PrEP Communication Intervention for Female Clients of a Needle Exchange

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Enhanced Intervention; Behavioral: Basic Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • Prevention Point Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PrEP Uptake and Adherence	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.	one month, three months, three months post intervention
PrEP Adherence Within Past Week	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.	one month, three months, three months post intervention
PrEP Adherence Appraisal	One item Medication Adherence question (one item with 5 option scale). "Excellent, Very good, Good, Poor, Very Poor".	one month, three months, three months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping Self-Efficacy	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.	Three months, three months post-intervention
Decisional Conflict	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.	Three months, Three months post intervention
PrEP Benefits	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.	three months, three months post-intervention
PrEP Barriers	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.	Three months, Three month post intervention
PrEP Beliefs	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.	Three month, Three month post intervention

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Principal Investigator: Sarah B Bass, PhD, MPH, Temple University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 25028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All research products from the study will be made available to other qualified individuals within the scientific community, government agencies and other interested parties after publication of results. Requests for raw data from other scientists will be considered with provision of the following information: A brief description of the specific aims and/or hypotheses, data requirements, and proposed analyses, how the data will be used, timeframe for use, and Institutional Review Board (IRB) approvals. All materials developed during the study, as well as any research instruments, will also be made available upon request. In addition, qualified individuals who are interested in the PrEP messaging and the methods from which they are created, as well as the analysis methods generated by this research, will have access after publication. It is our full intention to share all findings generated by this study, and subsequent lessons learned, with others in the scientific community.
• IPD Sharing Time Frame: Three months after end of intervention data collection.
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No