Skip to main content
Clinical Trials/NCT01926184
NCT01926184
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country110 target enrollmentJanuary 2013

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
October 8, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

Loading locations...

Similar Trials