Development of a Methamphetamine Early Intervention

HIV Clinical Trial

Official title:

Development of a Methamphetamine Early Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174654
• Other study ID #: R21DA019420-01A1
• Secondary ID: R21DA019420-01A1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 2, 2010
• Last updated: December 12, 2012
• Start date: December 2006
• Est. completion date: April 2009

Study information

• Verified date: December 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavioral Research
• HIV
• Methamphetamine
• Sexual Behavior

Intervention

Behavioral:
• Contingency management
A 12-week contingency management intervention

Locations

Country	Name	City	State
United States	Lifelong AIDS Alliance	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-concordant unprotected anal intercourse		Baseline, 6, 12, 18, 24 weeks	No
Secondary	Number of non-concordant unprotected anal intercourse partners		Baseline, 6, 12, 18, 24 weeks	No
Secondary	Stimulant (methamphetamine and crack/cocaine) urinalyses		Baseline, 6, 12, 18, 24 weeks	No
Secondary	Self-reported methamphetamine use		Baseline, 6, 12, 18, 24 weeks	No