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

Study Overview
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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.

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

Conditions
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HIV/AIDS, Stimulant Use Disorders

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


Participation Criteria
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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 Exclusion Criteria: Inability to provide informed consent, evidenced by cognitive impairment HIV negative serostatus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARTEMIS+CM<br>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)<br>* 5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).<br>Behavioral: Contingency Management (CM)<br>* 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<br>* Other names: Positive Reinforcement Opportunity Project (PROP);|
| Placebo Comparator: Attention-Control+CM<br>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)<br>* 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<br>* Other names: Positive Reinforcement Opportunity Project (PROP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Viral Load | Log10 HIV viral load change and log10 viral load at 15 months | 15 Months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Treatment as Prevention, Methamphetamine, Cocaine, HIV viral Load