Motivational Interviewing + Contingency Management for HIV Prevention

(PRISM Trial)

Overseen By Adam Carrico Professor and Chair, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Florida International University

Disqualifiers: Unable to provide consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

840 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Motivational Interviewing + Contingency Management for HIV Prevention?

Research shows that Contingency Management (CM), which uses rewards to encourage positive behaviors, can help reduce HIV risk behaviors and improve medication adherence. Additionally, CM has been effective in promoting abstinence in substance use treatment, suggesting it could be beneficial in HIV prevention when combined with Motivational Interviewing. ^{1 2 3 4 5}

Is Motivational Interviewing + Contingency Management safe for humans?

Research on Contingency Management (CM) and Motivational Interviewing (MI) shows they are generally safe for humans. These methods have been used in various studies, including those involving HIV-positive individuals and substance users, without significant safety concerns. ^{1 2 6 7 8}

How does the treatment Motivational Interviewing + Contingency Management for HIV prevention differ from other treatments?

This treatment is unique because it combines Motivational Interviewing, which helps people find their own reasons to change, with Contingency Management, which uses rewards to encourage healthy behaviors. This combination is designed to improve adherence to HIV prevention strategies by providing both psychological support and tangible incentives. ^{2 3 6 7 9}

What is the purpose of this trial?

This is a hybrid type I, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (CM), motivational interviewing (MI), and MI+CM for optimizing entry or re-entry into the PrEP care continuum. A total of 840 participants will be randomized to CM (n = 280), MI (n = 280), or MI+CM (n = 280), all delivered via Telehealth. Monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a PrEP prescription (verified using a digital photo or detectable tenofovir diphosphate). Secondary outcomes will include: self-reported PrEP clinical evaluation by a PrEP provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).

Eligibility Criteria

The PRISM trial is for individuals with HIV/AIDS and methamphetamine disorder who are considering or re-considering pre-exposure prophylaxis (PrEP) treatment. Participants must be willing to engage in Telehealth sessions.

Inclusion Criteria

Non-reactive HIV antibody test results (past 3 months)

I identify as part of the sexual or gender minority.

I am not taking medication to prevent HIV.

Exclusion Criteria

Unwilling or unable to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Contingency Management (CM), Motivational Interviewing (MI), or a combination of both (MI+CM) delivered via Telehealth

12 months

Monthly follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of PrEP use and substance use behaviors

12 months

Monthly follow-up assessments

Treatment Details

Interventions

• Contingency Management
• Motivational Interviewing

Trial Overview This study tests the effectiveness of Motivational Interviewing (MI), Contingency Management (CM), and a combination of both (MI+CM) via Telehealth to encourage participants to fill their PrEP prescriptions, as part of HIV prevention efforts.

Participant Groups

Group I: Motivational Interviewing (MI) Experimental Treatment 1 Intervention

Two-session counseling intervention focusing on PrEP use (Session 1) as well as co-occurring substance use and HIV risk (Session 2)

Group II: MI+CM Experimental Treatment 2 Interventions

Both the CM and MI interventions described above.

Group III: Contingency Management Experimental Treatment 1 Intervention

Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.

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?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Findings from Research

A novel multi-target contingency management (CM) program was developed for HIV positive substance users, integrating various health and behavior targets to improve outcomes over a 6-month period.

The primary goal of the program is to achieve viral load suppression at 12 months, with participants able to earn up to $1160 through completing tasks related to health care visits, medication adherence, and drug use abatement, indicating a comprehensive approach to managing both health and substance use behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Multi-Target Contingency Management Intervention for HIV Positive Substance Users. Stitzer, M., Calsyn, D., Matheson, T., et al.[2019]

Contingency management (CM) is an effective treatment strategy that reinforces positive behaviors, such as drug abstinence and counseling attendance, and shows promise in improving HIV-related behaviors.

CM interventions, including voucher systems and cash incentives, can significantly reduce HIV risk behaviors and enhance adherence to HIV medications, making them versatile tools for both prevention and management in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management interventions for HIV-related behaviors. Haug, NA., Sorensen, JL.[2019]

In a study involving 74 cocaine-dependent methadone outpatients over 12 weeks, both voucher and prize-based contingency management (CM) interventions led to longer durations of abstinence compared to standard treatment.

The study found no significant differences in outcomes between the voucher and prize systems, indicating that both methods are effective in promoting abstinence during treatment, which is linked to better long-term recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. Petry, NM., Alessi, SM., Hanson, T., et al.[2021]

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]

The study is testing the effectiveness of a 5-session intervention called ARTEMIS, which aims to help HIV-positive men who use methamphetamine by enhancing their ability to manage emotions and find rewards outside of drug use, alongside a 12-week contingency management program.

The primary goal of the trial is to assess the impact of ARTEMIS on HIV viral load, with secondary outcomes including sustained viral suppression and psychological adjustment, highlighting its potential to improve both health and substance use outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. Carrico, AW., Jain, J., Discepola, MV., et al.[2019]

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 142 outpatients with cocaine or heroin dependence, both voucher and prize-based contingency management (CM) interventions led to longer treatment retention and greater durations of confirmed abstinence compared to standard treatment.

While there were no significant differences in abstinence rates at 6- and 9-month follow-ups, the duration of abstinence achieved during treatment was the strongest predictor of continued abstinence after treatment ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. Petry, NM., Alessi, SM., Marx, J., et al.[2016]

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]

References

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

Development of a Multi-Target Contingency Management Intervention for HIV Positive Substance Users. [2019]

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

Effectiveness of Motivational Incentives for Adolescent Marijuana Users in a School-Based Intervention. [2022]

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

Contingency management interventions for HIV-related behaviors. [2019]

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

Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. [2021]

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

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

6. England pubmed.ncbi.nlm.nih.gov

A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. [2019]

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

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

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

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]

9. England pubmed.ncbi.nlm.nih.gov

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