240 Participants Needed

Trauma-Focused Interventions for HIV Prevention in Women Who Inject Drugs

(TIARAS Trial)

AM
KL
KW
EM
Overseen ByErin McDowell, MA
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Drexel University
Must be taking: PrEP
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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?

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on PrEP (a medication to prevent HIV) to participate.

What data supports the effectiveness of this treatment for HIV prevention in women who inject drugs?

Research shows that contingency management, which uses rewards to encourage drug abstinence, can reduce HIV risk behaviors in drug users. Additionally, motivational incentives have been effective in improving treatment engagement and outcomes in substance abuse patients, suggesting potential benefits for HIV prevention in women who inject drugs.12345

Is contingency management safe for humans?

Contingency management, which involves providing rewards for drug abstinence, has been studied in various settings and is generally considered safe for humans. Research indicates that it does not lead to new drug use or coercion, and it is viewed positively by treatment providers.15678

How is the Contingency Management treatment unique for HIV prevention in women who inject drugs?

Contingency Management is unique because it uses motivational incentives, like prizes, to encourage positive behavior changes, such as reducing drug use and increasing safe practices, which is different from traditional treatments that may not use rewards as a primary method to promote behavior change.910111213

Research Team

AM

Alexis M Roth, PhD, MPH

Principal Investigator

Drexel University

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.
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)
Speaks/reads English
See 1 more

Exclusion Criteria

I am unable to understand and give consent for treatment.
I cannot visit the study site daily for the next 3 months.
Unwilling to provide specimen for PrEP-related clinical monitoring and adherence monitoring
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Contingency Management and Writing Intervention

Participants engage in contingency management and are randomly assigned to expressive or neutral writing exercises for 3 months

12 weeks
Weekly visits for writing sessions and urine screenings

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments at 3, 6, and 12 months

9 months
Follow-up assessments at 3-, 6-, and 12-months

Treatment Details

Interventions

  • Contingency Management
  • Expressive Writing
Trial OverviewThe '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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Expressive Writing + Contingency ManagementExperimental Treatment2 Interventions
A total of 120 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 120 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.

Contingency Management is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Contingency Management for:
  • Substance Use Disorders
  • Stimulant Use Disorder
  • Methamphetamine Use Disorder
🇪🇺
Approved in European Union as Contingency Management for:
  • Substance Use Disorders
  • Addiction Treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials
160
Recruited
48,600+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

Contingency management (CM) significantly reduced HIV risk behaviors among 116 methadone-maintained outpatients by providing rewards for drug abstinence, leading to lower HIV-Risk Taking Behaviour Scale (HRBS) scores over time compared to a control group.
Participants in the CM group showed a notable decrease in simultaneous cocaine and opiate use, indicating that CM effectively promotes abstinence, which in turn mediates the reduction in risky behaviors associated with HIV transmission.
Contingency management reduces injection-related HIV risk behaviors in heroin and cocaine using outpatients.Ghitza, UE., Epstein, DH., Preston, KL.[2021]
A treatment reinforcement plan (TRP) incentivized cocaine-using methadone patients with up to $15 per week for completing tasks related to their treatment, leading to significant engagement and retention in therapy.
Successful participation in the TRP during the first two months was linked to longer retention in methadone treatment, increased therapy attendance, and a reduction in cocaine use, highlighting the effectiveness of behavioral counseling techniques for high-risk patients.
Improving treatment engagement and outcomes for cocaine-using methadone patients.Villano, CL., Rosenblum, A., Magura, S., et al.[2019]
A survey of 214 substance use treatment providers revealed that while many clinics are using reward programs, they often do not follow effective practices recommended by research, such as providing higher reward amounts or immediate reinforcement.
Providers with more extensive training in contingency management (CM) were more likely to implement effective strategies, suggesting that better training could improve the quality of reward-based interventions in real-world settings.
Examining implementation of contingency management in real-world settings.Rash, CJ., Alessi, SM., Zajac, K.[2021]

References

Contingency management reduces injection-related HIV risk behaviors in heroin and cocaine using outpatients. [2021]
Improving treatment engagement and outcomes for cocaine-using methadone patients. [2019]
Examining implementation of contingency management in real-world settings. [2021]
Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. [2019]
Is exposure to an effective contingency management intervention associated with more positive provider beliefs? [2021]
Do research payments precipitate drug use or coerce participation? [2007]
Randomized controlled trial of a positive affect intervention for methamphetamine users. [2023]
Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. [2022]
Applying the Behavioral Model for Vulnerable Populations to Pre-Exposure Prophylaxis Initiation Among Women Who Inject Drugs. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Behavioral HIV risk reduction among people who inject drugs: meta-analytic evidence of efficacy. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Three city feasibility study of a body empowerment and HIV prevention intervention among women with drug use histories: Women FIT. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Substance use, sexual risk, and violence: HIV prevention intervention with sex workers in Pretoria. [2022]
Prevention interventions for human immunodeficiency virus in drug-using women with a history of partner violence. [2022]