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Rapid HIV Testing and Counseling in Drug Abuse Treatment

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Information provided by (Responsible Party):
Daniel J Feaster, University of Miami
ClinicalTrials.gov Identifier:
NCT00809445
First received: December 16, 2008
Last updated: October 13, 2015
Last verified: September 2014
Results First Received: August 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Substance-Related Disorders
Interventions: Behavioral: On-site HIV rapid test and brief, prevention counseling
Behavioral: On- site HIV rapid test & information
Behavioral: Referral for off-site HIV testing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adults receiving drug abuse treatment in drug treatment clinics were recruited, screened for eligibility, and randomized from Jan - May 2009 into 1 of 3 arms: 1) on-site HIV rapid testing with counseling; 2) on-site HIV rapid testing with information only; and 3) referral for off-site HIV testing. Participants were then followed at 1 and 6 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2473 patients were assessed for eligibility. Of these, 1313 were eligible and 1281 were randomized; 32 screened eligible, but were not randomized due to: failure to return to the study (n=30), lying about HIV status (n=1) and completing the baseline after the enrollment period closed (n=1).

Reporting Groups
  Description
HIV Testing Referral Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
HIV Rapid Test & Counseling 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.
HIV Rapid Test and Info On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.

Participant Flow for 2 periods

Period 1:   1 Month Follow-up
    HIV Testing Referral   HIV Rapid Test & Counseling   HIV Rapid Test and Info
STARTED   429   433   419 
COMPLETED   427   429   415 
NOT COMPLETED   2   4   4 
Lost contact                1                2                1 
Withdrew consent                1                1                1 
Death                0                1                1 
Incarcerated                0                0                1 

Period 2:   6 Month Follow-up
    HIV Testing Referral   HIV Rapid Test & Counseling   HIV Rapid Test and Info
STARTED   429   433   419 
COMPLETED   405   410   395 
NOT COMPLETED   24   23   24 
Lost contact                16                14                14 
Death                2                1                1 
Incarcerated                6                8                8 
Withdrew consent                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants were recruited from 12 community-based drug treatment programs. The Baseline Analysis Population represents the 1281 participants who completed baseline and were subsequently randomized.

Reporting Groups
  Description
HIV Testing Referral Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
HIV Rapid Test & Counseling 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.
HIV Rapid Test and Info On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Total Total of all reporting groups

Baseline Measures
   HIV Testing Referral   HIV Rapid Test & Counseling   HIV Rapid Test and Info   Total 
Overall Participants Analyzed 
[Units: Participants]
 429   433   419   1281 
Age 
[Units: Participants]
       
<=18 years   1   0   1   2 
Between 18 and 65 years   425   429   415   1269 
>=65 years   3   4   3   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.81  (10.76)   39.62  (11.19)   39.56  (11.77)   40.00  (11.35) 
Gender 
[Units: Participants]
       
Female   173   170   160   503 
Male   256   263   259   778 
Race/Ethnicity, Customized 
[Units: Participants]
       
Black or African American   89   88   86   263 
White   278   277   271   826 
American Indian/Alaskan Native   9   13   11   33 
Mixed race   34   34   30   98 
Other   19   21   21   61 
Hispanic   51   49   47   147 
Region of Enrollment 
[Units: Participants]
       
United States   429   433   419   1281 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-Report Receipt of HIV Test Results   [ Time Frame: One month post-randomization ]

2.  Primary:   Number of Risky Sexual Behaviors   [ Time Frame: Six months post-randomization ]

3.  Secondary:   Sharing of Needles Used in Drug Use   [ Time Frame: Six months ]

4.  Secondary:   Self-Report of Ever Having Been Tested   [ Time Frame: 1 month post-randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Lisa Metsch
Organization: Columbia University, Mailman School of Public Health
phone: 212-305-3577
e-mail: lm2892@columbia.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daniel J Feaster, University of Miami
ClinicalTrials.gov Identifier: NCT00809445     History of Changes
Other Study ID Numbers: 20080379
U10DA013720 ( US NIH Grant/Contract Award Number )
Study First Received: December 16, 2008
Results First Received: August 28, 2014
Last Updated: October 13, 2015
Health Authority: United States: Institutional Review Board