N/A
N=67
WeExPAnd: PrEP Demonstration Project Among Women at Risk for HIV Infection - Preexposure Prophylaxis (PrEP)
HIV-infection/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT04373551 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened — 67; 60; 27; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cultural adaptation of a patient-provider communication tool (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened |
67; 60; 27; 37; 2; 2 | — |
| PRIMARY Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients |
53; 14 | — |
| PRIMARY Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention |
53 | — |
| PRIMARY Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention |
18; 12; 5; 5; 1; 1 | — |
| PRIMARY Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention |
30.45 | — |
| PRIMARY Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention |
41.18 | — |
| SECONDARY PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2 |
1; 2; 2; 2; 0; 0 | — |
| SECONDARY PrEP Medication Adherence: Self-Reported PrEP Prescription Dosage Adherence Among Participants Who Initiated Oral PrEP at Both Site 1 and Site 2 |
72.14 | — |
| SECONDARY PrEP Clinic Visit Adherence at 3-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Both Site 1 and Site 2 |
95.83 | — |
| SECONDARY PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1 |
85.24 | — |
Summary
The objective of this application is to increase PrEP uptake among women vulnerable to HIV acquisition in the rural South, specifically those seeking care at Federally Qualified Healthcare Centers (FQHC) in rural Alabama.
The investigators will use a mixed-methods approach to adapt and pilot test a patient-provider communication tool from the Centers for Disease Control and Prevention (CDC) PrEP toolkit that focuses on the first three steps of the PrEP cascade (e.g., recognizing HIV risk, identifying as a PrEP candidate, and interested in PrEP) to increase PrEP uptake via referrals to local PrEP clinics.
Eligibility Criteria
Inclusion/Exclusion Criteria
Patients
- HIV-uninfected women
- Age 18 years or older
- English speaking
- Report sexual activity or anticipate sexual activity within 6 months
Data sourced from ClinicalTrials.gov (NCT04373551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.