Skip to main content
OpenTrials
Completed

NCT Number: NCT01161446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test

Behavioral

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

Device

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.

Primary outcomes

  1. HIV Testing Frequency

    Time frame: 15 months

    Number of HIV tests during follow-up reported by participants at end-of-study visit

Secondary outcomes

  1. 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

  2. Bacterial Sexually Transmitted Infections

    Time frame: Assessed at 15 months

    Includes syphilis, gonorrhea, and chlamydial infection

  3. Number of Male Condomless Anal Intercourse Partners in Last 3 Months

    Time frame: From 6 to 9 and 12 to 15 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Public Health - Seattle and King County

Registry information

Official study title

Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 13, 2010
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.