{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T19:00:32Z","timestamp":1782846032152,"version":"3.54.5"},"reference-count":35,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Form Res"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>HIV self-testing is an important strategy in the US Ending the HIV Epidemic initiative. To facilitate uptake of self-testing, we developed the mLab app, which complements existing self-test options to support the potential for higher uptake of the HIV self-test. Syphilis, a sexually transmitted infection with currently rising prevalence and overlap in risk profiles with HIV, could similarly benefit from the advantages of companion diagnostic mobile apps such as 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, which supports both HIV and syphilis testing through an image processing algorithm that incorporates a duplex HIV and syphilis point-of-care test.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We conducted a pilot study to assess the feasibility and usability of the mLab+ app for HIV and syphilis testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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 baseline and follow-up visits. Participants rated the usability of the app using the Health Information Technology Usability Evaluation Scale and the Post-Study System Usability Questionnaire 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. Feasibility was measured through recruitment pace, retention over 3 months, app usability, and paradata.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 20 participants, 19 identified as male and 1 identified as nonbinary. Most participants (n=16) were able to complete the DPP HIV-Syphilis test with facilitation support from the mLab+ app. The average duration of an app session, from after authentication until log-out or abandonment, was 30 minutes and 33 seconds (SD 21 minutes and 40 seconds). Apart from the 27% (13\/48) of sessions that were 5 minutes or less, the distribution of session durations was approximately normal. Users spent the longest time viewing testing screens (ie, timer screens, initial testing screen, test guided walkthroughs, test results, and picture and result upload). The overall mean scores on the Post-Study System Usability Questionnaire (2.65, SD 1.06) and Health Information Technology Usability Evaluation Scale (3.62, SD 1.07) indicated medium to high usability. The retention rate for the 3-month trial was 80% (16\/20).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The findings support the use of the mLab+ app as a tool for assisting consumers in self-testing for HIV and syphilis. The limitations of the study design warrant further examination outside of clinic settings to better understand the utility of these tools for improving consumer health outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/72955","type":"journal-article","created":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T22:51:12Z","timestamp":1767135072000},"page":"e72955-e72955","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility and Usability of an mHealth App (mLab+) to Guide Users Through HIV and Syphilis Self-Testing: Pilot Randomized Controlled Trial"],"prefix":"10.2196","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-1625-3450","authenticated-orcid":false,"given":"Maeve","family":"Brin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7077-535X","authenticated-orcid":false,"given":"Thomas F","family":"Scherr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5172-6846","authenticated-orcid":false,"given":"Janejira","family":"Chaiyasit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3546-0800","authenticated-orcid":false,"given":"Jianfang","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2354-9405","authenticated-orcid":false,"given":"Maura","family":"Abbott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9513-9416","authenticated-orcid":false,"given":"Robert","family":"Garofalo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8294-7801","authenticated-orcid":false,"given":"Lisa M","family":"Kuhns","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-0823-6335","authenticated-orcid":false,"given":"Tess","family":"Sky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-4796-4875","authenticated-orcid":false,"given":"Ian","family":"Esliker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2184-4045","authenticated-orcid":false,"given":"Rebecca","family":"Schnall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,12,30]]},"reference":[{"key":"R1","unstructured":"Guidelines on HIV self-testing and partner notification: supplement to consolidated guidelines on HIV testing services. Pan American Health Organization. 