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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04373551

Acronym

PrEP

Enrollment

Registered

2020-05-04

Start date

2022-03-07

Completion date

2024-06-30

Last updated

2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infection/AIDS

Keywords

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

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.

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.

Interventions

BEHAVIORALCultural 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened	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.
Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients	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
Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention	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)
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention	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
Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention	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.
Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention	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.

Secondary

Measure	Time frame	Description
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	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.
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	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.
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	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.
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	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMirjam-Colette Kempf, PhD, MPH

University of Alabama at Birmingham

Participant flow

Recruitment details

Patient participants were recruited from a Federally Qualified Health Care Center (FQHC) (Site 1) and an HIV and sexually transmitted infection (STI) clinic (Site 2) in Tuscaloosa, Alabama from March 2022-June 2024. First patient participant was enrolled March 7, 2022; last participant was enrolled in June 27, 2024.

Participants by arm

Arm	Count
Patient: Cultural Adaptation of a Patient-Provider Communication Tool The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use. Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.	67
Total	67

Arm

Count

Patient: Cultural Adaptation of a Patient-Provider Communication Tool

The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use. Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.

Total

Baseline characteristics

Characteristic	Patient: Cultural Adaptation of a Patient-Provider Communication Tool
Age, Continuous	37.6 years STANDARD_DEVIATION 11.9
Children No	22 Participants
Children Prefer not to answer	2 Participants
Children Yes	43 Participants
Do you plan to start taking PrEP as an HIV prevention method? No, not thinking about it	23 Participants
Do you plan to start taking PrEP as an HIV prevention method? Prefer not to answer	3 Participants
Do you plan to start taking PrEP as an HIV prevention method? Thinking about it; intend to start in the next month	10 Participants
Do you plan to start taking PrEP as an HIV prevention method? Thinking about it; may start in the next 6 months	21 Participants
Do you plan to start taking PrEP as an HIV prevention method? Yes, plan to start as soon as possible	10 Participants
Education Associate's/Bachelor's Degree	23 Participants
Education Graduate Degree	3 Participants
Education High School Diploma/GED	27 Participants
Education Some High School, No Diploma	14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Have household members living with HIV No	61 Participants
Have household members living with HIV Yes	6 Participants
Have you ever taken Pre-exposure Prophylaxis (PrEP) to prevent HIV infection? No	66 Participants
Have you ever taken Pre-exposure Prophylaxis (PrEP) to prevent HIV infection? Yes	1 Participants
Have you heard of a daily pill that an HIV-negative person can take to prevent getting HIV? No/Don't Know	45 Participants
Have you heard of a daily pill that an HIV-negative person can take to prevent getting HIV? Yes	22 Participants
Household Income $30,000 to less than $60,000	11 Participants
Household Income Less than $30,000	50 Participants
Household Income Missing	3 Participants
Household Income Prefer not to answer/Unknown	3 Participants
Housing A friend or relative's home/apartment	11 Participants
Housing Home/apartment owned by you/household member	10 Participants
Housing Other	1 Participants
Housing Prefer not to answer	1 Participants
Housing Publicly subsidized housing	2 Participants
Housing Renting home/apartment	42 Participants
How likely would you be to take this HIV prevention pill if it were available to you for free? Definitely would not take it	5 Participants
How likely would you be to take this HIV prevention pill if it were available to you for free? Definitely would take it	20 Participants
How likely would you be to take this HIV prevention pill if it were available to you for free? Might take it	19 Participants
How likely would you be to take this HIV prevention pill if it were available to you for free? Prefer not to answer	2 Participants
How likely would you be to take this HIV prevention pill if it were available to you for free? Probably would not take it	10 Participants
How likely would you be to take this HIV prevention pill if it were available to you for free? Probably would take it	11 Participants
Occupation/Income Source Disabled (permanently or temporarily)	13 Participants
Occupation/Income Source Looking for work or unemployed	7 Participants
Occupation/Income Source Other/Prefer not to answer	5 Participants
Occupation/Income Source Student	5 Participants
Occupation/Income Source Working/temporarily laid off	37 Participants
Primary Insurance Medicaid/Medicare	27 Participants
Primary Insurance None	19 Participants
Primary Insurance Other	3 Participants
Primary Insurance Prefer not to answer	1 Participants
Primary Insurance Private Insurance (e.g., Blue Cross)	17 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	65 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	67 Participants
Relationship Status Divorced/Separated	8 Participants
Relationship Status Married/In a relationship	20 Participants
Relationship Status Prefer not to answer	3 Participants
Relationship Status Single/Never married	35 Participants
Relationship Status Widowed	1 Participants
Religion Atheist	1 Participants
Religion Christian	56 Participants
Religion Other	2 Participants
Religion Prefer not to answer	8 Participants
Sex: Female, Male Female	67 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 67
other Total, other adverse events	0 / 67
serious Total, serious adverse events	0 / 67

Outcome results

Primary

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.

Time frame: On intervention day, directly after intervention delivery