Clinical Trials

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    Safety of Equine Tetanus Antitoxin for Prophylactic use In Ethiopia: A Retrospective Multicenter Study
    (Addis Ababa University, 2021-04-08) Michele Joseph; Abebaw Fekadu
    Tetanus remains an important public health problem in many parts of the world. It is indicated to cause an estimated 56,000 deaths annually worldwide. Among global tetanus deaths, 44% occur in sub-Saharan Africa, and the highest proportion of these occurs in East Africa. In 2017 WHO reported 20 cases of tetanus in Ethiopia. Although tetanus antitoxin (TAT, equine origin) has been replaced by human tetanus immunoglobulin (TIG), it is still in use in developing countries due to the high costs and limited access to TIG. Adverse reactions of TAT have not been studied in Ethiopians. Thus, conducting a Retrospective safety study on TAT in Ethiopia is important to promote public health and support improvement of the product by providing scientific evidence from the local context. Objective: To evaluate the safety of equine tetanus antitoxin when administered to adults under conditions of routine post-exposure prophylactic use in Ethiopia. Methods: A retrospective multicenter study was conducted in Addis Ababa covering three referral teaching public hospitals, (Tikur Anbessa Specialized Teaching Hospital and Zewditu Memorial Teaching Hospital and) and eight public health centers of with high client load for TAT. Charts of patients (n=1213) treated with equine anti toxin for prophylactic use for their wounds from January 2015 to December 2019, older than 18 years of age were reviewed. Results: We included 1213 medical record forms in the final analysis (994 males and 264 females) and the mean age was 29.33 years (SD = 11.41 years). Only 0.98%(12/264) of the females had history of TT vaccination. Among all the charts reviewed head trauma, trauma at workplace and open wound were most frequently seen and only one patient experienced adverse event following immunization. Conclusion and Recommendation: Even though there were major limitation on the data retrieved, on its clarity and completeness, findings from this retrospective study suggests that use of TAT is safe compared to number of injections and the overall disease reported in the country from January 2015 to December 2019. Large study with wider geographical converge will have significance in testing the validity of the current findings.
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    Five-year Trend Analysis of Tuberculosis Burden in Bahir Dar, Northwest Ethiopia, 2015 - 2019
    (Addis Ababa University, 2021-07) Mengesha, Dagmawi ; W/Amanuel, Yimtubezinash; Manyazewal, Tsegahun
    Background: Tuberculosis (TB) remains a major cause of morbidity and mortality in Ethiopia despite the increased availability of effective treatments. Trend analysis of issues and priorities affecting TB programs across different regions of the country is critical to ensure equitable and sustainable TB outcomes. Objective: The study aimed to determine the trends of TB burden in Bahir Dar, Northwest Ethiopia, for five years from 2015 to 2019. Methods: An institution-based retrospective study was conducted. Five-year data and records of individual cases screened for TB were reviewed from all government- and private-led healthcare facilities that implemented DOTs programs in Bahir Dar (N = 47) from January 1, 2015 to December 30, 2019. Data were collected with a data collection format adopted from the standard checklist of World Health Organization. The checklist contains unique code, age, sex, residence, HIV status, and year of diagnosis of subjects. First we categorized participants data and records based on their age as (<15, 15-24, 2534, 35-44, 45-65 and 65+), Sex (male/female), the type of TB infection (PTB+, PTB- and EPTB) and the years of diagnosis (2015, 2016, 2017, 2018 and 2019). A standard checklist was used to collect data relevant to screening, diagnosis, and treatment of TB. SPSS version 20 software was used for data analysis. Descriptive analysis, frequencies, and figures were used to explain the findings. Bivariate Logistic regression analysis was conducted primarily to check the association of each independent variable with the dependent variable. Multivariate logistic regression models were employed to analyze specific associations between variables. Odds ratio (OR) and 95% confidence interval (CIs) were calculated using logistic regression model to measure the strength of an association. Mean and standard deviation was used to summarize continuous variables. Pvalue <0.05 with corresponding 95% CI were taken significant values Results: A total of 4,275 TB cases record (2015-2019) were reviewed. The detection rate of TB were 2,151 (50.3%) extra pulmonary TB cases, 929 (21.7%) bacteriologically confirmed pulmonary TB cases, and 1,195 (28.0%) clinically confirmed pulmonary TB cases. Female patients account for 55.5% of the total cases. Patients from ages of 15-34 years were the most affected age groups (51.5 %), and ages of 65 years the least affected age group (7.5%). For HIV status, 2, 804/4275 (65.6 %) were HIV co-infected, of whom 46.5% were male and 53.5% were female. From the total TB patients, 33.0% (929/2804) of PTB+, 42.6% (1195/2804) of PTB- and 76.7% (2151/2804) of the EPTB were co-infected with HIV. Among bacteriologically confirmed pulmonary TB cases, 577 (62.1%) were female within the five-year period from 2015 – 2019. The prevalence of all forms of TB were 922 (21.6%), 812 (19.0%), 843 (19.7%), 876 (20.5%), and 822 (19.2%), respectively. The variables sex, HIV co-infection and age<15 (AOR: 1.7, 1.9, 1.4, CI: 1.4 -2.2, 1.6 -2.3, 1.1-1.7), respectively, were factors associated with TB infection. Conclusion:. Even though there was a declining trend of tuberculosis burden within the five-year study period, prevention and control strategies needs to be improved to achieve the stop TB strategies set by the WHO. For this successful achievement, a comprehensive TB diagnosis, care, treatment, and prevention approach is needed to improve TB programs continuously and accelerate the fight to End TB in this setting.
