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Trauma-Focused Interventions for HIV Prevention in Women Who Inject Drugs (TIARAS Trial)

N/A

Recruiting

Led By Alexis M Roth, PhD, MPH

Research Sponsored by Drexel University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

HIV-negative cisgender female

Must not have

Unable to provide informed consent

Unwilling or unable to return to the SSP daily for the next 90 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participant duration (1 year)

Summary

This trial will test whether addressing trauma can reduce HIV risk for women who inject drugs.

Who is the study for?

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.

What is being tested?

The 'TIARAS' program combines contingency management with expressive writing exercises aimed at addressing trauma. The study tests if this intervention reduces HIV risk among women who inject drugs by comparing it with neutral writing exercises over a year.

What are the potential side effects?

While specific side effects are not detailed, expressive writing may bring up emotional discomfort due to revisiting traumatic events. Contingency management typically does not have physical side effects but can affect behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a cisgender female and do not have HIV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give consent for treatment.

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I cannot visit the study site daily for the next 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participant duration (1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participant duration (1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and participant duration (1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HIV Acquisition Risk

Secondary study objectives

Cost effectiveness

Depression

Drug Abstinence

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Expressive Writing + Contingency ManagementExperimental Treatment2 Interventions

A total of 180 WWID will be randomly assigned to the EW+CM (expressive writing + contingency management) intervention arm. To begin each session, participants will complete a brief battery of psychological measures. Then, in a private setting, they will be asked to write for 20 minutes about a major trauma that occurred three or more months in the past. WWID who prefer not to write (e.g., have lower literacy) will be provided the opportunity to talk aloud about the traumatic experience while being audio recorded, which yields comparable effects to writing. Next, women will respond to a prompt that encourages cognitive processing of the trauma for ten additional minutes. To complete the session, participants will answer the same brief battery of psychological measures for the purposes of identifying acute distress. Those exhibiting clinically elevated distress symptoms will engage in a brief de-escalation and evaluation session with study staff who will be trained.

Group II: Neutral Writing + Contingency ManagementPlacebo Group1 Intervention

A total of 180 WWID will be randomly assigned to the attention-control arm which includes neutral writing + CM. Women in this group will complete the same pre/post psychological measures as the intervention group for the purposes of time matching. During the writing session, they will be asked to describe their schedule from the preceding day as if they were reporting facts, without discussing personal thoughts and feelings (e.g., describe what you did from the time you got up until the time you went to bed). Those with lower literacy can opt to talk aloud while being audio recorded. This is the same attention-control used our previous work which balances contact time and study incentives.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Expressive Writing

2011

Completed Phase 3

~1990

Contingency Management

2014

Completed Phase 4

~3440