PrEP Communication Intervention for Female Clients of a Needle Exchange

Temple University

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: Basic Intervention; Behavioral: Enhanced Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03541642

25028

Details and patient eligibility

About

This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative evaluation process. Using perceptual mapping, an innovative marketing evaluation technique, WWIDs' PrEP perceptions will be incorporated into messaging in targeted counseling, materials, and text messaging to encourage PrEP adherence. This will then be tested in a pilot Randomized Controlled Trial (RCT) by comparing it to a general PrEP intervention to assess for uptake and adherence to PrEP, as well as improved self-efficacy and lower decisional conflict.

Full description

Women who inject drugs (WWIDs) are at significantly higher risk of contracting HIV due to both needle sharing and sexual behaviors, yet utilize HIV prevention resources less. Analysis of studies testing pre-exposure prophylaxis (PrEP) has not tested effectiveness in WWIDs and little research exists on their specific barriers to uptake and adherence. The result is a significant group who is highly vulnerable to HIV infection and its negative health consequences, yet is less likely to benefit from PrEP. To address this gap this study will use a rigorous formative evaluation strategy utilizing a unique and innovative marketing evaluation technique. Using perceptual mapping and vector modeling analysis, the investigators will develop 3-D maps to identify specific message strategies to embed into an intervention using targeted PrEP counseling, written materials, and text based messaging and pilot tested for promise of efficacy compared to a general PrEP intervention. The intervention will address psycho-social barriers to PrEP through perceptual mapping but also societal and structural barriers by embedding it in a trusted syringe exchange and distributing medication through its medical clinic. Specific aims of the research are: 1. Assess WWIDs' perceptions of PrEP and potential barriers to use. To accomplish this the investigators will conduct focus groups (n=30) and interviews with syringe exchange staff (n=10) and develop a perceptual mapping survey. 2. Develop a targeted communication intervention based on vector modeling findings, including print materials, PrEP counseling, and text messages, and assess feasibility and acceptability. To accomplish this the investigators will conduct perceptual mapping surveys with HIV- WWIDs (n=100), do vector modeling analysis and create sample messages, concept test messages with WWIDs and staff (n=20), create intervention materials and conduct usability testing (n=20). 3. Pilot test the intervention by integrating into a syringe exchange to assess promise of efficacy. To accomplish this the investigators will conduct a randomized pilot (n=50) and test an "enhanced" intervention using targeted messages with a "basic" intervention that provides general PrEP counseling. To assess promise of efficacy the investigators will compare PrEP adherence (blood test; self report) and differences in PrEP attitudes, self-efficacy, and decisional conflict.

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• self-identifying women -HIV-
• 18 or older
• self-report either sharing needles or having unprotected sex in last month
• speak and read English
• Is not currently PrEP
• have cell phone that receives text messages
• have Medicaid/Medicare or other insurance that covers PrEP

Exclusion criteria

• self-identifying other than female
• HIV+
• under 18 years old
• Doesn't speak/read English
• No HIV risk in last three months
• Are on PrEP
• Do not have a cell phone that accepts text messages
• Do not have insurance that covers PrEP
• mental illness that interferes with cognitive understanding or ability to provide informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Enhanced Intervention

Experimental group

Description:

Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange

Treatment:

Behavioral: Enhanced Intervention

Basic Intervention

Active Comparator group

Description:

Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange

Treatment:

Behavioral: Basic Intervention