Clinical trial NCT01926184: RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Official title: Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Stimulant Use Disorders
Keywords: HIV/AIDS
Treatment as Prevention
Methamphetamine
Cocaine
HIV viral Load
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-08-20
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: HIV Viral Load
timeFrame: 15 Months
Secondary outcomes:
measure: Unsuppressed HIV viral load
timeFrame: 15 Months
measure: T-helper Count
timeFrame: 15 Months
measure: Methamphetamine and Cocaine Use (Stimulant Use)
timeFrame: 15 Months
measure: Psychological Adjustment
timeFrame: 15 Months
measure: Potentially Amplified Transmission (PAT) Risk Behavior
timeFrame: 15 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Alliance Health Project
state: California
Study officials:
affiliation: University of California, San Francisco
name: William Woods, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami University
name: Adam W. Carrico, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Judith T. Moskowitz, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrico AW, Gomicronmez W, Jain J, Shoptaw S, Discepola MV, Olem D, Lagana-Jackson J, Andrews R, Neilands TB, Dilworth SE, Evans JL, Woods WJ, Moskowitz JT. Randomized controlled trial of a positive affect intervention for methamphetamine users. Drug Alcohol Depend. 2018 Nov 1;192:8-15. doi: 10.1016/j.drugalcdep.2018.07.029. Epub 2018 Sep 5.
citation: Carrico AW, Jain J, Discepola MV, Olem D, Andrews R, Woods WJ, Neilands TB, Shoptaw S, Gomez W, Dilworth SE, Moskowitz JT. A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. BMC Public Health. 2016 Jul 30;16:673. doi: 10.1186/s12889-016-3325-1.