HIV InfectionseTestNCT03654690
eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men
A study testing HIV self-test and Counseling in people with HIV Infections, run by Brown University at 1 site in United States.
Trial summary
The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. 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 Infections
- What is being tested?
- HIV self-test and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 811 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to 1 May 2023
- 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
- report any of the following in the past six months: anal sex without condoms outside of a monogamous partnership with a recently tested, HIV-negative male, having been diagnosed with an STI, or being in an ongoing sexual partnership with an HIV-positive male
- not tested for HIV in the last 12 months
- have a stable residence in one of the site metros where they can securely receive packages
- use an iOS/Android smartphone with a data plan or home wifi
- fluent in either English or Spanish
Who cannot join
- currently on PrEP
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
The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.
Read the detailed description
HIV disproportionately affects men who have sex with men (MSM) in the United States, and new infections continue to increase particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Past studies estimate that up to 50% of these new infections originate from the approximately 20% of MSM who are unaware of their status. Expanded HIV testing can produce reductions in incidence when implemented on a broad scale by facilitating earlier diagnosis and treatment. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. Home-based, self-testing (HBST) for HIV offers considerable promise for increasing the number of MSM who are aware of their status by overcoming key barriers to clinic-based testing, such as inconvenience and confidentiality concerns. HBST may also be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HBST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care. Existing, FDA-approved HBST kits provide a free, 24-hour helpline that offers these services to those who seek it, but few users do, and this "passive" approach may miss critical opportunities to engage with MSM for further prevention services.
To address these challenges, the investigators developed a mobile health platform ("eTEST") that uses internet-of-things (IoT) technologies to monitor when HBST users open their tests in real time, allowing the investigators to provide timely, "active" follow-up counseling and referral over the phone after they do so. In a pilot study, the investigators show that providing HBST by mail at regular intervals boosted rates of any/repeat HIV testing among high-risk MSM compared with clinic-based testing reminders. Moreover, those who received follow-up phone counseling after HBST were more likely to receive risk reduction counseling, to consult with a medical provider about PrEP, and to initiate PrEP. Given these promising results, the proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.
- Conditions
- HIV Infections
- Being tested
- HIV self-test, Counseling
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV self-testDiagnostic test
Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
CounselingBehavioural
Post-Test HIV Risk ReductionCounseling
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will receive SMS text message reminders to get tested for HIV in a clinic. |
| Standard Self-Testing | Active comparator | Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors. Receives: Diagnostic Test: HIV self-test |
| Enhanced Self-Testing | Experimental | Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test. Receives: Diagnostic Test: HIV self-test; Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model Adjusted Probability of Any HIV Testing
We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing.
We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.
Measured: 12 month study period
Model Adjusted Probabilities of Repeat HIV Testing (>1)
We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing.
We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.
Measured: 12 months
HIV Diagnoses
count of participants who were ultimately diagnosed with HIV during the course of the study
Measured: 12 months
Secondary outcomes (2)
Model Predicted Probability of Receipt of a Prescription for Pre-exposure Prophylaxis (PrEP)
We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A binary variable reflecting whether participants had ever had a PrEP prescription in the past was included for the PrEP prescription model. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded.
Measured: 12 month study period
Model Predicted Probability of Receipt of Testing for Other Sexually-transmitted Infections
We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. A similar covariate for STI testing was included in the STI testing model. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start23 Jan 2019
- Primary completion1 May 2023
- Study completion1 May 2023
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 HIV InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Southern California, The Miriam Hospital, University of Mississippi Medical Center
- Responsible party
- Sponsor
- Investigators
- Tyler B Wray, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654690
- Sponsor's protocol ID
- 1804002021
- Other IDs
- 1R01MH114891-01A1
- Acronym
- eTest
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2018
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once the final dataset for this research has been assembled, the Project Coordinator will create an archival copy (which will contain no personally identifying information) to store, along with an electronic version of the codebooks of the study. Versions will be available in English, and outside investigators will be able to utilize the data by contacting the PIs and describing their purpose for using the data.
Publications
Wray TB, Chan PA, Klausner JD, Mena LA, Brock JB, Simpanen EM, Ward LM, Chrysovalantis S. eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men. Trials. 2020 Jul 16;21(1):654. doi: 10.1186/s13063-020-04554-1.
