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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Device: Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test

• Registration Number: NCT01161446
• Lead Sponsor: University of Washington

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-05
• Results First Submitted: 2017-05-10
• Results First Submitted QC: 2017-05-10
• Last Update Submitted: 2017-05-10
• Results First Posted: 2017-06-07
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 230

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

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Exclusion Criteria

• Unable to safely and confidentially receive or store a home testing kit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Testing	Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test	-

Primary Outcome Measures

Name	Time	Method
HIV Testing Frequency	15 months	Number of HIV tests during follow-up reported by participants at end-of-study visit

Secondary Outcome Measures

Name	Time	Method
Bacterial Sexually Transmitted Infections	Assessed at 15 months	Includes syphilis, gonorrhea, and chlamydial infection
Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months	From 6 to 9 months and 12 to 15 months of follow-up
Number of Male Condomless Anal Intercourse Partners in Last 3 Months	From 6 to 9 and 12 to 15 months

Trial Locations

Locations (1)

Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center; 🇺🇸 Seattle, Washington, United States