HIV InfectionsNCT03803683
Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)
A study testing mLab App, HIV Prevention Information and HIV Home Tests in people with HIV Infections, run by Rebecca Schnall, RN, MPH, PhD at 2 sites in United States.
Trial summary
The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- mLab App, HIV Prevention Information and HIV Home Tests
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2020to 2 Oct 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 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Birth sex male of any current gender identification;
- Understand and read English
- Substantial risk for acquiring HIV infection per CDC guidance (e.g.,YMSM or YTGW and recent anal sex with men)
- Smartphone ownership
- Self-report being HIV-negative or unknown status
- Understand the limitations of the OraQuick test and the mLab App
Show all 9Show fewer
- Not having been tested for HIV in the past 6 months (e.g., therefore being somewhat outside of the current CDC testing recommendations for high-risk populations)
- Not currently taking PrEP
- Receive a non-reactive result on the rapid HIV test at the Baseline visit
Who cannot join
- Persons who have a known diagnosis of HIV
- Persons for whom the investigators determine that participation may be detrimental to the participant or to the study (e.g., severe cognitive deficit).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lurie Children's Hospital
Chicago, Illinois, 60611
Columbia University School of Nursing
New York, New York, 10032
About this study
Official title: mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care
The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.
Read the detailed description
The number of youth living with human immunodeficiency virus (HIV) continues to rise, and they are disproportionately represented at each stage of the care continuum. Most relevant to this study, it is estimated that less than half of HIV-infected youth in the United States (US) have been diagnosed with HIV, and acquired immunodeficiency syndrome (AIDS)-related deaths among youth have increased over the past decade despite decreased death rates among all other age groups, pointing to the urgent need for increased testing among youth.
Black and Latino youth are at increased risk of poor HIV-related outcomes and have disparate testing rates as compared to White youth. Mobile Health (mHealth) technology is a powerful and relevant tool which represents a promising approach for improving outcomes among youth living with HIV. Youth are avid adopters and heavy users of smartphones and digital technologies, and these technologies offer opportunities to tailor interventions to developmental stages and personal needs. Importantly, these technologies are capable of delivering interventions in real-time and in ecologic settings. This creates an opportunity to remotely reach youth through mobile and connected health approaches to strengthen their HIV care continuum engagement and treatment outcomes. In response, the investigators have developed the mLab App, an innovative mobile and connected technology that combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide accessible, objective, secure, and real-time feedback on home-based OraQuick (lateral flow assay) HIV test results. The mLab App also contains an innovative automated data collection and a results reporting feature. Findings from the investigators' preliminary work in New York City indicate that youth perceive the mLab App as useful, easy to use, and effective at improving health outcomes and intend to use the technology. Furthermore, preliminary work in Africa support the sensitivity and specificity of the imaging algorithm for interpreting lateral flow assay results.
The investigators will conduct a careful, iterative process of technology refinement based on input from end users, experts, and the youth advisory board. The investigators will then enroll 525 high-risk youth (age 18-29 years) in a 12-month randomized controlled trial (RCT) to assess differences in HIV testing rates and linkage to care between three arms the intervention arm, the standard of care-HIV information control arm, and the HIV home test arm. Finally, the investigators will analyze paradata, defined as auxiliary data that capture details about the process of interaction with the technology, to understand the effect of user engagement of the mLab App on improving HIV testing rates and linkage to care. Interventions delivered through mHealth technology represent a promising approach for improving outcomes among youth.
