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
  Purpose

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.


Condition Intervention
HIV
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • HIV testing frequency [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 246
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home Testing 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.
No Intervention: Standard Testing

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161446

Locations
United States, Washington
Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Public Health - Seattle and King County
Investigators
Principal Investigator: Joanne D Stekler, MD, MPH University of Washington
  More Information

No publications provided

Responsible Party: Joanne Stekler, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01161446     History of Changes
Other Study ID Numbers: 36706-D, R01MH086360, NIMH86360-1
Study First Received: July 9, 2010
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
HIV
Home testing
Self-testing
HIV Infections/diagnosis
HIV Infections/prevention and control
AIDS Serodiagnosis
Oral fluids
Homosexuality, Male
Sexually transmitted diseases
Sexual behavior

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014