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Rapid HIV Testing and Counseling in Drug Abuse Treatment

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 1281
Recruitment Details 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 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).
Arm/Group Title HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Hide Arm/Group Description Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community. 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. On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Period Title: 1 Month Follow-up
Started 429 433 419
Completed 427 429 415
Not Completed 2 4 4
Reason Not Completed
Lost contact             1             2             1
Withdrew consent             1             1             1
Death             0             1             1
Incarcerated             0             0             1
Period Title: 6 Month Follow-up
Started 429 433 419
Completed 405 410 395
Not Completed 24 23 24
Reason Not Completed
Lost contact             16             14             14
Death             2             1             1
Incarcerated             6             8             8
Withdrew consent             0             0             1
Arm/Group Title HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info Total
Hide Arm/Group Description Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community. 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. On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info. Total of all reporting groups
Overall Number of Baseline Participants 429 433 419 1281
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 429 participants 433 participants 419 participants 1281 participants
<=18 years
1
   0.2%
0
   0.0%
1
   0.2%
2
   0.2%
Between 18 and 65 years
425
  99.1%
429
  99.1%
415
  99.0%
1269
  99.1%
>=65 years
3
   0.7%
4
   0.9%
3
   0.7%
10
   0.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 429 participants 433 participants 419 participants 1281 participants
40.81  (10.76) 39.62  (11.19) 39.56  (11.77) 40.00  (11.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 429 participants 433 participants 419 participants 1281 participants
Female
173
  40.3%
170
  39.3%
160
  38.2%
503
  39.3%
Male
256
  59.7%
263
  60.7%
259
  61.8%
778
  60.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 429 participants 433 participants 419 participants 1281 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 429 participants 433 participants 419 participants 1281 participants
429 433 419 1281
1.Primary Outcome
Title Self-Report Receipt of HIV Test Results
Hide Description 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.
Time Frame One month post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who provided self-report of either receipt or non-receipt of testing results at one month follow-up are included. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively
Arm/Group Title HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Hide Arm/Group Description:
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
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.
On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Overall Number of Participants Analyzed 424 424 409
Measure Type: Number
Unit of Measure: participants
78 338 347
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
Comments Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test & counseling+HIV rapid test and info versus HIV testing referral.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments a-prior threshold for statistical significance is .025
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 4.52
Confidence Interval (2-Sided) 97.5%
3.57 to 5.72
Estimation Comments The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm
2.Primary Outcome
Title Number of Risky Sexual Behaviors
Hide Description 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).
Time Frame Six months post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who provided self-report of number of unprotected sex acts (vaginal or anal sex without a condom) at six-month follow-up are included.
Arm/Group Title HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Hide Arm/Group Description:
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
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.
On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Overall Number of Participants Analyzed 387 385 371
Mean (Standard Deviation)
Unit of Measure: number of unprotected sex acts
20.5  (49.8) 21.3  (47.6) 21.3  (44.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
Comments Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test & counseling+HIV rapid test and info versus HIV testing referral.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments a-priori threshold for statistical significance is .025
Method generalized estimating equations (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter incidence rate raios (IRR)
Estimated Value 1.04
Confidence Interval (2-Sided) 97.5%
0.95 to 1.14
Estimation Comments Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Rapid Test & Counseling, HIV Rapid Test and Info
Comments

The data analysis information presented is for the comparison of the 2 on-site testing groups.

Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments a-priori threshold for statistical significance is .025
Method Generalized estimating equations (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence rate ratio (IRR)
Estimated Value 1.03
Confidence Interval (2-Sided) 97.5%
0.84 to 1.26
Estimation Comments Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm
3.Secondary Outcome
Title Sharing of Needles Used in Drug Use
Hide Description 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.
Time Frame Six months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Hide Arm/Group Description:
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
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.
On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Overall Number of Participants Analyzed 401 402 385
Measure Type: Number
Unit of Measure: n of people changing needle sharing
Number discontinuing sharing 17 32 24
Number initiating sharing 2 1 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments a priori threshold for significance was .05
Method Chi-squared
Comments Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles
4.Secondary Outcome
Title Self-Report of Ever Having Been Tested
Hide Description The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.
Time Frame 1 month post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number reporting having taken an HIV test, whether they received results or not, at one month follow-up. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively
Arm/Group Title HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Hide Arm/Group Description:
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
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.
On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Overall Number of Participants Analyzed 424 424 409
Measure Type: Number
Unit of Measure: participants
103 344 352
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments a-priori threshold for statistical significance is .05
Method Chi-squared
Comments chi-square = 428.2466, Df=2
Time Frame AE will be reported within 7 days of the site becoming aware of the event. 24 hr expedited reporting is required for reportable serious adverse events. Lead investigators and the NIDA assigned Safety Monitor will be notified within 24 hours.
Adverse Event Reporting Description Research staff will use a standard checklist to document adverse events at each research visit following randomization. This information will be collected and documented in the study database via CRF.
 
Arm/Group Title HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Hide Arm/Group Description Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community. 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. On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
All-Cause Mortality
HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/429 (0.47%)      2/433 (0.46%)      2/419 (0.48%)    
Cardiac disorders       
Myocardial infarction   1/429 (0.23%)  1 1/433 (0.23%)  1 0/419 (0.00%)  0
General disorders       
Overdose   0/429 (0.00%)  0 0/433 (0.00%)  0 2/419 (0.48%)  2
Death  [1]  0/429 (0.00%)  0 1/433 (0.23%)  1 0/419 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastatic neoplasm   2/429 (0.47%)  2 0/433 (0.00%)  0 0/419 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
unknown cause; "general disorders" selected as default
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIV Testing Referral HIV Rapid Test & Counseling HIV Rapid Test and Info
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/429 (0.00%)      0/433 (0.00%)      0/419 (0.00%)    
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
Responsible Party: Daniel J Feaster, University of Miami
ClinicalTrials.gov Identifier: NCT00809445     History of Changes
Other Study ID Numbers: 20080379
U10DA013720 ( U.S. NIH Grant/Contract )
First Submitted: December 16, 2008
First Posted: December 17, 2008
Results First Submitted: August 28, 2014
Results First Posted: September 17, 2014
Last Update Posted: October 14, 2015