A Technology-Based Intervention Among Young Men Who Have Sex With Men and Nonbinary People (The Conectad@s Project): Protocol for A Vanguard Mixed Methods Study

Background In many parts of the world, including Brazil, uptake for biomedical interventions has been insufficient to reverse the HIV epidemic among key populations at high risk for HIV, including men who have sex with men. Young MSM (YMSM), particularly Black YMSM, have high HIV incidence, low viral suppression, and low preexposure prophylaxis (PrEP) uptake and adherence. Therefore, novel approaches to increase the HIV biomedical interventions uptake by YMSM are urgently needed. Objective We describe the Conectad@s Project, which aims to: (1) estimate the prevalence and incidence of HIV and other sexually transmitted infections, the onset of sexual risk behavior, and barriers to biomedical interventions among YMSM aged 18 to 24 years in Rio de Janeiro, Brazil; and (2) conduct a technology-based adherence intervention study to promote a rapid linkage of YMSM to HIV care or prevention, and support and sustain adherence. Methods A cross-sectional survey will be conducted with 400 YMSM recruited using respondent-driven sampling (RDS) adapted for social media-based sampling, preceded by a formative phase. HIV and sexually transmitted infections testing will be conducted, including early HIV infection biomarker detection. Behavioral, partnership, network, and structural measures will be collected through structured questionnaires. All individuals recruited for the survey will have access to HIV risk assessment, antiretroviral therapy (ART), PrEP, prevention counseling, and a technology-based adherence intervention. Those who accept the adherence intervention will receive weekly text messages via a social networking app (WhatsApp) for 24 weeks, with follow-up data collected over 48 weeks. Results The Conectad@s project has been approved by our local institutional review board (#CAAE 26086719.0.0000.4262) in accordance with all applicable regulations. Questionnaires for the RDS survey and intervention were developed and tested in 2020, formative interviews were conducted in January and February 2021 to guide the development of the RDS, and enrollment is planned to begin in early 2022. Conclusions The Conectad@s Project is a vanguard study that, for the first time, will apply digital RDS to sample and recruit YMSM in Brazil and rapidly connect them to ART, PrEP, or prevention counseling through a technology-based adherence intervention. RDS will allow us to estimate HIV prevalence among YMSM and measure HIV infection biomarkers in the context of the onset of risky behavior. The data will lay the groundwork to adapt and implement HIV prevention strategies, identify barriers to the earliest HIV infection diagnosis, immediate ART or PrEP initiation, and detect new clusters of HIV transmission. International Registered Report Identifier (IRRID) DERR1-10.2196/34885

Coproducing Knowledge of the Implementation of Complex Digital Health Interventions for Adults with Acquired Brain Injury and their Communication Partners: Protocol for a Mixed Methods Study

Background The Social Brain Toolkit, conceived and developed in partnership with stakeholders, is a novel suite of web-based communication interventions for people with brain injury and their communication partners. To support effective implementation, the developers of the Social Brain Toolkit have collaborated with people with brain injury, communication partners, clinicians, and individuals with digital health implementation experience to coproduce new implementation knowledge. In recognition of the equal value of experiential and academic knowledge, both types of knowledge are included in this study protocol, with input from stakeholder coauthors. Objective This study aims to collaborate with stakeholders to prioritize theoretically based implementation targets for the Social Brain Toolkit, understand the nature of these priorities, and develop targeted implementation strategies to address these priorities, in order to support the Social Brain Toolkit’s implementation. Methods Theoretically underpinned by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework of digital health implementation, a maximum variation sample (N=35) of stakeholders coproduced knowledge of the implementation of the Social Brain Toolkit. People with brain injury (n=10), communication partners (n=11), and clinicians (n=5) participated in an initial web-based prioritization survey based on the NASSS framework. Survey completion was facilitated by plain English explanations and accessible captioned videos developed through 3 rounds of piloting. A speech-language pathologist also assisted stakeholders with brain injury to participate in the survey via video teleconference. Participants subsequently elaborated on their identified priorities via 7 web-based focus groups, in which researchers and stakeholders exchanged stakeholder perspectives and research evidence from a concurrent systematic review. Stakeholders were supported to engage in focus groups through the use of visual supports and plain English explanations. Additionally, individuals with experience in digital health implementation (n=9) responded to the prioritization survey questions via individual interview. The results will be deductively analyzed in relation to the NASSS framework in a coauthorship process with people with brain injury, communication partners, and clinicians. Results Ethical approval was received from the University of Technology Sydney Health and Medical Research Ethics Committee (ETH20-5466) on December 15, 2020. Data were collected from April 13 to November 18, 2021. Data analysis is currently underway, with results expected for publication in mid-2022. Conclusions In this study, researchers supported individuals with living experience of acquired brain injury, of communicating with or clinically supporting someone post injury, and of digital health implementation, to directly access and leverage the latest implementation research evidence and theory. With this support, stakeholders were able to prioritize implementation research targets, develop targeted implementation solutions, and coauthor and publish new implementation findings. The results will be used to optimize the implementation of 3 real-world, evidence-based interventions and thus improve the outcomes of people with brain injury and their communication partners. International Registered Report Identifier (IRRID) DERR1-10.2196/35080

