NCT07318532

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 745 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

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.

Conditions

• HIV Prevention Program

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-02
• Primary completion: 2024-04-30
• Completion: 2024-06-30
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States