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

NCT04373551 | Completed Results

• 2 other identifiers: 3000038851R34MH118044-01A1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-infection/AIDS

Keywords

Pre exposure prophylaxis (PrEP); HIV prevention; African American women; cisgender women

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2

  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

  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

  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

  From enrollment to 12-months post-enrollment

Study Arms (1)

Patient: cultural adaptation of a patient-provider communication tool

EXPERIMENTAL

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

Interventions

Cultural adaptation of a patient-provider communication tool BEHAVIORAL

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

Also known as: CDC PrEP tool kit

Patient: cultural adaptation of a patient-provider communication tool

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 37286316 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Target enrollment was not met due to recruitment challenges, which limited the study's statistical power to detect intervention effects.

Results Point of Contact

• Title: Dr. Mirjam-Colette Kempf
• Organization: University of Alabama at Birmingham

MKempf@uab.edu

205-934-9333

Study Officials

• Mirjam-Colette Kempf, PhD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 4, 2020
• Study Start: March 7, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data will be available after analysis is completed.
• Access Criteria: Only de-identified information will be available.

Locations

US (1)