Clinical trial NCT01161446: Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)
Official title: Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Home testing
Self-testing
HIV Infections/diagnosis
HIV Infections/prevention and control
AIDS Serodiagnosis
Oral fluids
Homosexuality, Male
Sexually transmitted diseases
Sexual behavior
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Public Health - Seattle and King County
name: National Institute of Mental Health (NIMH)
First posted: 2010-07-13
Enrollment: 230
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: HIV Testing Frequency
timeFrame: 15 months
Secondary outcomes:
measure: Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months
timeFrame: From 6 to 9 months and 12 to 15 months of follow-up
measure: Bacterial Sexually Transmitted Infections
timeFrame: Assessed at 15 months
measure: Number of Male Condomless Anal Intercourse Partners in Last 3 Months
timeFrame: From 6 to 9 and 12 to 15 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Joanne D Stekler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katz DA, Golden MR, Hughes JP, Farquhar C, Stekler JD. HIV Self-Testing Increases HIV Testing Frequency in High-Risk Men Who Have Sex With Men: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):505-512. doi: 10.1097/QAI.0000000000001709.