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

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ClinicalTrials.gov Identifier: NCT01926184
Recruitment Status : Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William Woods, University of California, San Francisco

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Stimulant Use Disorders Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS) Behavioral: Contingency Management (CM) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Actual Study Start Date : January 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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).
 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)
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.
 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)


Outcome Measures
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Primary Outcome Measures :
  1. HIV Viral Load [ Time Frame: 15 Months ]
    Log10 HIV viral load change and log10 viral load at 15 months


Secondary Outcome Measures :
  1. Sustained HIV viral suppression [ Time Frame: 15 Months ]
    Sustained HIV viral suppression over the 15-month follow-up period.

  2. T-helper Count [ Time Frame: 15 Months ]
    Change in t-helper (CD4+) count

  3. 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.

  4. Psychological Adjustment [ Time Frame: 15 Months ]
    Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.

  5. 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 the 15-month follow-up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926184


Locations
United States, California
Alliance Health Project
San Francisco, California, United States, 94102
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Community-Based Partner for Contingency Management  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: William Woods, Professor, School of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01926184     History of Changes
Other Study ID Numbers: R01DA033854 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by William Woods, University of California, San Francisco:
HIV/AIDS
Treatment as Prevention
Methamphetamine
Cocaine
HIV viral Load

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors