Expression of Stress Markers During Meth Treatment (EXPRESS+)
Study Details
Study Description
Brief Summary
This is a non-randomized behavioral trial that aims to investigate whether changes in inflammatory and type I IFN expression coincide with changes in methamphetamine use and viral load over the course of 12 weeks in HIV-positive people assigned male at birth with and without methamphetamine use disorder.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
This is a within-subjects, two-arm study with 35 HIV-positive people assigned male at birth receiving contingency management for treatment of methamphetamine use disorder and 20 HIV-positive people assigned male at birth serving as a non-substance-using healthy control (N=55 total). HIV-positive participants with methamphetamine use disorder who meet the eligibility criteria will be assigned to the contingency management treatment group. HIV-positive participants who do not use substances and meet the specific criteria will be assigned to the non-substance-using control group. Participants will be observed over 8 weeks, with another follow-up 4 weeks thereafter.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Contingency Management for Methamphetamine Reduction 8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests |
Behavioral: Contingency Management
A positive reinforcement behavioral treatment with escalating rewards for consecutive negative urine tests, starting at $10 and capped at a maximum of $40 per negative result.
|
No Intervention: Non-substance-using Control Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine. |
Outcome Measures
Primary Outcome Measures
- Change in Inflammatory and Type I IFN Gene Expression over 12 weeks [every 4 weeks, at baseline, Week 4, Week 8, and Week 12]
Change in gene expression values -- based on count per million or reference gene normalized mRNA extracted from leukocytes and mapped to 53 a priori specified genes -- averaged over 4 times points using mixed linear regression
- Change in Methamphetamine Use over 12 weeks [twice weekly for 8 weeks with 4-week follow-up in the contingency management group; once every 4 weeks over 12 weeks for the control group.]
Change in odds of methamphetamine use -- based on qualitative urine test result -- over 12 weeks.
Secondary Outcome Measures
- Change in HIV Viral Suppression over 12 weeks [Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)]
Change in odds of viral suppression -- based on viral load cut-off of < 200 c/mL blood -- over 12 weeks
Eligibility Criteria
Criteria
Inclusion Criteria:
For Contingency Management:
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Assigned male sex at birth
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18 to 45 years of age
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Reports having sex with men in the past 12 months.
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HIV-positive (confirmed by certification or by HIV rapid test)
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Has an HIV care provider (last seen in the past 12 months)
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Has a current antiretroviral prescription
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Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5
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Urine test is positive for methamphetamine within 30 days of their screening visit
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Seeking treatment for methamphetamine use disorder.
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Ability to attend twice weekly appointments for drug testing and treatment
For Non-substance-using Control:
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Assigned male sex at birth
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18 to 45 years of age
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Reports having sex with men in the past 12 months.
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HIV-positive (confirmed by certification or by HIV rapid test)
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Has an HIV care provider (last seen in the past 12 months)
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Has a current antiretroviral prescription
Exclusion Criteria:
For Contingency Management:
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Identifies as (cis- or transgender) female
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Reports another current or past substance use disorder
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Reports being in another intervention or clinical trial for substance use
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Positive test for opioids, cocaine, and/or MDMA
For Non-substance-using Control:
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Identifies as (cis- or transgender) female
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Positive test for methamphetamine, opioids, cocaine, and/or MDMA.
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Reports substance use (methamphetamine, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 months
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Reports past or current substance use disorder
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | UCLA Vine Street Clinic | Los Angeles | California | United States | 90038 |
Sponsors and Collaborators
- University of California, Los Angeles
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Michael J Li, PhD, UCLA Department of Family Medicine
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 20-001564
- K01DA051329