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Completed

NCT Number: NCT01926184

RCT 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 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)

Behavioral

5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).

Contingency management (CM)

Behavioral

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 names: Positive Reinforcement Opportunity Project (PROP)

Primary outcomes

  1. HIV Viral Load

    Time frame: 15 Months

    Log10 HIV viral load change and log10 viral load at 15 months

Secondary outcomes

  1. Unsuppressed HIV viral load

    Time frame: 15 Months

    Any unsuppressed viral load (>= 200 copies/mL) 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 an unsuppressed HIV viral load (>= 200 copies/mL) over the 15-month follow-up.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users

Acronym: ARTEMIS

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2013
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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