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

HIV-infection/AIDS Clinical Trial

— PrEP  

Official title:

PrEP Demonstration Project Among Women at Risk for HIV Infection

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04373551
• Other study ID #: 300003885
• Secondary ID: 1R34MH118044-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this application is to increase PrEP uptake among AA women at-risk for HIV-infection 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 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.

Description:

The investigators propose: (1) to explore the HIV risk perceptions of AA women with recent PrEP use, AA women who are candidates for PrEP, and providers and identify preferences around patient-provider communication about HIV risk and PrEP services that address the needs of AA women.

(2A) To systematically adapt a patient-provider communication tool to increase PrEP uptake at two FQHCs in rural Alabama, using an iterative implementation process; and (2B). To assess the feasibility, acceptability, and preliminary impact of the patient-provider communication intervention on PrEP uptake among AA women and their providers in a pilot pre-/post-intervention design.

As part of aim 2B), the investigators will also systematically document and evaluate reasons for declining a PrEP referral, reasons for incomplete referrals, reasons for failing to initiate PrEP after a successful referral, and ongoing PrEP use at 3 months and 12 months post PrEP initiation among our sample.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 125
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion/Exclusion Criteria

Patients

• Cisgender

• African American

• HIV-uninfected women

• Age 18 years or older

• English speaking

• Report HIV risk and/or recent PrEP use.

Providers

• Physicians, nurse practitioners, physician assistants, nurses, medical assistants, social workers/counselors or other potential/actual PrEP service providers

• English speaking

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• HIV-infection/AIDS
• Infections

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (4)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Beth Israel Deaconess Medical Center, Massachusetts General Hospital, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP uptake changes	To examine changes in PrEP uptake rates in the participating clinics comparing 3 years before and the year after the implementation of the protocol. Uptake will be calculated by the ratio of patients initiating PrEP to the number of eligible patients screened.	baseline, 3 months, and 12 months
Primary	Intervention feasibility changes	The following variable will be analyzed to determine feasibility: Number of participants screened, enrolled, and number who agreed to use PrEP and adhered to their prescribed regimen; reasons for declining enrollment, prematurely leaving the study, refusing a referral, failing to attend a PrEP clinic visit, and/or discontinuing PrEP. Recruitment and scheduling strategies, participant contact, and feasibility of administering instruments (e.g. assessment duration), will be documented and analyzed at each time frame.	baseline, 3 months, and 12 months
Primary	Intervention acceptability	All participants will be asked to consent to an in-depth, qualitative phone interview exploring their perceptions of the study, as well as an evaluation of the PrEP uptake intervention.	Through study completion, an average of 12 months
Secondary	PrEP adherence	The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire (i.e. Visual Analog Scale only) will be used to assess PrEP adherence, as is currently practice in the participating clinics. ACTG 's scores range from 0-4 with 4 indicating more adherence with 0 least adherent.	3 months and 12 months
Secondary	Clinic visit adherence changes	The following variable will be analyzed to determine adherence: PrEP visits adhered to, divided by visits scheduled. The change in retention to clinic care visits will be assessed at each assessment over 6-month intervals, which is in line with the 6 months post-intervention interval.	3 months and 12 months
Secondary	Biological measures of HIV, STIs and pregnancy	HIV and pregnancy tests (every visit) and STI tests (baseline and 6 months) will be performed for all patients. This combined data will help to identify biological measures.	baseline, 3 months, and 12 months