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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Testing<br> | Behavioral: Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test<br>* 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.<br>Device: Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test<br>* 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.<br>|
| No Intervention: Standard Testing<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Testing Frequency | Number of HIV tests during follow-up reported by participants at end-of-study visit | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Bacterial Sexually Transmitted Infections | Includes syphilis, gonorrhea, and chlamydial infection | Assessed at 15 months | 
| Number of Male Condomless Anal Intercourse Partners in Last 3 Months |  | From 6 to 9 and 12 to 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Home testing, Self-testing, HIV Infections/diagnosis, HIV Infections/prevention and control, AIDS Serodiagnosis, Oral fluids, Homosexuality, Male, Sexually transmitted diseases, Sexual behavior