Trauma-Focused Interventions for HIV Prevention in Women Who Inject Drugs
(TIARAS Trial)
Trial Summary
What is the purpose of this trial?
The goal of this randomized controlled trial is to test the effectiveness of "TIARAS," a trauma intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). To be eligible for this study, participants must have been prescribed pre-exposure prophylaxis (PrEP), a medication taken to prevent HIV, at Prevention Point Philadelphia, a large harm reduction agency located in Philadelphia (PA, USA), or Courage Medicine, a nonprofit health services clinic located in Philadelphia (PA, USA). Enrollment in this study lasts for 12-months so that we can see if TIARAS reduces HIV risk immediately after the intervention ends and whether these effects last over time. During the first 3 months, participants engage in contingency management (CM), an evidenced-based intervention to reduce drug use and HIV risk. We will use CM to encourage engagement in PrEP care as well as stimulant/opioid abstinence. Also during the first 3-months, participants are randomly assigned to complete expressive writing exercises to address a previously undisclosed trauma or neutral writing exercises. Half of the participants will be assigned to the trauma writing group and the other half will be assigned to the neutral writing group. To understand the impact of TIARAS on HIV risk, we will collect and analyze data from surveys, interviews, and biological specimen during the 12-month study period. Our main questions are: * Does participation in TIARAS reduce HIV risk among WWID? * If observed, how long do beneficial effects last? * How and why do WWID experience benefits from TIARAS?
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on PrEP (a medication to prevent HIV) to participate.
What data supports the effectiveness of this treatment for HIV prevention in women who inject drugs?
Research shows that contingency management, which uses rewards to encourage drug abstinence, can reduce HIV risk behaviors in drug users. Additionally, motivational incentives have been effective in improving treatment engagement and outcomes in substance abuse patients, suggesting potential benefits for HIV prevention in women who inject drugs.12345
Is contingency management safe for humans?
How is the Contingency Management treatment unique for HIV prevention in women who inject drugs?
Contingency Management is unique because it uses motivational incentives, like prizes, to encourage positive behavior changes, such as reducing drug use and increasing safe practices, which is different from traditional treatments that may not use rewards as a primary method to promote behavior change.910111213
Research Team
Alexis M Roth, PhD, MPH
Principal Investigator
Drexel University
Eligibility Criteria
This trial is for HIV-negative cisgender women over 18 who inject drugs and speak/read English. They must be new or non-adherent patients of PrEP at Prevention Point Philadelphia, not pregnant, able to consent, and willing to visit the site daily for 90 days and provide specimens.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Contingency Management and Writing Intervention
Participants engage in contingency management and are randomly assigned to expressive or neutral writing exercises for 3 months
Follow-up
Participants are monitored for safety and effectiveness after the intervention, with assessments at 3, 6, and 12 months
Treatment Details
Interventions
- Contingency Management (Behavioral Intervention)
- Expressive Writing (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Drexel University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator