Clinical trial NCT04373551: WeExPAnd: PrEP Demonstration Project Among Women At Risk for HIV Infection - Preexposure Prophylaxis (PrEP)
Official title: PrEP Demonstration Project Among Women At Risk for HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-infection/AIDS
Keywords: Pre exposure prophylaxis (PrEP)
HIV prevention
African American women
cisgender women
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: National Institute of Mental Health (NIMH)
First posted: 2020-05-04
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this application is to increase PrEP uptake among AA 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 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: 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.

Eligibility criteria: Inclusion/Exclusion Criteria

Patients

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

Providers

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

Primary outcomes:
measure: PrEP uptake changes
timeFrame: baseline, 3 months, and 12 months
measure: Intervention feasibility changes
timeFrame: baseline, 3 months, and 12 months
measure: Intervention acceptability
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: PrEP adherence
timeFrame: 3 months and 12 months
measure: Clinic visit adherence changes
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mirjam-Colette Kempf, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: