Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)
|ClinicalTrials.gov Identifier: NCT01161446|
Recruitment Status : Completed
First Posted : July 13, 2010
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|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|
- HIV Testing Frequency [ Time Frame: 15 months ]Number of HIV tests during follow-up reported by participants at end-of-study visit
- 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 ]
- Bacterial Sexually Transmitted Infections [ Time Frame: Assessed at 15 months ]Includes syphilis, gonorrhea, and chlamydial infection
- Number of Male Condomless Anal Intercourse Partners in Last 3 Months [ Time Frame: From 6 to 9 and 12 to 15 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161446
|United States, Washington|
|Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Joanne D Stekler, MD, MPH||University of Washington|