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Development of a Methamphetamine Early Intervention

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV
Sexual Behavior
Methamphetamine
Behavioral Research
 Behavioral: Contingency management
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Development of a Methamphetamine Early Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Non-concordant unprotected anal intercourse [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 127
Study Start Date: December 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Referral to community resources
Experimental: Contingency Management Behavioral: Contingency management
A 12-week contingency management intervention
Other Name: Voucher-based reinforcement

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174654

Locations
United States, Washington
Lifelong AIDS Alliance
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Matthew Golden University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01174654     History of Changes
Other Study ID Numbers: R21 DA019420-01A1, R21DA019420-01A1
Study First Received: August 2, 2010
Last Updated: December 12, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on March 01, 2015