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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Adam Carrico, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01926184
First received: August 16, 2013
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
HIV/AIDS
Stimulant Use Disorders
Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)
Behavioral: Contingency Management (CM)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • HIV Viral Load [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Log10 HIV viral load change and log10 viral load at 12 months


Secondary Outcome Measures:
  • Sustained HIV viral suppression [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Sustained HIV viral suppression over the 12-month follow-up period.

  • T-helper Count [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Change in t-helper (CD4+) count

  • Methamphetamine Use [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Changes in methamphetamine use (assessed via self-report and urine toxicology screening) over the 12-month follow-up.

  • Psychological Adjustment [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Changes in positive affect, negative affect, and depressive symptoms over the follow-up.

  • HIV Transmission Risk Behavior [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Changes in self-reported HIV transmission risk behavior over follow-up.


Estimated Enrollment: 230
Study Start Date: January 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Exclusion Criteria:

  • Inability to provide informed consent, evidenced by cognitive impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926184

Contacts
Contact: Walter Gomez, M.A. walter.gomez@ucsf.edu

Locations
United States, California
Tenderloin Clinical Research Center Recruiting
San Francisco, California, United States, 94103
Contact: Adina Redditt    415-632-5074      
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Adam W Carrico, Ph.D. University of California, San Francisco
Principal Investigator: Judith T. Moskowitz, Ph.D., MPH University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: Adam Carrico, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01926184     History of Changes
Other Study ID Numbers: R01-DA033854, R01DA033854
Study First Received: August 16, 2013
Last Updated: August 19, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Methamphetamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014