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

PrEP Demonstration Project Among Women at Risk for HIV Infection

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.

Study Overview

• Status: Completed
• Conditions: HIV-infection/AIDS
• Intervention / Treatment: Behavioral: Cultural adaptation of a patient-provider communication tool

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion/Exclusion Criteria

Patients

• HIV-uninfected women
• Age 18 years or older
• English speaking
• Report sexual activity or anticipate sexual activity within 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient: cultural adaptation of a patient-provider communication tool; Strengthening of the PrEP care continuum by developing and testing an intervention designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at substantial risk for HIV infection; developing and testing an intervention to reduce racial/disparities in PrEP uptake and use.

Behavioral: Cultural adaptation of a patient-provider communication tool; Adaptation of a patient-provider communication tool for PrEP uptake utilized among women and their providers in a pilot pre/post-intervention design.; Other Names: CDC PrEP tool kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened	To determine intervention feasibility through analysis of enrollment rates (i.e., proportion of eligible patient participants who consent to participate, decline, or are lost to follow-up over the total number of eligible patient participants screened) and reasons for declining enrollment.	Throughout recruitment period (approximately 24 months)
Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients	To determine intervention feasibility through the analysis of intervention completion rates (i.e., proportion of enrolled patient participants who completed the intervention) and reasons for incomplete intervention	Throughout recruitment period (approximately 24 months)
Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention	To determine intervention feasibility through the analysis of 3-month follow-up completion rates (i.e., proportion of enrolled patient participants with complete interventions with complete 3-month follow-up data)	Throughout recruitment and follow-up period (approximately 24 months)
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention	To determine intervention feasibility through the analysis of PrEP referral acceptance rates (i.e., proportion accepting PrEP referral among those offered) and reasons for declining a referral	Throughout recruitment period and follow-up period (approximately 24 months)
Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention	To determine intervention acceptability using the Client Satisfaction Questionnaire (CSQ-8), an 8-item instrument that measures patient participants' perceived value of the intervention. The CSQ-8 generates a total score by summing individual item responses, with possible scores ranging from 8 to 32, where higher scores reflect greater treatment satisfaction.	On intervention day, directly after intervention delivery
Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention	To determine preliminary effectiveness through PrEP uptake (i.e., proportion of patient participants who initiated PrEP (i.e., got PrEP prescription) over the number of eligible patients referred to PrEP) in the participating clinic post-intervention.	Enrollment to 3 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2	To determine PrEP medication regimen adherence, patient participants completed an adherence questionnaire using a 6-point Likert scale to self-report their perceived ability to take their PrEP medication as prescribed over the last 4 weeks. The scale ranged from excellent to very poor.	3-month Follow-up
PrEP Medication Adherence: Self-Reported PrEP Prescription Dosage Adherence Among Participants Who Initiated Oral PrEP at Both Site 1 and Site 2	To determine PrEP medication dosage adherence, patients completed an adherence questionnaire to self-report the percentage of PrEP medication they have taken in the last 4 weeks.	3-Month Follow-up
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	To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiate PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records.	From enrollment to 3-months post-enrollment
PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1	To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiated PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records.	From enrollment to 12-months post-enrollment

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Mental Health (NIMH); Massachusetts General Hospital; Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Mirjam-Colette Kempf, PhD, MPH, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Psaros C, Goodman GR, McDonald VW, Ott C, Blyler A, Rivas A, Shan L, Campbell M, Underwood E, Krakower D, Elopre L, Kudroff K, Sherr KH, Kempf MC. Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA. BMJ Open. 2023 Jun 7;13(6):e075250. doi: 10.1136/bmjopen-2023-075250.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: HIV prevention; African American women; Pre exposure prophylaxis (PrEP); cisgender women
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 300003885; 1R34MH118044-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our data sharing plans will be discussed with our NIH program officer and based on their feedback, may be altered. Our current plans call for the results of the process and outcome evaluations collected as part of this project will be shared via professional presentations and publications, and will also be shared upon request. De-identified data will also be electronically encrypted and archived for use by others who are interested in using this data. New procedures, protocols, data collection instruments and analytic routines will be made available to interested investigators.
• IPD Sharing Time Frame: Data will be available after analysis is completed.
• IPD Sharing Access Criteria: Only de-identified information will be available.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes