Trauma-Focused Interventions for HIV Prevention in Women Who Inject Drugs
(TIARAS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAlexis M Roth, PhD, MPH
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Drexel University
Must be taking: PrEP
Disqualifiers: Pregnant, others
Approved in 2 Jurisdictions
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.
12345Is 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.
15678How 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.
910111213Eligibility 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
+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
+1 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Prevention Point PhiladelphiaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Drexel UniversityLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Contingency management reduces injection-related HIV risk behaviors in heroin and cocaine using outpatients. [2021]Intravenous drug use is a major vector of HIV transmission. We assessed whether contingency management (CM), in which participants earn reinforcers for drug abstinence, reduces HIV risk behaviors in methadone-maintained opiate- and cocaine-using outpatients. Participants (n=116) were randomly assigned to prize-based CM or to receipt of prize draws noncontingently on a schedule yoked to the CM group. Both groups received methadone and individual counseling throughout treatment. The HIV-Risk Taking Behaviour Scale was administered in written questionnaire form at 2-week intervals (HRBS; [Darke, S., Hall, W., Heather, N., Ward, J., & Wodak, A. (1991). The reliability and validity of a scale to measure HIV risk-taking behaviour among intravenous drug users. AIDS, 5, 181-185]). A mediation analysis was conducted to determine whether abstinence from opiates and cocaine mediated the effect of CM on HRBS scores. Changes in HRBS scores over time differed significantly by treatment (F(9,334)=2.4, p
Improving treatment engagement and outcomes for cocaine-using methadone patients. [2019]A task-based behavioral contingency-the "treatment reinforcement plan" (TRP)-was implemented with cocaine-using methadone patients to increase treatment engagement and retention. Subjects (N = 57) were rewarded up to $15 per week in travel/food/entertainment vouchers for the completion of tasks related to their individual treatment needs. Eighteen types of tasks were contracted and completed with varying frequency. The largest categories of tasks were related to therapy attendance (N = 272; 58% completed), obtaining public entitlements (N = 165; 61% completed), medical/psychiatric appointments (N = 155; 70% completed), and obtaining Medicaid (N = 96; 54% completed). The highest proportion of tasks completed were related to human immunodeficiency virus (HIV) testing/education (N = 19; 100% completed), managing money (N = 17, 94% completed), and legal matters (N = 16, 88% completed). Successful TRP involvement during months 1-2 predicted longer retention in methadone treatment, greater therapy attendance during months 3-6, and lower proportion of cocaine-positive urines at 6-month follow-up. This research supports recent findings that early treatment engagement is associated with improved therapeutic relationships, increased retention, and reduced cocaine use. Behavioral counseling techniques may be especially helpful in addressing the complex needs of high-risk methadone patients, which in turn may facilitate treatment process and positive outcomes.
Examining implementation of contingency management in real-world settings. [2021]Very little is known about how reward programs are implemented in real-world substance use treatment settings and whether training in contingency management (CM), an empirically supported rewards-based intervention, impacts their design quality. Providers (N = 214) completed surveys assessing CM beliefs, training, and practices related to use of tangible rewards in treatment. For providers reporting they had not used rewards in treatment previously (54%, n = 116), we assessed beliefs about and interest in adopting a reward-based program. For those endorsing prior reward experience (46%, n = 98), we assessed the features and delivery of rewards and the relation of reward-based intervention training to 4 parameters related to CM efficacy: reinforcement magnitude, immediacy, frequency, and escalation. Among providers without reward experience, endorsement of supportive statements about CM predicted interest in adopting a rewards-based program. Providers with reward experience most often targeted treatment attendance and engaged in behaviors likely to decrease the effectiveness of the intervention, including use of low magnitudes (≤ $25/client), delayed reinforcement, failure to escalate reward values, and offering reward opportunities less than weekly. Providers with longer durations of training were more likely to engage in behaviors consistent with effective CM, including larger magnitude rewards and immediate delivery of rewards. Results indicate that real-world treatment clinics are using reward-based programs but not in ways consistent with research protocols. Longer training exposure is associated with greater adherence to some aspects of CM protocol design. Other evidence-based design features are not being implemented as recommended, even with training. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. [2019]To determine if prize-based abstinence incentives will differentially affect substance abuse outcomes in patients with different treatment histories.
Is exposure to an effective contingency management intervention associated with more positive provider beliefs? [2021]This study empirically examined opinions of treatment providers regarding contingency management (CM) programs while controlling for experience with a specific efficacious CM program. In addition to empirically describing provider opinions, we examined whether the opinions of providers at the sites that implemented the CM program were more positive than those of matched providers at sites that did not implement it. Participants from 7 CM treatment sites (n = 76) and 7 matched nonparticipating sites (n = 69) within the same nodes of the National Institute of Drug Abuse Clinical Trials Network completed the Provider Survey of Incentives (PSI), which assesses positive and negative beliefs about incentive programs. An intent-to-treat analysis found no differences in the PSI summary scores of providers in CM program versus matched sites, but correcting for experience with tangible incentives showed significant differences, with providers from CM sites reporting more positive opinions than those from matched sites. Some differences were found in opinions regarding costs of incentives, and these generally indicated that participants from CM sites were more likely to see the costs as worthwhile. The results from the study suggest that exposing community treatment providers to incentive programs may itself be an effective strategy in prompting the dissemination of CM interventions.
Do research payments precipitate drug use or coerce participation? [2007]Providing high-magnitude cash incentives to substance abuse clients to participate in research is frequently viewed as unethical based on the concerns that this might precipitate new drug use or be perceived as coercive. We randomly assigned consenting drug abuse outpatients to receive payments of 10 US dollars, 40 US dollars, or 70 US dollars in either cash or gift certificate for attending a 6-month research follow-up assessment. At the 6-month follow-up, participants received their randomly determined incentive and were then scheduled for a second follow-up appointment 3 days later to detect new instances of drug use. Findings indicated that neither the magnitude nor mode of the incentives had a significant effect on rates of new drug use or perceptions of coercion. Consistent with the contingency management literature, higher payments and cash payments were associated with increased follow-up rates. Finally, the results suggest that higher magnitude payments may be more cost-effective by reducing the need for more intensive follow-up efforts.
Randomized controlled trial of a positive affect intervention for methamphetamine users. [2023]Contingency management (CM) is an evidence-based intervention providing rewards in exchange for biomarkers that confirm abstinence from stimulants such as methamphetamine. We tested the efficacy of a positive affect intervention designed to boost the effectiveness of CM with HIV-positive, methamphetamine-using sexual minority men.
Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. [2022]Methamphetamine use is associated with HIV acquisition and transmission among men who have sex with men (MSM). Contingency management (CM), providing positive reinforcement for drug abstinence and withholding reinforcement when abstinence is not demonstrated, may facilitate reduced methamphetamine use and sexual risk. We compared CM as a stand-alone intervention to a minimal intervention control to assess the feasibility of conducting a larger, more definitive trial of CM; to define the frequency of behavioral outcomes to power such a trial; and, to compute preliminary estimates of CM's effectiveness.
Applying the Behavioral Model for Vulnerable Populations to Pre-Exposure Prophylaxis Initiation Among Women Who Inject Drugs. [2021]This study used Behavioral Model for Vulnerable Populations (BMVP) to identify factors associated with pre-exposure prophylaxis (PrEP) initiation among women who inject drugs (WWID) when PrEP was offered at a syringe services program (SSP). Participants (n = 89) were WWID, $ge18 years, and eligible for PrEP. Most (69) initiated PrEP. Chi square and t tests were used to identify bivariate relationships between BMVP factors and PrEP initiation. A greater proportion of PrEP initiators (compared to non-initiators) reported sexual assault, frequent SSP attendance, earning $ge$5,000 annually and inconsistent condom use. Findings can inform the development of gender-specific strategies to promote PrEP among WWID.
Behavioral HIV risk reduction among people who inject drugs: meta-analytic evidence of efficacy. [2023]We conducted a meta-analysis of randomized controlled trials (RCTs) to evaluate behavioral HIV risk reduction interventions targeting people who inject drugs. We included 37 RCTs evaluating 49 independent HIV risk reduction interventions with 10,190 participants. Compared to controls, intervention participants reduced injection drug use (IDU) and non-IDU, increased drug treatment entry, increased condom use, and decreased trading sex for drugs. Interventions were more successful at reducing IDU when participants were non-Caucasians, when content focused equivalently on drug-related and sex-related risks, and when content included interpersonal skills training specific for safer needle use. Condom use outcomes improved when two intervention facilitators were used instead of one. IDU outcomes did not decay, but condom use outcomes did. Behavioral interventions reduce risk behaviors among people who inject drugs, especially when interventions target both drug risk and sexual risk behaviors, and when they include certain behavioral skills components. Implications for future interventions are presented.
Three city feasibility study of a body empowerment and HIV prevention intervention among women with drug use histories: Women FIT. [2022]New intervention models are needed for HIV prevention among drug-using women.
Substance use, sexual risk, and violence: HIV prevention intervention with sex workers in Pretoria. [2022]This paper describes an HIV prevention intervention designed in the US that was adapted and implemented in South Africa. Using an experimental design, 93 women who reported recent substance use and sex trading were randomly assigned to a modified Standard HIV intervention or to a Woman-Focused HIV prevention intervention. Eighty women completed the one-month follow-up interview. Participants reported high rates of sexual risk and violence at baseline. At follow-up, findings showed decreases in the proportion of women reporting unprotected sex and the daily use of alcohol and cocaine. Daily alcohol and cocaine use decreased more for women receiving the Woman-Focused intervention. Although violence continued to be a problem, at follow-up Woman-Focused participants reported being victimized less often than women receiving the Standard intervention. This study demonstrates the feasibility of implementing cross-cultural behavioral HIV prevention interventions, and supports the need for future studies of women's contextual issues and the effectiveness of targeted interventions.
Prevention interventions for human immunodeficiency virus in drug-using women with a history of partner violence. [2022]The intersecting epidemics of human immunodeficiency virus (HIV) and partner violence disproportionately affect women who use drugs. Despite accumulating evidence throughout the world linking these epidemics, HIV prevention efforts focused on these synergistic issues as well as underlying determinants that contribute to the HIV risk environment (eg, housing instability, incarceration, policing practices, survival sex) are lacking. This article highlights selected behavior change theories and biomedical approaches that have been used or could be applied in HIV prevention interventions for drug-using women with histories of partner violence and in existing HIV prevention interventions for drug-using women that have been gender-focused while integrating histories of partner violence and/or relationship power dynamics. To date, there is a paucity of HIV prevention interventions designed for drug-using women (both in and outside of drug treatment programs) with histories of partner violence. Of the few that exist, they have been theory-driven, culture-specific, and address certain aspects of gender-based inequalities (eg, gender-specific norms, relationship power and control, partner violence through assessment of personal risk and safety planning). However, no single intervention has addressed all of these issues. Moreover, HIV prevention interventions for drug-using women with histories of partner violence are not widespread and do not address multiple components of the risk environment. Efficacious interventions should target individuals, men, couples, and social networks. There is also a critical need for the development of culturally tailored combination HIV prevention interventions that not only incorporate evidence-based behavioral and biomedical approaches (eg, microbicides, pre-exposure prophylaxis, female-initiated barrier methods) but also take into account the risk environment at the physical, social, economic and political levels. Ultimately, this approach will have a significant impact on reducing HIV infections among drug-using women with histories of partner violence.