Development of a Methamphetamine Early Intervention

NCT01174654 | Completed Phase 1

• 1 other identifier: R21DA019420-01A1
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Sexual Behavior; Methamphetamine; Behavioral Research

Outcome Measures

Primary Outcomes (1)

• Non-concordant unprotected anal intercourse

  Baseline, 6, 12, 18, 24 weeks

Secondary Outcomes (3)

• Number of non-concordant unprotected anal intercourse partners

  Baseline, 6, 12, 18, 24 weeks

• Stimulant (methamphetamine and crack/cocaine) urinalyses

  Baseline, 6, 12, 18, 24 weeks

• Self-reported methamphetamine use

  Baseline, 6, 12, 18, 24 weeks

Study Arms (2)

Referral to community resources

NO INTERVENTION

Contingency Management

EXPERIMENTAL

Behavioral: Contingency management

Interventions

Contingency management BEHAVIORAL

A 12-week contingency management intervention

Also known as: Voucher-based reinforcement

Contingency Management

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Lifelong AIDS Alliance

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• 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.

  PMID: 21172026 DERIVED

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Matthew Golden

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 3, 2010
• Study Start: December 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

US (1)