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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:
University of California, San Francisco
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
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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 |
|---|---|
| HIV/AIDS Stimulant Use Disorders | Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS) Behavioral: Contingency Management (CM) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking 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 William Woods, University of California, San Francisco:
Primary Outcome Measures:
- HIV Viral Load [ Time Frame: 15 Months ]Log10 HIV viral load change and log10 viral load at 12 months
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 230 |
| Actual Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | June 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 (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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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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
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 ) |
| Study First Received: | August 16, 2013 |
| Last Updated: | May 17, 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 |
ClinicalTrials.gov processed this record on July 27, 2017