

Exclusion criteria

  • N/A

Treatment and study plan

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.

Other names: W-PrEP

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: PrEP CGW

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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