Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)
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.
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 Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Conditions
HIV
Intervention
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test
Location
Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center
Seattle
Washington
United States
98104
Status
Recruiting
Source
University of Washington
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01161446
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Home Nursing
Nursing care given to an individual in the home. The care may be provided by a family member or a friend. Home nursing as care by a non-professional is differentiated from HOME CARE SERVICES provided by professionals: visiting nurse, home health agencies, hospital, or other organized community group.
Advance Directives
Declarations by patients, made in advance of a situation in which they may be incompetent to decide about their own care, stating their treatment preferences or authorizing a third party to make decisions for them. (Bioethics Thesaurus)
Advance Directive Adherence
Compliance by health personnel or proxies with the stipulations of ADVANCE DIRECTIVES (or similar directives such as RESUSCITATION ORDERS) when patients are unable to direct their own care.
Home Care Agencies
Public or private organizations that provide, either directly or through arrangements with other organizations, home health services in the patient's home. (Hospital Administration Terminology, 2d ed)
Dna Probes
Species- or subspecies-specific DNA (including COMPLEMENTARY DNA; conserved genes, whole chromosomes, or whole genomes) used in hybridization studies in order to identify microorganisms, to measure DNA-DNA homologies, to group subspecies, etc. The DNA probe hybridizes with a specific mRNA, if present. Conventional techniques used for testing for the hybridization product include dot blot assays, Southern blot assays, and DNA:RNA hybrid-specific antibody tests. Conventional labels for the DNA probe include the radioisotope labels 32P and 125I and the chemical label biotin. The use of DNA probes provides a specific, sensitive, rapid, and inexpensive replacement for cell culture techniques for diagnosing infections.
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