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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Stimulant Use Disorders; HIV/AIDS

Treatments: Behavioral: Contingency Management (CM); Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01926184

R01DA033854 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

ARTEMIS+CM

Experimental group

Description:

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).

Treatment:

Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)

Behavioral: Contingency Management (CM)

Attention-Control+CM

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Contingency Management (CM)