Status:

COMPLETED

mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention

Lead Sponsor:

Columbia University

Collaborating Sponsors:

National Institute of Nursing Research (NINR)

National Institute of Mental Health (NIMH)

Conditions:

HIV Infections

Sexually Transmitted Diseases, Viral

Eligibility:

MALE

18-39 years

Phase:

NA

Brief Summary

Men who have sex with men (MSM), especially young men who have sex with men (YMSM), and transgender women (TGW) have some of the highest rates of HIV and syphilis diagnoses in the United States. The g...

Detailed Description

From 2018 to 2019, the rate of syphilis increased by 11.2%. It has increased steadily since 2000 especially among men, in which MSM bear a disproportionate majority of cases (47% of all cases were amo...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 18-39 years of age
  • Assigned male sex at birth and identify as (1) a man or (2) a trans woman
  • Understand and read English
  • Self-identify as any race or ethnicity
  • Substantial risk for acquiring HIV infection per CDC (Centers for Disease Control) guidance
  • All participants must report having sex with a man/men
  • Smart phone ownership
  • Self-report being HIV-negative or unknown status
  • Self-report being negative for syphilis or unknown status
  • Not having been tested for HIV or syphilis in the past 3 months
  • Understand the limitations of the duplex lateral flow test and the mLab App Plus (e.g., a confirmatory test is needed and self-test must be performed in the presence of a qualified clinician)

Exclusion

    Key Trial Info

    Start Date :

    October 17 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 21 2024

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT06059443

    Start Date

    October 17 2023

    End Date

    June 21 2024

    Last Update

    March 5 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Columbia University Irving Medical Center

    New York, New York, United States, 10032

    2

    Vanderbilt University

    Nashville, Tennessee, United States, 37235

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