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      A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial

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          Abstract

          Background

          HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM.

          Objective

          The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app.

          Methods

          This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY.

          Results

          App refinement is underway. Enrollment for the pilot RCT began in October 2018.

          Conclusions

          MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities.

          International Registered Report Identifier (IRRID)

          PRR1-10.2196/10694

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          Most cited references32

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          Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination.

          D R Williams, Yan Yu, J Jackson … (1997)
          This article examines the extent to which racial differences in socio-economic status (SES), social class and acute and chronic indicators of perceived discrimination, as well as general measures of stress can account for black-white differences in self-reported measures of physical and mental health. The observed racial differences in health were markedly reduced when adjusted for education and especially income. However, both perceived discrimination and more traditional measures of stress are related to health and play an incremental role in accounting for differences between the races in health status. These findings underscore the need for research efforts to identify the complex ways in which economic and non-economic forms of discrimination relate to each other and combine with socio-economic position and other risk factors and resources to affect health.
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            Epidemiology and the web of causation: has anyone seen the spider?

            N Krieger (1994)
            'Multiple causation' is the canon of contemporary epidemiology, and its metaphor and model is the 'web of causation.' First articulated in a 1960 U.S. epidemiology textbook, the 'web' remains a widely accepted but poorly elaborated model, reflecting in part the contemporary stress on epidemiologic methods over epidemiologic theories of disease causation. This essay discusses the origins, features, and problems of the 'web,' including its hidden reliance upon the framework of biomedical individualism to guide the choice of factors incorporated in the 'web.' Posing the question of the whereabouts of the putative 'spider,' the author examines several contemporary approaches to epidemiologic theory, including those which stress biological evolution and adaptation and those which emphasize the social production of disease. To better integrate biologic and social understandings of current and changing population patterns of health and disease, the essay proposes an ecosocial framework for developing epidemiologic theory. Features of this alternative approach are discussed, a preliminary image is offered, and debate is encouraged.
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              What about N? A methodological study of sample-size reporting in focus group studies

              Benedicte Carlsen, Claire Glenton (2011)
              Background Focus group studies are increasingly published in health related journals, but we know little about how researchers use this method, particularly how they determine the number of focus groups to conduct. The methodological literature commonly advises researchers to follow principles of data saturation, although practical advise on how to do this is lacking. Our objectives were firstly, to describe the current status of sample size in focus group studies reported in health journals. Secondly, to assess whether and how researchers explain the number of focus groups they carry out. Methods We searched PubMed for studies that had used focus groups and that had been published in open access journals during 2008, and extracted data on the number of focus groups and on any explanation authors gave for this number. We also did a qualitative assessment of the papers with regard to how number of groups was explained and discussed. Results We identified 220 papers published in 117 journals. In these papers insufficient reporting of sample sizes was common. The number of focus groups conducted varied greatly (mean 8.4, median 5, range 1 to 96). Thirty seven (17%) studies attempted to explain the number of groups. Six studies referred to rules of thumb in the literature, three stated that they were unable to organize more groups for practical reasons, while 28 studies stated that they had reached a point of saturation. Among those stating that they had reached a point of saturation, several appeared not to have followed principles from grounded theory where data collection and analysis is an iterative process until saturation is reached. Studies with high numbers of focus groups did not offer explanations for number of groups. Too much data as a study weakness was not an issue discussed in any of the reviewed papers. Conclusions Based on these findings we suggest that journals adopt more stringent requirements for focus group method reporting. The often poor and inconsistent reporting seen in these studies may also reflect the lack of clear, evidence-based guidance about deciding on sample size. More empirical research is needed to develop focus group methodology.
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                Author and article information

                Contributors
                Katie B Biello:
                Center for Health Equity ResearchBrown University School of Public HealthBox G-S121-8Providence, RI, 02912United States1 401 863 3082katie_biello@brown.edu
                ORCID: http://orcid.org/0000-0002-5017-5699
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: January 2019
                Publication date (Electronic): 07 January 2019
                Volume: 8
                Issue: 1
                Electronic Location Identifier: e10694
                Affiliations
                [1 ] Center for Health Equity Research Brown University School of Public Health Providence, RI United States
                [2 ] Department of Behavioral & Social Sciences Brown University School of Public Health Providence, RI United States
                [3 ] The Fenway Institute Fenway Health Boston, MA United States
                [4 ] Department of Epidemiology Brown University School of Public Health Providence, RI United States
                [5 ] Department of Epidemiology Rollins School of Public Health Emory University Atlanta, GA United States
                [6 ] Behavior and Technology Lab Institute for Global Health and Infectious Diseases University of North Carolina at Chapel Hill Chapel Hill, NC United States
                [7 ] Division of Infectious Diseases Beth Israel Deaconess Medical Center Boston, MA United States
                [8 ] Department of Global Health and Population Harvard TH Chan School of Public Health Boston, MA United States
                Author notes
                Corresponding Author: Katie B Biello katie_biello@ 123456brown.edu
                Author information
                http://orcid.org/0000-0002-5017-5699
                http://orcid.org/0000-0002-8645-0664
                http://orcid.org/0000-0001-9256-2905
                http://orcid.org/0000-0002-7728-0587
                http://orcid.org/0000-0002-2421-923X
                http://orcid.org/0000-0001-7460-733X
                Article
                Publisher ID: v8i1e10694
                DOI: 10.2196/10694
                PMC ID: 6329428
                PubMed ID: 30617042
                SO-VID: bb03b7fe-198b-4d10-807c-cd660591a642
                Copyright © ©Katie B Biello, Elliot Marrow, Matthew J Mimiaga, Patrick Sullivan, Lisa Hightow-Weidman, Kenneth H Mayer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.01.2019.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                History
                Date received : 4 April 2018
                Date revision requested : 22 May 2018
                Date revision received : 16 July 2018
                Date accepted : 13 September 2018
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: adolescents,hiv,men who have sex with men,mhealth,mobile phone,pre-exposure prophylaxis
                Data availability:
                Keywords: adolescents, hiv, men who have sex with men, mhealth, mobile phone, pre-exposure prophylaxis

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