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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-10-08

Brief Summary

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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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Detailed Description

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Conditions

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HIV/AIDS Stimulant Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)

Intervention Type BEHAVIORAL

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

Contingency Management (CM)

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Contingency Management (CM)

Intervention Type 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

Interventions

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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).

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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Positive Reinforcement Opportunity Project (PROP)

Eligibility Criteria

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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