PrEP Communication Intervention for Female Clients of a Needle Exchange

Not Applicable

Completed

Conditions: HIV/AIDS

Interventions: Behavioral: Basic Intervention
Behavioral: Enhanced Intervention

Registration Number: NCT03541642

Lead Sponsor: Temple University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 35

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basic Intervention	Basic Intervention	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
Enhanced Intervention	Enhanced Intervention	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

Primary Outcome Measures

Name	Time	Method
PrEP Adherence Appraisal	one month, three months, three months post intervention	One item Medication Adherence question (one item with 5 option scale). "Excellent, Very good, Good, Poor, Very Poor".
Change in PrEP Uptake and Adherence	one month, three months, three months post intervention	Self-report PrEP adherence and bio-verified PrEP adherence to PrEP with urine assay (Synergy medical labs - Descovy Panel TFV:Creatinine Ratio-Descovy). Urine assay results will be categorized as a binary variable (yes/no) based upon value observed by all patients, with data at 1 month, 3 months and 3 months post intervention.
PrEP Adherence Within Past Week	one month, three months, three months post intervention	Self report PrEP adherence measure of PrEP use within the past week. Item asks "Of the seven doses of PrEP you were supposed to take during the last week, how many doses would you say you missed? Responses range from 0 to 7.

Secondary Outcome Measures

Name	Time	Method
Coping Self-Efficacy	Three months, three months post-intervention	Assess coping self-efficacy using the Coping Self-Efficacy Scale (13 item scale; 0-10 scale). Zero=cannot do at all,5=moderately certain can do and 10=certain can do. An overall CSE score (from 0 to 130) is created by summing the item ratings, with higher scores indicating higher coping self-efficacy.
Decisional Conflict	Three months, Three months post intervention	Assess decisional conflict with the Ottawa Decisional Conflict Scale. 13 items. 5 responses: Strongly Disagree (1), Disagree (2), Neither Agree or Disagree (3), Agree (4), Strongly Agree (5). Scores are summed and divided by the number of items(13) to produce an overall mean, ranging from 1 to 5. Lower scores indicate lower decisional conflict.
PrEP Benefits	three months, three months post-intervention	10 items assessed perceived benefits of PrEP. Items are asked on a 0-10 Likert, with 0 = strongly agree, 5 = unsure, 10 = strongly agree. Thus, higher scores indicate greater agreement with that item.
PrEP Barriers	Three months, Three month post intervention	12 items assessed perceived barriers to taking PrEP. Items are asked on a 0-10 Likert, with 0 = strongly disagree, 5 = unsure, 10 = strongly agree. Thus, higher score indicates greater agreement with that item.
PrEP Beliefs	Three month, Three month post intervention	9 items assessed perceived beliefs about PrEP. Items are asked on a 0-10 Likert, with 0 = strongly disagree, 5 = unsure, 10 = strongly agree. Thus, higher score indicates greater agreement with that item.