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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1
Columbia University Irving Medical Center
New York, New York, United States, 10032
2
Vanderbilt University
Nashville, Tennessee, United States, 37235