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    Five-year survival status of women diagnosed with cervical cancer and treatment impact at Tikur Anbessa hospital, Addis Ababa, Ethiopia; a retrospective cohort study
    (Addis Ababa University, 2021-06) Mose, Olyad; Medhin, Girmay (MSc., PhD ); Fekadu, Abebaw (MD, MSc, PhD, MRCPsych); Assefa, Mathewos(MD,Consultant Oncologist)
    Background: Worldwide, cancer of the cervix is one of the most common causes of cancer mortality among women, with about 288,000 deaths each year. While it is the second leading cause of cancer mortality among adult women globally, it is the most common cause of mortality in the economically emerging countries including in sub-Saharan Africa. The reason for this high mortality is likely to be the poor access to early detection or screening and treatment services. There is no sufficient Published data on the treatment outcome of cervical cancer in Ethiopia. This study would contribute to the evidence regarding the treatment outcome of cervical cancer. Objectives: To assess the five-year survival among women who attended for treatment of cervical cancer. Methods: A hospital based retrospective cohort study was conducted at the Oncology Department of Tikur Anbessa Specialized Hospital (TASH). Records of patients with a first diagnosis of cervical cancer were selected from a two-year medical records of cervical cancer patients who attended the oncology department of TASH from September 11/2012 to September 11/2014GC.Survival Outcome was evaluated over the subsequent five-year period until 2014GC. Because of the practical challenges of determining actual survival status, continuation in follow up (vs dropout from follow up) was used as a proxy indicator of survival. Descriptive statistics was employed to summarize basic socio-demographic and clinical variables. KaplanMeier and Cox-regression analysis was used to evaluate the potential role of various treatment modalities on survival outcome. Crude and adjusted Hazard ratios with 95% Confidence intervals were presented as measure of association. Statistical tests resulting in a p-value of less than 0.05 were considered statistically significant. Results: Among 1008 cancer patients who were diagnosed and started Treatment at Tikur Anbessa Specialized Hospital Oncology Center during the two-year selection period ,418 had cervical cancer and were included in the current study. At the end of the five-year only 9.9% (40) had survived in follow-up. For the majority, stage at presentation was late. Patients who arrived with later stages (Stage-III) cervical cancer had lower follow-up survival probabilities compared with earlier stage [stage-0, (Carcinoma in situ)] [Adjusted Hazard Ratio=2.17; 95% -CI= 1.40,3.40]. Those who had received combination therapy (Radiotherapy, chemotherapy and surgery) have better survival probability than those who were treated with Radiotherapy and Chemotherapy alone [Adjusted HR= (0.29, 95%CI, 0.84, 2.20), (2.52,95%-CI,1.80,3.40), and (2.02,95%-CI,1.10,3.80)] respectively. Conclusion and recommendation: The clinical factors identified as factors for survival in follow-up (e.g., stage at presentation) appear to justify using survival in follow-up as a proxy measure of survival. However, this is extremely crude proxy. Thus, well planned prospective study of survival is needed. Nevertheless, if the crude assumption is correct, ensuring access to early diagnosis, and treatment is an urgent priority for improving survival of patient with cervical cancer in Ethiopia. There is a need of creating awareness, primary prevention by vaccination, and increasing early detection programs to increase early stages at presentation which gives more opportunity to appropriate treatment. Furthermore, expanding more treatment centers and implementation of advanced Technology like Linear accelerator, rachytherapy and PET-scan needs urgent attention.
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    Efficacy and safety of vaccine trials conducted in Africa: a systematic review and Meta-analysis.
    (Addis Ababa University, 2021) Tesfai, Sara; Hailu, Asrat; Belete, Anteneh
    Background: vaccine preventable diseases have been of global concern. Vaccines are the best way for prevention. Studies are showing that there is disparity in efficacy of vaccines, in industrialized and in low-middle income countries. Additionally, vaccine related diseases aresaid to be occurring in recent decades. Africa produces less than one percent of vaccines and depends on imports. It is important to check how many of these imported vaccines have been subjected to clinical trials, to assess efficacy and safety before they are made available to mass consumption. This study is aimed to evaluate the vaccine trials conducted up to the end of 2020 with no start up period limit to inventory the type of trials undertaken in comparison with the vaccines that are in routine use in African countries and to assess vaccine effectiveness in African settings. Methodology: A systematic review and meta-analysis was carried out to assess the vaccine trials conducted in the 54 African countries. Eighteen WHO approved registries, 2 immunization schedule sites and databases were searched. Data were exported to MS excel and RevMan version 5.4 for analysis. Result: The largest vaccine trial for disease prevention purpose was seen for malaria with 119 (21.2%) whereas the lowest was for tetanus with 1 (0.2%) trial. Out of these vaccines, BCG and OPV are given in all African countries, whereas vaccines for; Hepatitis A Influenza (for both pediatric and adult), MenAC, bOPV, deworming, cholera, DTaP, TdIPV and dtaPHibIP are given only in one country each. From the 26 single disease specific vaccine 17 and from 13 combination vaccines 4 multi-disease vaccines was found to have gone through clinical trial which ranges from the lower 1 ( Tetanus) vaccine trial per disease of interest to the highest of 119 (Malaria) vaccine trials in the single disease specific trials. BCG and OPV given in all African countries (100%) attributed to only 55 (15.5 %) and 2 (0.5%) of the trials, respectively, whereas Malaria vaccine which is given only in 3 (5.5%) of African countries attributed to 119 (33.6%) of the trials. In the malaria vaccine trial review, highest efficacy [30%, 95% CI (0.59, 0.84)] was seen against severe malaria in both children and infants. Whereas, the lowest efficacy [20%, 95% CI (0.75, 0.86)] was found to be in 1st episode of malaria in infants. The highest efficacy [67%, 95% CI (0.16, 0.66)] was seen in HIV positive adults and the lowest efficacy [21%, 95% CI (0.44, 1.42)] was seen in HIV positive infants. The highest efficacy [52%, 95% CI (0.37, 0.61)] of the PCV vaccine was seen against 1st episode of IPD, and the lowest efficacy [13%, 95% CI (0.80, 0.96)] was seen against severe Pneumonia in HIV negative individuals. Conclusion: The overall efficacy of the three types of vaccines that are included in this review was found to be low, and no significant SAEs were found across the vaccines. We found no vaccines terminated for futility. Safety data of these studies were mainly acquired from phase 3 trials not phase 4, we couldn’t assess the safety issues identified from outside of a controlled environment i.e., for a long term effect and the issues seen in general populations.
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    Assessment of Prevalence and Associated Factors of Polypharmacy among Elderly Patients Admitted to Federal Police Referral Hospital, Addis Ababa, Ethiopia
    (Addis Abeba University, 2021-08) Geleta, Melka; Prof.Makonnen, Eyasu; Abay, Solomon M(PhD)
    Background: Polypharmacy is one of the major concerns in the healthcare sector as it has a strong association with increased treatment costs, morbidity and adverse drug reactions (ADR). Elderly patients are prone to these risks for they are exposed to many coexisted chronic and acute illnesses that lead to polypharmacy. In Ethiopia, there is a dearth of studies exploring the prevalence and associated factors of polypharmacy in elderly patients. Objective: To determine the prevalence of polypharmacy and its associated factors among elderly patients admitted to Federal Police Referral Hospital (FPRH) in Addis Ababa, Ethiopia. Methods: A healthcare facility-based, retrospective cross-sectional study was carried out in FPHR, one of the two federal-level military hospitals in Addis Ababa. Medical charts of elderly patients who were admitted to the hospital in the period 01 January 2019 to 01 January 2020 were reviewed for polypharmacy. Using an adapted and structured data extraction tool, data were abstracted on patient characteristics, diseases encountered, co-morbidities, and the type and categories of the drugs administered. Data were analyzed using SPSS software version 25. Logistic regression was used to assess the association and an odds ratio (OR) with a corresponding 95% confidence interval (CI) was used. Results: A total of 376 medical charts were reviewed, of which five or more drugs were prescribed in 180 (47.9%) charts, with a mean of 4.57. This indicated the occurrence of polypharmacy in FPRH. In the logistic regression, cardiovascular disease (AOR = 7.456, 95% CI [2.109 - 26.360], p = 0.002) and endocrine disorders (AOR = 7.331, 95% CI [1.988 - 27.043], p = 0.003) showed a significant association with polypharmacy. Conclusions: Polypharmacy is highly prevalent among elderly patientss admitted to FPRH. Cardiovascular disease, endocrine disorders, and comorbidity with one to three diseases were the major predictors of polypharmacy. We recommend that medication practices for elderly patients need to be improved through training of clinical practitioners, regular review of patients’ medication charts, particularly patients with cardiovascular disease and endocrine disorders, and further ingagement of clinical pharmacists in elderly care and treatment.
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    Treatment Outcome of Drug-resistant Tuberculosis and Associated Factors at St.peter Specialized Hospital Addis Ababa, Ethiopia.
    (Addis Abeba University, 2021-08) Abebe, Mekdelawit; Prof. Hailu, Asrat; Dr. Woldeamanuel, Yimtubezenash
    INTRODUCTION:Drug Resistant Tuberculosis is defined as tuberculosis that does not respond to antituberculosis agent. Data on the outcome of MDR/RR-TB and associated factors is highly needed to evaluate the efficiencies of the MDR/ RR-TB treatment program. However, The treatment outcome of MDR/RR-TB at St. Peter Specialized Hospital is not studied. OBJECTIVE: To assess treatment outcomes of MDR/RR-TB and its associated factors at St. Peter Specialized Hospital, Addis Ababa, Ethiopia from 2015 to 2020. METHODS: A retrospective study was conducted among patients treated for drug-resistant tuberculosis from January 2015 - December 2020 at St. Peter specialized hospital. This study included 335 patients treated for multidrug resistant or rifampicine-resistant tuberculosis. The main outcome variable was overall MDR/RR-TB treatment outcome classified as successful and poor. Data were collected by trained nurses. Data entry and analysis were performed using Excel and SPSS. The relationship between MDR/RR-TB treatment outcome and associated factors was evaluated by fitting logistic regression. The final multivariable logistic regression model was a good fit for the data and had no multicollinearity issue. Statistical significance was considered at p<0.05. RESULTS: Treatment success was achieved in 71.3% of the patients. The adjusted odds of poor treatment outcome were twice higher in those who had a habit of frequent alcohol drinking (AOR=2.07, p=0.039). Likewise, the adjusted odds of poor treatment outcome was more than 2folds higher in patients who had a positive result for HIV test. Concerning mortality, the likelihood of death was found to increase by 5% as age advances by one year (AOR=1.05, p<0.001). In addition, the risk of death was more than 3-fold higher among MDR/RR-TB patients co-infected with HIV (AOR=3.81, p<0.001). CONCLUSION: In this study, the overall treatment success was consistent with studies carried out in different regions of Ethiopia. Again, a higher danger of poor treatment outcome and death was observed among people who drink alcohol, co-infected with HIV/AIDS, and the elderly.Patents with MDR/RR-TB patients, use alcohol and are co-infected with HIV/AIDS should be given greater attention during therapy. More studies should be done to generate data on the factors affecting the treatment of MDR/RR-TB patients to improve the outcome of treatment. INTRODUCTION:Drug Resistant Tuberculosis is defined as tuberculosis that does not respond to antituberculosis agent. Data on the outcome of MDR/RR-TB and associated factors is highly needed to evaluate the efficiencies of the MDR/ RR-TB treatment program. However, The treatment outcome of MDR/RR-TB at St. Peter Specialized Hospital is not studied. OBJECTIVE: To assess treatment outcomes of MDR/RR-TB and its associated factors at St. Peter Specialized Hospital, Addis Ababa, Ethiopia from 2015 to 2020. METHODS: A retrospective study was conducted among patients treated for drug-resistant tuberculosis from January 2015 - December 2020 at St. Peter specialized hospital. This study included 335 patients treated for multidrug resistant or rifampicine-resistant tuberculosis. The main outcome variable was overall MDR/RR-TB treatment outcome classified as successful and poor. Data were collected by trained nurses. Data entry and analysis were performed using Excel and SPSS. The relationship between MDR/RR-TB treatment outcome and associated factors was evaluated by fitting logistic regression. The final multivariable logistic regression model was a good fit for the data and had no multicollinearity issue. Statistical significance was considered at p<0.05. RESULTS: Treatment success was achieved in 71.3% of the patients. The adjusted odds of poor treatment outcome were twice higher in those who had a habit of frequent alcohol drinking (AOR=2.07, p=0.039). Likewise, the adjusted odds of poor treatment outcome was more than 2folds higher in patients who had a positive result for HIV test. Concerning mortality, the likelihood of death was found to increase by 5% as age advances by one year (AOR=1.05, p<0.001). In addition, the risk of death was more than 3-fold higher among MDR/RR-TB patients co-infected with HIV (AOR=3.81, p<0.001). CONCLUSION: In this study, the overall treatment success was consistent with studies carried out in different regions of Ethiopia. Again, a higher danger of poor treatment outcome and death was observed among people who drink alcohol, co-infected with HIV/AIDS, and the elderly.Patents with MDR/RR-TB patients, use alcohol and are co-infected with HIV/AIDS should be given greater attention during therapy. More studies should be done to generate data on the factors affecting the treatment of MDR/RR-TB patients to improve the outcome of treatment.
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    Digital health interventions for clinical care and treatment of tuberculosis and HIV: Capacity and readiness assessment of healthcare facilities in Addis Ababa, Ethiopia
    (Addis Abeba University, 2021-06) Adere, Emnet Getachew; Dr. Manyazewal, Tsegahun(PhD ); Dr. Woldeamanuel, Yimtubezinash(MD, PhD)
    Background: Digital Health Interventions (DHIs) such as electronic health (eHealth) and mobile health (mHealth) are emerging as promising technologies to advance clinical care and treatment. However, many of these breakthroughs have not reached the people most in need to tackle the rising burden of diseases such as Tuberculosis (TB) and Human Immunodeficiency Virus (HIV). People living in low-income countries are at high risk of many health conditions than those living in other regions while having the least access to such technologies. There is a high level of concern that low-income countries lack the infrastructure and human resource capacity needed to effectively adopt, implement, and scale up DHIs. Being one of the top 30 high TB and HIV burden countries globally, Ethiopia exerts efforts to meet the global targets to End TB by 2035 and End HIV/AIDS by 2030. DHIs could transform TB and HIV clinical care and treatment services in Ethiopia. However, the country needs an in-depth assessment of the healthcare system’s capacity and readiness to absorb and implement DHIs. Objective: This study aimed to assess the capacity and readiness of healthcare facilities to adopt and implement DHIs for TB and HIV care and treatment. Method: This study was a multi-center, facility-based, mixed-method, cross-sectional study. The study included 14 government healthcare facilities: 10 health centers and four hospitals with high TB/HIV clients load in Addis Ababa, Ethiopia. The participants were healthcare providers who provide TB and HIV clinical care and treatment services in the study facilities. With a purposive sampling method, two healthcare providers have participated from each included site. Using a questionnaire framed by the Technology Readiness and Acceptance Model, data were collected from the participants that assessed their experience using digital health technologies and the potential readiness of their healthcare facilities to implement DHIs. Using a tool framed by the unified theory of acceptance and use of technology (UTAUT) model, data were collected from participants who hold a solid prior experience of using DHIs to understand further the level of acceptability of such digital health technologies. A multiple linear regression model to determine the relationship between dependent and independent variables. Cronbach’s alpha test was performed to evaluate the internal consistency and reliability. Using an adapted checklist, the healthcare facilities were assessed to investigate their infrastructure and human resource capacity to adopt and implement DHIs. Result: There were 76 healthcare providers actively engaged in HIV/TB clinical care services in the selected 14 study sites, of whom 60 met the inclusion criteria and participated in this study. sixty-two percent of the participants were working in HIV clinics, 37% of them had more than 10 years of working experience, 65% of them held a minimum of BSc degree, 60% were female, and 42% were aged between 31-40 years. According to the responses, 80% of the healthcare providers had the experience of using DHIs to facilitate their healthcare delivery. Most of them had internet access and computers in their facilities. Seventy-five percent