HIVNCT01161446
Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)
A study testing Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test in people with HIV, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to safely and confidentially receive or store a home testing kit
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test
- 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
- Medical subject headings
- HIV Infections, Disease, Homosexuality, Male, Sexually Transmitted Diseases, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody TestBehavioural
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.
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Testing | Experimental | Not described Receives: 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 |
| Standard Testing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing Frequency
Number of HIV tests during follow-up reported by participants at end-of-study visit
Measured: 15 months
Secondary outcomes (3)
Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months
Measured: From 6 to 9 months and 12 to 15 months of follow-up
Bacterial Sexually Transmitted Infections
Includes syphilis, gonorrhea, and chlamydial infection
Measured: Assessed at 15 months
Number of Male Condomless Anal Intercourse Partners in Last 3 Months
Measured: From 6 to 9 and 12 to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health - Seattle and King County, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joanne Stekler, University of Washington
- Investigators
- Joanne D Stekler, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161446
- Sponsor's protocol ID
- 36706
- Other IDs
- R01MH086360, NIMH86360-1
- Status last verified
- May 2017
- First submitted
- 9 Jul 2010
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29697595
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection
- ClinicalTrials.gov ID
- NCT01161446
- Acronym / sponsor ID
- 36706
- Conditions
- HIV
- Keywords
- HIV, Home testing, Self-testing, HIV Infections/diagnosis, HIV Infections/prevention and control, AIDS Serodiagnosis, Oral fluids, Homosexuality, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Public Health - Seattle and King County, National Institute of Mental Health (NIMH)
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Testing | Experimental | 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 |
| Standard Testing | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male
- Age ≥18
- Has sex with men
- HIV-negative
- Meets PHSKC HIV/STD Program definition of "high risk"
Key exclusion criteria (1 listed)
- Unable to safely and confidentially receive or store a home testing kit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody TestParticipants 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. | Behavioural | Home Testing |
| Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody TestThe 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. | Device | Home Testing |
Primary outcome
HIV Testing Frequency
Time frame: 15 months
Number of HIV tests during follow-up reported by participants at end-of-study visit
3 secondary outcomes
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
Number of Male Condomless Anal Intercourse Partners in Last 3 Months
Time frame: From 6 to 9 and 12 to 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29697595Katz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne D Stekler, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test in people with HIV, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Testing Frequency (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01161446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.