- Conditions
- HIV Infections
- Being tested
- mLab App, HIV Prevention Information, HIV Home Tests
- Keywords
- mLab, HIV prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mLab AppDevice
The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention InformationBehavioural
Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home TestsDevice
Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
| Study group | Role | What they receive |
|---|---|---|
| mLab App Intervention | Experimental | Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information. Receives: Device: mLab App; Behavioral: HIV Prevention Information; Device: HIV Home Tests |
| Standard of Care HIV Information Control Arm | Active comparator | Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information. Receives: Behavioral: HIV Prevention Information |
| HIV Home Tests | Active comparator | Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information. Receives: Behavioral: HIV Prevention Information; Device: HIV Home Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Youth Tested for HIV
Total number of youth tested for HIV at 6 months
Measured: 6 months
Total Number of Youth Tested for HIV
Total number of youth tested for HIV at 12 months
Measured: 12 months
Secondary outcomes (8)
Total Number of HIV Negative/ Positive Results
Total number of HIV negative/ positive results at 6 months
Measured: 6 months
Total Number of HIV Negative/ Positive Results
Total number of HIV negative/ positive results at 12 months
Measured: 12 months
Total Number of Youth Who Link to HIV Care Services
Total number of youth who link to HIV care services at 6 months
Measured: 6 months
Total Number of Youth Who Link to HIV Care Services
Total number of youth who link to HIV care services at 12 months
Measured: 12 months
Number of Sexual Partners in the Past 3 Months
Number of Sexual Partners in the past 3 months collected at the 6 month mark
Measured: 6 months
Number of Sexual Partners in the Past 3 Months
Number of Sexual Partners in the past 3 months collected at the 12 month mark
Measured: 12 months
Number of Condomless Anal Sex Acts
Number of condomless anal sex acts in the past 3 months at 6 months
Measured: 6 months
Number of Condomless Anal Sex Acts
Number of condomless anal sex acts in the past 3 months at 12 months
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 posted14 Jan 2019
- Study start21 Jan 2020
- Primary completion2 Oct 2023
- Study completion2 Oct 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 (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Schnall, RN, MPH, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, RN, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803683
- Sponsor's protocol ID
- AAAR8760
- Other IDs
- R01MH118151
- Status last verified
- Nov 2024
- First submitted
- 2 Sep 2018
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Scherr TF, Hardcastle A, Moore CP, Majji D, Kuhns LM, Garofalo R, Schnall R. Exploring digital health user engagement: General app usage patterns from a clinical trial with the mLab App. PLOS Digit Health. 2026 Jun 25;5(6):e0001452. doi: 10.1371/journal.pdig.0001452. eCollection 2026 Jun.
PubMed 42348489Schnall R, Scherr TF, Kuhns LM, Janulis P, Jia H, Wood OR, Almodovar M, Garofalo R. Efficacy of the mLab App: a randomized clinical trial for increasing HIV testing uptake using mobile technology. J Am Med Inform Assoc. 2025 Feb 1;32(2):275-284. doi: 10.1093/jamia/ocae261.
PubMed 39560363Wood OR, Garofalo R, Kuhns LM, Scherr TF, Zetina APM, Rodriguez RG, Nash N, Cervantes M, Schnall R. A randomized controlled trial of an mHealth intervention for increasing access to HIV testing and care among young cisgender men and transgender women: the mLab App study protocol. BMC Public Health. 2021 Oct 29;21(1):1959. doi: 10.1186/s12889-021-12015-w.
PubMed 34715833
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care
- ClinicalTrials.gov ID
- NCT03803683
- Acronym / sponsor ID
- AAAR8760
- Conditions
- HIV Infections
- Keywords
- mLab, HIV prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Rebecca Schnall, RN, MPH, PhDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.
Detailed description
The number of youth living with human immunodeficiency virus (HIV) continues to rise, and they are disproportionately represented at each stage of the care continuum. Most relevant to this study, it is estimated that less than half of HIV-infected youth in the United States (US) have been diagnosed with HIV, and acquired immunodeficiency syndrome (AIDS)-related deaths among youth have increased over the past decade despite decreased death rates among all other age groups, pointing to the urgent need for increased testing among youth.
Black and Latino youth are at increased risk of poor HIV-related outcomes and have disparate testing rates as compared to White youth. Mobile Health (mHealth) technology is a powerful and relevant tool which represents a promising approach for improving outcomes among youth living with HIV. Youth are avid adopters and heavy users of smartphones and digital technologies, and these technologies offer opportunities to tailor interventions to developmental stages and personal needs. Importantly, these technologies are capable of delivering interventions in real-time and in ecologic settings. This creates an opportunity to remotely reach youth through mobile and connected health approaches to strengthen their HIV care continuum engagement and treatment outcomes. In response, the investigators have developed the mLab App, an innovative mobile and connected technology that combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide accessible, objective, secure, and real-time feedback on home-based OraQuick (lateral flow assay) HIV test results. The mLab App also contains an innovative automated data collection and a results reporting feature. Findings from the investigators' preliminary work in New York City indicate that youth perceive the mLab App as useful, easy to use, and effective at improving health outcomes and intend to use the technology. Furthermore, preliminary work in Africa support the sensitivity and specificity of the imaging algorithm for interpreting lateral flow assay results.
