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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Diseases, Viral; Syphilis
• Intervention / Treatment: Behavioral: mLab App Plus

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 among MSM in 2019). HIV and syphilis rates continue to rise among YMSM. While MSM account for only about 2% of the US population, they are most affected by HIV, constituting 56% of people living with HIV (PLWH).

Moreover, the rate of syphilis among MSM is profoundly elevated, at least 100 times higher than that in men who have sex with women and even higher among YMSM. Importantly, syphilis makes it easier to both acquire and transmit HIV, and about half of MSM who have syphilis are co-infected with HIV. The risk of syphilis and HIV continues to rise in YMSM in New York City, the study site. Given these epidemiologic risk factors for HIV and syphilis, there is a strong scientific premise for this pilot study that proposes to test innovative and effective HIV and sexually transmitted infection (STI) testing, prevention, and treatment models. Given that approximately 17% of MSM living with HIV in the U.S. are unaware of their status and significant comorbid syphilis in that population, both pathogens may be simultaneously transmitted. The increasing number of syphilis diagnosed in MSM highlights the importance of STI control in this population, not just for the health of the patient, but also for prevention of HIV and syphilis in uninfected persons. YMSM and YTGW, and specifically Blacks and Latinos, are disproportionately infected with HIV.

In response to the need for interventions to increase HIV testing in youth, our study team developed the mLab App, which affords advantages over existing self-test options to support the potential for higher uptake of the HIV self-test. The app provides HIV prevention information, push notification reminders for testing, step-by-step instructions for using the OraQuick HIV tests (OraQuick), and an image upload function so individuals can send an image of their OraQuick HIV test to the study team. In response to the mLab App study and the scientific evidence of need for at-home syphilis point of care (POC) testing among YMSM and YTGW, we propose to implement the 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 YTGW who initiate self-testing for HIV and syphilis.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mLab App Plus; Participants randomized to intervention will receive standard of care counseling, complete online surveys, be provided with the mLab App Plus, and a box of condoms. The intervention arm will also complete two HIV/Syphilis Ab Combo Rapid Tests (DPP® HIV-Syphilis Test) at their baseline (first test) and 3-month follow- up (second test) appointments.	Behavioral: mLab App Plus; Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test
No Intervention: Standard of Care; Participants randomized to standard care will receive standard of care counseling, complete online surveys and be sent an email with links to mobile-optimized online prevention information, including Pre-Exposure Prophylaxis(PrEP) and HIV/STI testing information found on the Centers for Disease Control (CDC) website, and a box of condoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus	A successful self-test is defined as having completed the DPP® HIV-Syphilis test by themselves and having accurately identified and interpreted their HIV and Syphilis statuses as determined by the supervising clinician. In the event that the clinician, rather than the participant administers the DPP® HIV-Syphilis test, the test is not recorded as a successful self-test.	3-Month Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Negative/Positive Results	The number of participants who tested reactive (R) or positive and/or non-reactive (NR) or negative for syphilis and HIV using the DPP® HIV-Syphilis test with mLab App Plus. Test results appear in a single reading with the results of both HIV and syphilis.	3-Month Follow-up
Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only)	The number of Young Men who have sex with men/ Young transgender women referred for HIV/STI services (participants with HIV and/or syphilis only). Using count of referral for participants that tested positive (reactive) to HIV and/or syphilis using mLabApp Plus.	3-Month Follow-up
Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services	The number of Young Men who have sex with men/ Young transgender women linked to (attend one appointment) HIV/STI prevention or care services. Using count of appointments attended.	3-Month Follow-up

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH); National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Rebecca Schnall, PhD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Sexually Transmitted Diseases, Bacterial; Treponemal Infections; Sexually Transmitted Diseases; Virus Diseases; Syphilis; Sexually Transmitted Diseases, Viral
• Other Study ID Numbers: AAAU3380; R01MH118151 (U.S. NIH Grant/Contract); K24NR018621 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No