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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

No Placebo-Only Group

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.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV Suppression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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