Higher loss of livelihood and impoverishment in households affected by tuberculosis compared to non-tuberculosis affected households in Zimbabwe: A cross-sectional study.

Tuberculosis (TB) disproportionally affects poor people, leading to income and non-income losses. Measures of socioeconomic impact of TB, e.g. impoverishment and patient costs are inadequate to capture non-income losses. We applied impoverishment and a multidimensional measure on TB and non-TB affected households in Zimbabwe. We conducted a cross-sectional study in 270 households: 90 non-TB; 90 drug-susceptible TB (DS-TB), 90 drug-resistant TB (DR-TB) during the COVID-19 pandemic (2020-2021). Household data included ownership of assets, number of household members, income and indicators on five capital assets: financial, human, social, natural and physical. Households with incomes per capita below US$1.90/day were considered impoverished. We used principal component analysis on five capital asset indicators to create a binary outcome variable indicating loss of livelihood. Log-binomial regression was used to determine associations between loss of livelihood and type of household. TB-affected households were more likely to report episodes of TB and household members requiring care than non-TB households. The proportions of impoverished households were 81% (non-TB), 88% (DS-TB) and 94% (DR-TB) by the time of interview. Overall, 56% (152/270) of households sold assets: 44% (40/90) non-TB, 58% (52/90) DS-TB and 67% (60/90) DR-TB. Children's education was affected in 33% (55/168) of TB-affected compared to 14% (12/88) non-TB households. Overall, 133 (50%) households experienced loss of livelihood, with TB-affected households almost twice as likely to experience loss of livelihood; adjusted prevalence ratio (aPR = 1.78 [95%CI:1.09-2.89]). The effect of TB on livelihood was most pronounced in poorest households (aPR = 2.61, [95%CI:1.47-4.61]). TB-affected households experienced greater socioeconomic losses compared to non-TB households. Multisectoral social protection is crucial to mitigate impacts of TB and other shocks, especially targeting poorest households.

Assessing operational readiness: Regulatory landscape and compliance in zimbabwe for medical devices and in vitro diagnostic medical devices.

The regulation of medical devices and In Vitro Diagnostic (IVD) medical devices have lagged significantly, especially in low- and middle-income countries. Disparities in regulating medical and IVD medical devices in Africa are below the global average. This may translate to poor access to quality-assured medical and IVD devices, resulting in undesirable health outcomes. Operational readiness to regulate medical and IVD devices at the Medicines Control Authority of Zimbabwe (MCAZ) was assessed. The aim was to determine the strengths and gaps and propose an action plan that can be monitored and evaluated to assess progress over time. We used the World Health Organization (WHO) Global Benchmarking Tool for medical devices and IVDs methodology to evaluate regulatory oversight of these products. Purposive sampling was used for data collection using researcher-administered global benchmarking tool factsheets and document reviews to evaluate the implementation of the regulatory functions. The regulatory functions assessed were the National Regulatory System, Registration and Market Authorization, Vigilance, Market Surveillance and Control, Licensing Establishment, Regulatory Inspection, Laboratory Testing, and Clinical Trials Oversight. The MCAZ attained maturity level 1, with a regulatory system score of 79%, registration and market authorization 44%, vigilance 27%, market surveillance and control 40%, licensing establishment 62%, regulatory inspection 68%, laboratory testing 88%, and clinical trials 18%. Condoms and gloves were the only regulated medical devices in Zimbabwe. IVDs were not regulated by the MCAZ. This review showed that the regulatory system is not robust, fit for purpose, responsive, transparent, or proportionate to the risk classification of medical devices and IVDs. It is crucial to amend the Medicines and Allied Substance Control Act to incorporate the definition and classification of medical devices and IVDs, regulatory authority establishment, licensing and registration, quality management system, conformity assessment, post-market surveillance, labeling and instructions for use, capacity building and training, and international harmonization.

Navigating regulatory landscape: A qualitative exploration of medical devices and in vitro diagnostic medical devices oversight in Zimbabwe through key stakeholder perspectives.

