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

MedStar Health

Status: Completed

Conditions: HIV Prevention Program

Treatments: Behavioral: The women's PrEP Project (W-PrEP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07318532

R34MH128046 (U.S. NIH Grant/Contract)

MedstarRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 745 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Receiving care at the study-site clinic

Exclusion criteria

• N/A

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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745 participants in 1 patient group

PrEP CGW Pilot: W-PrEP intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: The women's PrEP Project (W-PrEP)