PubMed 32677999
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT03654690
- Acronym / sponsor ID
- eTest / 1804002021
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Southern California, The Miriam Hospital, University of Mississippi Medical Center
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.
Detailed description
HIV disproportionately affects men who have sex with men (MSM) in the United States, and new infections continue to increase particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Past studies estimate that up to 50% of these new infections originate from the approximately 20% of MSM who are unaware of their status. Expanded HIV testing can produce reductions in incidence when implemented on a broad scale by facilitating earlier diagnosis and treatment. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. Home-based, self-testing (HBST) for HIV offers considerable promise for increasing the number of MSM who are aware of their status by overcoming key barriers to clinic-based testing, such as inconvenience and confidentiality concerns. HBST may also be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HBST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care. Existing, FDA-approved HBST kits provide a free, 24-hour helpline that offers these services to those who seek it, but few users do, and this "passive" approach may miss critical opportunities to engage with MSM for further prevention services.
To address these challenges, the investigators developed a mobile health platform ("eTEST") that uses internet-of-things (IoT) technologies to monitor when HBST users open their tests in real time, allowing the investigators to provide timely, "active" follow-up counseling and referral over the phone after they do so. In a pilot study, the investigators show that providing HBST by mail at regular intervals boosted rates of any/repeat HIV testing among high-risk MSM compared with clinic-based testing reminders. Moreover, those who received follow-up phone counseling after HBST were more likely to receive risk reduction counseling, to consult with a medical provider about PrEP, and to initiate PrEP. Given these promising results, the proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will receive SMS text message reminders to get tested for HIV in a clinic. |
| Standard Self-Testing | Active comparator | Diagnostic Test: HIV self-testParticipants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors. |
| Enhanced Self-Testing | Experimental | Diagnostic Test: HIV self-test, Behavioral: CounselingParticipants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- report any of the following in the past six months: anal sex without condoms outside of a monogamous partnership with a recently tested, HIV-negative male, having been diagnosed with an STI, or being in an ongoing sexual partnership with an HIV-positive male
- not tested for HIV in the last 12 months
- have a stable residence in one of the site metros where they can securely receive packages
- use an iOS/Android smartphone with a data plan or home wifi
- fluent in either English or Spanish
Key exclusion criteria (1 listed)
- currently on PrEP
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 |
|---|---|---|
| HIV self-testHome delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test) | Diagnostic test | Enhanced Self-Testing, Standard Self-Testing |
| CounselingPost-Test HIV Risk ReductionCounseling | Behavioural | Enhanced Self-Testing |
Primary outcome
Model Adjusted Probability of Any HIV Testing
Time frame: 12 month study period
We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.
Model Adjusted Probabilities of Repeat HIV Testing (>1)
Time frame: 12 months
We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.
HIV Diagnoses
Time frame: 12 months
count of participants who were ultimately diagnosed with HIV during the course of the study
2 secondary outcomes
Model Predicted Probability of Receipt of a Prescription for Pre-exposure Prophylaxis (PrEP)
Time frame: 12 month study period
Model Predicted Probability of Receipt of Testing for Other Sexually-transmitted Infections
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32677999Wray TB, Chan PA, Klausner JD, Mena LA, Brock JB, Simpanen EM, Ward LM, Chrysovalantis S. eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men. Trials. 2020 Jul 16;21(1):654. doi: 10.1186/s13063-020-04554-1.
- Individual participant dataSharing planned: Yes. Once the final dataset for this research has been assembled, the Project Coordinator will create an archival copy (which will contain no personally identifying information) to store, along with an electronic version of the codebooks of the study. Versions will be available in English, and outside investigators will be able to utilize the data by contacting the PIs and describing their purpose for using the data.
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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.
Tyler B Wray, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV self-test and Counseling in people with HIV Infections, 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 10 Apr 2025. 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 10 Apr 2025). 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?
Model Adjusted Probability of Any HIV Testing (time frame: 12 month study period). 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?
On the ClinicalTrials.gov record for NCT03654690, 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 10 Apr 2025.