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Rapid HIV Testing and Counseling

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Information provided by (Responsible Party):
Lisa R Metsch, University of Miami
ClinicalTrials.gov Identifier:
NCT00809445
First received: December 16, 2008
Last updated: January 26, 2012
Last verified: January 2012
History of Changes

December 16, 2008
January 26, 2012
January 2009
January 2010   (final data collection date for primary outcome measure)
  • Receipt of HIV test results [ Time Frame: One month post-randomization ] [ Designated as safety issue: No ]
  • Number of risky sexual behaviors [ Time Frame: Six months post-randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00809445 on ClinicalTrials.gov Archive Site
Use of injection drugs [ Time Frame: Six months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rapid HIV Testing and Counseling
HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.

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.

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Substance-Related Disorders
  • Behavioral: On-site HIV rapid test and brief, prevention counseling
    Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
  • Behavioral: On- site HIV rapid test & information
    Participants will be offered an on-site oral fluid HIV rapid test with basic info.
  • Behavioral: Referral for off-site HIV testing
    Participants will be offered a referral list of HIV testing agencies in the community.
  • Experimental: HIV rapid test & counseling
    Intervention: Behavioral: On-site HIV rapid test and brief, prevention counseling
  • Experimental: HIV rapid test and info
    Intervention: Behavioral: On- site HIV rapid test & information
  • Active Comparator: HIV testing referral
    Intervention: Behavioral: Referral for off-site HIV testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1281
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00809445
NIDA-CTN-0032, U10DA013720
Yes
Lisa R Metsch, University of Miami
University of Miami
  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco
Principal Investigator: Lisa Metsch, Ph.D. University of Miami
Principal Investigator: Grant Colfax, M.D. City/County of San Francisco Public Health Department
University of Miami
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP