Design, development, and testing of a voice-text mobile health application to support Tuberculosis medication adherence in Uganda.

BACKGROUND: Tuberculosis (TB) continues to persist with a high disease burden globally. Non-adherence to treatment remains a major problem to TB control. In Uganda, one in every four TB patients does not adhere to their TB medication. The purpose of this study was to design, develop and assess implementation of a voice-text-based mobile application to support TB patients' adherence to medication. METHODS: Design science research methodology (DSRM) was utilized to develop a voice-text-based mobile health application. Agile software methodology was used to achieve steps of DSRM that are; design and development. Focus group discussions (FGDs) and Key informant interviews (KIIs) were conducted and data analysed using thematic content analysis. RESULTS: During problem identification, Stigma, transport costs, being asymptomatic, drug side effects, lack of family support were identified as challenges affecting adherence. Technologies identified and used for the development of the voice-text application included; extensible mark-up language (XML) File, Apache server, Ubuntu Server, Hypertext Pre-processor, and jQuery. In the pilot study, 27 voice messages were broadcasted, 85.2% were delivered, 103 text messages were sent and 92.2% were delivered to the intended recipients. CONCLUSIONS: Voice-text message mobile health application can be used to reach a wider patient population and it has the capability of addressing some of the challenges affecting TB medication adherence.

Vaccine Licensure in the Absence of Human Efficacy Data.

Clinical vaccine development and regulatory approval generally occurs in a linear, sequential manner: Phase 1: safety, immunogenicity; Phase 2: immunogenicity, safety, dose ranging, and preliminary efficacy; Phase 3: definitive efficacy, safety, lot consistency; and following regulatory approval, Phase 4: post-marketing safety and effectiveness. For candidate filovirus vaccines, where correlates of protection have not been identified, and phase 2 and 3 efficacy of disease prevention trials untenable, large and/or protracted, each trial may span decades, with full licensure expected only after several decades of development. Given the urgent unmet need for new Marburg virus and Ebola Sudan virus vaccines, the Sabin Vaccine Institute hosted a key stakeholder virtual meeting in May 2021 to explore the possibility of licensure by use of an "animal rule-like" licensure process, based on a risk/benefit assessment specific to regional needs and informed by epidemiology. This may be appropriate for diseases where there are no or limited treatment options, and those prone to sporadic outbreaks with high rates of transmission, morbidity, and mortality. The discussion focused on two contexts: licensure within the Ugandan regulatory environment, a high burden country where Ebola vaccine trials are ongoing, and licensure by the United States FDA-a well-resourced regulatory agency.