Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

Study Summary

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?

Primary Outcome

Our primary outcome will be a composite of two measures: self-reported behavioral HIV risk (syringe sharing or condomless sex) and objectively measured adherence to PrEP. To assess PrEP adherence in women initiating daily oral Tenofovir-based (TFV) PrEP products, we will collect scalp hair at baseline, 3, 6, and 12 months. Specimens will be tested using liquid chromatography/tandem mass spectrometry to quantify TFV concentrations levels. In primary analysis, and TFV level \>/= 0.025.ng, consiste

Conditions Studied

Interventions

• BEHAVIORAL Contingency Management
• BEHAVIORAL Expressive Writing

Study Locations (1)