mLab App Plus

About Study

HIV and syphilis rates continue to rise among young men who have sex with men (YMSM). While men who have sex with men (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.

The purpose of the mLab App Plus study is to assess the feasibility of the “mLab App Plus” in assisting the use of the DPP HIV/Syphilis test as a self-test.

Study visits will be in-person at our clinic in Washington Heights. During these visits participants will take a survey and receive STI counseling and some participants will self-administer an HIV/Syphilis test and test our app. This is a 3-month study with only 2 visits. The first visit will take 2-3 hours and the second visit will take about 1-2 hours. Participants will be compensated $40 after completing the baseline visit and $60 after the 3-month follow-up.

For Participants 

Eligible participants will schedule a visit at our location in Washington Heights. During this visit, you will decide to consent to participate in this study. If consent is given, you will then be randomized into one of two arms: the intervention arm or the control arm. Once randomized, all participants will complete a baseline survey answering questions regarding your demographic information, health literacy, sexual history, and sexual practices. Regardless of the study arm, all participants will receive standard of care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clincis that provide PrEP.

• 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 guidance (e.g., Sexual partner with HIV and/or recent bacterial STD and/or high number of sexual partners and/or history of inconsistent or no condom use and/or commercial sex work)
  • All participants must report having sex with a man/men 
  • Smartphone 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
• Link for the screener
• Resources detailing participant profile:

For Researchers

The implementation of HIV self-testing for YMSM provides an opportunity for self-testing of another STI prevalent in the MSM community: syphilis. MSM comprise approximately 46% of cases of concurrent HIV and syphilis infection in the US. The biological nature of syphilis infection, specifically syphilitic ulcer proliferation, facilitates transmission of HIV, making it highly dangerous for PLWH. Syphilis infections in PLWH were also associated with higher HIV viral load and lower CD4 cell counts, and therefore worsen the severity of HIV-related symptoms. Considering the increased harm caused by coinfection with syphilis amongst PLWH, there is a need for increased concurrent testing for HIV and syphilis.

Study link to clinicaltrials.gov. 

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