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Rapid HIV Testing and Counseling in Drug Abuse Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00809445
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : September 17, 2014
Last Update Posted : October 14, 2015
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Information provided by (Responsible Party):
Daniel J Feaster, University of Miami

Tracking Information
First Submitted Date  ICMJE December 16, 2008
First Posted Date  ICMJE December 17, 2008
Results First Submitted Date  ICMJE August 28, 2014
Results First Posted Date  ICMJE September 17, 2014
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • Self-Report Receipt of HIV Test Results [ Time Frame: One month post-randomization ]
    The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.
  • Number of Risky Sexual Behaviors [ Time Frame: Six months post-randomization ]
    The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • Receipt of HIV test results [ Time Frame: One month post-randomization ]
  • Number of Risky Sexual Behaviors [ Time Frame: Six months post-randomization ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • Sharing of Needles Used in Drug Use [ Time Frame: Six months ]
    Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.
  • Self-Report of Ever Having Been Tested [ Time Frame: 1 month post-randomization ]
    The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
Use of injection drugs [ Time Frame: Six months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid HIV Testing and Counseling in Drug Abuse Treatment
Official Title  ICMJE HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Substance-Related Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: HIV rapid test & counseling
    Participants will be offered an oral fluid HIV rapid test (via oral swab) and brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach (Project RESPECT-2 counseling). Prior to receiving testing, study participants must first provide consent for HIV testing. Consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test.
    Intervention: Behavioral: On-site HIV rapid test and brief, prevention counseling
  • Experimental: HIV rapid test and info
    Participants will be offered an oral fluid HIV rapid test (via oral swab). Prior to receiving testing, study participants must first provide consent for HIV testing. Again, consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test. Participants will receive rapid HIV testing and test results after signing the consent to be tested. In both Groups 1 and 2, participants who test reactive (preliminary positive) will be counseled on the sexual risk behaviors associated with transmission of HIV and the acquisition of STDs, as is current clinical practice with those testing HIV positive. Confirmed positives will be linked to HIV primary care.
    Intervention: Behavioral: On- site HIV rapid test & information
  • Active Comparator: HIV testing referral
    Participants randomized to group 3 will receive a referral list for HIV community-testing agencies. Each CTP site will have previously prepared an extensive referral list of testing sites in the surrounding geographic area. By virtue of their status as patients in the CTPs, they will receive whatever HIV testing and HIV education referrals the CTPs normally provide to their patients. This is the standard of care at CTPs that do not provide on-site testing.
    Intervention: Behavioral: Referral for off-site HIV testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2009)
1281
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
1272
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809445
Other Study ID Numbers  ICMJE 20080379
U10DA013720 ( U.S. NIH Grant/Contract )" onClick="openNewWindow('https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=U10DA013720&Fy=all'); return false">U10DA013720 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel J Feaster, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Lisa Metsch, Ph.D. Columbia University
Principal Investigator: Grant Colfax, M.D. PATH
PRS Account University of Miami
Verification Date September 2014

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