CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 219 enrolled
Drug / intervention
Expressive Writing +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05192434
NCT05192434N/AActive

Efficacy of a Trauma Intervention for Affect Regulation, Adherence, and Substance Use to Optimize PrEP for Women Who Inject Drugs

Drexel University·interventional·Posted Jan 14, 2022·Updated Dec 23, 2025

In Brief

A clinical study evaluating Expressive Writing and Contingency Management for HIV Infections and 2 related conditions. Active but no longer recruiting, targeting 219 participants across 1 site.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/AActive
202220232024202520262027
First PostedJan 14, 2022
Enrollment StartJun 17, 2022
Primary CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 4.5 years agoPrimary completion in 6 months

Interventions

Expressive Writingbehavioral

Expressive writing (EW) is a safe, acceptable, and effective intervention for improving psychological adjustment. Via brief directed writing sessions, EW facilitates disclosure of traumatic events. At a basic level, emotional expression and disclosure are important because they reduce the need to unconsciously direct psychological energy towards suppressing emotions from traumatic events.

Contingency Managementbehavioral

Contingency management (CM) is a proven strategy to reduce drug use and HIV risk behavior. Also known as a conditional cash transfer, CM reinforces positive behavior with tangible rewards. In the context of substance use treatment, monetary incentives are typically used to reinforce drug-negative urine specimens.