2016. URL: https:\/\/www.paho.org\/en\/documents\/guidelines-hiv-self-testing-and-partner-notification-supplement-consolidated-guidelines [Accessed 10-11-2025]"},{"issue":"5 Suppl 1","key":"R2","doi-asserted-by":"publisher","first-page":"S6","DOI":"10.1016\/j.amepre.2021.06.002","article-title":"HIV testing strategies for health departments to end the epidemic in the U.S","volume":"61","author":"Delaney","journal-title":"Am J Prev Med"},{"issue":"9","key":"R3","doi-asserted-by":"publisher","first-page":"844","DOI":"10.1001\/jama.2019.1343","article-title":"Ending the HIV epidemic: a plan for the United States","volume":"321","author":"Fauci","journal-title":"JAMA"},{"issue":"38","key":"R4","doi-asserted-by":"publisher","first-page":"1322","DOI":"10.15585\/mmwr.mm7038a2","article-title":"Increasing access to HIV testing through direct-to-consumer HIV self-test distribution - United States, March 31, 2020-March 30, 2021","volume":"70","author":"Hecht","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"1","key":"R5","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1001\/jamainternmed.2019.5222","article-title":"Effect of internet-distributed HIV self-tests on HIV diagnosis and behavioral outcomes in men who have sex with men: a randomized clinical trial","volume":"180","author":"MacGowan","journal-title":"JAMA Intern Med"},{"issue":"4","key":"R6","doi-asserted-by":"publisher","first-page":"312","DOI":"10.1521\/aeap.2021.33.4.312","article-title":"Usability evaluation of the mLab app for improving home HIV testing behaviors in youth at risk of HIV infection","volume":"33","author":"Sanabria","journal-title":"AIDS Educ Prev"},{"issue":"2","key":"R7","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1093\/jamia\/ocae261","article-title":"Efficacy of the mLab app: a randomized clinical trial for increasing HIV testing uptake using mobile technology","volume":"32","author":"Schnall","journal-title":"J Am Med Inform Assoc"},{"issue":"4","key":"R8","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1007\/s10461-015-1240-6","article-title":"Do high-risk young adults use the HIV self-test appropriately? Observations from a think-aloud study","volume":"20","author":"Schnall","journal-title":"AIDS Behav"},{"issue":"1","key":"R9","doi-asserted-by":"publisher","DOI":"10.1186\/s12889-024-21228-8","article-title":"A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada","volume":"25","author":"Galli","journal-title":"BMC Public Health"},{"key":"R10","unstructured":"U.S. syphilis cases reach highest numbers since the 1950s. Centers for Disease Control and Prevention. 2024. URL: https:\/\/www.cdc.gov\/nchhstp\/newsroom\/releases\/2024\/STI-Surveillance-Report-2022.html [Accessed 10-11-2025]"},{"key":"R11","unstructured":"Sexually transmitted diseases surveillance. Centers for Disease Control and Prevention. 2017. URL: https:\/\/stacks.cdc.gov\/view\/cdc\/59237 [Accessed 10-11-2025]"},{"key":"R12","unstructured":"Syphilis & MSM (men who have sex with men). Centers for Disease Control and Prevention. 2023. URL: https:\/\/www.cdc.gov\/std\/treatment-guidelines\/msm.htm [Accessed 10-11-2025]"},{"issue":"4","key":"R13","doi-asserted-by":"publisher","first-page":"408","DOI":"10.1097\/QAI.0b013e318230e1ca","article-title":"Men who have sex with men have a 140-fold higher risk for newly diagnosed HIV and syphilis compared with heterosexual men in New York City","volume":"58","author":"Pathela","journal-title":"J Acquir Immune Defic Syndr"},{"key":"R14","unstructured":"Sexually transmitted disease surveillance 2014. Centers for Disease Control and Prevention. 2015. URL: https:\/\/stacks.cdc.gov\/view\/cdc\/36835 [Accessed 10-11-2025]"},{"key":"R15","unstructured":"Sexually transmitted infections surveillance 2023. Centers for Disease Control and Prevention. 2023. URL: https:\/\/www.cdc.gov\/sti-statistics\/media\/pdfs\/2025\/09\/2023_STI_Surveillance_Report_FINAL_508.pdf [Accessed 10-11-2025]"},{"issue":"4","key":"R16","doi-asserted-by":"publisher","first-page":"1229","DOI":"10.1007\/s10461-021-03478-4","article-title":"Experiences of transgender women who used a dual HIV\/syphilis rapid self-test to screen themselves and potential sexual partners (the SMARTtest study)","volume":"26","author":"Rael","journal-title":"AIDS Behav"},{"issue":"S4","key":"R17","doi-asserted-by":"publisher","first-page":"S277","DOI":"10.2105\/AJPH.2018.304751","article-title":"Using sexual orientation and gender identity to monitor disparities in HIV, sexually transmitted infections, and viral hepatitis","volume":"108","author":"Shover","journal-title":"Am J Public Health"},{"issue":"1","key":"R18","doi-asserted-by":"publisher","first-page":"e1","DOI":"10.2105\/AJPH.2018.304727","article-title":"Estimating the prevalence of HIV and sexual behaviors among the US transgender population: a systematic review and meta-analysis, 2006-2017","volume":"109","author":"Becasen","journal-title":"Am J Public Health"},{"issue":"2","key":"R19","doi-asserted-by":"publisher","first-page":"144","DOI":"10.1016\/j.jana.2009.07.008","article-title":"Relationships between stigma, social support, and depression in HIV-infected African American women living in the rural southeastern United States","volume":"21","author":"Vyavaharkar","journal-title":"J Assoc Nurses AIDS Care"},{"issue":"6","key":"R20","doi-asserted-by":"publisher","first-page":"501","DOI":"10.1177\/0956462420979852","article-title":"Acceptability of dual HIV\/syphilis rapid test in community- and home-based testing strategy among transgender women in Buenos