PrEP Communication Intervention for Female Clients of a Needle Exchange

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development and Pilot Testing of a PrEP Communication Intervention and Integration Into Existing HIV Testing Services for Female IV Drug Using Clients of a Needle Exchange

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Enhanced Intervention
* Behavioral: Basic Intervention


Participation Criteria
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Eligibility Criteria
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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 Never used 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 or previously been 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women participants will be randomized to condition upon consent based on a random numbers table. Intervention arm will get enhanced intervention with customized messages and counseling/text messaging; control arm will get basic intervention with medical counseling and text message reminders.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Intervention<br>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 | Behavioral: Enhanced Intervention<br>* Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange<br>|
| Active Comparator: Basic Intervention<br>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 | Behavioral: Basic Intervention<br>* General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PrEP uptake and adherence | Asses uptake and adherence to PrEP with blood test. Blood test results will be compared to adherence benchmarks for Tenofovir-Emtricitabine and categorized as a binary variable (yes/no) based upon the mean value observed by all patients, with data at 1 month, 3 months and 3 months post intervention. | one month, three months, three months post intervention | 
| Change in PrEP adherence | medication adherence scales and prescription pick up. Self report adherence measures on how often medication is taken and compared across the three time points. Percent of prescription pick-up as proxy measure. | one month, three months, three months post intervention | 
| Change in PrEP adherence | one item Medication Adherence question (one item with six option scale). None of the time, a little of the time, some of the time, a good bit of the time, most of the time, and all of the time | one month, three months, three months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Coping Self-Efficacy | Assess coping self-efficacy using the Coping Self Efficacy (CSE) scale (13 item scale; 0 to 10 scale). Zero=cannot do at all,5=moderately certain can do and 10=certain can do. An overall CSE score is created by summing the item ratings, with higher scores indicating higher coping self efficacy. | baseline, three months, 3 months post-intervention | 
| Change in PrEP attitudes/perceptions | Assess PrEP attitudes/perceptions with perceptual mapping survey items | baseline, three months, 3 months post-intervention | 
| Change in Decisional Conflict | Assess decision conflict with the Ottawa Decisional Conflict Scale - Low Literacy Version. (10 items) Three responses: Yes, No, Unsure. Yes=0, Unsure=2, No=4. 10 items are summed; divided by 10 and then multiplied by 25. Ranges from zero (no decisional conflict) to 100 (extremely high decisional conflict) | baseline, three months, 3 months post intervention |