NCT06059443Completed
mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention
mLab App Plus: A Randomized Controlled Trial of an mHealth Intervention for Increasing Access to HIV and Syphilis Testing and Care Among Young Men
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
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 goal of this study is to pilot the mobile Lab (mLab) App Plus to assess YMSM's and YTGW's abilities to perform and interpret self-tests for HIV and syphilis and consequently increase the number of YMSM and young transgender woman (YTGW) who initiate self-testing for HIV and syphilis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 22 Sept 2023
- Start date
- 17 Oct 2023
- Primary completion date
- 21 Jun 2024
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT06059443
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 17 Oct 2023 to the primary completion date, 21 Jun 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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)
Age in the registry: 18 years to 39 years · Sex: Male · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
Related publications
- Feasibility and Usability of an mHealth App (mLab+) to Guide Users Through HIV and Syphilis Self-Testing: Pilot Randomized Controlled Trial.JMIR Form Res · 2025 · PMID 41468606
This page is information, not medical advice. Discuss any trial with your doctor.