PrEPwise Pilot Among Black Women in Eastern Virginia

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Boston University
Study ID
NCT07398482
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PrEPwise — BEHAVIORAL
    PrEPwise intervention is a tablet-based PrEP decision aid delivered by community health workers (CHW) to Black women in the context of their regular HIV testing visits. The intervention includes: Tailored PrEP decision aid providing information on HIV risks, PrEP choices, PrEP costs, how to use PrEP, Adherence guidance, side effects, and access points for obtaining PrEP.
  • Usual care — OTHER
    Usual care includes providing general HIV prevention information, basic PrEP information, and information about other available clinic services.

Study Details

HIV is a virus that affects many people, but Black women in the U.S. are a population at a much higher risk of getting it compared to white women-about 18 times higher. Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective). The problem is that many Black women, especially those living in the Southern U.S., don't know about this medicine called PrEP or find it hard to access it. To address this, healthcare providers sometimes use "decision aids" which are tools, like brochures or videos, designed to help people understand their medical options and make informed choices based on what's important to them. While these tools have worked well for other health issues, they haven't been widely used for preventing HIV. The challenges are doctors do not have enough time to explain PrEP fully to patients during clinic visits and also some Black women do not trust the healthcare system because of a long history of unfair treatment toward Black communities. Community health workers (CHWs) are trained health workers from the same communities as their patients and can facilitate their ability to provide culturally appropriate health education and information consistent with patients' values and needs. Because of this, patients are often more comfortable talking to them. This project aims to test the acceptability and effectiveness of a decision tool to be integrated into HIV testing services to help Black women decide if PrEP is right for them. The investigators are calling this intervention PrEPwise. A tool originally designed for women dealing with opioid addiction will be adapted to fit the needs of Black women living in the South. The long-term goal of this project is to make it easier for Black women to learn about PrEP and decide whether to use it, ultimately helping lower the number of new HIV cases in Black women.

Key Dates

Start date
Apr 30, 2027
Status verified
Feb 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PrEPwise (PrEPdecision aid)
    Participants randomized to this arm who are HIV negative will receive the behavioral intervention PrEPwise at the HIV testing clinic.
  • Active Comparator: Usual care
    Participants randomized to this arm will receive usual care including standard HIV testing, general HIV information, prep information and information about other available services.

Primary Outcome Measure

Acceptability to Participants of PrEPwise Intervention [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
LGBT Life Center (5360 Robin Hood Road, Norfolk, VA 23513NorfolkVirginia23513
Sylvia Shangani, PhD
617-358-1347

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