[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05558345":3,"trial-entities:NCT05558345":87,"trial-summary:NCT05558345":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":45,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":58,"locations":60,"central_contacts":79,"overall_officials":82,"references":85,"see_also_links":86},"NCT05558345","20-001564","Expression of Stress Markers During Meth Treatment (EXPRESS+)","Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder","UNKNOWN","2026-03-31","2024-05","2024-05-07","2022-09-01","University of California, Los Angeles","OTHER",false,"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.",[19,20],"Substance-Related Disorders","HIV",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},55,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Contingency Management","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.",[35],"Contingency Management for Methamphetamine Reduction",[37,41],{"measure":38,"description":39,"timeFrame":40},"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",{"measure":42,"description":43,"timeFrame":44},"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.",[46],{"measure":47,"description":48,"timeFrame":49},"Change in HIV Viral Suppression over 12 weeks","Change in odds of viral suppression -- based on viral load cut-off of \\\u003C 200 c\u002FmL blood -- over 12 weeks","Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)","MALE","18 Years","45 Years",true,{"inclusion":55,"exclusion":56,"raw_text":57},[],[],"Inclusion Criteria:\n\nFor Contingency Management:\n\n1. Assigned male sex at birth\n2. 18 to 45 years of age\n3. Reports having sex with men in the past 12 months.\n4. HIV-positive (confirmed by certification or by HIV rapid test)\n5. Has an HIV care provider (last seen in the past 12 months)\n6. Has a current antiretroviral prescription\n7. Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5\n8. Urine test is positive for methamphetamine within 30 days of their screening visit\n9. Seeking treatment for methamphetamine use disorder.\n10. Ability to attend twice weekly appointments for drug testing and treatment\n\nFor Non-substance-using Control:\n\n1. Assigned male sex at birth\n2. 18 to 45 years of age\n3. Reports having sex with men in the past 12 months.\n4. HIV-positive (confirmed by certification or by HIV rapid test)\n5. Has an HIV care provider (last seen in the past 12 months)\n6. Has a current antiretroviral prescription\n\nExclusion Criteria:\n\nFor Contingency Management:\n\n1. Identifies as (cis- or transgender) female\n2. Reports another current or past substance use disorder\n3. Reports being in another intervention or clinical trial for substance use\n4. Positive test for opioids, cocaine, and\u002For MDMA\n\nFor Non-substance-using Control:\n\n1. Identifies as (cis- or transgender) female\n2. Positive test for methamphetamine, opioids, cocaine, and\u002For MDMA.\n3. Reports substance use (methamphetamine, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, and\u002For tobacco) in the past 6 months\n4. Reports past or current substance use disorder",[59],"ADULT",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":76},"UCLA Vine Street Clinic","RECRUITING","Los Angeles","California","90038","United States",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Michael J Li, PhD","CONTACT","310-794-8530","mjli@mednet.ucla.edu",{"name":70,"role":75},"PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},34.05223,-118.24368,[80],{"name":70,"role":71,"phone":81,"email":73},"3107948530",[83],{"name":70,"affiliation":84,"role":75},"UCLA Department of Family Medicine",[],[],{"nct_id":4,"conditions":88,"biomarkers":91},[89,90],"HIV Infection","Substance-Related Disorder",[],{"nct_id":4,"found":53,"summary":93,"prompt_version":103},{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is a non-randomized study with two groups, involving a total of 55 participants. One group receives Contingency Management, and the other is a control group.","completed","EXPRESS+ Study: Methamphetamine Use and HIV","This study, called EXPRESS+, is looking at how a behavioral treatment called Contingency Management affects methamphetamine use and the body's stress response in men living with HIV. Contingency Management offers rewards, starting at $10 and increasing, for clean urine tests. We want to see if changes in your body's inflammatory (swelling) and Type I IFN (immune response) genes are connected to changes in your methamphetamine use and viral load over 12 weeks. You may be able to join if you are a man between 18 and 45 years old, living with HIV, and have used methamphetamine. The study is currently unclear about its recruitment status.","Participants will be followed for 4 weeks after the initial 8-week observation period, for a total of 12 weeks.",105,"Participants will be observed over 8 weeks, with an additional follow-up 4 weeks later. Methamphetamine use will be measured twice weekly for 8 weeks in one group, and every 4 weeks for 12 weeks in the control group.","Not stated in the trial record.",[32],"v2"]