Expression of Stress Markers During Meth Treatment (EXPRESS+)

Not Applicable

Recruiting

• Conditions: Substance-Related Disorders; HIV
• Interventions: Behavioral: Contingency Management

• Registration Number: NCT05558345
• Lead Sponsor: University of California, Los Angeles

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.

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 Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 55

Inclusion Criteria

For Contingency Management:

1. Assigned male sex at birth
2. 18 to 45 years of age
3. Reports having sex with men in the past 12 months.
4. HIV-positive (confirmed by certification or by HIV rapid test)
5. Has an HIV care provider (last seen in the past 12 months)
6. Has a current antiretroviral prescription
7. Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5
8. Urine test is positive for methamphetamine within 30 days of their screening visit
9. Seeking treatment for methamphetamine use disorder.
10. Ability to attend twice weekly appointments for drug testing and treatment

For Non-substance-using Control:

1. Assigned male sex at birth
2. 18 to 45 years of age
3. Reports having sex with men in the past 12 months.
4. HIV-positive (confirmed by certification or by HIV rapid test)
5. Has an HIV care provider (last seen in the past 12 months)
6. Has a current antiretroviral prescription

Exclusion Criteria

For Contingency Management:

1. Identifies as (cis- or transgender) female
2. Reports another current or past substance use disorder
3. Reports being in another intervention or clinical trial for substance use
4. Positive test for opioids, cocaine, and/or MDMA

For Non-substance-using Control:

1. Identifies as (cis- or transgender) female
2. Positive test for methamphetamine, opioids, cocaine, and/or MDMA.
3. Reports substance use (methamphetamine, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 months
4. Reports past or current substance use disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingency Management for Methamphetamine Reduction	Contingency Management	8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UCLA Vine Street Clinic; 🇺🇸 Los Angeles, California, United States