Aires, Argentina","volume":"32","author":"Zalazar","journal-title":"Int J STD AIDS"},{"key":"R21","unstructured":"Syphilis and people with HIV. HIV.gov. 2024. URL: https:\/\/www.hiv.gov\/hiv-basics\/staying-in-hiv-care\/other-related-health-issues\/syphilis [Accessed 10-11-2025]"},{"key":"R22","unstructured":"Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. HIV.gov. 2023. URL: https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections\/syphilis [Accessed 10-11-2025]"},{"issue":"15","key":"R23","doi-asserted-by":"publisher","first-page":"2075","DOI":"10.1097\/00002030-200410210-00012","article-title":"Syphilis increases HIV viral load and decreases CD4 cell counts in HIV-infected patients with new syphilis infections","volume":"18","author":"Buchacz","journal-title":"AIDS"},{"issue":"5","key":"R24","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph19053002","article-title":"HIV and STI testing preferences for men who have sex with men in high-income countries: a scoping review","volume":"19","author":"Kularadhan","journal-title":"Int J Environ Res Public Health"},{"key":"R25","unstructured":"Screening recommendations and considerations referenced in treatment guidelines and original sources. Centers for Disease Control and Prevention. 2024. URL: https:\/\/www.cdc.gov\/std\/treatment-guidelines\/screening-recommendations.htm [Accessed 10-11-2025]"},{"issue":"Suppl 1","key":"R26","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1177\/00333549141291S103","article-title":"Missed opportunities for concurrent HIV-STD testing in an academic emergency department","volume":"129 Suppl 1","author":"Klein","journal-title":"Public Health Rep"},{"issue":"8","key":"R27","doi-asserted-by":"publisher","first-page":"1457","DOI":"10.2105\/AJPH.2012.301162","article-title":"Substance use among HIV-infected patients engaged in primary care in the United States: findings from the Centers for AIDS Research Network of Integrated Clinical Systems cohort","volume":"103","author":"Mimiaga","journal-title":"Am J Public Health"},{"issue":"12","key":"R28","doi-asserted-by":"publisher","first-page":"2010","DOI":"10.1093\/cid\/ciy810","article-title":"Randomized controlled trial of a mobile health intervention to promote retention and adherence to preexposure prophylaxis among young people at risk for human immunodeficiency virus: the EPIC study","volume":"68","author":"Liu","journal-title":"Clin Infect Dis"},{"issue":"1","key":"R29","doi-asserted-by":"publisher","DOI":"10.2196\/mhealth.8851","article-title":"Health information technology usability evaluation scale (Health-ITUES) for usability assessment of mobile health technology: validation study","volume":"6","author":"Schnall","journal-title":"JMIR Mhealth Uhealth"},{"issue":"1","key":"R30","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1080\/10447319509526110","article-title":"IBM computer usability satisfaction questionnaires: psychometric evaluation and instructions for use","volume":"7","author":"Lewis","journal-title":"Int J Hum Comput Interact"},{"key":"R31","doi-asserted-by":"crossref","unstructured":"Kreuter F . Improving Surveys with Paradata: Analytic Uses of Process Information. Vol 581. John Wiley & Sons; 2013. [doi: 10.1002\/9781118596869] ISBN: 9781118596869","DOI":"10.1002\/9781118596869"},{"issue":"3","key":"R32","doi-asserted-by":"publisher","first-page":"463","DOI":"10.1207\/S15327590IJHC143&4_11","article-title":"Psychometric evaluation of the PSSUQ using data from five years of usability studies","volume":"14","author":"Lewis","journal-title":"Int J of Human-Comp Interaction"},{"issue":"10","key":"R33","doi-asserted-by":"publisher","first-page":"2178","DOI":"10.1093\/cid\/ciz603","article-title":"Syphilis self-testing: a nationwide pragmatic study among men who have sex with men in China","volume":"70","author":"Wang","journal-title":"Clin Infect Dis"},{"issue":"9","key":"R34","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.31853","article-title":"Efficacy of MyPEEPS mobile, an HIV prevention intervention using mobile technology, on reducing sexual risk among same-sex attracted adolescent males: a randomized clinical trial","volume":"5","author":"Schnall","journal-title":"JAMA Netw Open"},{"issue":"5","key":"R35","doi-asserted-by":"publisher","first-page":"1560","DOI":"10.1007\/s10461-019-02718-y","article-title":"SMARTtest: a smartphone app to facilitate HIV and syphilis self- and partner-testing, interpretation of results, and linkage to care","volume":"24","author":"Bal\u00e1n","journal-title":"AIDS Behav"}],"container-title":["JMIR Formative Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/formative.jmir.org\/2025\/1\/e72955","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:03:25Z","timestamp":1782842605000},"score":1,"resource":{"primary":{"URL":"https:\/\/formative.jmir.org\/2025\/1\/e72955"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,30]]},"references-count":35,"URL":"https:\/\/doi.org\/10.2196\/72955","relation":{},"ISSN":["2561-326X"],"issn-type":[{"value":"2561-326X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,30]]},"article-number":"v9i5 Suppl 1e72955"}}