Skip to main content
OpenTrials
Completed

NCT Number: NCT01174654

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lifelong AIDS Alliance

Seattle, Washington, 98122, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

A 12-week contingency management intervention

Other names: Voucher-based reinforcement

Primary outcomes

  1. Non-concordant unprotected anal intercourse

    Time frame: Baseline, 6, 12, 18, 24 weeks

Secondary outcomes

  1. Number of non-concordant unprotected anal intercourse partners

    Time frame: Baseline, 6, 12, 18, 24 weeks

  2. Stimulant (methamphetamine and crack/cocaine) urinalyses

    Time frame: Baseline, 6, 12, 18, 24 weeks

  3. Self-reported methamphetamine use

    Time frame: Baseline, 6, 12, 18, 24 weeks

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 3, 2010
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.