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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA051329 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency Management for Methamphetamine Reduction | Experimental | 8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests |
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| Non-substance-using Control | No Intervention | Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12) |
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Inclusion Criteria:
For Contingency Management:
For Non-substance-using Control:
Exclusion Criteria:
For Contingency Management:
For Non-substance-using Control:
Assigned male sex at birth but does not identify as female.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael J Li, PhD | Contact | 3107948530 | mjli@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael J Li, PhD | UCLA Department of Family Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Vine Street Clinic | Recruiting | Los Angeles | California | 90038 | United States |
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.
After the PI completes publication of their specific aims and any secondary outcomes, data will be available for at least 3 years thereafter.
Submission and PI approval of a concept sheet
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 8, 2022 | Sep 21, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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