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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
Study Summary
This trial is testing a new app that combines HIV prevention information with reminders to get tested and get results in real-time. The goal is to improve HIV testing and care outcomes among youth living with and at-risk for HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total number of youth tested for HIV
Secondary outcome measures
Number of Sexual Partners in the past 6 months
Number of condomless anal sex acts
Total number of HIV negative/ positive results
+1 moreTrial 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
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,582 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You understand that the OraQuick test and the mLab App have some restrictions or limitations.
Research Study Groups:
This trial has the following groups:- Group 1: HIV Home Tests
- Group 2: mLab App Intervention
- Group 3: Standard of Care HIV Information Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adolescents of the appropriate age being considered for inclusion in this trial?
"Those that wish to be included in this study must lie between 18 and 29 years old. Separately, 108 trials are available for minors while 352 studies exist for adults over the age of 65."
Answered by AI
Does my profile make me a suitable candidate for this clinical research?
"This research trial is seeking 525 participants between 18 and 29 years of age, who have been clinically diagnosed with HIV."
Answered by AI
Are participants still being recruited for this clinical trial?
"The information available on clinicaltrials.gov attests that this medical trial is currently not looking for participants, as the latest update to its page was made on September 21st 2022. It should be noted however, that there are 484 other healthcare studies actively recruiting patients at present."
Answered by AI
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