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Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

Study acronym: TIARAS
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Enrollment target: estimated 240 to confirmed 219v13
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Publications: details revised at 1 of 13 entries
    v12
  3. Minor Site contact updated
    • Publications: details revised at 1 of 13 entries
    v11
  4. Notable Primary completion date: Apr 30, 2026 to Dec 31, 2026
    • Study completion date: Apr 1, 2027 to Dec 31, 2026
    v10
  5. Notable Enrollment target: 360 to 240v9 Show 5 more changesShow less
    • Primary completion date: Mar 31, 2026 to Apr 30, 2026
    • Study completion date: Apr 30, 2027 to Apr 1, 2027
    • Study description revised
    • Site contact updated
    • Publications: details revised at 1 of 13 entries
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary completion date: Mar 31, 2027 to Mar 31, 2026
    • Eligibility criteria expanded, about 4 words
    v8
  2. Minor Eligibility criteria expanded, about 9 words
    • Site contact updated
    • Publications: 12 to 13
    • Study description expanded, about 5 words
    v7
  3. Notable Primary completion date: Mar 31, 2026 to Mar 31, 2027
    • Study completion date: Apr 30, 2026 to Apr 30, 2027
    v6
  4. Minor Secondary endpoints: details revised at 1 of 6 entriesv5
  5. Notable Primary completion date: Sep 2025 to Mar 31, 2026v4 Show 4 more changesShow less
    • Study completion date: Sep 2025 to Apr 30, 2026
    • Start date: Jun 6, 2022 to Jun 17, 2022
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 322 words
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2022 to Jun 6, 2022
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 68 words
    v3
  7. Minor Secondary endpoints: details revised at 1 of 5 entriesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05192434
Lead Sponsor Drexel University
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)
HIV Infections, Opioid Use, Trauma, Psychological
Related terms HIV Infections, Psychological Trauma
Enrollment 219 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov