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Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)

mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03803683
Enrollment
525
Registered
2019-01-14
Start date
2020-01-21
Completion date
2023-10-02
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

mLab, HIV prevention

Brief 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. 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.

Interventions

DEVICEmLab App

The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.

BEHAVIORALHIV Prevention Information

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.

DEVICEHIV Home Tests

Youth randomized into this arm will receive OraQuick® In-Home HIV Test.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Rebecca Schnall, RN, MPH, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 * 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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Total Number of Youth Tested for HIV6 monthsTotal number of youth tested for HIV at 6 months

Secondary

MeasureTime frameDescription
Total Number of HIV Negative/ Positive Results6 monthsTotal number of HIV negative/ positive results at 6 months
Total Number of Youth Who Link to HIV Care Services6 monthsTotal number of youth who link to HIV care services at 6 months
Number of Sexual Partners in the Past 3 Months6 monthsNumber of Sexual Partners in the past 3 months collected at the 6 month mark
Number of Condomless Anal Sex Acts6 monthsNumber of condomless anal sex acts in the past 3 months at 6 months

Countries

United States

Participant flow

Pre-assignment details

525 participants enrolled, however 523 were randomized as two participants withdrew prior to randomization.

Participants by arm

ArmCount
mLab App Intervention
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. mLab App: 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 Information: 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 Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
211
Standard of Care HIV Information Control Arm
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. HIV Prevention Information: 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.
208
HIV Home Tests
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. HIV Prevention Information: 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 Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
104
Total523

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up411812
Overall StudyWithdrawal by Subject914

Baseline characteristics

CharacteristicmLab App InterventionStandard of Care HIV Information Control ArmHIV Home TestsTotal
Age, Continuous24.3 years
STANDARD_DEVIATION 3.23
23.9 years
STANDARD_DEVIATION 3.34
24.3 years
STANDARD_DEVIATION 3.28
24.1 years
STANDARD_DEVIATION 3.28
Any HIV test in the past 6 months74 Participants60 Participants22 Participants156 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
73 Participants61 Participants26 Participants160 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
137 Participants147 Participants77 Participants361 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants2 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
2 Participants4 Participants1 Participants7 Participants
Race/Ethnicity, Customized
Asian or Asian American
25 Participants31 Participants11 Participants67 Participants
Race/Ethnicity, Customized
Black or African-American
22 Participants19 Participants6 Participants47 Participants
Race/Ethnicity, Customized
Hispanic or Latino/Latinx
5 Participants6 Participants1 Participants12 Participants
Race/Ethnicity, Customized
Multiracial
21 Participants13 Participants15 Participants49 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Something else
12 Participants17 Participants6 Participants35 Participants
Race/Ethnicity, Customized
Unknown/Not Reported
1 Participants0 Participants1 Participants2 Participants
Race/Ethnicity, Customized
White or Caucasian
123 Participants118 Participants62 Participants303 Participants
Region of Enrollment
United States
211 participants208 participants104 participants523 participants
Sex/Gender, Customized
Genderqueer
7 Participants0 Participants2 Participants9 Participants
Sex/Gender, Customized
Male
186 Participants193 Participants96 Participants475 Participants
Sex/Gender, Customized
Non-binary
9 Participants13 Participants1 Participants23 Participants
Sex/Gender, Customized
Other
2 Participants0 Participants1 Participants3 Participants
Sex/Gender, Customized
Trans Feminine
7 Participants2 Participants4 Participants13 Participants
Sexual Orientation
Bisexual
36 Participants24 Participants12 Participants72 Participants
Sexual Orientation
Gay/homosexual
142 Participants156 Participants82 Participants380 Participants
Sexual Orientation
Other
6 Participants0 Participants3 Participants9 Participants
Sexual Orientation
Queer
25 Participants27 Participants5 Participants57 Participants
Sexual Orientation
Straight/heterosexual
2 Participants1 Participants2 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 2110 / 2080 / 104
other
Total, other adverse events
0 / 2110 / 2080 / 104
serious
Total, serious adverse events
0 / 2110 / 2080 / 104

Outcome results

Primary

Total Number of Youth Tested for HIV

Total number of youth tested for HIV at 6 months

Time frame: 6 months

Population: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mLab App InterventionTotal Number of Youth Tested for HIV154 Participants
Standard of Care HIV Information Control ArmTotal Number of Youth Tested for HIV123 Participants
HIV Home TestsTotal Number of Youth Tested for HIV68 Participants
Primary

Total Number of Youth Tested for HIV

Total number of youth tested for HIV at 12 months

Time frame: 12 months

Population: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mLab App InterventionTotal Number of Youth Tested for HIV145 Participants
Standard of Care HIV Information Control ArmTotal Number of Youth Tested for HIV109 Participants
HIV Home TestsTotal Number of Youth Tested for HIV64 Participants
Secondary

Number of Condomless Anal Sex Acts

Number of condomless anal sex acts in the past 3 months at 12 months

Time frame: 12 months

Population: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.

