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

37 Participants Needed

Trial Summary

What is the purpose of this trial?

Methamphetamine use and associated sequelae have been rising, and represent a major barrier to successful control of the HIV epidemic. Methamphetamine use is associated with poor adherence to antiretroviral therapy for HIV, and we propose a trial of contingency management (providing incentives for behavioral change) targeting both reduced methamphetamine use and improved adherence to HIV medications. We will utilize a real-time, point-of-care urine assay for both outcomes, aiming to evaluate feasibility, acceptability and preliminary effectiveness of HIV care-based contingency management. We will also study hair levels as a quantitative outcome for reduction in methamphetamine use.

Research Team

Ayesha Appa, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+