The investigators will conduct a careful, iterative process of technology refinement based on input from end users, experts, and the youth advisory board. The investigators will then enroll 525 high-risk youth (age 18-29 years) in a 12-month randomized controlled trial (RCT) to assess differences in HIV testing rates and linkage to care between three arms the intervention arm, the standard of care-HIV information control arm, and the HIV home test arm. Finally, the investigators will analyze paradata, defined as auxiliary data that capture details about the process of interaction with the technology, to understand the effect of user engagement of the mLab App on improving HIV testing rates and linkage to care. Interventions delivered through mHealth technology represent a promising approach for improving outcomes among youth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mLab App Intervention | Experimental | Device: mLab App, Behavioral: HIV Prevention Information, Device: HIV Home TestsYouth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information. |
| Standard of Care HIV Information Control Arm | Active comparator | Behavioral: HIV Prevention InformationYouth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information. |
| HIV Home Tests | Active comparator | Behavioral: HIV Prevention Information, Device: HIV Home TestsYouth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Birth sex male of any current gender identification;
- Understand and read English
- Substantial risk for acquiring HIV infection per CDC guidance (e.g.,YMSM or YTGW and recent anal sex with men)
- Smartphone ownership
- Self-report being HIV-negative or unknown status
Key exclusion criteria (2 listed)
- Persons who have a known diagnosis of HIV
- Persons for whom the investigators determine that participation may be detrimental to the participant or to the study (e.g., severe cognitive deficit).
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 |
|---|---|---|
| mLab AppThe mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test. | Device | mLab App Intervention |
| HIV Prevention InformationYouth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website. | Behavioural | HIV Home Tests, Standard of Care HIV Information Control Arm, mLab App Intervention |
| HIV Home TestsYouth randomized into this arm will receive OraQuick® In-Home HIV Test. | Device | HIV Home Tests, mLab App Intervention |
Primary outcome
Total Number of Youth Tested for HIV
Time frame: 6 months
Total number of youth tested for HIV at 6 months
Total Number of Youth Tested for HIV
Time frame: 12 months
Total number of youth tested for HIV at 12 months
8 secondary outcomes
Total Number of HIV Negative/ Positive Results
Time frame: 6 months
Total Number of HIV Negative/ Positive Results
Time frame: 12 months
Total Number of Youth Who Link to HIV Care Services
Time frame: 6 months
Total Number of Youth Who Link to HIV Care Services
Time frame: 12 months
Number of Sexual Partners in the Past 3 Months
Time frame: 6 months
Number of Sexual Partners in the Past 3 Months
Time frame: 12 months
Number of Condomless Anal Sex Acts
Time frame: 6 months
Number of Condomless Anal Sex Acts
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 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42348489Scherr TF, Hardcastle A, Moore CP, Majji D, Kuhns LM, Garofalo R, Schnall R. Exploring digital health user engagement: General app usage patterns from a clinical trial with the mLab App. PLOS Digit Health. 2026 Jun 25;5(6):e0001452. doi: 10.1371/journal.pdig.0001452. eCollection 2026 Jun.
- Derived from this study: PubMed 39560363Schnall R, Scherr TF, Kuhns LM, Janulis P, Jia H, Wood OR, Almodovar M, Garofalo R. Efficacy of the mLab App: a randomized clinical trial for increasing HIV testing uptake using mobile technology. J Am Med Inform Assoc. 2025 Feb 1;32(2):275-284. doi: 10.1093/jamia/ocae261.
- Derived from this study: PubMed 34715833Wood OR, Garofalo R, Kuhns LM, Scherr TF, Zetina APM, Rodriguez RG, Nash N, Cervantes M, Schnall R. A randomized controlled trial of an mHealth intervention for increasing access to HIV testing and care among young cisgender men and transgender women: the mLab App study protocol. BMC Public Health. 2021 Oct 29;21(1):1959. doi: 10.1186/s12889-021-12015-w.
- 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.
Rebecca Schnall, PhD, RN principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mLab App, HIV Prevention Information and HIV Home Tests in people with HIV Infections, run by Rebecca Schnall, RN, MPH, PhD at 2 sites 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 9 inclusion and 2 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 26 Nov 2024). 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?
Total Number of Youth Tested for HIV (time frame: 6 months). The study lists 2 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 NCT03803683, which also lists 3 linked publications.
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 26 Nov 2024.