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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH128046 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reach |
| Each study visit within the 4 month intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Adoption |
| Two-month intervention training period |
| Intervention characteristics: organizational and patient perspectives |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41337677 | Result | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 6, 2026 | |
| Reset | Jan 21, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2021 | Dec 23, 2025 | SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 6, 2026 | Jan 21, 2026 |
Note, this is a clinic-level intervention. Thus the "participant" is the clinic.
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| 6 months (four month intervention and two months of follow-up) |