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Background: In the global strategy to eliminate leprosy, there remains a need for early case detection to successfully interrupt transmissions. Poor knowledge about leprosy and leprosy-related stigma are key drivers of delayed diagnosis and treatment. Sensitization campaigns to inform and increase awareness among the general population are an integral part of many national neglected tropical disease programs. Despite their importance, the effectiveness of such campaigns has not been rigorously studied in the West African context. A multilingual rural setting with low health literacy in this region presents challenges to the potential impact of sensitization campaigns., Objective: The primary objective of this study is to assess the causal effect of common practice community sensitization campaigns on leprosy-related knowledge and stigma at the community level and among community health volunteers. Additionally, we will test the potential of novel educational audio tools in the 15 most prominent local languages to overcome literacy and language barriers and amplify sensitization campaigns., Methods: We will conduct a cluster randomized controlled trial using a sequential mixed methods approach in 60 rural communities across all regions of Togo, West Africa. The study features 2 intervention arms and 1 control arm, with intervention and control assignments made at the community level through randomization. Communities in intervention arm 1 will receive a sensitization campaign in line with the current Togolese national neglected tropical disease program. Communities in intervention arm 2 will receive the same sensitization campaign along with educational audio tools distributed to community households. The control arm will receive no intervention before data collection. Quantitative outcome measures on knowledge and stigma will be collected from a random sample of 1200 individuals. Knowledge will be assessed using the 9-item standardized Knowledge, Attitudes, and Practices Questionnaire. Stigma will be measured using the 7-item Social Distance Scale and the 15-item Explanatory Model Interview Catalogue Community Stigma Scale. We will estimate intention-to-treat effects at the individual level, comparing the outcomes of the intervention and control arms. In an accompanying qualitative component, we will conduct in-depth interviews with community members, community health volunteers, and health care workers in both treatment arms and the control arm to explore intervention and stigma-related experiences., Results: This paper describes and discusses the protocol for a mixed methods cluster randomized controlled trial. Data collection is planned to be completed in June 2024, with ongoing data analysis. The first results are expected to be submitted for publication by the end of 2024., Conclusions: This trial will be among the first to test the causal effectiveness of community-based sensitization campaigns and audio tools to increase knowledge and reduce leprosy-related stigma. As such, the results will inform health policy makers, decision-makers, and public health practitioners designing sensitization campaigns in rural multilingual settings., Trial Registration: German Clinical Trials Register DRKS00029355; https://drks.de/search/en/trial/DRKS00029355., International Registered Report Identifier (irrid): DERR1-10.2196/52106., (©Dominik Jockers, Akila Wimima Bakoubayi, Kate Bärnighausen, P'tanam P'kontème Bando, Stefanie Pechar, Teresia Wamuyu Maina, Jonas Wachinger, Mark Vetter, Yawovi Djakpa, Bayaki Saka, Piham Gnossike, Nora Maike Schröder, Shuyan Liu, Denis Agbenyigan Yawovi Gadah, Christa Kasang, Till Bärnighausen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.04.2024.)

Background: Uncontrolled hypertension is a leading risk factor for cardiovascular diseases. In Uganda, such diseases account for approximately 10% of all deaths, with 1 in 5 adults having hypertension (>90% of the hypertensive cases are uncontrolled). Although basic health care in the country is available free of cost at government facilities, regularly accessing medication to control hypertension is difficult because supply chain challenges impede availability. Clients therefore frequently suspend treatment or buy medication individually at private facilities or pharmacies (incurring significant costs). In recent years, mobile health (mHealth) interventions have shown increasing potential in addressing health system challenges in sub-Saharan Africa, but the acceptability, feasibility, and uptake conditions of mobile money approaches to chronic disease management remain understudied., Objective: This study aims to design and pilot-test a mobile money-based intervention to increase the availability of antihypertensive medication and lower clients' out-of-pocket payments. We will build on existing local approaches and assess the acceptability, feasibility, and uptake of the designed intervention. Furthermore, rather than entering the study setting with a ready-made intervention, this research will place emphasis on gathering applied ethnographic insights early, which can then inform the parameters of the intervention prototype and concurrent trial., Methods: We will conduct a mixed methods study following a human-centered design approach. We will begin by conducting extensive qualitative research with a range of stakeholders (clients; health care providers; religious, cultural, and community leaders; academics; and policy makers at district and national levels) on their perceptions of hypertension management, money-saving systems, and mobile money in the context of health care. Our results will inform the design, iterative adaptation, and implementation of an mHealth-facilitated pooled financing intervention prototype. At study conclusion, the finalized prototype will be evaluated quantitatively via a randomized controlled trial., Results: As of August 2023, qualitative data collection, which started in November 2022, is ongoing, with data analysis of the first qualitative interviews underway to inform platform and implementation design. Recruitment for the quantitative part of this study began in August 2023., Conclusions: Our results aim to inform the ongoing discourse on novel and sustainable pathways to facilitate access to medication for the management of hypertension in resource-constrained settings., Trial Registration: German registry of clinical trials DRKS00030922; https://drks.de/search/en/trial/DRKS00030922., International Registered Report Identifier (irrid): DERR1-10.2196/46614., (©Josephine Schwab, Jonas Wachinger, Richard Munana, Maxencia Nabiryo, Isaac Sekitoleko, Juliette Cazier, Rebecca Ingenhoff, Caterina Favaretti, Vasanthi Subramonia Pillai, Ivan Weswa, John Wafula, Julius Valentin Emmrich, Till Bärnighausen, Felix Knauf, Samuel Knauss, Christine K Nalwadda, Nikkil Sudharsanan, Robert Kalyesubula, Shannon A McMahon. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.11.2023.)