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

NCT06059443 | Completed Results

• 3 other identifiers: AAAU3380K24NR018621R01MH118151
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 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.

Conditions

HIV Infections; Sexually Transmitted Diseases, Viral; Syphilis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Number of Negative/Positive Results

  3-Month Follow-up

• Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only)

  3-Month Follow-up

• Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services

  3-Month Follow-up

Study Arms (2)

mLab App Plus

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

mLab App Plus BEHAVIORAL

Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test

mLab App Plus

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: Assigned male sex at birth and identify as (1) a man or (2) a trans woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases, Viral; Syphilis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial

Results Point of Contact

• Title: Dr. Rebecca Schnall
• Organization: Columbia University School of Nursing

rb897@cumc.columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to one of two trial arms using the randomization module in REDCap. We will use block randomization with randomly permutated blocks to reduce opportunities for selection bias
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion (Nursing)

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: October 17, 2023
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Locations

US (2)