Clinical trial NCT00809445: Rapid HIV Testing and Counseling in Drug Abuse Treatment
Official title: HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of California, San Francisco
First posted: 2008-12-17
Enrollment: 1281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.

Detailed description: This is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of HIV test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV sexual risk behaviors. Injection drug risk behavior will be a secondary outcome. Participants will complete a baseline assessment to report their demographics, HIV testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups. At one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV test results. At six months post-randomization, participants will complete a follow-up assessment to assess any changes in their HIV sexual risk behaviors.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* HIV-negative or HIV status unknown
* No receipt of results from HIV test initiated within last 12 months
* Be able to communicate in English

Primary outcomes:
measure: Self-Report Receipt of HIV Test Results
timeFrame: One month post-randomization
measure: Number of Risky Sexual Behaviors
timeFrame: Six months post-randomization
Secondary outcomes:
measure: Sharing of Needles Used in Drug Use
timeFrame: Six months
measure: Self-Report of Ever Having Been Tested
timeFrame: 1 month post-randomization
Other outcomes:
Locations:
city: Tucson
country: United States
facility: La Frontera Center, Inc.
state: Arizona
city: Danbury
country: United States
facility: Midwestern Connecticut Council on Alcoholism
state: Connecticut
city: Plainville
country: United States
facility: Wheeler Clinic
state: Connecticut
city: Baltimore
country: United States
facility: Glenwood Life Counseling Center
state: Maryland
city: Cape Girardeau
country: United States
facility: Gibson Recover Centers
state: Missouri
city: Santa Fe
country: United States
facility: The Life Link
state: New Mexico
city: Salisbury
country: United States
facility: Daymark Recovery Services, Inc.
state: North Carolina
city: Portland
country: United States
facility: CODA
state: Oregon
city: Pittsburgh
country: United States
facility: Addiction Medicine Services (Western Psychiatric Institute)
state: Pennsylvania
city: Columbia
country: United States
facility: Morris Village Alcohol and Drug Treatment Center
state: South Carolina
city: Columbia
country: United States
facility: Lexington / Richland Alcohol and Drug Abuse Council
state: South Carolina
city: Chesterfield
country: United States
facility: Chesterfield CSB Substance Abuse Service
state: Virginia
Study officials:
affiliation: Columbia University
name: Lisa Metsch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: PATH
name: Grant Colfax, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Metsch LR, Feaster DJ, Gooden L, Matheson T, Mandler RN, Haynes L, Tross S, Kyle T, Gallup D, Kosinski AS, Douaihy A, Schackman BR, Das M, Lindblad R, Erickson S, Korthuis PT, Martino S, Sorensen JL, Szapocznik J, Walensky R, Branson B, Colfax GN. Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. Am J Public Health. 2012 Jun;102(6):1160-7. doi: 10.2105/AJPH.2011.300460. Epub 2012 Apr 19.
citation: Schackman BR, Metsch LR, Colfax GN, Leff JA, Wong A, Scott CA, Feaster DJ, Gooden L, Matheson T, Haynes LF, Paltiel AD, Walensky RP. The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial. Drug Alcohol Depend. 2013 Feb 1;128(1-2):90-7. doi: 10.1016/j.drugalcdep.2012.08.009. Epub 2012 Sep 9.
citation: Schackman BR, Leff JA, Barter DM, DiLorenzo MA, Feaster DJ, Metsch LR, Freedberg KA, Linas BP. Cost-effectiveness of rapid hepatitis C virus (HCV) testing and simultaneous rapid HCV and HIV testing in substance abuse treatment programs. Addiction. 2015 Jan;110(1):129-43. doi: 10.1111/add.12754.