Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- University of California, San Francisco
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- HIV Viral Load
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
HIV Viral Load
Time Frame: 15 Months
Log10 HIV viral load change and log10 viral load at 15 months
Secondary Outcomes
- Unsuppressed HIV viral load(15 Months)
- T-helper Count(15 Months)
- Methamphetamine and Cocaine Use (Stimulant Use)(15 Months)
- Psychological Adjustment(15 Months)
- Potentially Amplified Transmission (PAT) Risk Behavior(15 Months)