N/A
Completed N=40
mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention
Source: ClinicalTrials.gov NCT06059443 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus — 12 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus |
12 | — |
| SECONDARY The Number of Negative/Positive Results |
12; 3; 0; 0 | — |
| SECONDARY Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only) |
3 | — |
| SECONDARY Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services |
— | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT06059443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.