Rapid HIV Testing and Counseling in Drug Abuse Treatment

This study has been completed.
Sponsor:
Collaborators:
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: September 9, 2014
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  
Number of Participants  
[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
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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:

Responsible Party: Daniel J Feaster, University of Miami
ClinicalTrials.gov Identifier: NCT00809445     History of Changes
Other Study ID Numbers: 20080379, U10DA013720
Study First Received: December 16, 2008
Results First Received: August 28, 2014
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board