Medical devices and In Vitro Diagnostics (IVDs) are vital for public health and accessible healthcare. Still, there is an imbalance in high-quality products in Low and Middle-Income Countries (LMICs). Zimbabwe's regulatory framework for medical devices and IVDs is unclear, leading to ineffective compliance and surveillance. As a result, there are knowledge gaps regarding pre-market and post-market regulatory elements to ensure the safety, quality and performance of medical devices and IVDs used in Zimbabwe. Our study aimed to explore the current status of medical devices and IVD regulations in Zimbabwe. Semi-structured interviews were conducted with 12 regulators from the Medicines Control Authority of Zimbabwe (MCAZ) National Microbiology Reference Laboratory (NMRL), Medical Laboratory and Clinical Scientists Council (MLCScCZ) to understand the current status of medical devices and IVD regulations in Zimbabwe. Three participants completed a questionnaire to understand the regulatory landscape in Zimbabwe. Three key informant interviews were conducted with three regulators from the South African Health Products Regulatory Authority (SAHPRA), Tanzanian Medicines and Medical Devices Authority (TMDA), and World Health Organization Regulatory Systems Strengthening (WHO RSS) to learn best practices to create a roadmap for Zimbabwe. We analyzed qualitative data using a thematic analysis. The findings reveal significant deficiencies and gaps in the legal framework for regulating medical devices and IVDs, highlighting the need for a legal framework and the absence of more comprehensive regulations. Regulatory entities face capacity limitations, especially in regulating medical devices and IVDs. Conformity assessment processes, medical devices, IVD classification criteria, and post-market surveillance also represent challenges, highlighting the need for a well-defined framework and regulatory procedures. The Zimbabwean regulatory system pathway is reactive, prompting several regulatory initiatives to address needs. Despite facing challenges, there is recognition of the importance of collaboration among regulatory authorities, emphasizing a shared commitment to improving and strengthening medical devices and IVD regulations for improved patient safety. By advocating for a proactive, comprehensive, and legally sound approach, indicating the potential for collaboration and synergy, this study provides a foundation for well-informed policy recommendations to guide enhancements and build a framework for a resilient, efficient, and transparent regulatory environment in the Zimbabwe and African regions as a whole.

Higher loss of livelihood and impoverishment in households affected by tuberculosis compared to non-tuberculosis affected households in Zimbabwe: a cross-sectional study.

Introduction: Tuberculosis (TB) disproportionally affects poor people, leading to income and non-income losses. Measures of socioeconomic impact of TB, e.g. impoverishment and patient costs are inadequate to capture non-income losses. We applied impoverishment and a multidimensional measure on TB and non-TB affected households in Zimbabwe. Methods: We conducted a cross-sectional study in 270 households: 90 non-TB; 90 drug-susceptible TB (DS-TB), 90 drug-resistant TB (DR-TB) during the COVID-19 pandemic (2020-2021). Household data included ownership of assets, number of household members, income and indicators on five capital assets: financial, human, social, natural and physical. We determined proportions of impoverished households for periods 12 months prior and at the time of the interview. Households with incomes below US$1.90/day were considered to be impoverished. We used principal component analysis on five capital asset indicators to create a binary outcome variable indicating loss of livelihood. Log-binomial regression was used to determine associations between loss of livelihood and type of household. Results: TB-affected households reported higher previous episodes of TB and household members requiring care than non-TB households. Households that were impoverished 12 months prior to the study were: 21 non-TB (23%); 40 DS-TB (45%); 37 DR-TB (41%). The proportions increased to 81%, 88% and 94%, respectively by the time of interview. Overall, 56% (152/270) of households sold assets: 44% (40/90) non-TB, 58% (52/90) DS-TB and 67% (60/90) DR-TB. Children's education was affected in 31% (56/180) of TB-affected compared to 13% (12/90) non-TB households. Overall, 133(50%) households experienced loss of livelihood, with TB-affected households twice as likely to experience loss of livelihood; adjusted prevalence ratio (aPR=2.02 (95%CI:1.35-3.03)). The effect of TB on livelihood was most pronounced in poorest households (aPR=2.64, (95%CI:1.29-5.41)). Conclusions: TB-affected households experienced greater socioeconomic losses compared to non-TB households. Multidimensional measures of TB are crucial to inform multisectoral approaches to mitigate impacts of TB and other shocks.

Coping with drug resistant tuberculosis alongside COVID-19 and other stressors in Zimbabwe: A qualitative study.

