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mLab App for Human Immunodeficiency Virus Infection

N/A
Waitlist Available
Led By Rebecca Schnall, PhD, RN
Research Sponsored by Rebecca Schnall, RN, MPH, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial tests the mLab App, a mobile tool that helps young people aged 18-29 test for HIV at home. The app sends reminders, uses the phone's camera to check test results instantly, and securely records the data. It aims to increase HIV testing and improve care among youth who are at high risk for HIV. The mLab App combines HIV prevention information with a mobile phone imaging feature for interpreting at-home HIV test results, aiming to improve testing rates and linkage to care among high-risk youth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total number of youth tested for HIV
Secondary study objectives
Number of Sexual Partners in the past 6 months
Number of condomless anal sex acts
Total number of HIV negative/ positive results
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: mLab App InterventionExperimental Treatment3 Interventions
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.
Group II: HIV Home TestsActive Control2 Interventions
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.
Group III: Standard of Care HIV Information Control ArmActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mLab App
2020
N/A
~530
HIV Prevention Information
2020
N/A
~530
HIV Home Tests
2020
N/A
~530

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,011 Total Patients Enrolled
Rebecca Schnall, RN, MPH, PhDLead Sponsor
Rebecca Schnall, PhD, RNPrincipal Investigator - Columbia University
Columbia University
2 Previous Clinical Trials
240 Total Patients Enrolled

Media Library

HIV Home Tests Clinical Trial Eligibility Overview. Trial Name: NCT03803683 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: HIV Home Tests, mLab App Intervention, Standard of Care HIV Information Control Arm
Human Immunodeficiency Virus Infection Clinical Trial 2023: HIV Home Tests Highlights & Side Effects. Trial Name: NCT03803683 — N/A
HIV Home Tests 2023 Treatment Timeline for Medical Study. Trial Name: NCT03803683 — N/A
~94 spots leftby Sep 2025
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