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Trial record 3 of 30 for:    " July 07, 2010":" August 06, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)

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ClinicalTrials.gov Identifier: NCT01161446
Recruitment Status : Completed
First Posted : July 13, 2010
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborators:
Public Health - Seattle and King County
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joanne Stekler, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition HIV
Interventions Behavioral: Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test
Device: Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test
Enrollment 230
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Home Testing Standard Testing
Hide Arm/Group Description Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up. HIV testing as usual.
Period Title: Overall Study
Started 116 114
Completed 98 99
Not Completed 18 15
Reason Not Completed
Lost to Follow-up             18             14
Withdrawal by Subject             0             1
Arm/Group Title Home Testing Standard Testing Total
Hide Arm/Group Description Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up. HIV testing as usual. Total of all reporting groups
Overall Number of Baseline Participants 116 114 230
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 116 participants 114 participants 230 participants
35.5
(27 to 45.5)
37.5
(29 to 47)
36
(28 to 46)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
116
 100.0%
114
 100.0%
230
 100.0%
[1]
Measure Description: Sex at birth
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Hispanic or Latino
21
  18.1%
13
  11.4%
34
  14.8%
Not Hispanic or Latino
93
  80.2%
99
  86.8%
192
  83.5%
Unknown or Not Reported
2
   1.7%
2
   1.8%
4
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   4.3%
7
   6.1%
12
   5.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
   9.5%
10
   8.8%
21
   9.1%
White
90
  77.6%
79
  69.3%
169
  73.5%
More than one race
7
   6.0%
11
   9.6%
18
   7.8%
Unknown or Not Reported
3
   2.6%
7
   6.1%
10
   4.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 116 participants 114 participants 230 participants
116 114 230
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
High school or less
14
  12.1%
14
  12.3%
28
  12.2%
Some college, Associate's, or technical training
44
  37.9%
32
  28.1%
76
  33.0%
Bachelor's degree or more
57
  49.1%
65
  57.0%
122
  53.0%
Unknown or not reported
1
   0.9%
3
   2.6%
4
   1.7%
Living Situation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Alone in a house or apartment
40
  34.5%
47
  41.2%
87
  37.8%
With a sex partner, lover, or spouse
16
  13.8%
18
  15.8%
34
  14.8%
With friends or roommates
46
  39.7%
31
  27.2%
77
  33.5%
With parents, guardians, or other relatives
4
   3.4%
12
  10.5%
16
   7.0%
In school or university dormitories
1
   0.9%
0
   0.0%
1
   0.4%
No regular place to stay, couch surfing, homeless
8
   6.9%
5
   4.4%
13
   5.7%
Unknown or not reported
1
   0.9%
1
   0.9%
2
   0.9%
Number of HIV tests in last year  
Median (Inter-Quartile Range)
Unit of measure:  HIV tests
Number Analyzed 116 participants 114 participants 230 participants
2
(1 to 3)
2.5
(1 to 4)
2
(1 to 4)
Currently tests for HIV on regular basis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Yes
66
  56.9%
73
  64.0%
139
  60.4%
No
50
  43.1%
39
  34.2%
89
  38.7%
Unknown or not reported
0
   0.0%
2
   1.8%
2
   0.9%
Ever used a home HIV test  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Yes
2
   1.7%
10
   8.8%
12
   5.2%
No
113
  97.4%
104
  91.2%
217
  94.3%
Unknown or not reported
1
   0.9%
0
   0.0%
1
   0.4%
Gender of sex partners in last 3 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Men
107
  92.2%
107
  93.9%
214
  93.0%
Women
1
   0.9%
0
   0.0%
1
   0.4%
Both men and women
8
   6.9%
6
   5.3%
14
   6.1%
Unknown or not reported
0
   0.0%
1
   0.9%
1
   0.4%
Number of male sex partners in last 3 months  
Median (Inter-Quartile Range)
Unit of measure:  Partners
Number Analyzed 116 participants 114 participants 230 participants
5
(3 to 10)
5.5
(3 to 10)
5
(3 to 10)
Number of male condomless anal intercourse partners in last 3 months  
Median (Inter-Quartile Range)
Unit of measure:  Partners
Number Analyzed 116 participants 114 participants 230 participants
1
(0.5 to 2)
1
(1 to 3)
1
(1 to 3)
Any condomless anal intercourse with an HIV-discordant partner in last 3 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Yes
37
  31.9%
34
  29.8%
71
  30.9%
No
70
  60.3%
74
  64.9%
144
  62.6%
Unknown or not reported
9
   7.8%
6
   5.3%
15
   6.5%
Methamphetamine use in last 3 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Yes
12
  10.3%
10
   8.8%
22
   9.6%
No
103
  88.8%
103
  90.4%
206
  89.6%
Unknown or not reported
1
   0.9%
1
   0.9%
2
   0.9%
Inhaled nitrite use in last 3 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Yes
39
  33.6%
35
  30.7%
74
  32.2%
No
77
  66.4%
79
  69.3%
156
  67.8%
Diagnosis of bacterial sexually transmitted infection at enrollment visit  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 114 participants 230 participants
Yes
9
   7.8%
19
  16.7%
28
  12.2%
No
107
  92.2%
95
  83.3%
202
  87.8%
1.Primary Outcome
Title HIV Testing Frequency
Hide Description Number of HIV tests during follow-up reported by participants at end-of-study visit
Time Frame 15 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Testing Standard Testing
