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HIV self-testing (HIVST) is increasingly being sought and offered globally, yet there is limited information about the test features that will be required for an HIV self-test to be easy to use, acceptable to users, and feasible for manufacturers to produce. We conducted formative usability research with participants who were naïve to HIVST using five prototypes in Kenya, Malawi, and South Africa. The tests selected ranged from early-stage prototypes to commercially ready products and had a diverse set of features. A total of 150 lay users were video-recorded conducting unsupervised self-testing and interviewed to understand their opinions of the test. Participants did not receive a test result, but interpreted standardized result panels. This study demonstrated that users will refer to the instructions included with the test, but these can be confusing or difficult to follow. Errors were common, with less than 25 % of participants conducting all steps correctly and 47.3 % of participants performing multiple errors, particularly in sample collection and transfer. Participants also had difficulty interpreting results. To overcome these issues, the ideal HIV self-test requires pictorial instructions that are easy to understand, simple sample collection with integrated test components, fewer steps, and results that are easy to interpret. [ABSTRACT FROM AUTHOR]

Background: Full coverage of childhood vaccines is a persistent challenge in low- and middle-income countries, suggesting the presence of specific contextual barriers. The emergence of the COVID-19 pandemic further worsened the situation. The complementary use of community-based participatory research (CBPR) and human-centered design (HCD) approaches has the potential to effectively create tailored interventions for improving public health outcomes. This protocol provides examples of methods to evaluate the use of these novel approaches in low- and middle-income countries. The 'Let's talk about vaccines' project is a multisite community-based participatory project by VillageReach that uses the CBPR and HCD approaches to identify the barriers and co-create interventions/solutions to address under two routine immunization access and uptake in Malawi and Mozambique., Methods: Guided by the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, this evaluation prospectively evaluates the effectiveness (on under-two immunization coverage and related outcomes) of VillageReach's co-created interventions and processes of implementation (reach, adoption, implementation and maintenance) in two districts in Mozambique and two in Malawi. This paper will also describe the theory of change for VillageReach's project. Thematic analysis will be used to analyze the qualitative data, and interrupted time series analysis used to analyze the co-created interventions' effectiveness on specific under two immunization outcomes. The analysis will integrate complex systems thinking and constructs inherent in health systems strengthening., Discussion: This evaluation is an opportunity to share the use of novel and best practices, opportunities and challenges for improved community-responsive programming in routine immunization. It will be fundamental in providing evidence on the impact of interventions, evidence on mechanisms behind improvements in under- two immunization outcomes due to codesigned community-driven solutions and informing their scalability in similar contexts. Findings will inform the development of a comprehensive framework to guide the scalability of community-based approaches on childhood immunization uptake and access into similar contexts., Competing Interests: The authors declare that they have no competing interests., (Copyright: © 2024 Shuro et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)