Development of a Methamphetamine Early Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01174654
First received: August 2, 2010
Last updated: December 12, 2012
Last verified: December 2012

August 2, 2010
December 12, 2012
December 2006
April 2009   (final data collection date for primary outcome measure)
Non-concordant unprotected anal intercourse [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01174654 on ClinicalTrials.gov Archive Site
  • Number of non-concordant unprotected anal intercourse partners [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
  • Stimulant (methamphetamine and crack/cocaine) urinalyses [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
  • Self-reported methamphetamine use [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Development of a Methamphetamine Early Intervention
Development of a Methamphetamine Early Intervention

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • HIV
  • Sexual Behavior
  • Methamphetamine
  • Behavioral Research
Behavioral: Contingency management
A 12-week contingency management intervention
Other Name: Voucher-based reinforcement
  • No Intervention: Referral to community resources
  • Experimental: Contingency Management
    Intervention: Behavioral: Contingency management
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01174654
R21 DA019420-01A1, R21DA019420-01A1
No
University of Washington
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Matthew Golden University of Washington
University of Washington
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP