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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Public Health - Seattle and King County
Information provided by (Responsible Party):
Joanne Stekler, University of Washington
ClinicalTrials.gov Identifier:
NCT01161446
First received: July 9, 2010
Last updated: July 2, 2014
Last verified: July 2014

July 9, 2010
July 2, 2014
July 2010
December 2014   (final data collection date for primary outcome measure)
HIV testing frequency [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01161446 on ClinicalTrials.gov Archive Site
  • Self-reported sexual risk behaviors [ Time Frame: From 6 to 9 months and 12 to 15 months of follow-up ] [ Designated as safety issue: No ]
  • Bacterial sexually transmitted infections [ Time Frame: Assessed at 15 months ] [ Designated as safety issue: No ]
    Includes syphilis, gonorrhea, and chlamydial infection
Same as current
Not Provided
Not Provided
 
Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)
Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection

The purpose of this study is to determine whether the availability of home self-testing for HIV will increase HIV testing frequency among men who have sex with men without negatively impacting their risk for HIV acquisition.

HIV counseling and testing remains one of the most effective HIV prevention interventions because many individuals newly diagnosed with HIV infection will alter their behaviors to reduce the risk of HIV transmission to others. In the U.S., men who have sex with men (MSM) represent the group with the greatest risk for HIV acquisition despite a high penetrance of testing, in part because their frequent exposures and infrequent testing can result in long intervals between HIV acquisition and diagnosis. Efforts to prevent HIV transmission among MSM must therefore increase the frequency of HIV testing and thereby decrease the time interval that infected individuals are unaware of their status and their potential for transmission. Home self-testing for HIV may increase the frequency of HIV testing, but there are concerns that it may also have negative consequences, including decreased access to risk reduction counseling.

We will randomize 246 MSM at high risk of HIV acquisition either to have access to home self-testing for HIV using the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test or to standard, clinic-based HIV testing for 15 months to determine the effects of home self-testing availability on HIV testing frequency and markers of risk for HIV acquisition and to assess the acceptability and ease of use of home self-testing. After screening to determine eligibility, study visits will occur at baseline and at 15 months. Both visits will include HIV/STD screening and surveys regarding HIV testing and risk behaviors. During follow-up, participants will be asked to complete brief online surveys after testing for HIV.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
HIV
  • Behavioral: 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.
  • Device: 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.
  • Experimental: Home Testing
    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
  • No Intervention: Standard Testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
246
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • Age ≥18
  • Has sex with men
  • HIV-negative
  • Meets PHSKC HIV/STD Program definition of "high risk"
  • Plans to live in Seattle for the next 15 months

Exclusion Criteria:

  • Unable to safely and confidentially receive or store a home testing kit
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01161446
36706-D, R01MH086360, NIMH86360-1
Yes
Joanne Stekler, University of Washington
University of Washington
  • Public Health - Seattle and King County
  • National Institute of Mental Health (NIMH)
Principal Investigator: Joanne D Stekler, MD, MPH University of Washington
University of Washington
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP