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.

One Health monitoring reveals invasive freshwater snail species, new records, and undescribed parasite diversity in Zimbabwe.

BACKGROUND: Snail-borne trematodes afflict humans, livestock, and wildlife. Recognizing their zoonotic potential and possible hybridization, a One Health approach is essential for effective control. Given the dearth of knowledge on African trematodes, this study aimed to map snail and trematode diversity, focusing on (i) characterizing gastropod snail species and their trematode parasites, (ii) determining infection rates of snail species as intermediate hosts for medically, veterinary, and ecologically significant trematodes, and (iii) comparing their diversity across endemic regions. METHODS: A cross-sectional study conducted in 2021 in Chiredzi and Wedza districts in Zimbabwe, known for high human schistosomiasis prevalence, involved malacological surveys at 56 sites. Trematode infections in snails were detected through shedding experiments and multiplex rapid diagnostic polymerase chain reactions (RD-PCRs). Morphological and molecular analyses were employed to identify snail and trematode species. RESULTS: Among 3209 collected snail specimens, 11 species were identified, including schistosome and fasciolid competent snail species. We report for the first time the invasive exotic snail Tarebia granifera in Zimbabwe, which was highly abundant, mainly in Chiredzi, occurring at 29 out of 35 sites. Shedding experiments on 1303 snails revealed a 2.24% infection rate, with 15 trematode species identified through molecular genotyping. Five species were exclusive to Chiredzi: Bolbophorus sp., Schistosoma mansoni, Schistosoma mattheei, Calicophoron sp., and Uvulifer sp. Eight were exclusive to Wedza, including Trichobilharzia sp., Stephanoprora amurensis, Spirorchid sp., and Echinostoma sp. as well as an unidentified species of the Plagiorchioidea superfamily. One species, Tylodelphys mashonensis, was common to both regions. The RD-PCR screening of 976 non-shedding snails indicated a 35.7% trematode infection rate, including the presence of schistosomes (1.1%) Fasciola nyanzae (0.6%). In Chiredzi, Radix natalensis had the highest trematode infection prevalence (33.3%), while in Wedza, R. natalensis (55.4%) and Bulinus tropicus (53.2%) had the highest infection prevalence. CONCLUSIONS: Our xenomonitoring approach unveiled 15 trematode species, including nine new records in Zimbabwe. Schistosoma mansoni persists in the study region despite six mass deworming rounds. The high snail and parasite diversity, including the presence of exotic snail species that can impact endemic species and biomedically important trematodes, underscores the need for increased monitoring.

Health system lessons from the global fund-supported procurement and supply chain investments in Zimbabwe: a mixed methods study.

BACKGROUND: The Global Fund partnered with the Zimbabwean government to provide end-to-end support to strengthen the procurement and supply chain within the health system. This was accomplished through a series of strategic investments that included infrastructure and fleet improvement, training of personnel, modern equipment acquisition and warehouse optimisation. This assessment sought to determine the effects of the project on the health system. METHODS: This study employed a mixed methods design combining quantitative and qualitative research methods. The quantitative part entailed a descriptive analysis of procurement and supply chain data from the Zimbabwe healthcare system covering 2018 - 2021. The qualitative part comprised key informant interviews using a structured interview guide. Informants included health system stakeholders privy to the Global Fund-supported initiatives in Zimbabwe. The data collected through the interviews were transcribed in full and subjected to thematic content analysis. RESULTS: Approximately 90% of public health facilities were covered by the procurement and distribution system. Timeliness of order fulfillment (within 90 days) at the facility level improved from an average of 42% to over 90% within the 4-year implementation period. Stockout rates for HIV drugs and test kits declined by 14% and 49% respectively. Population coverage for HIV treatment for both adults and children remained consistently high despite the increasing prevalence of people living with HIV. The value of expired commodities was reduced by 93% over the 4-year period. Majority of the system stakeholders interviewed agreed that support from Global Fund was instrumental in improving the country's procurement and supply chain capacity. Key areas include improved infrastructure and equipment, data and information systems, health workforce and financing. Many of the participants also cited the Global Fund-supported warehouse optimization as critical to improving inventory management practices. CONCLUSION: It is imperative for governments and donors keen to strengthen health systems to pay close attention to the procurement and distribution of medicines and health commodities. There is need to collaborate through joint planning and implementation to optimize the available resources. Organizational autonomy and sharing of best practices in management while strengthening accountability systems are fundamentally important in the efforts to build institutional capacity.

Development and validation of a job aid: Tool to reduce infections in home-based stroke.

BACKGROUND:  Stroke patients who are discharged from hospital because of limited access to rehabilitation facilities are cared for by lay caregivers who at times have limited knowledge of infection prevention and control (IPC). User-friendly educational interventions can help bridge this knowledge gap and enhance safe care of these persons. AIM:  To describe the development and validation of educational interventions for home-based stroke patients. The validation process enhanced the reliability and validity of the job aid resulting in standardised quality patient care of stroke patients. SETTING:  Mutasa district, Manicaland province, Zimbabwe. METHODS:  The systematic six steps in quality intervention development guided the development of the job aid. Graphic designers assisted with development of diagrams and annotations. A purposively selected eight-member panel of IPC expert reviewers was invited to validate the job aid using a standardised validation tool. RESULTS:  The panel agreed that the job aid's title, target group and media of instruction were adequately explained, and the background could be easily understood during practice. The content was approved with some modifications on the description of instructions to caregivers. Seven reviewers agreed that the materials used ensured understandability, acceptability, practicability and usability of the educational interventions by caregivers, and one reviewer was neutral in commenting effectiveness of the job aid. CONCLUSION:  The developed job aid addressed knowledge barriers in IPC for caregivers, and the reviewers confirmed that the developed job aid was adequate for effective use by lay home-based caregivers.Contribution: Utilisation of this intervention standardises patient care practices.

Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation Test (GIFT).

INTRODUCTION: A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1ß has been developed as a point-of-care test-called the Genital InFlammation Test (GIFT)-for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care. METHODS AND ANALYSIS: We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical ('diagnostic study') and a qualitative, modelling and economic ('an integration into care study') part. The diagnostic study aims to evaluate GIFT's performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms. ETHICS AND DISSEMINATION: Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d'Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484). TRIAL REGISTRATION NUMBER: NCT05723484.

Diagnostic Performance of STANDARD™ M10 Multidrug-resistant Tuberculosis Assay for Detection of Mycobacterium tuberculosis and Rifampicin and Isoniazid Resistance in Zimbabwe.

BACKGROUND: Although Zimbabwe has transitioned out of the 30 high-burden countries, it still remained in the 30 high multidrug-resistant (MDR)/rifampicin-resistant tuberculosis (TB) burden. Rapid detection of rifampicin (RIF) and isoniazid (INH) is essential for the diagnosis of MDR-TB. The World Health Organization has recommended the use of molecular WHO-recommended rapid diagnostic (mWRD) for TB and DR-TB. STANDARD™ M10 MDR-TB assay is a new molecular rapid diagnostic assay developed by SD Biosensor for the detection of Mycobacterium tuberculosis (MTB) and RIF and INF resistance. This study aims to determine the diagnostic accuracy of STANDARD™ M10 MDR-TB assay. METHODS: The study was conducted on 214 samples with different MTB and RIF and INH resistance status. The STANDARD™ M10 MDR-TB assay was performed according to the manufacturer's instructions. Xpert MTB/RIF Ultra, MGIT culture, and phenotypic drug susceptibility testing are used as comparative methods. RESULTS: The sensitivity and specificity of STANDARD™ M10 MDR-TB assay for the detection of MTB are 99% and 97.9%, respectively. The sensitivity and specificity of the assay for detection of MDR-TB were 97.8% and 100%, respectively. CONCLUSION: The STANDARD™ M10 MDR-TB assay demonstrated high diagnostic accuracy in the detection of MTB and RIF and INH resistance. This molecular assay can also be used as an alternative to other mWRD assays.

Self-regulated learning of anatomy during the COVID-19 lockdown period in a low-income setting.

In March 2020, universities in Zimbabwe temporarily closed and switched to remote learning to contain the spread of SARS Cov2 infections. The sudden change to distance learning gave autonomy to students to direct their own learning. To understand how the students at the University of Zimbabwe and Midlands State University adapted to emergency remote learning, focus group discussions and a self-administered questionnaire survey based on the self-regulated learning inventory were conducted to capture cognitive, motivational, and emotional aspects of anatomy learning during the COVID-19 pandemic. Thematic analysis was used to identify patterns among these students' lived experiences. Two coders analyzed the data independently and discussed the codes to reach a consensus. The results showed that students at the two medical schools cognitively and meta-cognitively planned, executed and evaluated self-regulated strategies in different ways that suited their environments during the COVID-19 lockdown. Several factors, such as demographic location, home setting/situation, socioeconomic background and expertise in using online platforms, affected the students' self-directed learning. Students generally adapted well to the constraints brought about by the lockdown on their anatomy learning in order to learn effectively. This study was able to highlight important self-regulated learning strategies that were implemented during COVID-19 by anatomy learners, especially those in low-income settings, and these strategies equip teachers and learners alike in preparation for similar future situations that may result in forced remote learning of anatomy.

Antenatal care coverage and early childhood mortality in Zimbabwe: new interpretations from nationally representative household surveys.

Zimbabwe has implemented universal antenatal care (ANC) policies since 1980 that have significantly contributed to improvements in ANC access and early childhood mortality rates. However, Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS), two of Zimbabwe's main sources of health data and evidence, often provide seemingly different estimates of ANC coverage and under-five mortality rates. This creates confusion that can result in disparate policies and practices, with potential negative impacts on mother and child health in Zimbabwe. We conducted a comparability analysis of multiple DHS and MICS datasets to enhance the understanding of point estimates, temporal changes, rural-urban differences and reliability of estimates of ANC coverage and neonatal, infant and under-five mortality rates (NMR, IMR and U5MR, separately) from 2009 to 2019 in Zimbabwe. Our two samples z-tests revealed that both DHS and MICS indicated significant increases in ANC coverage and declines in IMR and U5MR but only from 2009 to 2015. NMR neither increased nor declined from 2009 to 2019. Rural-urban differences were significant for ANC coverage (2009-15 only) but not for NMR, IMR and U5MR. We found that there is a need for more precise DHS and MICS estimates of urban ANC coverage and all estimates of NMR, IMR and U5MR, and that shorter recall periods provide more reliable estimates of ANC coverage in Zimbabwe. Our findings represent new interpretations and clearer insights into progress and gaps around ANC coverage and under-five mortality rates that can inform the development, implementation, monitoring and evaluation of policy and practice responses and further research in Zimbabwe.

"Endless opportunities": A qualitative exploration of facilitators and barriers to scale-up of two-way texting follow-up after voluntary medical male circumcision in Zimbabwe.

In Zimbabwe, the ZAZIC consortium employs two-way, text-based (2wT) follow-up to strengthen post-operative care for voluntary medical male circumcision (VMMC). 2wT scaled nationally with evidence of client support and strengthened follow-up. However, 2wT uptake among healthcare providers remains suboptimal. Understanding the gap between mobile health (mHealth) potential for innovation expansion and scale-up realization is critical for 2wT and other mHealth innovations. Therefore, we conducted an exploratory qualitative study with the objective of identifying 2wT program strengths, challenges, and suggestions for scale up as part of routine VMMC services. A total of 16 in-depth interviews (IDIs) with diverse 2wT stakeholders were conducted, including nurses, monitoring & evaluation teams, and technology partners-a combination of perspectives that provide new insights. We used both inductive and deductive coding for thematic analysis. Among 2wT drivers of expansion success, interviewees noted: 2wT care benefits for clients; effective hands-on 2wT training; ease of app use for providers; 2wT saved time and money; and 2wT strengthened client/provider interaction. For 2wT scale-up challenges, staff shortages; network infrastructure constraints; client costs; duplication of paper and electronic reporting; and complexity of digital tools integration. To improve 2wT robustness, respondents suggested: more staff training to offset turnover; making 2wT free for clients; using 2wT to replace paper VMMC reporting; integrating with routine VMMC reporting systems; and expanding 2wT to other health areas. High stakeholder participation in app design, implementation strengthening, and evaluation were appreciated. Several 2wT improvements stemmed from this study, including enrollment of multiple people on one number to account for phone sharing; 2wT inclusion of minors ages 15+; clients provided with $1 to offset SMS costs; and reduced SMS messages to clients. Continued 2wT mentoring for staff, harmonization of 2wT with Ministry e-health data systems, and increased awareness of 2wT's client and provider benefits will help ensure successful 2wT scale-up.

"I am still human and worth a life:" a qualitative study of the impacts of a community based, peer-led, treatment support model for young adults living with HIV in Zimbabwe.

Background: A persistent treatment gap remains between children and adults living with HIV. The Zvandiri program, developed by Africaid, is one of the few models of differentiated service delivery for children, adolescents, and youth that has been shown to improve outcomes along the HIV care continuum, employing Community Adolescent Treatment Supporters (CATS) to offer peer counseling and patient navigation. Our qualitative study provides an in-depth analysis of the feelings and experiences Zimbabwean youth had following an HIV diagnosis, and the ways that CATS facilitated linkage and retention in care. Methods: We conducted in-depth interviews in Shona with adolescents and young adults who were recently diagnosed with HIV in Zimbabwe. Interviews were audio-recorded, transcribed, and then translated to English. Interviews were coded in Dedoose using a structured a priori codebook. We wrote semi-structured summary memos for each interview. We co-conducted thematic analysis, guided by interpretive phenomenology with a team of Zimbabwean and American experienced qualitative researchers and community partners. We co-developed memos to elaborate and understand key themes across interviews. Results: Most of our interview participants recounted an immediate sense of loss upon testing HIV positive and a fear that "there was no hope for the future." CATS played a pivotal role for youth, providing emotional, educational, and logistical support to facilitate treatment initiation, adherence, and persistence in care. The CATS program supported youth through multiple approaches: group sessions, individual meetings, and via text or phone. While CATS offered counseling and comfort to participants, they emphasized the long-term importance of identifying at least one other person in participants' lives who could know their status and support them around HIV. Conclusion: Our findings delineate some of the key concerns that face youth after receiving an HIV diagnosis and the ways that a community-based adherence peer navigation program supported participants to navigate both their feelings and the health care system. Results can inform practice at community-based agencies that are implementing or considering peer youth navigation programs and garner support for policy to fund interventions for youth.

The lived experiences of HIV-positive women in rural Zimbabwe: A qualitative focus group study.

BACKGROUND:  The study explored and described the meaning attached to the lived experiences of women living with human immunodeficiency virus (HIV) in the rural context of Zimbabwe. Stigma and discrimination negatively impact one's ability to perform the expected social roles, the quality of life, and the efforts to prevent the spread of HIV and acquired immunodeficiency syndrome (AIDS) and reduce HIV-related mortality. Thus, the study aims to understand the meaning attached to the lived experiences of HIV-positive women living in rural areas or villages of Matabeleland South province in Zimbabwe. METHODS:  The study used a qualitative, descriptive, and exploratory design. Four focus group discussions were conducted with 24 HIV-positive rural women living in Matabeleland South province, Zimbabwe. An Interpretative Phenomenological Analysis (IPA) was adopted to explore and describe the meaning attached to the lived experiences of women living with HIV. RESULTS:  Two interconnected themes were identified in the analysis with their sub-themes. These were: (1) struggle for social belonging, with subthemes - loss of social belonging and reduced access to community-based empowerment opportunities and (2) struggle for maintaining the quality of life with subthemes - lack of need-based community healthcare and food insecurity. CONCLUSION:  Being a woman living with HIV in rural Zimbabwe means a perpetual struggle to maintain one's humanness and quality of life.Contribution: This study's results will support the efforts of the Zimbabwean government to improve the quality of life of HIV-positive women living in rural areas.

Social and structural drivers of HIV vulnerability among a respondent-driven sample of feminine and non-feminine presenting transgender women who have sex with men in Zimbabwe.

INTRODUCTION: We sought to characterize social and structural drivers of HIV vulnerability for transgender women (TGW) in Zimbabwe, where TGW are not legally recognized, and explore differences in vulnerability by feminine presentation. METHODS: A secondary analysis was conducted with a sub-sample of participants recruited from a 2019 respondent-driven sampling survey that comprised men who have sex with men, TGW and genderqueer individuals assigned male sex at birth, from two cities in Zimbabwe. Survey questionnaires captured information related to socio-demographics, sexual and substance use behaviours, and social and structural barriers to HIV services. Secondary analyses were restricted to participants who identified as female, transfemale or transwomen (236/1538) and were unweighted. Descriptive statistics were used to calculate sample estimates and chi-square and Fisher's exact tests were used to assess differences in vulnerability by feminine presentation. RESULTS: Among 236 TGW, almost half (45.3%) presented as feminine in the 6 months preceding the survey and 8.5% had ever used hormones to affirm their gender identities. Median age among TGW was 23 years (interquartile range: 20-26). Feminine presenting TGW in our sample had higher prevalence of arrest (15.9% vs. 3.9%), rejection by family/friends (38.3% vs. 14.0%), employment termination (11.2% vs. 3.9%), employment refusal (14.0% vs. 3.9%), denial of healthcare (16.8% vs. 2.3%), physical, sexual or verbal harassment or abuse (59.8% vs. 34.1%), alcohol dependence (32.7% vs. 12.4%), recent transactional sex with a male or TGW partner (30.8% vs. 13.3%) and recent non-injection drug use (38.3% vs. 20.2%) than non-feminine presenting TGW (all p-value <0.05). CONCLUSIONS: Findings suggest that TGW, particularly feminine presenting TGW, experience social and structural inequities which may contribute to HIV vulnerability. Interventions aimed at addressing inequities, including trans competency training for providers and gender-affirming, psychosocial and legal support services for TGW, might mitigate risk.

Malnutrition enteropathy in Zambian and Zimbabwean children with severe acute malnutrition: A multi-arm randomized phase II trial.

Malnutrition underlies almost half of all child deaths globally. Severe Acute Malnutrition (SAM) carries unacceptable mortality, particularly if accompanied by infection or medical complications, including enteropathy. We evaluated four interventions for malnutrition enteropathy in a multi-centre phase II multi-arm trial in Zambia and Zimbabwe and completed in 2021. The purpose of this trial was to identify therapies which could be taken forward into phase III trials. Children of either sex were eligible for inclusion if aged 6-59 months and hospitalised with SAM (using WHO definitions: WLZ <-3, and/or MUAC <11.5 cm, and/or bilateral pedal oedema), with written, informed consent from the primary caregiver. We randomised 125 children hospitalised with complicated SAM to 14 days treatment with (i) bovine colostrum (n = 25), (ii) N-acetyl glucosamine (n = 24), (iii) subcutaneous teduglutide (n = 26), (iv) budesonide (n = 25) or (v) standard care only (n = 25). The primary endpoint was a composite of faecal biomarkers (myeloperoxidase, neopterin, α1-antitrypsin). Laboratory assessments, but not treatments, were blinded. Per-protocol analysis used ANCOVA, adjusted for baseline biomarker value, sex, oedema, HIV status, diarrhoea, weight-for-length Z-score, and study site, with pre-specified significance of P < 0.10. Of 143 children screened, 125 were randomised. Teduglutide reduced the primary endpoint of biomarkers of mucosal damage (effect size -0.89 (90% CI: -1.69,-0.10) P = 0.07), while colostrum (-0.58 (-1.4, 0.23) P = 0.24), N-acetyl glucosamine (-0.20 (-1.01, 0.60) P = 0.67), and budesonide (-0.50 (-1.33, 0.33) P = 0.32) had no significant effect. All interventions proved safe. This work suggests that treatment of enteropathy may be beneficial in children with complicated malnutrition. The trial was registered at ClinicalTrials.gov with the identifier NCT03716115.

Blood donation projections using hierarchical time series forecasting: the case of Zimbabwe's national blood bank.

BACKGROUND: The discrepancy between blood supply and demand requires accurate forecasts of the blood supply at any blood bank. Accurate blood donation forecasting gives blood managers empirical evidence in blood inventory management. The study aims to model and predict blood donations in Zimbabwe using hierarchical time series. The modelling technique allows one to identify, say, a declining donor category, and in that way, the method offers feasible and targeted solutions for blood managers to work on. METHODS: The monthly blood donation data covering the period 2007 to 2018, collected from the National Blood Service Zimbabwe (NBSZ) was used. The data was disaggregated by gender and blood groups types within each gender category. The model validation involved utilising actual blood donation data from 2019 and 2020. The model's performance was evaluated through the Mean Absolute Percentage Error (MAPE), uncovering expected and notable discrepancies during the Covid-19 pandemic period only. RESULTS: Blood group O had the highest monthly yield mean of 1507.85 and 1230.03 blood units for male and female donors, respectively. The top-down forecasting proportions (TDFP) under ARIMA, with a MAPE value of 11.30, was selected as the best approach and the model was then used to forecast future blood donations. The blood donation predictions for 2019 had a MAPE value of 14.80, suggesting alignment with previous years' donations. However, starting in April 2020, the Covid-19 pandemic disrupted blood collection, leading to a significant decrease in blood donation and hence a decrease in model accuracy. CONCLUSIONS: The gradual decrease in future blood donations exhibited by the predictions calls for blood authorities in Zimbabwe to develop interventions that encourage blood donor retention and regular donations. The impact of the Covid-19 pandemic distorted the blood donation patterns such that the developed model did not capture the significant drop in blood donations during the pandemic period. Other shocks such as, a surge in global pandemics and other disasters, will inevitably affect the blood donation system. Thus, forecasting future blood collections with a high degree of accuracy requires robust mathematical models which factor in, the impact of various shocks to the system, on short notice.

Interventions for Type 2 Diabetes reduction among older people living with HIV in Harare.

BACKGROUND: Interventions for Type 2 Diabetes reduction among older people aged more than 50 years living with HIV (PLWH) are pertinent as they face excess risks amid a growing population of ageing PLWH. AIM: To describe interventions for Type 2 Diabetes reduction among older people living with HIV in Harare Urban DistrictSetting: The study was conducted in a low socio-economic setting from five primary health care clinics in Harare urban District. METHODS: A qualitative multi-method approach was applied using an exploratory descriptive design and an integrative review literature. The exploratory descriptive study collected data from two purposively selected samples; (1) older PLWH and (2) nurses. Whittemore and Knafl's framework was used for the integrative literature review with articles from 2013 to 2023 selected. Data source triangulation was applied using Braun and Clark's content analysis framework. Ethical approval was obtained (14056739_CREC_CHS_2022). RESULTS: 23 older PLWH with mean age, 62 years, 9 nurses with an average of 6 years' experience and 12 articles comprised the three data sources.  Key themes that emerged were that, screening should include; assessment from a younger age; assessment of HIV and ART-specific risks; diagnostic testing of Type 2 diabetes tests at ART initiation and routinely. Health education should provide information on adequate physical activity parameters and increased consumption of fruits and vegetables. Metformin may be considered as a pharmacological intervention where lifestyle interventions fail. CONCLUSION: The proposed interventions suggest measures to reduce Type 2 Diabetes and mitigate excess risks faced by older PLWH.Contribution: Improved screening, health education and pharmacological interventions for older PLWH in primary health care settings enable Type 2 Diabetes reduction.

A situational and stakeholder analysis of health technology assessment in Zimbabwe.

OBJECTIVES: Systematic priority setting is necessary for achieving high-quality healthcare using limited resources in low- and middle-income countries. Health technology assessment (HTA) is a tool that can be used for systematic priority setting. The objective of this study was to conduct a stakeholder and situational analysis of HTA in Zimbabwe. METHODS: We identified and analyzed stakeholders using the International Decision Support Initiative checklist. The identified stakeholders were invited to an HTA workshop convened at the University of Zimbabwe. We used an existing HTA situational analysis questionnaire to ask for participants' views on the need, demand, and supply of HTA. A follow-up survey was done among representatives of stakeholder organizations that failed to attend the workshop. We reviewed two health policy documents relevant to the HTA. Qualitative data from the survey and document review were analyzed using thematic analysis. RESULTS: Forty-eight organizations were identified as stakeholders for HTA in Zimbabwe. A total of 41 respondents from these stakeholder organizations participated in the survey. Respondents highlighted that the HTA was needed for transparent decision making. The demand for HTA-related evidence was high except for the health economic and ethics dimensions, perhaps reflecting a lack of awareness. Ministry of Health was listed as a major supplier of HTA data. CONCLUSIONS: There is no formal HTA agency in the Zimbabwe healthcare system. Various institutions make decisions on prioritization, procurement, and coverage of health services. The activities undertaken by these organizations provide context for the institutionalization of HTA in Zimbabwe.

High uptake of menstrual health information, products and analgesics within an integrated sexual reproductive health service for young people in Zimbabwe.

BACKGROUND: Despite being integral to women's well-being, achieving good menstrual health (MH) remains a challenge. This study examined MH services uptake (including information, analgesics, and a choice of MH products - the menstrual cup and reusable pads) and sustained use of MH products within an integrated sexual and reproductive health intervention for young people in Zimbabwe. METHODS: This mixed-methods study was nested within a cluster randomised trial of integrated sexual and reproductive health services (CHIEDZA) for youth in three provinces (Harare, Mashonaland East, and Bulawayo). The study collected qualitative and quantitative data from 27,725 female clients aged 16-24 years, who accessed CHIEDZA from April 2019 - March 2022. Using a biometric (fingerprint recognition) identification system, known as SIMPRINTS, uptake of MH information, products, and analgesics and other services was tracked for each client. Descriptive statistics and logistic regression were used to investigate MH service uptake and product choice and use over time, and the factors associated with these outcomes. Thematic analysis of focus group discussions and interviews were used to further explore providers' and participants' experiences of the MH service and CHIEDZA intervention. RESULTS: Overall, 36,991 clients accessed CHIEDZA of whom 27,725 (75%) were female. Almost all (n = 26,448; 95.4%) took up the MH service at least once: 25433 took up an MH product with the majority (23,346; 92.8%) choosing reusable pads. The uptake of cups varied across province with Bulawayo province having the highest uptake (13.4%). Clients aged 20-24 years old were more likely to choose cups than reusable pads compared with those aged 16-19 years (9.4% vs 6.0%; p < 0.001). Over the implementation period, 300/1819 (16.5%) of clients swapped from the menstrual cup to reusable pads and 83/23346 (0.4%) swapped from reusable pads to the menstrual cup. Provision of the MH service encouraged uptake of other important SRH services. Qualitative findings highlighted the provision of free integrated SRH and MH services that included a choice of MH products and analgesics in a youth-friendly environment were key to high uptake and overall female engagement with SRH services. CONCLUSIONS: High uptake demonstrates how the MH service provided much needed access to MH products and information. Integration of MH within an SRH intervention proved central to young women accessing other SRH services.

Factors affecting hand hygiene practice during the COVID-19 pandemic in the Zimbabwean population: a qualitative study.

BACKGROUND: Practicing hand hygiene is recommended as one of the key preventive measures for reducing the transmission of COVID-19 and other infectious agents. However, it is often not practiced frequently enough or correctly by the public. We aimed to identify barriers to and facilitators of hand hygiene in the Zimbabwean population during the COVID-19 pandemic. METHODS: A qualitative study was conducted with a purposive sample of health workers, village health workers, church leaders, traditional healers, teachers, youth leaders and the general population selected from ten districts across the country from September to October 2022. Semistructured interviews were conducted with 3 key informant interviews per site. In addition, one homogenous focus group discussion was also conducted per site using a focus group discussion guide. The data were recorded on audiotapes, transcribed verbatim, and translated into English. All the analyses were performed manually using thematic analysis. RESULTS: Two themes were identified as facilitators of hand hygiene. These include individual factors (knowledge of hand hygiene practices and how they are performed) and access-related factors (access to hand washing infrastructure, soap, and sanitizers). Among the barriers to hand hygiene, four themes were identified: individual factors (knowledge gaps in proper hand washing, lack of conviction about hand hygiene, and habitual behaviour), access-related factors (lack of access to hand washing infrastructure, soap, and sanitizers), safety concerns (concern about the side effects of sanitizers), and sociocultural and religious factors (social customs, cultural beliefs, values, and religious practices). CONCLUSION: During public health emergencies, there is a need for people to access uninterrupted, on-premises water supplies to promote compliance with hand hygiene. The provision of clean water and hand washing facilities is critical for vulnerable communities to afford them the opportunity to improve quality of life and facilitate resilience in the event of future pandemics. Community engagement is important for identifying vulnerability factors to provide appropriate mitigatory measures.