[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07213258":3,"trial-entities:NCT07213258":104,"trial-summary:NCT07213258":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":50,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":68,"locations":70,"central_contacts":90,"overall_officials":96,"references":102,"see_also_links":103},"NCT07213258","R21DA060856","CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM","RECRUITING","2027-07-31","2026-08","2026-08-26","2026-04-24","University of California, San Diego","OTHER",true,"The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are:\n\n* To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates.\n* To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.","The CHAMPION (Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM) study, a randomized controlled trial that aims to pilot test state-of-the-art multi-modal pharmaco-behavioral interventions to increase PrEP adherence among HIV-negative MSM who use meth, versus a waitlist control. The study will enroll 100 HIV-negative MSM with mild or moderate meth use disorder (MUD) and sub-optimal PrEP adherence. The study will follow participants for 6 months. The intervention arm will receive the 6-month mHealth intervention package, CHAMPION, at baseline, while the waitlist control will receive it at month-3 follow-up. Results of this pilot study will determine the viability of combining interventions that reduce meth use and enhance PrEP adherence, informing the direction of future interventions for MSM who use meth.",[18,19,20],"PrEP Adherence","Methamphetamine Use Disorder","HIV",[22,23,24,25,26,27,28,29,30],"MSM","HIV Negative","mild MUD","moderate MUD","Methamphetamine Use Disorder (MUD)","CBT4CBT","PrEPAPP","mHealth","Cognitive Behavioral Therapy","INTERVENTIONAL","PREVENTION",[34],"NA",{"count":36,"type":37},100,"ESTIMATED",[39,45],{"type":40,"name":41,"description":42,"armGroupLabels":43},"BEHAVIORAL","CHAMPION Intervention","MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.",[44],"CHAMPION Intervention Arm",{"type":40,"name":46,"description":47,"armGroupLabels":48},"Delayed CHAMPION Package","Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.",[49],"Waitlist Control Arm",[51,55],{"measure":52,"description":53,"timeFrame":54},"Feasibility & Acceptability of CHAMPION","We will calculate the following feasibility and acceptability measures:\n\n1. study completion rate (mean, standard deviation)\n2. days of PrEPAPP use (mean, standard deviation)\n3. CBT4CBT virtual sessions completed (mean, standard deviation)","6 months",{"measure":56,"description":57,"timeFrame":58},"PrEP adherence","We will examine the preliminary efficacy of CHAMPION vs. a waitlist control on increasing PrEP adherence, compared to a waitlist control as determined by dried blood spot (DBS) tests. In preparation for a larger efficacy trial, we will explore the preliminary efficacy of CHAMPION vs. waitlist control in increasing PrEP adherence. PrEP drug levels in DBS samples will be dichotomized as PrEP adherence, or not, using established cut-offs for protective levels of PrEP. We will calculate the following outcome measure:\n\n1.) Number and percent adherent to PrEP, based on DBS.","6-Months",[],"MALE","18 Years","40 Years",false,{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. HIV-negative\n2. Cis-gender male\n3. Age 18-40 years old\n4. Mild or moderate MUD (by DSM-5 SCID criteria)\n5. Anal intercourse with one or more male partners in the past 6 months\n6. Started daily oral PrEP more than 30 days ago and self-reported not always taking PrEP as prescribed in the past 30 days (consistent with PrEP It! inclusion criteria)\n7. Willingness to participate in an mHealth study with a 6-month follow-up\n8. Residing in San Diego or San Francisco County\n\nExclusion Criteria:\n\n1. Residing outside of San Diego or San Francisco County\n2. Any condition that, in the principal investigator's judgment interferes with safe study participation or adherence to study procedures\n3. Not able\u002Fwilling to complete virtual\u002Fremote visits\n4. Not willing to learn to self-collect dried blood spots using a finger stick",[69],"ADULT",[71],{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":87},"Center on Substance Use and Health","San Francisco","California","94102","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Glenn-Milo Santos","CONTACT","628-217-6231","Glenn-milo.Santos@ucsf.edu",{"name":84,"role":80,"phone":85,"email":86},"Allie Dunham","530-925-3398","allie.dunham@sfdph.org",{"lat":88,"lon":89},37.77493,-122.41942,[91,94],{"name":92,"role":80,"phone":81,"email":93},"Glenn-Milo Santos, PhD, MPH","glenn-milo.santos@ucsf.edu",{"name":95,"role":80,"phone":85,"email":86},"Alexandrea Dunham, B.A.",[97,100],{"name":92,"affiliation":98,"role":99},"University of California, San Francisco","PRINCIPAL_INVESTIGATOR",{"name":101,"affiliation":12,"role":99},"Kiyomi Tsuyuki, PhD, MPH",[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Amphetamine-induced organic mental disorder",[],{"nct_id":4,"found":14,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is a randomized controlled trial, meaning participants will be assigned by chance to either receive the CHAMPION program right away or after a delay. The study aims to enroll 100 participants.","completed","CHAMPION Study: Improving PrEP Adherence and Addressing Methamphetamine Use","This study, called CHAMPION, is testing a new mobile health (mHealth) program to help HIV-negative men who have sex with men (MSM) better take their PrEP (pre-exposure prophylaxis) medication and address mild to moderate methamphetamine use. PrEP is a daily medicine that can help prevent HIV. The CHAMPION program uses two mHealth tools, PrEPAPP and CBT4CBT, to help with both PrEP adherence and methamphetamine use. Researchers want to see if this program is practical and well-received, and if it helps people take their PrEP more consistently. You might be able to join if you are an HIV-negative cisgender man between 18 and 40, have mild or moderate methamphetamine use disorder, have had anal sex with men recently, and have not been taking your daily PrEP as prescribed for at least 30 days. The study plans to enroll 100 participants, but its current status is unclear.","Participants will be followed for 6 months, with PrEP adherence measured at the 6-month mark.",145,"Participants will be followed for 6 months. Those in the intervention group will receive the CHAMPION program for 6 months, while the delayed group will receive informational resources for 3 months, then the CHAMPION program for the final 3 months.","Not stated in the trial record.",[],"v2"]