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RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users (ARTEMIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William Woods, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01926184
First received: August 16, 2013
Last updated: May 17, 2017
Last verified: May 2017
August 16, 2013
May 17, 2017
January 2013
June 2018   (Final data collection date for primary outcome measure)
HIV Viral Load [ Time Frame: 15 Months ]
Log10 HIV viral load change and log10 viral load at 12 months
HIV Viral Load [ Time Frame: 12 Months ]
Log10 HIV viral load change and log10 viral load at 12 months
Complete list of historical versions of study NCT01926184 on ClinicalTrials.gov Archive Site
  • Sustained HIV viral suppression [ Time Frame: 15 Months ]
    Sustained HIV viral suppression over the 12-month follow-up period.
  • T-helper Count [ Time Frame: 15 Months ]
    Change in t-helper (CD4+) count
  • Methamphetamine and Cocaine Use [ Time Frame: 15 Months ]
    Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 12-month follow-up.
  • Psychological Adjustment [ Time Frame: 15 Months ]
    Changes in positive affect, negative affect, and depressive symptoms over the follow-up.
  • Potentially Amplified Transmission (PAT) Risk Behavior [ Time Frame: 15 Months ]
    Changes in self-reported HIV transmission risk behavior with a detectable HIV viral load (> 200 copies/ml) over follow-up.
  • Sustained HIV viral suppression [ Time Frame: 12 Months ]
    Sustained HIV viral suppression over the 12-month follow-up period.
  • T-helper Count [ Time Frame: 12 Months ]
    Change in t-helper (CD4+) count
  • Methamphetamine Use [ Time Frame: 12 Months ]
    Changes in methamphetamine use (assessed via self-report and urine toxicology screening) over the 12-month follow-up.
  • Psychological Adjustment [ Time Frame: 12 Months ]
    Changes in positive affect, negative affect, and depressive symptoms over the follow-up.
  • HIV Transmission Risk Behavior [ Time Frame: 12 Months ]
    Changes in self-reported HIV transmission risk behavior over follow-up.
Not Provided
Not Provided
 
RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users
In the era of HIV treatment as prevention (TasP), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases HIV viral load among populations that are more likely to engage in HIV transmission risk behavior. Because methamphetamine-using men who have sex with men (MSM) are at greater risk for acquiring and transmitting medication-resistant strains of HIV, interventions targeting stimulant use in this population of high-risk men could boost the effectiveness of TasP. At present, only conditional cash transfer approaches such as contingency management (CM) have demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who are not actively seeking formal treatment. The proposed RCT will examine the efficacy of a positive affect intervention that is designed to optimize the effectiveness of CM to achieve long-term reductions in stimulant use and HIV viral load in this population. the investigators' team will examine the efficacy of this integrative intervention in a randomized controlled trial (RCT) with 230 HIV-positive, methamphetamine-using MSM. After enrolling in CM, participants will be randomized to receive either: 1) the positive affect intervention; or 2) a attention-matched control condition. Follow-up data will be collected at 3, 6, and 12 months post-randomization. This RCT will provide an opportunity to examine the efficacy of an integrative intervention designed to promote long-term reductions in HIV viral load as the primary outcome. Secondary outcomes that will be examined include: increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+) count, and decreases HIV transmission risk behavior. Identifying an efficacious intervention approach to decrease HIV viral load among methamphetamine-using MSM would substantially support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate HIV-related health disparities.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV/AIDS
  • Stimulant Use Disorders
  • Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)
    5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).
  • Behavioral: Contingency Management (CM)
    12-week CM protocol that provides escalating monetary reinforcement for biological evidence of methamphetamine abstinence. Delivered as the standard of care for non-treatment-seeking methamphetamine-using MSM in San Francisco. Delivered to both the intervention and attention-control arms
    Other Name: Positive Reinforcement Opportunity Project (PROP)
  • Experimental: ARTEMIS+CM
    This is a 5-session, individually delivered intervention that is designed to enhance positive affect. It is designed to boost and extend the effectiveness of contingency management (CM).
    Interventions:
    • Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)
    • Behavioral: Contingency Management (CM)
  • Placebo Comparator: Attention-Control+CM
    Attention-matched, 5-session control condition consisting of brief-self report psychological measures and neutral writing exercises. Contingency management (CM) is also administered to this arm.
    Intervention: Behavioral: Contingency Management (CM)
Carrico AW, Jain J, Discepola MV, Olem D, Andrews R, Woods WJ, Neilands TB, Shoptaw S, Gómez W, Dilworth SE, Moskowitz JT. A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. BMC Public Health. 2016 Jul 30;16:673. doi: 10.1186/s12889-016-3325-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
December 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years old
  • Documentation of HIV-positive serostatus
  • Speak English
  • Biological verification of recent methamphetamine use
  • Completion of at least three contingency management (CM) visits
  • Self reported anal sex with a man (MSM) in the past 12 months

Exclusion Criteria:

  • Inability to provide informed consent, evidenced by cognitive impairment
  • HIV negative serostatus
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01926184
R01DA033854( U.S. NIH Grant/Contract )
R01DA033854 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
William Woods, University of California, San Francisco
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Principal Investigator: William Woods, Ph.D. University of California, San Francisco
Principal Investigator: Adam W. Carrico, Ph.D. Miami University
Principal Investigator: Judith T. Moskowitz, Ph.D., MPH Northwestern University
University of California, San Francisco
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP