Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs
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 for Prevention Point Philadelphia, a large harm reduction agency 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?
Conditions:
🦠 HIV Infections 🦠 Opioid Use 🦠 Trauma, Psychological
🗓️ Study Start (Actual) 17 June 2022
🗓️ Primary Completion (Estimated) 31 March 2026
✅ Study Completion (Estimated) 30 April 2026
👥 Enrollment (Estimated) 360
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • a) HIV-negative cisgender female, b) age ≥ 18 years, c) speaks/reads English d) reporting past 6 months day non-prescription injection drug use and any of the following: NEW PrEP PATIENT: prescribed daily oral or injectable PrEP at Prevention Point Philadelphia within 30 days. For injectable PrEP, they will be considered new if they have received a prescription but have not had their first injection. or NON-ADHERENT DAILY ORAL PrEP PATIENT: initiated PrEP at Prevention Point Philadelphia 30 or more days ago who reports any non-adherence or reports consistent adherence but has PrEP-related drug levels indicating non-adherence (verified with urine-based tenofovir testing) or NON-ADHERENT INJECTABLE PrEP PATIENT: initiated injectable PrEP at Prevention Point Philadelphia but is outside of the window to receive their next injection (verified in participant's electronic medical record)

    Exclusion Criteria:

    • a) Unable to provide informed consent; b); unwilling or unable to return to the SSP daily for the next 90 days; c) unwilling to provide specimen for PrEP-related clinical monitoring and adherence monitoring; d) pregnant.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 January 2022
  • First Submitted that Met QC Criteria 5 January 2022
  • First Posted 14 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 April 2023
  • Last Update Posted 27 April 2023
  • Last Verified April 2023