PrEPwise Pilot Among Black Women in Eastern Virginia

NCT07398482 | Not Yet Recruiting

• 2 other identifiers: H-456711K01MH136935-01A1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; Sexually Transmitted Infection

Keywords

Pre-Exposure Prophylaxis (PrEP); Community Health Worker (CHW)

Outcome Measures

Primary Outcomes (4)

• Acceptability to Participants of PrEPwise Intervention

  Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.

  3 months

• Acceptability to Community Health Workers (CHWs) of PrEPwise Intervention

  Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.

  3 months

• PrEPwise intervention Feasibility

  Feasibility will be assessed though process measures including number of participants contacted, number screened for eligibility, number enrolled, and number lost to follow-up.

  3 months

• PrEPwise Intervention Fidelity

  Fidelity will be assessed measured using a 10-item fidelity checklist, completed by participants after intervention delivery. Each item on the checklist indicates whether a specific component was delivered as expected (e.g., "The CHW discussed PrEP side effects with me") Items are scores as "yes=1" or "no=0". Total scores range from 0-10, with higher scores indicating higher fidelity to the intervention protocol.

  3 months

Secondary Outcomes (8)

• PrEP initiation

  3 months

• PrEP persistence

  3 months

• Perceived HIV risk

  3 months

• PrEP knowledge

  3 months

• PrEP attitude

  3 months

Study Arms (2)

PrEPwise (PrEPdecision aid)

EXPERIMENTAL

Participants randomized to this arm who are HIV negative will receive the behavioral intervention PrEPwise at the HIV testing clinic.

Behavioral: PrEPwise

Usual care

ACTIVE COMPARATOR

Participants randomized to this arm will receive usual care including standard HIV testing, general HIV information, prep information and information about other available services.

Other: Usual care

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.

PrEPwise (PrEPdecision aid)

Usual care OTHER

Usual care includes providing general HIV prevention information, basic PrEP information, and information about other available clinic services.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black women seeking HIV testing services at the community HIV testing clinic
• Eligible for PrEP according to CDC guidelines
• Willing to be followed for 3 months
• Able to provide contact information
• Able to provide informed consent

You may not qualify if:

• Participated in the development of the intervention (provided input in the adaptation of PrEP decision aid)
• Unable to provide informed consent
• Unable to provide contact information
• Currently using PrEP

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

LGBT Life Center (5360 Robin Hood Road, Norfolk, VA 23513

Norfolk, Virginia, 23513, United States

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvia Shangani, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvia Shangani, PhD

CONTACT

617 358 1347; sylvia65@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 10, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)