NCT04373551: PrEP

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

Completed NA Results posted Last updated 12 December 2025

What this trial tests

NA trial testing Cultural adaptation of a patient-provider communication tool in HIV-infection/AIDS in 67 participants. Completed in 30 June 2024.

Timeline

7 March 2022

Primary endpoint
30 June 2024

30 June 2024

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	67
Start date	7 March 2022
Primary completion	30 June 2024
Estimated completion	30 June 2024
Sites	1 location across United States

Drugs / interventions tested

• Cultural adaptation of a patient-provider communication tool

Conditions studied

• HIV-infection/AIDS — all drugs for HIV-infection/AIDS →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, female only, with HIV-infection/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened Primary · Throughout recruitment period (approximately 24 months)

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.

Enrolled

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	67

Declined: No interest in research

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	60

Declined: Does not feel at risk for HIV

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	27

Declined: No time

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	37

Declined: New medication hesitancy

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	2

Declined: Other - already on PrEP

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	2

Declined: Multiple reasons

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	5

Declined: No reason provided

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	3

Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients Primary · Throughout recruitment period (approximately 24 months)

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

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	53
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	14

Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention Primary · Throughout recruitment and follow-up period (approximately 24 months)

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)

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	53

Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention Primary · Throughout recruitment period and follow-up period (approximately 24 months)

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

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	18
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	12
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	5
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	5

Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention Primary · On intervention day, directly after intervention delivery

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.

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	30.45	± 1.78

Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention Primary · Enrollment to 3 months 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.

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	41.18	21.56 – 64.05

PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2 Secondary · 3-month Follow-up

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.

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	1
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	2
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	2
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	2

PrEP Medication Adherence: Self-Reported PrEP Prescription Dosage Adherence Among Participants Who Initiated Oral PrEP at Both Site 1 and Site 2 Secondary · 3-Month Follow-up

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.

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	72.14	± 22.33

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 Secondary · From enrollment to 3-months post-enrollment

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.

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	95.83	± 11.78

PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1 Secondary · From enrollment to 12-months post-enrollment

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.

Group	Value	95% CI
Patient: Cultural Adaptation of a Patient-Provider Communication Tool	85.24	± 20.35

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Psaros C, Goodman GR, McDonald VW, Ott C, et al · · 2023 · cited 3× · PMID 37286316 · DOI 10.1136/bmjopen-2023-075250