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

This study has been completed.
Sponsor:
Collaborators:
Public Health - Seattle and King County
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joanne Stekler, University of Washington
ClinicalTrials.gov Identifier:
NCT01161446
First received: July 9, 2010
Last updated: May 10, 2017
Last verified: May 2017
Results First Received: May 10, 2017  
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

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Home Testing 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.
Standard Testing HIV testing as usual.

Participant Flow:   Overall Study
    Home Testing   Standard Testing
STARTED   116   114 
COMPLETED   98   99 
NOT COMPLETED   18   15 
Lost to Follow-up                18                14 
Withdrawal by Subject                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.
No text entered.

Reporting Groups
  Description
Home Testing 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.
Standard Testing HIV testing as usual.
Total Total of all reporting groups

Baseline Measures
   Home Testing   Standard Testing   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   114   230 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 35.5 
 (27 to 45.5) 
 37.5 
 (29 to 47) 
 36 
 (28 to 46) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      116 100.0%      114 100.0%      230 100.0% 
[1] Sex at birth
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   116   114   230 
Education 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: HIV tests]
Median (Inter-Quartile Range)
 2 
 (1 to 3) 
 2.5 
 (1 to 4) 
 2 
 (1 to 4) 
Currently tests for HIV on regular basis 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Partners]
Median (Inter-Quartile Range)
 5 
 (3 to 10) 
 5.5 
 (3 to 10) 
 5 
 (3 to 10) 
Number of male condomless anal intercourse partners in last 3 months 
[Units: Partners]
Median (Inter-Quartile Range)
 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Yes      9   7.8%      19  16.7%      28  12.2% 
No      107  92.2%      95  83.3%      202  87.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HIV Testing Frequency   [ Time Frame: 15 months ]

2.  Secondary:   Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months   [ Time Frame: From 6 to 9 months and 12 to 15 months of follow-up ]

3.  Secondary:   Bacterial Sexually Transmitted Infections   [ Time Frame: Assessed at 15 months ]

4.  Secondary:   Number of Male Condomless Anal Intercourse Partners in Last 3 Months   [ Time Frame: From 6 to 9 and 12 to 15 months ]


  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:  
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
e-mail: dkatz7@u.washington.edu



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
Study First Received: July 9, 2010
Results First Received: May 10, 2017
Last Updated: May 10, 2017