of the participants found the technologies advantageous than the traditional system and the majority preferred to use the DHIs in their healthcare facility. The major factors that influence healthcare providers’ willingness to use different technologies were educational level (β= .097, t= 3.784, p= .006), age (β= -.227, t= -1.757, p= .027), work experience (β= -.366, t= -2.855, p= .016). Respondents who had experience using digital adherence technology for TB felt that remote monitoring of medication adherence benefits both patients and providers. Similarly, respondents who had experience using smart care technology for HIV felt that the technology helps to retrieve patients’ data easily and simplify their work. The strongest facilitator of their acceptance and the use of the digital adherence technology were perceptions of positive performance expectancy (i.e., perceived usefulness). According to Cronbach’s alpha test, all factors were greater than 0.7, and such values suggest a high level of internal consistency and reliability of related items. The majority of respondents reported the absence of regulatory policy and guidelines as the major gap to adopt and use DHTs in their facilities. The correlation between technological readiness and organizational cultural readiness was considered to being significant (r = 0.8). Thirty-one percent of the healthcare facilities had prior needs assessments made to make their sites ready for new DHIs. The data showed that 57.1% of facilities had skilled staff on payroll for maintaining computers and other dysfunctions related to technologies. The average number of computers in each facility was about 20. most of the healthcare providers used Wi-Fi while 42.9% of them used both Wi-Fi and broadband internet. Of the 14 facilities, 35.7% had the plan to establish a functional Local Area Network for interconnectivity to give better services. Conclusion: The present data confirm that many public healthcare facilities in Addis Ababa have already begun implementing various DHIs/e-Health systems for TB/HIV services and the level of acceptability of these technologies by healthcare providers was noticeably good. Thus, there is an excellent opportunity for DHIs to be integrated into the healthcare system in tertiary health facilities in Ethiopia with appropriate training and education. However, most of the available digital health technologies in the facilities were utilized without reliable DHIs/eHealth regulatory policy in place. Thus, there is a critical need for DHIs/e-Health regulatory policies and some improvement is needed in DHIs/e-Health strategic planning (core readiness). There should be a prior need assessment and proper training given to healthcare providers to properly adopt and implement new DHIs in healthcare facilities.
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    Assessment of capacity for conducting drug trials in Ethiopia: a cross-sectional situation analysis
    (Addis Abeba University, 2021-07) Amano, Aliyi; Hanlon, Charlotte(PhD); Medhin, Girmay (PhD)
    Abstract Background: Several development organizations have argued that clinical trials (CTs) in LMICs are crucial for advancing public health and development. In order to ensure that clinical trials facilities (CTFs) can respond to this demand, it is vital that a country has sufficient capacity in various aspects including infrastructure to conduct CTs. Despite, different capacity challenges that affecting research systems in LMICs have been recognized; substantial amount of this evidence is inferred from experiences with specific institutions or programmes and does not build on systematic baseline data and conceptual frameworks. Furthermore, CTs funders are increasingly looking for evidence that investigators are linked to CTFs with sufficient expertise and infrastructure, so it is critical that the prevailing capacity of this resource is assessed and the need for any further capacity strengthening is identified. Objective: To assess existing capacity of conducting clinical trials, perceived gaps and priorities for capacity strengthening for CTFs in Ethiopia. Methods: An institutional-based cross-sectional situational analysis was carried out using mixed methods approaches: online semi-structured interviews with key informants, document review, and an email-based, self-administered checklist of key domains of CTs infrastructure and capacity. The data was collected from September-November 2020. Descriptive statistical methods were used to summarize quantitative data. Qualitative data were transcribed verbatim and analyzed using a framework approach. NVivo software version 12 (QSR International Pty Ltd.) was used to manage qualitative data Findings from quantitative and qualitative study components were triangulated. Results: Of the 27 CTFs currently conducting drug trials in Ethiopia, 13 (48% response rate) responded to at least one assessment, 7 responded to both assessments, 3 responded only to the quantitative questionnaire and 3 responded only to qualitative interview. The results from the 10 CTFs who responded to the quantitative assessment indicated that they had 159 staff linked to the CTF, comprising 112 (70.4%) of the scientific staff and 47 (29.6%) support staff. Among the 10 leading causes of death in Ethiopia, only two were included in the trial portfolio of the CTFs. A total of 35 CTs had been conducted in the 10 CTFs, with 46% of these being locally developed protocols and phase III trials. Two CTFs reported ownership of research laboratory and data management units with external certification. Onsite monitoring was used by most CTFs, but the indicators that were monitored varied across the CTFs. Synthesis of nine key informant interviews highlighted the current capacity challenges, identified priority areas to develop capacity and the factors affecting availability of CTF funds and the sustainability of CTFs infrastructure. Conclusions: This study has identified that Ethiopian CTFs have limited capacity to conduct CTs due to a lack of physical infrastructure, workforce, CTs experiences, and data management, as well as a lack of institutional structures to support CTs at various levels. Furthermore, a number of priority areas for capacity development have been identified, calling for a coordinated effort of different stakeholders and funders.
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    A systematic Review and Meta-analysis of Antimicrobial Prescriptions in East Africa
    (Addis Abeba University, 2021-06) Joan, Acam; Dr.Medhin, Girmay; Prof.Makonnen, Eyasu; Otiku, Paul Kuodi
    Background: Antimicrobial resistance is one of the major global health problems that has been worsened due to poor antibiotic stewardship by health workers and improper use of antimicrobial by the patients among other factors. Quality data representative of the extent of poor antimicrobial stewardship in low- and middle-income countries is scanty, but high incidences of antimicrobial resistance are increasingly reported in many settings across the globe. The objective of the present study was, therefore, to evaluate prescriptions for antimicrobials in East Africa. Methods: A comprehensive literature search strategy that includes text words and medical subject headings was developed and applied to predefined electronic databases. Two researchers independently screened the titles and abstracts of the outputs of the literature search. Full texts were then independently reviewed by the two researchers. Extracted data from included studies were pooled using meta-analysis. Results: Majority of the included studies (30.8%) were retrieved from Ethiopia, followed by Sudan, Kenya and Tanzania each contributing 19.2%. The overall proportion of encounter with antimicrobials reported was 57% (95%CI 42%; 73%). Ethiopia had an overall patient encounter with antimicrobials of 63% [95%CI: 50%, 76%] followed by Sudan with an overall encounter with antimicrobials of 62% [95%CI: 34%, 85%]. Studies included from Kenya reported the overall encounter with antimicrobials of 54% [95%CI: 15%, 90%], whereas studies from Tanzania reported an overall patient encounter with antimicrobials of 40% [95%CI: 21%, 60%]. Conclusion: Prescription patterns demonstrated in this review significantly deviate from WHO recommendations suggesting inappropriate antimicrobial use in the East African countries. Considering the global threat posed by antimicrobial resistance, perhaps countries with few research being carried out on antimicrobial use patterns and resistance should focus more resources on this important research agenda as a matter of public health priority.
