HIV(eTEST)NCT02876926
Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing
A study testing "Smart" home-based test for HIV, Home-based testing only and Reminder letters for clinic-based testing in people with HIV, run by Brown University at 1 site in United States.
Trial summary
This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing. 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?
- "Smart" home-based test for HIV, Home-based testing only and Reminder letters for clinic-based testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 15 Feb 2018
- 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
- Sex with a partner met online in the past year
- Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis
- Own a smartphone (iOS or Android) with a service contract and data plan
- Have a stable address where mail can be received
- Speak English fluently
Who cannot join
- Having tested for HIV in the last year
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02906
About this study
Official title: Exploring Use of a Real-time, Remote Monitoring and Follow-up System for Home-based, HIV Self-testing Among High-risk Men Who Have Sex With Men (MSM)
This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.
- Conditions
- HIV
- Being tested
- "Smart" home-based test for HIV, Home-based testing only, Reminder letters for clinic-based testing
- Keywords
- HIV testing, Self-testing, Counseling, Referral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Smart" home-based test for HIVBehavioural
A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
Home-based testing onlyBehavioural
A standard home-based HIV test kit.
Reminder letters for clinic-based testingBehavioural
Letters reminding patients to get tested at a free clinic location
| Study group | Role | What they receive |
|---|---|---|
| "Enhanced" home-based testing | Experimental | These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care. Receives: Behavioral: "Smart" home-based test for HIV |
| Home-based testing alone | Active comparator | These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided. Receives: Behavioral: Home-based testing only |
| Reminders for clinic-based testing | Sham comparator | Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free. Receives: Behavioral: Reminder letters for clinic-based testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received HIV Testing
Count of the number of participants who reported receiving HIV testing.
Measured: Up to 28 weeks
Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis
Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.
Measured: Up to 28 weeks
Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis
Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
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.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Wray, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876926
- Sponsor's protocol ID
- 1508001315
- Acronym
- (eTEST)
- Status last verified
- Jan 2019
- First submitted
- 17 Aug 2016
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Use of a Real-time, Remote Monitoring and Follow-up System for Home-based, HIV Self-testing Among High-risk Men Who Have Sex With Men (MSM)
- ClinicalTrials.gov ID
- NCT02876926
- Acronym / sponsor ID
- (eTEST) / 1508001315
- Conditions
- HIV
- Keywords
- HIV testing, Self-testing, Counseling, Referral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 19 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Enhanced" home-based testing | Experimental | Behavioral: "Smart" home-based test for HIVThese participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care. |
| Home-based testing alone | Active comparator | Behavioral: Home-based testing onlyThese participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided. |
| Reminders for clinic-based testing | Sham comparator | Behavioral: Reminder letters for clinic-based testingParticipants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sex with a partner met online in the past year
- Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis
- Own a smartphone (iOS or Android) with a service contract and data plan
- Have a stable address where mail can be received
- Speak English fluently
Key exclusion criteria (1 listed)
- Having tested for HIV in the last year
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 |
|---|---|---|
| "Smart" home-based test for HIVA standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring. | Behavioural | "Enhanced" home-based testing |
| Home-based testing onlyA standard home-based HIV test kit. | Behavioural | Home-based testing alone |
| Reminder letters for clinic-based testingLetters reminding patients to get tested at a free clinic location | Behavioural | Reminders for clinic-based testing |
Primary outcome
Number of Participants Who Received HIV Testing
Time frame: Up to 28 weeks
Count of the number of participants who reported receiving HIV testing.
Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis
Time frame: Up to 28 weeks
Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.
Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis
Time frame: Up to 28 weeks
Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Smart" home-based test for HIV, Home-based testing only and Reminder letters for clinic-based testing in people with HIV, run by Brown University 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 5 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 19 Apr 2019. 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. Some participants in this study may receive a placebo. 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 19 Apr 2019). 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?
Number of Participants Who Received HIV Testing (time frame: Up to 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2019.