Contingency Management for HIV and Stimulant Use Disorder

(CoMBo Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Disqualifiers: Unable to provide urine testing

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

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with both HIV and a stimulant use disorder, particularly those who struggle to adhere to their HIV medication. The approach, known as contingency management (also called Motivational Incentives, Prize Method, or Carrot and Stick Method), involves offering rewards for positive changes, such as reducing methamphetamine use and consistently taking HIV medication. Participants will undergo regular urine tests to monitor their progress. This trial may suit individuals who use stimulants, have HIV or are at risk for it, and find it challenging to follow their HIV treatment plan. As an unphased trial, this study provides a unique opportunity to explore innovative treatment strategies for improved health outcomes.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. It focuses on improving adherence to HIV medications, so you may need to continue those.

What prior data suggests that this contingency management method is safe for participants?

Research has shown that contingency management is a promising method to help people reduce methamphetamine use. This approach involves giving rewards for positive actions, such as taking medication on time or staying drug-free.

Studies have found that this method can help people adhere to their HIV treatment and reduce drug use. Importantly, contingency management is generally well-received, with no reports of serious side effects. Instead, it can motivate and support individuals.

Overall, existing research supports the safety of using contingency management for those dealing with methamphetamine use and HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contingency management for HIV and stimulant use disorder because it offers a novel approach by using behavioral incentives rather than traditional medications. Unlike standard treatments that focus primarily on medication management, contingency management motivates patients by providing rewards for meeting specific health goals, like reducing stimulant use and adhering to HIV medications. This method can lead to more engaged patients and potentially quicker behavioral changes, which is why it's generating interest as a promising complement to existing treatment options.

What evidence suggests that contingency management is effective for reducing methamphetamine use and improving HIV medication adherence?

Studies have shown that using rewards to encourage healthy behavior, known as contingency management, effectively helps people with stimulant use disorder. In this trial, participants will receive contingency management to support reduced stimulant use and adherence to HIV medication. This method has been linked to better adherence to HIV medications and reduced drug use. Research indicates that financial incentives can help maintain low HIV viral loads, crucial for managing the disease. Additionally, contingency management has proven effective even for individuals using both stimulants and opioids. Overall, using rewards to promote positive behavior changes shows promise in improving health outcomes for those with both HIV and stimulant use disorder. ^{1 2 3 4 6}

Who Is on the Research Team?

Ayesha Appa, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with HIV who also struggle with stimulant use, specifically methamphetamine. Participants should be currently using methamphetamines and have difficulty sticking to their antiretroviral therapy (ART) for HIV. The study excludes details on specific inclusion or exclusion criteria.

Inclusion Criteria

Stimulant use disorder

I am living with HIV or at high risk for HIV.

I have not been consistently taking my HIV medication as prescribed.

Exclusion Criteria

Unable to provide urine testing weekly

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once weekly contingency management in clinic to support reduced stimulant use and HIV medication adherence

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including in-depth interviews and hair level analysis

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management

Trial Overview The study tests a strategy called contingency management, which rewards patients for reducing methamphetamine use and improving adherence to HIV medication. It uses real-time urine tests to monitor progress and hair analysis to measure long-term changes in drug use.

How Is the Trial Designed?

Group I: Contingency management arm Experimental Treatment 1 Intervention

Participants are offered once weekly contingency management in clinic to support reduced stimulant use and HIV medication adherence.

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?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

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

Harm Reduction Contingency Management for Stimulant Use ... Both methamphetamine and cocaine have been repeatedly associated with antiretroviral therapy (ART) nonadherence, HIV viremia, and progression to AIDS; by some ...

2. researchgate.net researchgate.net/publication/392448330_Harm_reduction_contingency_management_for_stimulant_use_reduction_and_ART_adherence_in_HIV_primary_care_an_implementation-effectiveness_study_protocol_Preprint

Harm reduction contingency management for stimulant use ... Financial incentives for suppressed viral loads could contribute to the eradication of the HIV/AIDS epidemic. View. Show abstract. Reduced drug ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11033782/

Combined Contingency Management for Both Stimulant ... ... HIV, stimulant use disorder ... disorder have demonstrated poor outcomes including reduced ART adherence and faster progression to AIDS.

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

contingency-management-advisory-pep24-06-001.pdf CM is equally effective among those with concurrent stimulant and opioid use disorder, as well as in ... Current HIV/AIDS Report, 3(4):154–9. https://doi.org/ ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06564792

Contingency Management in HIV Care for Both Stimulant ... Contingency Management in HIV Care for Both Stimulant Use & ART Adherence. a study on Stimulant Use HIV/AIDS Immunodeficiency ...

6. health.ny.gov health.ny.gov/health_care/medicaid/ebbrac/2025/docs/2025-04-02_contingency_mgmt_sud_rpt.pdf

Contingency Management for Stimulant Use Disorder Health ... depression, and may also be used in diet aids.40 Psychostimulant abuse ... CM: contingency management; HIV: human immunodeficiency virus; KQ: key question.