Development of a Methamphetamine Early Intervention
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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 |
- Non-concordant unprotected anal intercourse [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
- 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 |
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| United States, Washington | |
| Lifelong AIDS Alliance | |
| Seattle, Washington, United States, 98122 | |
| Principal Investigator: | Matthew Golden | University of Washington |
More Information
Additional 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 |
Additional relevant MeSH terms:
|
Methamphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013