Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in Inflammatory and Type I IFN Gene Expression over 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Inflammatory and Type I IFN Gene Expression over 12 weeks
时间窗: 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
时间窗: 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.
次要结局
- Change in HIV Viral Suppression over 12 weeks(Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12))
研究者
Michael J. Li, PhD, MPH
Assistant Professor In-Residence
University of California, Los Angeles