Evaluation of a Healthy Relationship Smartphone App With Indigenous Young People: Protocol for a Co-designed Stepped Wedge Randomized Trial

Background We co-designed a smartphone app, Harmonised, with taitamariki (young people aged 13-17 years) to promote healthy intimate partner relationships. The app also provides a pathway for friends and family, or whānau (indigenous Māori extended family networks), to learn how to offer better support to taitamariki. Objective The aim of our taitamariki- and Māori-centered study is to evaluate the implementation of the app in secondary schools. The study tests the effectiveness of the app in promoting taitamariki partner relationship self-efficacy (primary outcome). Methods We co-designed a pragmatic, randomized, stepped wedge trial (retrospectively registered on September 12, 2019) for 8 Aotearoa, New Zealand, secondary schools (years 9 through 13). The schools were randomly assigned to implement the app in 1 of the 2 school terms. A well-established evaluation framework (RE-AIM [Reach, Effectiveness, Adoption, Implementation, Maintenance]) guided the selection of mixed data collection methods. Our target sample size is 600 taitamariki enrolled across the 8 schools. Taitamariki will participate by completing 5 web-based surveys over a 15-month trial period. Taitamariki partner relationship self-efficacy (primary outcome) and well-being, general health, cybersafety management, and connectedness (secondary outcomes) will be assessed with each survey. The general effectiveness hypotheses will be tested by using a linear mixed model with nested participant, year-group, and school random effects. The primary analysis will also include testing effectiveness in the Māori subgroup. Results The study was funded by the New Zealand Ministry of Business, Innovation, and Employment in October 2015 and approved by the Auckland University of Technology Ethics Committee on May 3, 2017 (application number: 17/71). Conclusions This study will generate robust evidence evaluating the impact of introducing a healthy relationship app in secondary schools on taitamariki partner relationship self-efficacy, well-being, general health, cybersafety management, and connectedness. This taitamariki- and indigenous Māori–centered research fills an important gap in developing and testing strengths-based mobile health interventions in secondary schools. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12619001262190; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377584 International Registered Report Identifier (IRRID) RR1-10.2196/24792

Investigating the Implementation of SMS and Mobile Messaging in Population Screening (the SIPS Study): Protocol for a Delphi Study

Background The use of mobile messaging, including SMS, and web-based messaging in health care has grown significantly. Using messaging to facilitate patient communication has been advocated in several circumstances, including population screening. These programs, however, pose unique challenges to mobile communication, as messaging is often sent from a central hub to a diverse population with differing needs. Despite this, there is a paucity of robust frameworks to guide implementation. Objective The aim of this protocol is to describe the methods that will be used to develop a guide for the principles of use of mobile messaging for population screening programs in England. Methods This modified Delphi study will be conducted in two parts: evidence synthesis and consensus generation. The former will include a review of literature published from January 1, 2000, to October 1, 2021. This will elicit key themes to inform an online scoping questionnaire posed to a group of experts from academia, clinical medicine, industry, and public health. Thematic analysis of free-text responses by two independent authors will elicit items to be used during consensus generation. Patient and Public Involvement and Engagement groups will be convened to ensure that a comprehensive item list is generated that represents the public’s perspective. Each item will then be anonymously voted on by experts as to its importance and feasibility of implementation in screening during three rounds of a Delphi process. Consensus will be defined a priori at 70%, with items considered important and feasible being eligible for inclusion in the final recommendation. A list of desirable items (ie, important but not currently feasible) will be developed to guide future work. Results The Institutional Review Board at Imperial College London has granted ethical approval for this study (reference 20IC6088). Results are expected to involve a list of recommendations to screening services, with findings being made available to screening services through Public Health England. This study will, thus, provide a formal guideline for the use of mobile messaging in screening services and will provide future directions in this field. Conclusions The use of mobile messaging has grown significantly across health care services, especially given the COVID-19 pandemic, but its implementation in screening programs remains challenging. This modified Delphi approach with leading experts will provide invaluable insights into facilitating the incorporation of messaging into these programs and will create awareness of future developments in this area. International Registered Report Identifier (IRRID) PRR1-10.2196/32660