TY - JOUR
T1 - A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men
AU - Carrico, Adam W.
AU - Jain, Jennifer
AU - Discepola, Michael V.
AU - Olem, David
AU - Andrews, Rick
AU - Woods, William J.
AU - Neilands, Torsten B.
AU - Shoptaw, Steven
AU - Gómez, Walter
AU - Dilworth, Samantha E.
AU - Moskowitz, Judith T.
N1 - Funding Information:
This randomized controlled trial is funded by the National Institute on Drug Abuse (R01-DA033854; Woods, Carrico & Moskowitz, PIs) and National Institute on Mental Health (K24-MH093225; Moskowitz, PI).
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/7/30
Y1 - 2016/7/30
N2 - Background: 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. Methods/Design: 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. Discussion: 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. Trial registration: This trial was registered on clinicaltrials.gov (NCT01926184) on August 16, 2013.
AB - Background: 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. Methods/Design: 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. Discussion: 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. Trial registration: This trial was registered on clinicaltrials.gov (NCT01926184) on August 16, 2013.
KW - Contingency management
KW - HIV/AIDS
KW - Men who Have Sex with men
KW - Methamphetamine
KW - Positive affect
KW - Resilience
UR - http://www.scopus.com/inward/record.url?scp=84979743512&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84979743512&partnerID=8YFLogxK
U2 - 10.1186/s12889-016-3325-1
DO - 10.1186/s12889-016-3325-1
M3 - Article
C2 - 27476110
AN - SCOPUS:84979743512
SN - 1471-2458
VL - 16
JO - BMC Public Health
JF - BMC Public Health
IS - 1
M1 - 673
ER -
