PrEPwise Pilot Among Black Women in Eastern Virginia

Boston University

Status: Begins enrollment in a year or more

Conditions: Sexually Transmitted Infection; HIV Infections

Treatments: Other: Usual care; Behavioral: PrEPwise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07398482

H-45671

1K01MH136935-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

PrEPwise (PrEPdecision aid)

Experimental group

Description:

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

Treatment:

Behavioral: PrEPwise

Usual care

Active Comparator group

Description:

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

Treatment:

Other: Usual care