ArmMeasureValue (MEAN)Dispersion
mLab App InterventionNumber of Condomless Anal Sex Acts7.01 condomless anal sex actsStandard Deviation 12.15
Standard of Care HIV Information Control ArmNumber of Condomless Anal Sex Acts8.33 condomless anal sex actsStandard Deviation 15.75
HIV Home TestsNumber of Condomless Anal Sex Acts8.32 condomless anal sex actsStandard Deviation 11.49
Secondary

Number of Condomless Anal Sex Acts

Number of condomless anal sex acts in the past 3 months at 6 months

Time frame: 6 months

Population: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.

ArmMeasureValue (MEAN)Dispersion
mLab App InterventionNumber of Condomless Anal Sex Acts7.35 condomless anal sex actsStandard Deviation 15.34
Standard of Care HIV Information Control ArmNumber of Condomless Anal Sex Acts8.21 condomless anal sex actsStandard Deviation 21.67
HIV Home TestsNumber of Condomless Anal Sex Acts7.56 condomless anal sex actsStandard Deviation 9.93
Secondary

Number of Sexual Partners in the Past 3 Months

Number of Sexual Partners in the past 3 months collected at the 6 month mark

Time frame: 6 months

Population: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.

ArmMeasureValue (MEAN)Dispersion
mLab App InterventionNumber of Sexual Partners in the Past 3 Months2.12 partnersStandard Deviation 3.98
Standard of Care HIV Information Control ArmNumber of Sexual Partners in the Past 3 Months1.69 partnersStandard Deviation 3.56
HIV Home TestsNumber of Sexual Partners in the Past 3 Months1.78 partnersStandard Deviation 1.9
Secondary

Number of Sexual Partners in the Past 3 Months

Number of Sexual Partners in the past 3 months collected at the 12 month mark

Time frame: 12 months

Population: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.

ArmMeasureValue (MEAN)Dispersion
mLab App InterventionNumber of Sexual Partners in the Past 3 Months2.24 partnersStandard Deviation 4.8
Standard of Care HIV Information Control ArmNumber of Sexual Partners in the Past 3 Months2.11 partnersStandard Deviation 7.44
HIV Home TestsNumber of Sexual Partners in the Past 3 Months2.43 partnersStandard Deviation 3.57
Secondary

Total Number of HIV Negative/ Positive Results

Total number of HIV negative/ positive results at 6 months

Time frame: 6 months

Population: 154 in Arm 1, 123 in Arm 2, and 68 in Arm 3 analyzed as this was the number of participants that completed the HIV test and from which data was collected.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
mLab App InterventionTotal Number of HIV Negative/ Positive ResultsNegative154 Participants
mLab App InterventionTotal Number of HIV Negative/ Positive ResultsPositive0 Participants
Standard of Care HIV Information Control ArmTotal Number of HIV Negative/ Positive ResultsNegative123 Participants
Standard of Care HIV Information Control ArmTotal Number of HIV Negative/ Positive ResultsPositive0 Participants
HIV Home TestsTotal Number of HIV Negative/ Positive ResultsNegative68 Participants
HIV Home TestsTotal Number of HIV Negative/ Positive ResultsPositive0 Participants
Secondary

Total Number of HIV Negative/ Positive Results

Total number of HIV negative/ positive results at 12 months

Time frame: 12 months

Population: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
mLab App InterventionTotal Number of HIV Negative/ Positive ResultsNegative161 Participants
mLab App InterventionTotal Number of HIV Negative/ Positive ResultsPositive0 Participants
Standard of Care HIV Information Control ArmTotal Number of HIV Negative/ Positive ResultsNegative189 Participants
Standard of Care HIV Information Control ArmTotal Number of HIV Negative/ Positive ResultsPositive0 Participants
HIV Home TestsTotal Number of HIV Negative/ Positive ResultsNegative88 Participants
HIV Home TestsTotal Number of HIV Negative/ Positive ResultsPositive0 Participants
Secondary

Total Number of Youth Who Link to HIV Care Services

Total number of youth who link to HIV care services at 6 months

Time frame: 6 months

Population: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mLab App InterventionTotal Number of Youth Who Link to HIV Care Services0 Participants
Standard of Care HIV Information Control ArmTotal Number of Youth Who Link to HIV Care Services0 Participants
HIV Home TestsTotal Number of Youth Who Link to HIV Care Services0 Participants
Secondary

Total Number of Youth Who Link to HIV Care Services

Total number of youth who link to HIV care services at 12 months

Time frame: 12 months

Population: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mLab App InterventionTotal Number of Youth Who Link to HIV Care Services0 Participants
Standard of Care HIV Information Control ArmTotal Number of Youth Who Link to HIV Care Services0 Participants
HIV Home TestsTotal Number of Youth Who Link to HIV Care Services0 Participants

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026