An interventional study of Contingency Management in Substance-Related Disorders and HIV, sponsored by University of California, Los Angeles. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
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.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's planned enrollment of 55 is below the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.
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For Contingency Management:
For Non-substance-using Control:
Exclusion Criteria:
For Contingency Management:
For Non-substance-using Control:
8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests
Behavioral: Contingency Management
Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine.
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.
Change in Inflammatory and Type I IFN Gene Expression over 12 weeks
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
Time frame: every 4 weeks, at baseline, Week 4, Week 8, and Week 12
Change in Methamphetamine Use over 12 weeks
Change in odds of methamphetamine use -- based on qualitative urine test result -- over 12 weeks.
Time frame: 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 HIV Viral Suppression over 12 weeks
Change in odds of viral suppression -- based on viral load cut-off of \< 200 c/mL blood -- over 12 weeks
Time frame: Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — It is possible that future collaborators of the PI (e.g., other UCLA investigators) may conduct secondary analyses on the data to answer other research questions. The other investigator may submit a concept for a research question and hypothesis to be tested using the data. This would require PI approval of a concept, and co-authorship/involvement of the PI on the study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After the PI completes publication of their specific aims and any secondary outcomes, data will be available for at least 3 years thereafter.
Access criteria: Submission and PI approval of a concept sheet
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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