title: A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men.
abstract: Contingency management (CM) is an evidence-based intervention providing tangible rewards as positive reinforcement for abstinence from stimulants such as methamphetamine. Integrative approaches targeting affect regulation could boost the effectiveness of CM in community-based settings and optimize HIV/AIDS prevention efforts.
  
  
  
  This randomized controlled trial with HIV-positive, methamphetamine-using men who have sex with men (MSM) is examining the efficacy of a 5-session, individually delivered positive affect regulation intervention - Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS). ARTEMIS is designed to sensitize individuals to non-drug-related sources of reward as well as assist with managing depression and other symptoms of stimulant withdrawal during CM. HIV-positive, methamphetamine-using MSM who are enrolled in a community-based, 12-week CM program are randomized to receive ARTEMIS or an attention-matched control condition. Follow-up assessments are conducted at 3, 6, 12, and 15 months after enrollment in CM. Four peripheral venous blood samples are collected over the 15-month follow-up with specimen banking for planned biomarker sub-studies. The primary outcome is mean HIV viral load. Secondary outcomes include: sustained HIV viral suppression, T-helper cell count, psychological adjustment, stimulant use, and potentially amplified transmission risk behavior.
  
  
  
  Implementation of this randomized controlled trial highlights the importance of delineating boundaries between research activities and community-based service provision. It also provides insights into best practices for integrating the distinct agendas of academic and community partners in clinical research. This trial is currently enrolling and data collection is anticipated to be completed in September of 2018.
  
  
  
  This trial was registered on clinicaltrials.gov ( NCT01926184 ) on August 16, 2013.
authors.affiliation: Department of Public Health Sciences, University of Miami School of Medicine, 1120 NW 14th St., Office 1005, Miami, FL, 33136, USA. a.carrico@miami.edu.
authors.forename: Adam W
authors.initials: AW
authors.lastname: Carrico
authors.affiliation: University of California, San Francisco School of Nursing, San Francisco, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Jain
authors.affiliation: San Francisco AIDS Foundation, San Francisco, USA.
authors.forename: Michael V
authors.initials: MV
authors.lastname: Discepola
authors.affiliation: University of California, San Francisco School of Nursing, San Francisco, USA.
authors.forename: David
authors.initials: D
authors.lastname: Olem
authors.affiliation: San Francisco AIDS Foundation, San Francisco, USA.
authors.forename: Rick
authors.initials: R
authors.lastname: Andrews
authors.affiliation: University of California, San Francisco School of Nursing, San Francisco, USA.|University of California, San Francisco Center for AIDS Prevention Studies, San Francisco, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Woods
authors.affiliation: University of California, San Francisco Center for AIDS Prevention Studies, San Francisco, USA.
authors.forename: Torsten B
authors.initials: TB
authors.lastname: Neilands
authors.affiliation: Departments of Family Medicine and Psychiatry, University of California, Los Angeles David Geffen School of Medicine, Los Angeles, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Shoptaw
authors.affiliation: University of California, San Francisco School of Nursing, San Francisco, USA.
authors.forename: Walter
authors.initials: W
authors.lastname: Gómez
authors.affiliation: University of California, San Francisco Center for AIDS Prevention Studies, San Francisco, USA.
authors.forename: Samantha E
authors.initials: SE
authors.lastname: Dilworth
authors.affiliation: Department of Medical Social Sciences, Northwestern University, San Francisco, USA.
authors.forename: Judith T
authors.initials: JT
authors.lastname: Moskowitz
mesh_terms: D000328:Adult; D019969:Amphetamine-Related Disorders / Q000523:psychology / Q000534:rehabilitation*; D001521:Behavior Therapy; D015658:HIV Infections; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D008694:Methamphetamine; D012054:Reinforcement, Psychology; D012309:Risk-Taking; D012747:Sexual Partners; D016896:Treatment Outcome
chemical_list: D008694:Methamphetamine
keywords: Contingency management; HIV/AIDS; Men who Have Sex with men; Methamphetamine; Positive affect; Resilience