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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07318532
Acronym
PrEP CGW
Enrollment
745
Registered
2026-01-06
Start date
2023-01-02
Completion date
2024-06-30
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention Program

Keywords

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

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.

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.

Interventions

BEHAVIORALThe 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Medstar Health Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Note, this is a clinic-level intervention. Thus the participant is the clinic.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Receiving care at the study-site clinic

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
ReachEach 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

MeasureTime frameDescription
AdoptionTwo-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)
Intervention characteristics: organizational and patient perspectives6 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026