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    Self sampling HPV testing as cervical cancer screening approach among women living in low-middle-income -countries: Systematic review and Meta-analysis.
    (Addis Abeba University, 2021) Amanuel, Hanna; Dr.W/Amanuel, Yimtubezinash; Prof.Makonnen, Eyasu
    Background: More than 85% of cervical cancer deaths occur in low-middle-income countries, and 90% of the mortality burden is primarily attributed to low coverage of cervical cancer screening. Self-sampling HPV could increase the overall cervical screening and contribute to alleviating the burden of cervical cancer in LMICs (low-middle-income countries) Objective: The general objective of this review and meta-analysis was to see if self-sampling HPV screening method can increase uptake of cervical cancer screening in low-middle-income countries. Methods: CENTRAL (Cochrane Central Registry of controlled trials), MEDLINE (through PubMed),, WHO Global Health Library, and EMBASE were searched. Reference lists of the relevant studies found were assessed to further search for relevant studies. The MeSH terms for HPV (MeSH (DNA Probes, HPV) (Human Papillomavirus DNA Tests)) and cervical cancer MeSH term (uterine cervical neoplasms) were found and as for the term self-sampling, there was no MeSH term found therefore method of text words/synonyms (Self-sampling, Selfcollection, Self-obtained) for self-sampling was used. For the LMIC, LMIC filter prepared by Cochrane from all LMIC countries listed by World bank was used. Where multiple studies reported the same comparable outcome of interest, we conducted a metaanalysis. Random-effects models was used to generate pooled effect size of relative risk with a 95% confidence interval using RevMan 5.4. Results: Six RCTs (randomized control trials) were included in this review. The studies were from Ethiopia, Kenya, Nigeria, Uganda, Argentina, and Mexico. These studies included a total of 39,274 participants with in the age group ranged from 25 – 65 years. All the studies compared an interventional group of HPV self-sampling method with a control group of a standard of care. HPV self-sampling was reported to be acceptable, and participants stated the device was easy to use and they would use HPV self-sampling instead of the regular hospital screening in the future. There were no adverse events associated with the self-sampling device. In the meta-analysis, uptake of cervical cancer screening services showed that the likelihood of participants to use self-sampling HPV screening method was 75% higher than with standard of care (RR: 1.72, 95% CI 1.58 to 1.87, Isquared: 72%) with insignificant I2, (MODERATE quality of evidence). However, there was no difference between linkage to care between the two groups (RR=1.18, 95% CI 0.77 to 1.81, I2= 87%) (VERY LOW quality of evidence). Conclusion: Self-sampling HPV screening technique has the potential to increase the uptake of cervical cancer screening in LMICs, and is acceptable by women. Moreover, this technique helps overcome many barriers to cervical cancer screening in LMICs such as lack of trained personnel, lack of laboratory supplies, infrastructure, socio-religious and cultural barriers to pelvic examination, limited physical access to patient populations, and the need for spousal permission. As this can reduce social inequalities in access to cervical screening, it helps alleviate the cervical cancer burden in LMICs.
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    System and site readiness for conducting active surveillance of adverse Events following Immunization in Addis Ababa, Ethiopia.
    (Addis Abeba University, 2021-06) Dagnachew, Eden; Prof.Makonnen, Eyasu; Dr.Yimer, Getnet
    Background: Vaccine pharmacovigilance (PV) aims to detect, assess, comprehend, communicate and manage adverse events following immunization (AEFI). To help distinguish vaccine related AEFIs from coincidental occurrences, an active PV prospective surveillance programs (e.g. hospitalbased sentinel sites) are needed. We describe our experience in assessing system and facility readiness for implementing a pilot active AEFI PV in Addis Ababa, Ethiopia. Method: Three hospitals were selected for this study after objectively evaluating all the government hospitals in Addis Ababa using parameters ;ongoing collaborations with the Ethiopian Food and Drug Authority (EFDA), previous experience in research, being referral government hospital and proximity to key AEFI stakeholders in Addis Ababa. We developed a readiness assessment together with scoring tool and system readiness assessment tool by adapting published framework. The site assessment was conducted via in person interview of specific departments in each hospital while a desk review of AEFI guideline, Expanded Program for Immunization (EPI) guideline, EFDA and Ethiopian Public Health Institute (EPHI) website was done for system readiness. Results: Three out of thirteen (23.1%) hospitals in Addis Ababa met the criteria for our site assessment. During the system readiness assessment, we found that essential components were in place, Specific regulation and proclamation on AEFI surveillance except mentioning responsibility of every stakeholder on the guideline was, however absent. Based on the scoring tool, Tikur Anbessa Specialized Hospital (TASH) scored 94 out of 155 (60.6%), Saint Paul Hospital Millennium Medical College scored 75 out of 155 (48.38%) and Gandi Memorial Hospital scored 62 out of 155 (40%). Paper-based records were used by all departments except those of laboratory and radiology in TASH and SPHMMC. International Classification of Disease (ICD) 9/10 coding was only used in TASH. Copies of national AEFI guidelines were not present in all departments and reporting forms were found only in 4 departments surveyed across the three hospitals. Staff at both Gandi Memorial Hospital and SPHMMC reported absence of training on AEFI surveillance. Conclusion: TASH has the highest score after assessing readiness for piloting active AEFI surveillance. We also identified the following areas for improvement in all hospitals to ensure successful implementation: training, making guideline and reporting forms available, and ensuring a system that accommodates paper-based and electronic record systems.
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    Impact of COVID-19 on tuberculosis and HIV care and treatment services in Addis Ababa, Ethiopia.
