JMIR Publications

ABSTRACT

Background:

HIV self-testing is an important strategy in the Ending the HIV Epidemic initiative in the US. To facilitate uptake of HIV self-testing, our study team developed the mLab App, which complements existing self-test options to support the potential for higher uptake of the HIV self-test. Syphilis, an STI with currently rising prevalence and overlap in risk profiles, could similarly benefit from the advantages of companion diagnostic mobile apps like mLab. Due to the success of the mLab App in promoting HIV self-testing during a randomized controlled trial and the scientific evidence of need for at-home syphilis testing, our team developed the mLab App Plus which supports both HIV and syphilis testing through an image-processing algorithm that incorporates a duplex HIV/syphilis point-of-care test.

Objective:

We conducted a pilot study to assess the feasibility and usability of the mLab App Plus for HIV and syphilis testing.

Methods:

We recruited participants who were assigned male sex at birth and reported sex with another man. Participants came to the Nurse Practitioner Group Clinic for their baseline and follow-up visits to complete a survey and use the app to guide them through self-testing in the presence of a qualified clinician. Participants rated usability of the app with the Health Information Technology Usability Evaluation (Health-ITUES) and the Post Study System Usability Questionnaire (PSSUQ) at their 3-month follow-up visit. The primary outcome was the number of participants who were able to self-administer the DPP® HIV-Syphilis test with the assistance of the mLab App Plus. Feasibility was measured through recruitment pace, retention over 3 months, usability of the app and paradata.

Results:

Nineteen of the 20 participants (95%) identified as male and 1 (5%) as nonbinary. Most participants (80%) were able to complete DPP HIV/Syphilis testing with facilitation support from the mLab App Plus. The average duration of an app session, from after authentication until logout or abandonment, was 30 minutes and 33 seconds. Notwithstanding the 27% of sessions that were 5 minutes or less, the distribution of session durations was approximately normal. Users spent the longest time viewing testing screens (i.e., timer screens, the initial testing screen, the tests guided walkthroughs, test results, and picture and results upload). The overall mean scores of the PSSUQ (2.65) and Health-ITUES (3.62) indicate medium to high usability. The retention rate for the 3-month trial was 80%.

Conclusions:

Findings support the use of the mLab App Plus as a tool for assisting consumers to self-test for HIV and syphilis. Limitations of the study design warrant further examination outside of the clinic setting to better understand the utility of these tools for improving consumer health outcomes. Clinical Trial: NCT06059443