PrEPwise Pilot Among Black Women in Eastern Virginia (PrEPwise)

Feasibility and Preliminary Effectiveness of PrEPwise Intervention on PrEP Initiation Among Black Women in Eastern Virginia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Sexually Transmitted Infection
• Intervention / Treatment: Behavioral: PrEPwise; Other: Usual care

Detailed Description

The study will follow a type-1 effectiveness-implementation hybrid design as a single-site, single-blinded randomized controlled trial. The following procedures detail the study conduct and masking approach:

Baseline Visit:

• Informed consent process
• Collection of demographic information
• Administration of baseline survey assessing: Perceived HIV risk, PrEP knowledge, PrEP attitudes, PrEP stigma, Discrimination/racism experiences, PrEP norms, Decisional conflict, and Self-efficacy

Randomization and Intervention Delivery:

• Random assignment will be conducted at the individual level with 1:1 allocation using random block sizes of 2
• Randomization assignments will be generated through REDCap's randomization module by the study data analyst
• Only participants will be blinded to their study arm assignment. Study staff delivering the intervention cannot be blinded due to the nature of the behavioral intervention
• Participants will be informed they will receive either enhanced or standard HIV prevention information, without specifying their assigned arm
• The research assistant conducting outcome assessments will be different from the staff delivering the intervention

• Immediate post-intervention survey assessing implementation outcomes

  • Intervention acceptability
  • Intervention feasibility
  • Intervention fidelity 3-Month Follow-up Visit:

• Assessment of effectiveness outcomes:

  • PrEP initiation status
  • PrEP persistence
  • Changes in baseline measures
• Collection of pharmacy fill data. At the 3-month follow-up visit, participants will be asked to self-report whether they initiated PrEP and if they obtained refills.

Additional Procedures:

• Qualitative interviews with a subsample (n=20) of participants to explore perspectives about intervention acceptability, fidelity, barriers, and recommendations for adaptations

The research hypothesis is:

Compared to the control arm, the intervention arm will have (1) a higher percentage of Black women initiate PrEP at 3-months, (2) increased PrEP and HIV risk awareness at 3-month follow-up, (3) reduced HIV PrEP stigma, (4) increased trust in healthcare, and (5) Increased decisional certainty in the choice and intention to use PrEP at 3-month follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvia Shangani, PhD; Phone Number: 617 358 1347; Email: sylvia65@bu.edu

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23513
      • LGBT Life Center (5360 Robin Hood Road, Norfolk, VA 23513
      • Contact: Sylvia Shangani, PhD; Phone Number: 617-358-1347; Email: sylvia65@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PrEPwise (PrEPdecision aid); Participants randomized to this arm who are HIV negative will receive the behavioral intervention PrEPwise at the HIV testing clinic.	Behavioral: PrEPwise; 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.
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.	Other: Usual care; Usual care includes providing general HIV prevention information, basic PrEP information, and information about other available clinic services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation	PrEP initiation is defined as having at least one PrEP prescription fill during the 3-month period of the study using pharmacy fill data.	3 months
PrEP persistence	PrEP persistence is defined as the length of time that a person continued to refill PrEP prescription without an interruption of more than 30 days. PrEP persistence will be assessed using pharmacy refill data obtained at 3-month follow-up. Participants will be categorized as either PrEP-persistence (refilled prescription within 30 days of the previous fill running out) or PrEP non-persistent (gap of >30 days between refills). This binary outcome indicates whether participants maintained continuous PrEP coverage throughout the 3-month study period	3 months
Perceived HIV risk	Perceived HIV risk will be measured using the Centers for Disease Control (CDC) 5-item screening tool to determine PrEP eligibility for heterosexual women. Questions assess behavioral risk factors. These questions are: having a sexual partner who is HIV positive, having condomless sex with partners of unknown status, having a bacterial sexually transmitted infection (STI) in the past 6 months, exchanging sex for money or drugs, and injecting drugs. A "yes" response to any of these questions indicates a risk factor. Participants who respond to one or more items are considered at high HIV risk and meet CDC criteria for PrEP eligibility. Higher numbers indicate greater perceived HIV risk.	3 months
PrEP knowledge	PrEP knowledge will be assessed using 13-item knowledge scale developed by Walsh et al. (2019). This scale measures knowledge about PrEP through true/false items covering topics including: what PrEP is, how it works, its effectiveness in preventing HIV, who should use, side effects, and how to access it. Items are scored as correct=1 or incorrect/don't know=0. Total scores range from 0 to 13, with higher scores indicating greater knowledge about PrEP.	3 months
PrEP attitude	PrEP attitudes will be assessed using 5-item attitudes scale developed by Walsh et al. (2019). This scale measures attitudes toward PrEP use including perceptions of effectiveness, safety, responsibility, adherence burden, and government safety assurance. Responses are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores re calculated by summing item responses, with higher scores indicating more positive attitudes toward PrEP.	3 months
PrEP stigma	PrEP stigma will be assessed using 5-item HIV PrEP Stigma scale developed by Walsh et al. (2020). This scale measures perceptions of stigma associated with PrEP use, including judgments about PrEP users, embarrassment about obtaining PrEP, and concerns about disclosure to friends, family, and sexual partners. Responses are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5(strongly agree). Total scores range from 5-25, with higher scores indicating greater perceived PrEP stigma.	3 months
Decisional conflict	Decisional conflict will be assessed using the 16-item Decisional Conflict Scale (DCS) developed by O'Connor (1995). The scale measures uncertainty in decision-making across five subscales: uncertainty, feeling uninformed, unclear values, unsupported in decision-making, and ineffective decision-making. Items are rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). Items are summed, divided by 16 then multiplied by 25. Score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).	3 months
Intersectional discrimination experiences	Intersectional discrimination experiences. Intersectional discrimination will be assessed using the validated 31-item Intersectional Discrimination Index (InDI) developed by Scheim and Bauer (2019). The index consists of three subscales measuring: 1) anticipated discrimination (9 items), 2) day-to-day discrimination (9 items), and 3) major discrimination experiences (13 items). Participants rate frequency of discrimination experiences, with higher scores indicting greater experiences of discrimination.	3 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sylvia Shangani, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Community Health Worker (CHW); Pre-Exposure Prophylaxis (PrEP)
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Pathological Conditions, Signs and Symptoms; HIV Infections; Sexually Transmitted Diseases
• Other Study ID Numbers: H-45671; 1K01MH136935-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No