Clinical trial NCT03541642: PrEP Communication Intervention for Female Clients of a Needle Exchange
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in PrEP Uptake and Adherence
timeFrame: one month, three months, three months post intervention
measure: PrEP Adherence Within Past Week
timeFrame: one month, three months, three months post intervention
measure: PrEP Adherence Appraisal
timeFrame: one month, three months, three months post intervention
Secondary outcomes:
measure: Coping Self-Efficacy
timeFrame: Three months, three months post-intervention
measure: Decisional Conflict
timeFrame: Three months, Three months post intervention
measure: PrEP Benefits
timeFrame: three months, three months post-intervention
measure: PrEP Barriers
timeFrame: Three months, Three month post intervention
measure: PrEP Beliefs
timeFrame: Three month, Three month post intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Prevention Point Philadelphia
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Sarah B Bass, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: