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Trial record 15 of 181 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT01926184
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William Woods, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 16, 2013
First Posted Date  ICMJE August 20, 2013
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
HIV Viral Load [ Time Frame: 15 Months ]
Log10 HIV viral load change and log10 viral load at 15 months
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
HIV Viral Load [ Time Frame: 12 Months ]
Log10 HIV viral load change and log10 viral load at 12 months
Change History Complete list of historical versions of study NCT01926184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2019)
  • Unsuppressed HIV viral load [ Time Frame: 15 Months ]
    Any unsuppressed viral load (>= 200 copies/mL) over the 15-month follow-up period.
  • T-helper Count [ Time Frame: 15 Months ]
    Change in T-helper (CD4+) count
  • Methamphetamine and Cocaine Use (Stimulant Use) [ Time Frame: 15 Months ]
    Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 15-month follow-up.
  • Psychological Adjustment [ Time Frame: 15 Months ]
    Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.
  • Potentially Amplified Transmission (PAT) Risk Behavior [ Time Frame: 15 Months ]
    Changes in self-reported HIV transmission risk behavior with an unsuppressed HIV viral load (>= 200 copies/mL) over the 15-month follow-up.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Official Title  ICMJE Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Brief Summary 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 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 team will examine the efficacy of this integrative intervention in a randomized controlled trial (RCT) with 110 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, 12, and 15 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, unsuppressed viral load, 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV/AIDS
  • Stimulant Use Disorders
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2013)
230
Actual Study Completion Date  ICMJE October 8, 2018
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01926184
Other Study ID Numbers  ICMJE R01DA033854( U.S. NIH Grant/Contract )
R01DA033854 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Woods, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
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
PRS Account University of California, San Francisco
Verification Date January 2019

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