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

Not Applicable

Completed

• Conditions: Stimulant Use Disorders; HIV/AIDS
• Interventions: Behavioral: Contingency Management (CM); Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)

• Registration Number: NCT01926184
• Lead Sponsor: University of California, San Francisco

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 available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-20
• Primary Completion: 2018-10-08
• Study Completion: 2018-10-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

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

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Exclusion Criteria

• Inability to provide informed consent, evidenced by cognitive impairment
• HIV negative serostatus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention-Control+CM	Contingency Management (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.
ARTEMIS+CM	Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)	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).
ARTEMIS+CM	Contingency Management (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).

Primary Outcome Measures

Name	Time	Method
HIV Viral Load	15 Months	Log10 HIV viral load change and log10 viral load at 15 months

Secondary Outcome Measures

Name	Time	Method
Unsuppressed HIV viral load	15 Months	Any unsuppressed viral load (\>= 200 copies/mL) over the 15-month follow-up period.
T-helper Count	15 Months	Change in T-helper (CD4+) count
Methamphetamine and Cocaine Use (Stimulant Use)	15 Months	Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 15-month follow-up.
Psychological Adjustment	15 Months	Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.
Potentially Amplified Transmission (PAT) Risk Behavior	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.

Trial Locations

Locations (1)

Alliance Health Project; 🇺🇸 San Francisco, California, United States