Clinical Trials Directory

Trials / Completed

CompletedNCT04373551

WeExPAnd: PrEP Demonstration Project Among Women at Risk for HIV Infection - Preexposure Prophylaxis (PrEP)

PrEP Demonstration Project Among Women at Risk for HIV Infection

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
67 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Investigators completed formative qualitative research to explore the HIV risk perceptions of African American or Black (AA) women with recent PrEP use, AA women who are candidates for PrEP, and providers and to identify preferences around patient-provider communication about HIV risk and PrEP services (Aim 1). The investigators then systematically adapted a patient-provider communication tool to increase PrEP uptake at federally qualified health centers in Alabama, using an iterative implementation process (Aim 2A), and assessed the feasibility, acceptability, and preliminary impact of the patient-provider communication intervention on PrEP uptake among women in a pilot pre-/post-intervention design (Aim 2B). Provider training completion rates and satisfaction with the communication tool were assessed to evaluate implementation feasibility and intervention delivery. The study systematically documented and evaluated reasons for declining PrEP referrals, incomplete referrals, failure to initiate PrEP after successful referral, and ongoing PrEP use at 3 and 12 months post-intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCultural adaptation of a patient-provider communication toolAdaptation of a patient-provider communication tool for PrEP uptake utilized among women and their providers in a pilot pre/post-intervention design.

Timeline

Start date
2022-03-07
Primary completion
2024-06-30
Completion
2024-06-30
First posted
2020-05-04
Last updated
2025-12-12
Results posted
2025-12-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04373551. Inclusion in this directory is not an endorsement.