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

(TIARAS Trial)

Overseen By Erin McDowell, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Drexel University

Must be taking: PrEP

Disqualifiers: Pregnant, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

240 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{9 10 11 12 13}

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?

Research Team

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

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

I am a cisgender female and do not have HIV.

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

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 Overview 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.

Participant Groups

Group I: Expressive Writing + Contingency Management Experimental Treatment 2 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 Management Placebo Group 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. Rash, CJ., Alessi, SM., Zajac, K.[2021]

Prize-based abstinence incentives combined with standard treatment did not show significant differences in effectiveness for patients with varying treatment histories, indicating that the incentives may be equally beneficial regardless of prior treatment experience.

The study involved treatment-seeking outpatients and assessed outcomes like the longest period of abstinence and negative urine drug screens, suggesting that these incentives can be a consistent motivational tool across diverse patient backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. Killeen, T., Carter, R., Copersino, M., et al.[2019]

Providers at treatment sites that implemented contingency management (CM) programs had more positive opinions about these programs compared to matched providers at sites that did not implement CM, especially when accounting for their experience with tangible incentives.

The study suggests that exposure to CM programs can positively influence provider attitudes, which may help in promoting the adoption of these effective interventions in community treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is exposure to an effective contingency management intervention associated with more positive provider beliefs? Kirby, KC., Carpenedo, CM., Stitzer, ML., et al.[2021]

Offering high cash incentives to substance abuse clients for research participation did not lead to increased rates of new drug use or perceptions of coercion, suggesting that such incentives can be ethically implemented without negative consequences.

Higher cash payments were linked to better follow-up attendance rates, indicating that they may be a cost-effective strategy for improving participant retention in research studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do research payments precipitate drug use or coerce participation? Festinger, DS., Marlowe, DB., Croft, JR., et al.[2007]

A study involving 110 HIV-positive sexual minority men showed that a positive affect intervention, when combined with contingency management (CM), significantly increased positive feelings and mindfulness over three months.

Participants who received the positive affect intervention experienced reduced cravings for methamphetamine and reported lower stimulant use, suggesting that enhancing emotional well-being can improve treatment outcomes in substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for methamphetamine users. Carrico, AW., Gόmez, W., Jain, J., et al.[2023]

In a study involving 127 men who have sex with men (MSM) using methamphetamine, a 12-week contingency management (CM) intervention did not significantly reduce methamphetamine use compared to a minimal intervention control group.

Although retention in the study was high at 84%, participants receiving CM were more likely to report increased methamphetamine use during and after the intervention, suggesting that CM may not lead to sustained reductions in drug use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. Menza, TW., Jameson, DR., Hughes, JP., et al.[2022]

In a study of 89 women who inject drugs, 69 participants successfully initiated pre-exposure prophylaxis (PrEP) when offered at a syringe services program, highlighting the program's effectiveness in promoting PrEP uptake.

Factors associated with PrEP initiation included a history of sexual assault, frequent attendance at the syringe services program, an annual income of $5,000 or more, and inconsistent condom use, suggesting that targeted strategies could enhance PrEP promotion among vulnerable women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the Behavioral Model for Vulnerable Populations to Pre-Exposure Prophylaxis Initiation Among Women Who Inject Drugs. Felsher, M., Bellamy, S., Piecara, B., et al.[2021]

A meta-analysis of 37 randomized controlled trials involving 10,190 participants showed that behavioral interventions significantly reduced injection drug use and increased safe practices like condom use among people who inject drugs.

Interventions were particularly effective when they addressed both drug-related and sexual risks, included interpersonal skills training for safer needle use, and utilized two facilitators for condom use education, indicating that comprehensive and well-structured programs yield better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral HIV risk reduction among people who inject drugs: meta-analytic evidence of efficacy. Copenhaver, MM., Johnson, BT., Lee, IC., et al.[2023]

The Women FIT study successfully engaged 189 women with drug-using histories in a four-session, peer-led intervention, achieving a high retention rate of 95% over two months.

Participants in the intervention showed significant improvements in body knowledge and protection methods compared to the control group, highlighting the effectiveness of body empowerment in HIV/STI prevention strategies for high-risk women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three city feasibility study of a body empowerment and HIV prevention intervention among women with drug use histories: Women FIT. Gollub, EL., Morrow, KM., Mayer, KH., et al.[2022]

A study involving 93 women in South Africa showed that a Woman-Focused HIV prevention intervention led to significant decreases in unprotected sex and daily substance use compared to a Standard intervention.

Women in the Woman-Focused group reported less victimization from violence at follow-up, highlighting the intervention's potential to address both HIV risk and safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance use, sexual risk, and violence: HIV prevention intervention with sex workers in Pretoria. Wechsberg, WM., Luseno, WK., Lam, WK., et al.[2022]

There is a significant gap in HIV prevention interventions specifically designed for drug-using women with histories of partner violence, despite the overlapping risks these groups face.

Effective interventions should be culturally tailored and address multiple aspects of the risk environment, including behavioral and biomedical strategies, to significantly reduce HIV infections among this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention interventions for human immunodeficiency virus in drug-using women with a history of partner violence. Stockman, JK., Ludwig-Barron, N., Hoffman, MA., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Contingency management reduces injection-related HIV risk behaviors in heroin and cocaine using outpatients. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Improving treatment engagement and outcomes for cocaine-using methadone patients. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Is exposure to an effective contingency management intervention associated with more positive provider beliefs? [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

Do research payments precipitate drug use or coerce participation? [2007]

7. Ireland pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for methamphetamine users. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Applying the Behavioral Model for Vulnerable Populations to Pre-Exposure Prophylaxis Initiation Among Women Who Inject Drugs. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Behavioral HIV risk reduction among people who inject drugs: meta-analytic evidence of efficacy. [2023]

11. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Substance use, sexual risk, and violence: HIV prevention intervention with sex workers in Pretoria. [2022]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Prevention interventions for human immunodeficiency virus in drug-using women with a history of partner violence. [2022]