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HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S. (Aware)

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ClinicalTrials.gov Identifier: NCT01154296
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2014
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
University of California, San Francisco
Oregon Health and Science University
Medical University of South Carolina
Research Foundation for Mental Hygiene, Inc.
Duke University
The Emmes Company, LLC
San Francisco Department of Public Health
University of California
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Lisa Metsch, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Screening
Conditions HIV/AIDS
Sexually Transmitted Infections
Intervention Behavioral: RESPECT-2 Counseling
Enrollment 5012
Recruitment Details Individuals seeking services at 9 sexually transmitted disease (STD) clinics across the U.S. were recruited, screened and randomized between April 2010 - December 2010.
Pre-assignment Details Study personnel made 14,948 approaches to STD clinic patients; some were approached multiple times. Of the 6,239 consenting to be screened, 5028 were eligible (80.6%); 16 of these were not randomized due to: decision to decline (n=3), not returning (n=11), not testing with HIV/STD battery (n=1) and not completing baseline activities (n=1).
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Period Title: Randomization and Intervention
Started 2505 2507
Completed 2500 2505
Not Completed 5 2
Reason Not Completed
Decided to decline             1             1
Declined by staff             1             0
Did not return             1             0
Left before test             0             1
Left clinic early             2             0
Period Title: 6-month Follow-up
Started 2505 2507
Completed 2177 2179
Not Completed 328 328
Reason Not Completed
Lost contact             269             275
Incarcerated             37             32
Withdrew consent             14             15
Death             3             2
Declined by Study Coordinator             5             4
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2) Total
Hide Arm/Group Description

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only. Total of all reporting groups
Overall Number of Baseline Participants 2505 2507 5012
Hide Baseline Analysis Population Description
6,239 patients approached provided consent to be screened. Of these, 5,028 were eligible (80.6%) and 5012 (99.5% of those eligible) were randomized; 16 screened eligible, but were not randomized due to: decision to decline (3), not returning (11), not testing with HIV/STD battery (1) and not completing baseline activities (1).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
<25 years 1705 1727 3432
>=25 years 800 780 1580
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
Male sex 1655 1653 3308
Female sex 850 854 1704
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
Black 1045 1053 2098
Hispanic 382 385 767
White 798 794 1592
Other 280 275 555
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2505 participants 2507 participants 5012 participants
2505 2507 5012
Men who have sex with men (MSM), #   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
689 711 1400
[1]
Measure Description: Men were classified as MSM if, at study intake, they reported any previous anal or oral sex with males or if on the baseline sexual risk behavior questions they reported having anal or oral sexwith another male at any time during the study. All men who did not meet the definition of MSM were classified as men who have sex with women.
Any STI, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
1049 1092 2141
Any STI excluding trichomoniasis, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
1016 1070 2086
Gonorrhea, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
137 145 282
Chlamydia, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
238 254 492
Trichomoniasis, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
126 119 245
Syphilis, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
28 35 63
HSV-2, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
758 793 1551
HIV, #  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2505 participants 2507 participants 5012 participants
29 24 53
# of sex acts   [1] 
Least Squares Mean (Standard Deviation)
Unit of measure:  Sex acts
Number Analyzed 2505 participants 2507 participants 5012 participants
34.6  (1.0809) 33.4  (1.0431) 34.0  (0.751)
[1]
Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.
# of unprotected sex acts   [1] 
Least Squares Mean (Standard Deviation)
Unit of measure:  Unprotected sex acts
Number Analyzed 2505 participants 2507 participants 5012 participants
23.9  (0.9578) 22.6  (0.9068) 23.3  (0.6594)
[1]
Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.
# of partners   [1] 
Least Squares Mean (Standard Deviation)
Unit of measure:  Partners
Number Analyzed 2505 participants 2507 participants 5012 participants
4.7  (0.1141) 4.6  (0.1135) 4.6  (0.08047)
[1]
Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.
# of unprotected partners   [1] 
Least Squares Mean (Standard Deviation)
Unit of measure:  Unprotected partners
Number Analyzed 2505 participants 2507 participants 5012 participants
2.1  (0.05812) 2.1  (0.05696) 2.1  (0.04069)
[1]
Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.
1.Primary Outcome
Title STI Incidence
Hide Description Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description:

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed 2039 2032
Measure Type: Number
Unit of Measure: participants
250 226
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
Comments A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter adjusted risk ratio (aRR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.94 to 1.33
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Sexual Risk Behavior -- # of Sex Acts
Hide Description Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description:

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed 2505 2507
Least Squares Mean (Standard Error)
Unit of Measure: sex acts
28.6  (1.1312) 29.1  (1.1553)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
Comments Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence rate ratio (IRR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.90 to 1.09
Estimation Comments In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.
3.Secondary Outcome
Title Sexual Risk Behavior -- # of Unprotected Sex Acts
Hide Description Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description:

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed 2505 2507
Least Squares Mean (Standard Error)
Unit of Measure: unprotected sex acts
17.4  (0.9791) 18.3  (1.0381)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
Comments Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio (IRR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.86 to 1.13
Estimation Comments In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.
4.Secondary Outcome
Title Sexual Risk Behavior -- # of Partners
Hide Description Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description:

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed 2505 2507
Least Squares Mean (Standard Error)
Unit of Measure: partners
2.7  (0.07454) 3.0  (0.08386)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
Comments Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio (IRR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.82 to 0.94
Estimation Comments In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.
5.Secondary Outcome
Title Sexual Risk Behavior -- # of Unprotected Partners
Hide Description Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description:

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed 2505 2507
Least Squares Mean (Standard Error)
Unit of Measure: unprotected partners
1.1  (0.03749) 1.1  (0.03845)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
Comments Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio (IRR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.90 to 1.05
Estimation Comments In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.
6.Secondary Outcome
Title Sexual Risk Behavior -- # of Sex Acts With Substance Use
Hide Description Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description:

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed 952 952
Measure Type: Number
Unit of Measure: sex acts with substance use
115 106
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Ratio (aRR)
Estimated Value 1.14
Confidence Interval 95%
0.89 to 1.46
Estimation Comments [Not Specified]
Time Frame Adverse events were captured post-randomization and were collected at each research visit. Other safety information is based on spontaneous reports and not specifically required by the study team.
Adverse Event Reporting Description Only the following events were required for reporting as AEs: medical events that are directly related to the collection of the HIV and STI test samples (e.g. irritation at the testing site); additional AE were assessed based on report of untoward events that participant or investigator believes are a direct result of the study.
 
Arm/Group Title Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Hide Arm/Group Description

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
All-Cause Mortality
Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/2505 (0.12%)      2/2507 (0.08%)    
Cardiac disorders     
Heart failure * 1  0/2505 (0.00%)  0 1/2507 (0.04%)  1
General disorders     
Death, cause unknown * 1 [1]  1/2505 (0.04%)  1 0/2507 (0.00%)  0
victim of homicide, secondary to robbery * 1 [2]  1/2505 (0.04%)  1 0/2507 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer * 1  1/2505 (0.04%)  1 0/2507 (0.00%)  0
Metastatic colon cancer * 1  0/2505 (0.00%)  0 1/2507 (0.04%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
"General disorders" selected as default; cause of death is unknown
[2]
"General disorders" selected as default; cause is homicide
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Rapid HIV Testing w/ Counseling (Group 1) Rapid HIV Testing & Information Only (Group 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2505 (0.00%)      0/2507 (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
Layout table for Results Point of Contact information
Name/Title: Lisa Metsch, PhD, Stephen Smith Professor and Chair of Sociomedical Sciences
Organization: Department of Sociomedical Sciences/Mailman School of Public Health/Columbia University
Phone: 212-305-3577
EMail: lm2892@columbia.edu
Layout table for additonal information
Responsible Party: Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier: NCT01154296    
Other Study ID Numbers: AAAK3153
1RC2DA028973-01 ( U.S. NIH Grant/Contract )
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: July 29, 2014
Results First Posted: September 29, 2014
Last Update Posted: September 29, 2014