Households in low-resource settings are more vulnerable to events which adversely affect their livelihoods, including shocks e.g. death of family members, droughts and more recently COVID-19. Drug Resistant Tuberculosis (DR-TB) is another shock that inflicts physical, psychological and socioeconomic burden on individuals and households. We describe experiences and coping strategies among people affected by DR-TB and their households in Zimbabwe during the COVID-19 pandemic, 2020-2021. We purposively selected 16 adults who had just completed or were completing treatment for DR-TB for in-depth interviews. We transcribed audio-recordings verbatim and translated the transcripts into English. Data were coded both manually and using NVivo 12 (QSR International), and were analysed thematically. Health seeking from providers outside the public sector, extra-pulmonary TB and health system factors resulted in delayed DR-TB diagnosis and treatment and increased financial drain on households. DR-TB reduced productive capacity and narrowed job opportunities leading to income loss that continued even after completion of treatment. Household livelihood was further adversely affected by lockdowns due to COVID-19, outbreaks of bird flu and cattle disease. Stockouts of DR-TB medicines, common during COVID-19, exacerbated loss of productive time and transport costs as medication had to be accessed from other clinics. Reversible coping strategies included: reducing number of meals; relocating in search of caregivers and/or family support; spending savings; negotiating with school authorities to keep children in school. Some households adopted irreversible coping strategies e.g. selling productive assets and withdrawing children from school. DR-TB combined with COVID-19 and other stressors and pushed households into deeper poverty and vulnerability. Multisectoral approaches that combine health systems and socioeconomic interventions are crucial to mitigate diagnostic delays and suffering, and meaningfully support people with DR-TB and their households to compensate the loss of livelihoods during and post DR-TB treatment.

Coping with drug resistant tuberculosis alongside COVID-19 and other stressors in Zimbabwe: a qualitative study.

Background: Households in low-resource settings are more vulnerable to events which adversely affect their livelihoods, including shocks such as the death of a family member, inflation, droughts and more recently COVID-19. Drug Resistant Tuberculosis (DR-TB) is also another shock that inflicts physical, psychological and socioeconomic burden on individuals and households. We describe experiences and coping strategies among people affected by DR-TB and their households in Zimbabwe during the COVID-19 pandemic, 2020 to 2021. Methods: We conducted 16 in-depth interviews with adults who had just completed or were completing treatment. Interview themes included health seeking behaviour, impact of DR-TB on livelihoods and coping strategies adopted during treatment. We analysed data using thematic analyses. Results: Health seeking from providers outside the public sector, extra-pulmonary TB and health system factors resulted in delayed DR-TB diagnosis and treatment and increased financial drain on households. DR-TB reduced productive capacity and narrowed job opportunities leading to income loss that continued even after completion of treatment. Household livelihood was further adversely affected by lockdowns due to COVID-19, outbreaks of bird flu and cattle disease. Stockouts of DR-TB medicines, common during COVID-19, exacerbated loss of productive time and transport costs as medication had to be accessed from other clinics that were further away. Reversible coping strategies included: reducing number of meals; relocating in search of caregivers and/or family support; spending savings; negotiating with school authorities to keep children in school. Some households had to adopt irreversible coping strategies such as selling productive assets and withdrawing children from school. Conclusion: DR-TB combined with COVID-19 and other stressors pushed households into deeper poverty, and vulnerability. Multi-sectoral approaches that combine health systems, psychosocial and economic interventions are crucial to mitigate diagnostic delays and suffering, and meaningfully support people with DR-TB and their households to compensate the loss of livelihoods during and post DR-TB treatment.

Coverage and effectiveness of conditional cash transfer for people with drug resistant tuberculosis in Zimbabwe: A mixed methods study.

The End TB strategy recommends social protection to mitigate socio-economic impacts of tuberculosis. Zimbabwe started implementing a conditional cash transfer (CCT) programme for people on drug resistant tuberculosis (DR-TB) treatment in 2013. We aimed to determine the proportion of people receiving CCT and effectiveness of CCT in improving treatment outcomes, explore their experiences with registering for CCT and understand the impact of CCT from the perspective of beneficiaries. Data from 2014-2021 were extracted from TB registers and CCT payment records within the National TB Programme. Sixteen in-depth interviews were conducted with people who were completing treatment or had completed treatment within two months. Poisson regression, adjusted for province, year of treatment, age and sex was used to investigate associations between receiving CCT and successful treatment outcomes among people who were in DR-TB care for ≥3 months after treatment initiation. Qualitative data were analyzed using thematic analysis. A total of 481 people were included in the quantitative study. Of these, 53% (254/481) received CCT at some point during treatment. People who exited DR-TB care within three months were 73% less likely to receive CCT than those who did not (prevalence ratio (PR) = 0.27 [95%CI: 0.18-0.41]). Among those who were alive and in care three months after treatment initiation, CCT recipients were 32% more likely to have successful outcomes than those who did not (adjusted PR = 1.32, [95%CI: 1.00-1.75]). Qualitative results revealed lack of knowledge about availability of CCT among people with DR-TB and missed opportunities by healthcare providers to provide information about availability of CCT. Delays and inconsistencies in disbursements of CCT were frequent themes. CCT were associated with successful treatment outcomes. Improvements in coverage, timeliness and predictability of disbursements are recommended.