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
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2021
CompletedResults Posted
Study results publicly available
February 5, 2024
CompletedFebruary 5, 2024
May 1, 2023
3.5 years
February 28, 2018
June 1, 2022
May 24, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
Coping Self-Efficacy
Three months, three months post-intervention
Decisional Conflict
Three months, Three months post intervention
PrEP Benefits
three months, three months post-intervention
PrEP Barriers
Three months, Three month post intervention
PrEP Beliefs
Three month, Three month post intervention
Study Arms (2)
Enhanced Intervention
EXPERIMENTALWomen 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
Basic Intervention
ACTIVE COMPARATORWomen 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
Interventions
Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
Eligibility Criteria
You may qualify if:
- self-identifying women -HIV-
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prevention Point Philadelphia
Philadelphia, Pennsylvania, 19134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations were: 1.COVID-19 - delayed/disrupted recruitment efforts; 2. 51% of randomized participants were lost-to-follow-up prior to receiving a PrEP prescription due to lack of venous access and lag time getting to see an HIV tester or doctor who were only available certain days due to COVID-19 protocols; 3. Time to engage women for time necessary to complete baseline procedures, HIV testing, and bloodwork as the need to use drugs to avoid withdrawal symptoms superseded study participation.
Results Point of Contact
- Title
- Dr. Sarah Bass
- Organization
- Temple University
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah B Bass, PhD, MPH
Temple University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2018
First Posted
May 30, 2018
Study Start
June 1, 2018
Primary Completion
December 17, 2021
Study Completion
December 17, 2021
Last Updated
February 5, 2024
Results First Posted
February 5, 2024
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Three months after end of intervention data collection.
- 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).
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.