Hide Arm/Group Description:
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
HIV testing as usual.
Overall Number of Participants Analyzed 98 99
Mean (95% Confidence Interval)
Unit of Measure: HIV tests
5.3
(4.7 to 6.0)
3.6
(3.2 to 4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Home Testing, Standard Testing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months
Hide Description [Not Specified]
Time Frame From 6 to 9 months and 12 to 15 months of follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Included "Overall Number of Participants Analyzed" as number who completed follow-up. However, only participants who responded to the question regarding non-concordant condomless anal intercourse in the last 3 months were included in this analysis for each time point.
Arm/Group Title Home Testing Standard Testing
Hide Arm/Group Description:
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
HIV testing as usual.
Overall Number of Participants Analyzed 98 99
Measure Type: Count of Participants
Unit of Measure: Participants
Measured at 9 months Number Analyzed 77 participants 79 participants
16
  20.8%
17
  21.5%
Measured at end of study (15 months) Number Analyzed 90 participants 94 participants
26
  28.9%
23
  24.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Home Testing, Standard Testing
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority bound: Self-testing was to be considered non-inferior to standard testing if the upper bound of the 95% confidence interval for the odds ratio fell below 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.61 to 1.90
Estimation Comments The home testing arm represents the numerator and the standard testing arm the denominator.
3.Secondary Outcome
Title Bacterial Sexually Transmitted Infections
Hide Description Includes syphilis, gonorrhea, and chlamydial infection
Time Frame Assessed at 15 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes only participants who received screening for sexually transmitted infections at the end-of-study visit.
Arm/Group Title Home Testing Standard Testing
Hide Arm/Group Description:
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
HIV testing as usual.
Overall Number of Participants Analyzed 93 90
Measure Type: Count of Participants
Unit of Measure: Participants
5
   5.4%
11
  12.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Home Testing, Standard Testing
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Home testing was to be considered non-inferior to standard testing with respect to STI prevalence if the upper bound of the 95% confidence interval for the difference between the two arms (home - standard) fell below 10%.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -0.068
Confidence Interval (2-Sided) 95%
-0.16 to 0.016
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Male Condomless Anal Intercourse Partners in Last 3 Months
Hide Description [Not Specified]
Time Frame From 6 to 9 and 12 to 15 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Included "Overall Number of Participants Analyzed" as number who completed follow-up. However, only participants who responded to the question regarding condomless anal intercourse partners in the last 3 months were included in this analysis for each time point.
Arm/Group Title Home Testing Standard Testing
Hide Arm/Group Description:
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
HIV testing as usual.
Overall Number of Participants Analyzed 98 99
Mean (Standard Error)
Unit of Measure: number of partners
Measured at 9 months Number Analyzed 80 participants 80 participants
1.375  (0.207) 2.050  (0.313)
Measured at end of study (15 months) Number Analyzed 98 participants 99 participants
2.337  (0.355) 2.141  (0.314)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Home Testing, Standard Testing
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Self-testing was to be considered non-inferior with respect to the number of reported male CAI partners if the upper bound of the 95% CI for the fold-difference in the number of partners between the two arms (self ÷ standard testing) fell below 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.64 to 1.33
Estimation Comments The home testing arm represents the numerator and the standard testing arm the denominator.
Time Frame During study follow up (approximately 15 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Home Testing Standard Testing
Hide Arm/Group Description

Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.

Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV.

HIV testing as usual.
All-Cause Mortality
Home Testing Standard Testing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Home Testing Standard Testing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)   0/114 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Home Testing Standard Testing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)   0/114 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David Katz
Organization: University of Washington
Phone: 206-744-5877
Responsible Party: Joanne Stekler, University of Washington
ClinicalTrials.gov Identifier: NCT01161446     History of Changes
Other Study ID Numbers: 36706
R01MH086360 ( U.S. NIH Grant/Contract )
NIMH86360-1
First Submitted: July 9, 2010
First Posted: July 13, 2010
Results First Submitted: May 10, 2017
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017