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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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mLab App Plus: A Randomized Controlled Trial of an mHealth Intervention for Increasing Access to HIV and Syphilis Testing and Care Among Young Men

Conditions
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HIV Infections, Sexually Transmitted Diseases, Viral, Syphilis

Intervention / Treatment
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* Behavioral: mLab App Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-35 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mLab App Plus<br>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<br>* Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test<br>|
| No Intervention: Standard of Care<br>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?
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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. | Baseline and 3-Month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of negative/positive results | The number of negative/positive results | Baseline and 3-Month Follow-up | 
| 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 | Baseline and 3-Month Follow-up | 
| 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 | Baseline and 3-Month Follow-up |