Clinical trial NCT01174654: Development of a Methamphetamine Early Intervention
Official title: Development of a Methamphetamine Early Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV
Sexual Behavior
Methamphetamine
Behavioral Research
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-03
Enrollment: 127
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.


Eligibility criteria: Inclusion Criteria:

* Anal sex with another man in the month prior to enrollment
* Use of methamphetamine on at least 2 days in the month prior to enrollment

Exclusion Criteria:

* Plans to move from the study catchment area within 6 months of enrollment
* A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years

Primary outcomes:
measure: Non-concordant unprotected anal intercourse
timeFrame: Baseline, 6, 12, 18, 24 weeks
Secondary outcomes:
measure: Number of non-concordant unprotected anal intercourse partners
timeFrame: Baseline, 6, 12, 18, 24 weeks
measure: Stimulant (methamphetamine and crack/cocaine) urinalyses
timeFrame: Baseline, 6, 12, 18, 24 weeks
measure: Self-reported methamphetamine use
timeFrame: Baseline, 6, 12, 18, 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Lifelong AIDS Alliance
state: Washington
Study officials:
affiliation: University of Washington
name: Matthew Golden
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menza TW, Jameson DR, Hughes JP, Colfax GN, Shoptaw S, Golden MR. Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. BMC Public Health. 2010 Dec 20;10:774. doi: 10.1186/1471-2458-10-774.