    (Addis Abeba University, 2021-06) Haile, Dagmawi Chilot; Dr.Manyazewal, Tsegahun(PhD ); Dr. Woldeamanuel, Yimtubezinash(MD, PhD)
    Background:Coronavirus disease 2019 (COVID-19) pandemic has infected 173,674,509 people globally resulting in 3,744,408 deaths as of 09 June 2021.Ethiopia is categorized under COVID19 epidemic phase III (advancing outbreak). There are global concerns and predictions that COVID-19 would severely affect tuberculosis (TB) and HIV care and treatment services in resource-constrained countries. Objective: To assess the real-time impact of COVID-19 on TB and HIV care and treatment services in Addis Ababa, Ethiopia. Methods: This was a facility-based, multicentre, cross-sectional study in 10 health centers with high TB/HIV patients in Addis Ababa, Ethiopia. Participants were patients with TB and/or HIV who have been attending TB and/or HIV clinical care and treatment in the study sites in the COVID-19 pandemic period. Data were collected using adapted, interviewer-based questionnaires to investigate the impact of COVID-19 in their routine care and treatment services. Data were entered into Epi Info version 7 and exported to SPSS version 26 for analysis. Variables with a P-value ≤ 0.25 in the bivariate analysis were included in the multivariate logistic regression. Statistical significance was declared if P-value < 0.05. Results: The study included a total of 424 informed and consented participants.Study participants who missed appointments for medication refill were 98 (23.1%).When the effects of other independent variables on appointments/visits for refill were controlled,the following characteristics were found to be the most important pridictors of missed appointments (P < 0.05):age ≥55 [AOR=13.74, 95% CI (4.331-436.428)], monthly income 3001-10000 [AOR=0.05, 95% CI (0.003-0.803)], fear of COVID-19 [AOR=59.14, 95% CI (3.804-9195.85)], transport disruption [AOR=56.91, 95% CI (1.930-16781.4)], reduced income for traveling to health facility [AOR=12.52, 95% CI (19.115-8194.9)],contacting healthcare providers quickly[AOR=0.11, 95% CI (0.017-0.742)], soap availability [AOR=0.01, 95% CI (0.0000.845)], pharmacy accessibility, [AOR=0.01, 95% CI (0.000-0.611)], shortage of some medications [AOR=10.72, 95% CI (1.033-111.290)], and tremendous shortage of non-medical support [AOR=15.30, 95% CI (1.075-218.039)]. The participants were well aware of the COVID-19 preventive measures. According to the participants, the most effective COVID-19 preventive measures were use of facemask (88.4%), frequent handwashing with soap (81.4%), and staying at home (76.4%). The most costly COVID-19 preventive measures that cause financial burden to the patients were costs for buying facemasks [242 (57.1%)], soaps for handwashing [97 (22.9%)], and disinfectants [223 (52.6%)]. Participants responded that the healthcare providers were polite and respectful (99.5%), and willing to listen and answer their questions (99.5%) and give attention to their individual needs (98.6%). Participants who missed follow-up dignositic tests were 97 (22.9%). Variables which were found to be statisticaly significant included the following: age ≥55 [AOR=0.14, 95% CI (0.021-0.909)], denied helth services [AOR=0.20, 95% CI (0.054-0.729)], reduced income for traveling to health facility [AOR=0.06, 95% CI (0.008-0.408)], much harder non medical support [AOR=0.02, 95% CI (0.001-0.404)]. Participants who missed counseling services were 92 (21.7%). In multivariate logistic regression, the following were statisticaly significant: age ≥55 [AOR= 0.11,95% CI (0.016-0.733)], denied health services [AOR= 0.25, 95% CI (0.078-0.787)], fear of COVID-19 [AOR= 0.02, 95% CI (0.001-0.396)],reduced income [AOR= 0.04, 95% CI (0.005-0.333)], availability of soap [AOR= 22.65, 95%CI (1.302-393.974)], availability of sanitizer [AOR= 3.87, 95% CI (1.069-14.041)], slightly shortage of medicines [AOR= 0.26, 95% CI (0.081-0.846)]. Conclusion: COVID-19 pandemic impacted the care and treatment services of patients with HIV and TB negatively. The impact was primarily on their appointments for scheduled medication refills, clinical and laboratory follow-ups. The impact could be mitigated by providing education to the public, compensating travel expenses for eligible patients and their healthcare providers, continuing delivery of TB/HIV care and treatment services.
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    Comparison of efficacy and safety of dihydroartemisinin- piperaquine versus artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in African children: Systematic review and metaanalysis of randomized control trials
    (Addis Abeba University, 2021-06) Assefa, Dawit Getachew; Prof.Makonnen, Eyasu; Dr.Yismaw, Gizachew
    Background: Emergence of Plasmodium falciparum resistance to artemisinin and its derivatives poses a threat to global effort in controlling malaria. Resistance has already emerged to most antimalarial drugs in common use. While the concern on resistance in South East Asia but with potential benefits of DHA-PQ over other ACTs, it is necessary to assess if the antimalarial treatment efficacy of this regimen in Africa has changed. The aim of this review was, therefore, to compare the efficacy and safety of dihydroartemisinin-piperaquine and artemether-lumefantrine for treatment of uncomplicated P.falciparum malaria in African children. Method: An electronic systematic search method was used to search for articles from online databases PubMed/ MEDLINE, Embase, and Cochrane Center for Clinical Trial database (CENTRAL) for repossessing randomized control trials comparing efficacy and safety of DHA-PQ and AL for management of uncomplicated Plasmodium falciparum malaria in African children. The search was done from August 2020 to 30 April 2021. Using Rev-Man software (V5.4), R-studio, and Comprehensive Meta-analysis software, the data obtained from the included studies were assembled as risk ratio (RR), MD, and SMD with 95% confidence interval (CI). The per-protocol analysis was used. Result: In this review, 25 studies which involved a total of 13,198 participants were included. PCR unadjusted treatment failure in children aged between 6 months to 15 years was significantly lower in DHA-PQ treatment arm on day 28 than that of AL (RR 0.14, 95% CI 0.08 to 0.26; participants = 1302; studies = 4; I 2 = 0%, high quality of evidence). Consistently, the risk of treatment failure adjusted by PCR was significantly lower with DHA-PQ treatment group on day 28 (RR 0.45, 95% CI 0.29 to 0.68; participants = 8508; studies = 16; I 2 = 51%, high quality of evidence) and on day 42 (RR 0.60, 95% CI 0.47 to 0.78; participants = 5959; studies = 17; I 2 = 0%, high quality of evidence). However, the efficacy was ≥95% in both treatment groups on day 28. On days 28 and 42, a significant increase in serum hemoglobin level from the baseline was also observed in DHA-PQ treatment arm (SMD 0.15, 95% CI 0.05 to 0.26; participants = 2715; studies = 4; I = 32%, high quality of evidence) and (MD 0.35, 95% CI 0.12 to 0.59; participants = 1434; studies = 3; I 2 = 35%, high quality of evidence), respectively. However, DHA-PQ was somewhat coupled with a higher incidence of early vomiting (RR 2.26, 95% CI 1.46 to 3.50; participants = 7796; studies = 10; I 2 = 0%, high quality of evidence), vomiting (RR 1.02, 95% CI 0.87 to 1.19; participants = 8789; studies = 13; I 2 = 20%, high quality of evidence), cough (RR 1.06, 95% CI 1.01 to 1.11; participants = 8013; studies = 13; I 2 = 0%, high quality ofevidence), and diarrhea (RR 1.16, 95% CI 1.03 to 1.31; participants = 6841; studies = 11; I = 8%, high quality of evidence) were more frequent in DHA-PQ treatment arm. Conclusion: From this review, it can be concluded that DHA-PQ reduces recurrent infection and recrudescence with significant impact on hemoglobin recovery more than AL, and bothdrugs are well tolerated. DHA-PQ may, therefore be recommended as an alternative first linetreatment for uncomplicated falciparum malaria in Africa, while use of AL continues.
