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

Overview

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.

Full Title of Study: “PrEP Demonstration Project Among Women at Risk for HIV Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2022

Detailed 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 3/6 months post PrEP initiation among our sample.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • PrEP uptake changes
    • Time Frame: baseline, 3 months, and 6 months
    • 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.
  • Intervention feasibility changes
    • Time Frame: baseline, 3 months, and 6 months
    • 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.
  • Intervention acceptability
    • Time Frame: Through study completion, an average of 6 months
    • 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.

Secondary Measures

  • PrEP adherence
    • Time Frame: 3 months and 6 months
    • 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.
  • Clinic visit adherence changes
    • Time Frame: 3 months and 6 months
    • 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.
  • Biological measures of HIV, STIs and pregnancy
    • Time Frame: baseline, 3 months, and 6 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mirjam-Colette Kempf, Principle Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Mirjam-Colette Kempf, PhD, MPH, Principal Investigator, University of Alabama at Birmingham

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