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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three methods to help people start or restart using PrEP, a medication that prevents HIV. It compares motivational interviewing (a type of guided conversation) and contingency management (offering rewards for taking health steps), both individually and combined. Participants will join one of these groups and use Telehealth to connect with the study. Suitable candidates have not started PrEP, were assigned male at birth, and have used meth in the past three months. The trial aims to determine which method best encourages people to fill their PrEP prescriptions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that motivational interviewing (MI) yields positive results. It empowers individuals to manage their health, such as reducing risky behaviors. Research indicates that MI is generally safe and well-tolerated, with no serious side effects reported.

Studies have demonstrated that contingency management (CM) effectively uses rewards to promote healthy actions. It has been applied in HIV care and is considered safe. Participants typically handle it well, with no serious problems reported.

Combining MI and CM has also undergone study. This approach aims to further increase positive behaviors. Research suggests it is safe, with no major issues for participants.

Both MI and CM are generally regarded as safe. They emphasize coaching and rewards over medications, resulting in fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine motivational interviewing and contingency management to tackle HIV prevention in a novel way. Unlike standard HIV prevention methods that focus heavily on medication adherence alone, these treatments incorporate behavioral interventions. Motivational interviewing provides personalized counseling to encourage PrEP use and address substance use and HIV risk. Meanwhile, contingency management offers financial incentives to kickstart and maintain PrEP care, making the approach more engaging and supportive for participants. Together, these methods aim to enhance adherence and reduce risk behaviors more effectively than existing options.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that motivational interviewing (MI), one of the treatments in this trial, effectively encourages behaviors that prevent HIV. For example, one study found that MI significantly increased HIV testing and prevention efforts in communities. It also helped HIV-positive individuals feel more confident about practicing safer sex.

Contingency management (CM), another treatment option in this trial, uses rewards to promote healthy behaviors and has shown promising results as well. Studies have found that offering financial incentives can improve medication adherence and reduce risky behaviors related to HIV. CM is also recommended as a primary treatment for stimulant use, which can help lower HIV-related risks.

This trial will compare MI alone, CM alone, and a combination of MI and CM. Combining MI and CM might offer even greater benefits. This combined approach has been tested in other areas and has reduced drug use and improved adherence to HIV medications. Overall, both treatments show promise in supporting HIV prevention efforts, and their combination might enhance these outcomes. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12131609/

The effectiveness of monetary incentives in improving viral ... The financial incentives for HIV patients showed a statistically significant improvement in viral suppression and treatment adherence in the ≥ 1 ...

2. researchprotocols.org researchprotocols.org/2025/1/e67292

Harm Reduction Contingency Management for Stimulant ... Contingency management (CM) is a strategy incentivizing measurable behavior change that is recommended as the first-line treatment for stimulant ...

3. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00503-4

Readiness to implement contingency management to promote ... Contingency management (CM), an incentive-based intervention to encourage target behaviors, effectively promotes medication adherence.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2271179/

Contingency management reduces injection-related HIV ... The objective of the present study was to evaluate the efficacy of prize-based CM in reducing HIV-risk behaviors in methadone-maintained cocaine and opiate ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003639

Contingency Management and Pre-Exposure Prophylaxis ... We describe the rationale and study design for a new study, “Contingency Management and Pre-Exposure Prophylaxis (PrEP) Adherence Support Services (CoMPASS),” ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11665208/

Readiness to implement contingency management ... Contingency management (CM), the use of incentives to promote verifiable behavior change, has been utilized across the HIV care continuum [9], ...

7. library.samhsa.gov library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

contingency-management-advisory-pep24-06-001.pdf To promote program integrity and effectiveness, CM incentives should take the form of items, or vouchers or gift cards for items and services, that support ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00717444

Study Details | NCT00717444 | Healthy Activities for Prize ... In this Stage 1 therapy development project, we plan to develop, formalize, and derive effect size estimates of a contingency management (CM) therapy that ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12402737/

Harm Reduction Contingency Management for Stimulant Use ... To optimize care for safety-net populations living with comorbid stimulant use disorder and HIV, we designed a novel CM program incentivizing both stimulant use ...