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    Association of Maternal Dietary Pattern and Neural Tube Defects; A Case-control Study in Addis Ababa, Ethiopia
    (Addis Abeba University, 2020-07) Mohammedsanni, Afrah; Dr.Medhin, Girmay(MSc, PhD)
    Background: Neural Tube Defects (NTDs) are significant public health problems with complex etiology. Maternal nutrition is one of the environmental factors to contribute to the etiology of NTDs. This study aims to assess the relationship of diet with NTDs among pregnant women who received antenatal care services in Zewditu Memorial Hospital. Methods: We conducted a matched case-control study from January 1, 2020 to April 30, 2020 in Zewditu Memorial hospital, Addis Ababa. A total of 252 pregnant women (63 cases and 189 controls) were included in the study. Pregnant women were matched on age, gestational age and gravidity. We used a 70-item food frequency questionnaire to assess the dietary intake of pregnant women. Factor analysis was used to identify major dietary patterns. Cases and controls were confirmed by specialist gynecologists. Conditional logistic regression was used to assess the association between dietary patterns and neural tube defects. Result: We identified seven major dietary patterns using factor analysis: prudent pattern, traditional pattern, western pattern, Mediterranean pattern, raw meat and alcohol pattern, refined cereal and vegetable pattern and sugar and caffeine pattern. In the adjusted model, the odds of having a fetus affected with NTDs was 83% lower among women who had high intake of prudent pattern compared to those who had low intake (high vs. low intake: AOR=0.17; CI: 0.05 - 0.52). Likewise, women with high intakes of Mediterranean pattern scores were less likely to have a fetus affected with NTD (high vs. low intake: AOR=0.20; CI: 0.06 - 0.59). The odds of having NTDaffected fetus was 3 times higher among women with high consumption of traditional pattern scores (high vs. low intake: AOR=3.37; CI: 1.23 - 9.19) compared to those who with low consumption. There was no statistically significant association between western pattern adherence before pregnancy and neural tube defect in the adjusted model (high vs. low intake: AOR=1.40; CI: 0.41 - 4.73) Conclusion and recommendations: This study demonstrated that maternal adherence to high intake of prudent and Mediterranean diets a year before pregnancy have protective effects against NTDs. Conversely, pregnant women with high intake of traditional pattern one year prior to pregnancy are more likely to have a fetus affected with NTDs. Promoting healthy diet prior to pregnancy is one possible way to optimize reproductive outcomes. We suggest the application of dietary patterns as an approach to communicate healthy dietary choices to the public and formulate dietary guidelines.
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    Survival of Patients with Tuberculosis in Retreatment Programme with Guardian Administered Streptomycin in Malawi
    (Addis Abeba University, 2021-07) Mboma, Fides Christina; Prof. Fekadu, Abebaw (MD, MSc, PhD, MRCPsych)
    Background: Current ambulatory approaches for delivering treatment to patients with tuberculosis in Malawi have significant operational delivery challenges. This led to a clinical trial aimed at establishing if guardian administered streptomycin is non-inferior to hospital administered streptomycin. In order to establish effectiveness of guardian administered streptomycin, all integral outcomes including survival need to be assessed. Objectives: Based on secondary analysis of existing trial dataset, this study aimed to compare survival of patients with tuberculosis who received streptomycin administered at hospital or at home by a guardian controlling for potential factors that may confound or mediate effect of the treatments. Methods: In the original study - a non-inferiority, parallel, randomised, open label, phase III trial –204 patients were randomized to receive streptomycin at the hospital or in their homes where it was administered by a patient nominated guardian. One hundred and one patients were randomized into hospital arm while 103 into home-based group. Patients were followed up for ten months. In this study, comparison of survival between the treatment delivery options employed Logrank test. Cox proportional hazard model was used to identify factors that confound or mediate survival of patients. Potential factors included age, sex, TB class, TB category, HIV status, smoking status, drinking status and employment status of participants and education level of household head. Results: No significant difference was observed in survival of patients between the two groups (p-value = 0.726, HR 1.15 (0.52 to 2.55). All covariates except unemployment had no effect on survival of patients (CI for HR had 1). Conclusion: Use of patient nominated trained lay carers to administer streptomycin provides a potential convenient and cost-effective approach for treating patients with recurrent and drug resistant TB. However, decision for its adoption should be cautious due to small sample size used, switching of critically ill patients from home-based group to hospital arm, inadequate information on how patients selected guardians and lack of details on how TB resistance was assessed. A follow up study on assessment of acceptability of the proposed model of care would help understand if it could be successfully adopted and used to deliver long term TB injectable agents to patients.
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    Challenges and strategies for recruitment and retention of participants in clinical trials in Ethiopia: a qualitative study
    (Addis Abeba University, 2020-11) Wagaw, Lealem Minwuyelet; Fekadu, Abebawdu (MD, PhD); Makonnen, Eyasu (PhD)
    Introduction: Clinical trial is an extensive and demanding process, which takes approximately 10 to 15 years. Clinical trials require the active engagement of human subjects. Recruitment and retention of participants are two major challenges in conducting clinical trials. Poor recruitment and retention of participants in clinical trials can lead to major delays in the development of new products and interventions. This can also cause significant problems in the study validity as they could reduce the statistical power resulting in poor generalizability of the study. Objective: This study is aimed to identify potential challenges and strategies for enhancing recruitment and retention of participants in clinical trials in Ethiopia. Method: A qualitative methodology with a phenomenological approach employed. Semistructured interviews were conducted face to face and through telephone. Interviewees were purposively selected from five candidate study sites which are Armauer Hansen Research Institute, Zewditu Memorial Hospital, University of Gondar, Jimma University, and Addis Ababa University. These sites were chosen primarily because most clinical trials conducted in and potential clinical investigator candidates were employed and affiliated there. Investigators, clinical coordinators, physicians, nurses, and participants involved in clinical trials were the study respondents. The sample size was determined using the criterion of informational redundancy. Of 22 potential respondents approached, 19 consented to the interview. An open-ended topic guide was developed to facilitate in-depth interviews with respondents with sufficient freedom to describe their experiences and perspectives that they deemed relevant to the research questions. Interviews were audio-recorded with consent. Transcriptions were entered into Open Code and coded. Data were analyzed using thematic analysis. Result: Nine of the respondents (47.4%) were females. Respondents were involved as principal investigators (n=5), trial coordinators (n=7), nurses (n=2), physicians (n=2) and trial participants (n=3). Thematic analysis resulted in a generation of 3 main themes and 10 sub-themes. Clinical trial team factors (communication and system-related), participants’ factors (communication and interest related), and study factors (complexity of the study and cost-related) were listed as challenges for recruitment and retention of trial participants. Additionally, four subthemes are mentioned under the three themes as a strategy for recruitment and retention of trial participants, such as promoting clinical trials, improving communication skills, refining the clinical trial setting system, and having a good estimation of cost. Potential challenges and strategies for recruitment and retention of participants in clinical trials were identified under each sub-themes. Poor communication skills, mistreating participants, and lack of knowledge about existing trials are considered to be clinical trial team factors. Also, misconceptions about the trial, low-level education, lack of social support, and participants’ moves around were revealed to be an important challenge among trial participants’ factors. Also study factors such as long questionnaires and assessment, stringent eligibility criteria, frequent appointment, and extra, and inconvenient procedures. However, a wide range of strategies was identified such as increasing awareness, choosing an appropriate trial site, provisions of training, reimbursement and compassionate respectful care, and establishing an efficient tracking system may be the most important interventions to improve recruitment and retention of trial participants. Conclusions: Poor knowledge about research, and complexity of trials were the greatest challenges for low recruitment and retention. Interventions to improve knowledge and provisions of training to the clinical trial team and having compassionate respectful care, providing compensation, increasing awareness in the community are important strategies to consider when designing and planning recruitment and retention plan.
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    Challenges and prospects of the regional bioequivalence center initiative in Ethiopia: a qualitative study.
