About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

108 Participants

are divided into 2 treatment groups

Group A: PrEPwise (PrEPdecision aid)Experimental treatment 1 intervention

Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

3 months

2

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.

Time frame

3 months

3

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.

Time frame

3 months

4

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.

Time frame

3 months

Secondary outcomes

1

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.

Time frame

3 months

2

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

Time frame

3 months

3

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.

Time frame

3 months

4

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.

Time frame

3 months

PrEPwise Pilot Among Black Women in Eastern Virginia

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts