Expression of Stress Markers During Meth Treatment (EXPRESS+)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder

Conditions
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HIV, Substance-Related Disorders

Intervention / Treatment
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* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Contingency Management: Assigned male sex at birth 18 to 45 years of age Reports having sex with men in the past 12 months. HIV-positive (confirmed by certification or by HIV rapid test) Has an HIV care provider (last seen in the past 12 months) Has a current antiretroviral prescription Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5 Urine test is positive for methamphetamine within 30 days of their screening visit Seeking treatment for methamphetamine use disorder. Ability to attend twice weekly appointments for drug testing and treatment For Non-substance-using Control: Assigned male sex at birth 18 to 45 years of age Reports having sex with men in the past 12 months. HIV-positive (confirmed by certification or by HIV rapid test) Has an HIV care provider (last seen in the past 12 months) Has a current antiretroviral prescription Exclusion Criteria: For Contingency Management: Identifies as (cis- or transgender) female Reports another current or past substance use disorder Reports being in another intervention or clinical trial for substance use Positive test for opioids, cocaine, and/or MDMA For Non-substance-using Control: Identifies as (cis- or transgender) female Positive test for methamphetamine, opioids, cocaine, and/or MDMA. Reports substance use (methamphetamine, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 months Reports past or current substance use disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management for Methamphetamine Reduction<br>8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests | Behavioral: Contingency Management<br>* 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.<br>|
| No Intervention: Non-substance-using Control<br>Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) |