    (Addis Abeba University, 2020-10) Melesse, Yajeb; Hailu, Asrat (Prof, ); Belete, Anteneh(Dr. )
    Background: Evaluation of the interchangeability of multi-source generic drug products or bioequivalence study has become a crucial activity since the share of generic medicines in healthcare has enormously grown over the past few decades. Among four East African Countries, namely, Ethiopia, Kenya, Uganda and Tanzania, there has been an initiative to establish an accessible and affordable BE center for the regional pharmaceutical manufacturers. This study aims at assessing the challenges and prospects of the bioequivalence center initiative in Ethiopia. Methods: In-depth interview was conducted with individuals who were Ethiopian affiliates of the Regional Bioequivalence initiative; local pharmaceutical manufacturers, Ethiopian Food and Drug Administration, Regional Bioequivalence Center and other key stakeholders who are involved in the center capacity building. Data were collected using digital voice recorders, and transcribed. These data were analyzed using an inductive thematic analysis using Nvivo software and the findings were presented in narratives using the respondent‟s own words as illustrations. Results: Based on the findings, four major themes, one as an opportunity and three as challenges, were identified. The mere presence of the Regional Bioequivalence Center by itself was considered as an opportunity by most of the participants. In addition, a number of favorable conditions including awareness and demand for product quality and diversity, the presence of attractive incentive packages for local pharmaceutical manufacturers and the proliferation of the generic medicines market in the region were mentioned as opportunities. On the other hand, lack of resources and stakeholders‟ commitment as well as lack of regulatory enforcement were identified as challenges. Conclusions: The Bioequivalence center initiative has not functioned well as initially planned. The findings of this study suggest the need for government and key stakeholders to actively engage in the program to make the initiative viable. The significance of supporting this initiative could positively contribute to the creation of a competitive local manufacturing sector that will engage in the production of therapeutically interchangeable generic products and ultimately safeguard the health of the society at large.
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    Eastern Africa Countries Need and Readiness for Implementation of Harmonized Clinical Trials Regulation and National Ethics Review System: A Qualitative Study
    (Addis Abeba University, 2020-11) Ejamo, Assefa; Makonnen, Eyasu(Prof.); Woldeamanuel, Yimtubezinash(Dr. )
    Background: Medical products are regulated from premarket clinical trials to post marketing surveillance and phase IV clinical trials. Research organizations have responsibilities to conduct clinical trials subject to regulatory and national ethics review process before putting products on the market. Harmonized approaches for regulation of clinical trials and national ethics review are practiced globally including in Eastern Africa countries under regional economic communities. However, there are gaps in medicine regulatory in general and clinical trials regulatory and national ethics review harmonization in particular. Objective: The aim of this study was to assess the need and readiness for implementation of harmonized clinical trial regulation and national ethics review in Eastern Africa. Methodology: A qualitative study was conducted in selected Eastern Africa countries focusing on regional economic communities (RECs). Data were collected through semi structured questionnaire from National Regulatory Authorities, National Ethics Review Committee, development partners, sponsor and research institutions through email by assigning facilitators in each country, and were analyzed thematically using QDA Miner Lite qualitative data analysis software. Specific countries regulatory and ethics review system components were analyzed according to the nature of questions and responses. Results: It was noted that 5 Eastern Africa countries involved (Ethiopia, Kenya, Sudan, Uganda and Tanzania) in the present study had national legislations for medicines and clinical trials regulations. Shortage, lack of experience, lack of appropriate expertise and poor professional mix were staff related problems identified in this study. It was noted that clinical trial structures were established at directorate level in one country, at team level in three countries and none in one. These findings reflect countries readiness for implementation of harmonization initiative. Capacity building, utilizing limited resources in the region and ensuring quality were some of need related findings for implementation of harmonized approach. Existence of platforms like RECs, partners support and enabling conditions were identified opportunities for implementation of harmonized regulation and national ethics review. Challenges identified were lack of awareness, difference in administrative procedures, lack of commitment, resource limitation, and requiring long time for implementation of harmonization. Differences were also noted among countries and RECs (IGAD and EAC) in regulatory system and progress in implementation of harmonization initiative respectively. Conclusion: The readiness of most of the countries in regulating clinical trials is not adequate to implement harmonized clinical trials regulation and national ethics review. However, there is remarkable need for harmonization in the region. Countries need to strengthen their clinical trial regulatory and national ethics review system in consideration of harmonization.
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    Investigating researchers’ perceptions and experiences in conducting clinical trials toward zoonotic diseases in Ethiopia
    (Addis Abeba University, 2020-06) Adugna, Senait Belay; Giday, Mirutse (Prof.); Manyazewal, Tsegahun(Dr. )
    Background: The emergence and resurgence of zoonotic diseases have continued to be a major threat to global health and the economy. Developing countries are particularly vulnerable due to agricultural expansions and domestication of animals with humans. Scientifically sound clinical trials are important to find better ways to prevent, diagnose, and treat zoonotic diseases, while there is a lack of evidence to inform the clinical trials’ capacity and practice in countries highly affected with the diseases. This study aimed to investigate researchers’ perceptions and experiences in conducting clinical trials towards zoonotic diseases in Ethiopia. Methods: This study employed a descriptive, qualitative study design. It included major academic and research institutions in Ethiopia that had active engagements in veterinary and public health researches. It included the National Veterinary Institute, the National Animal Health Diagnostic and Investigation Center, the College of Veterinary Medicine at Addis Ababa University, the Ethiopian Public Health Institute, the Armauer Hansen Research Institute, and the College of Health Sciences at Addis Ababa University. In-depth interviews were conducted with 14 senior research investigators in the institutions who hold a proven exhibit primarily leading research activities or research units. Data were collected from October 2019 to April 2020. Data analysis was undertaken using open code 4.03 for qualitative data analysis. Results: Five major themes, with 18 sub-themes, emerged from the in-depth interviews in connection with. These were: challenges in the prevention, control, and treatment of zoonotic diseases; One Health approach to mitigate zoonotic diseases; personal and institutional experiences in conducting clinical trials on zoonotic diseases; barriers in conducting clinical trials towards zoonotic diseases; and strategies that promote conducting clinical trials on zoonotic diseases. Conducting clinical trials on zoonotic diseases in Ethiopia is hampered by a lack of clearly articulated ethics and regulatory frameworks, trial experts, financial resources, and good governance. Conclusions: In Ethiopia, conducting clinical trials on zoonotic diseases deserves due attention. Strengthening institutional and human resources capacity is a precondition to harness effective implementation of clinical trials on zoonotic diseases in the country. In Ethiopia where skilled human resource is scarce, One Health approach has the potential to form multidisciplinary teams to systematically improve clinical trials capacity and outcomes in the country.
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    Bacteriophage to overcome Nosocomial infections associated with multidrug-resistant bacterial pathogens: a systematic review and meta-analysis
    (Addis Abeba University, 2020-06) Benson, Ngolobe; Woldeamanuel, Yimtubezinash (MD, M.SC, PhD); Tesfay, Abraham(Dr. )
    Background : Antibiotic-resistant pathogens constitute an important and growing threat to public health. The emergence of multidrug-resistant organisms in nosocomial infections is being highly associated with frequent causes of morbidity and mortality in patients. In view of the growing threat of antibiotic resistance, the World Health Organization has warned for a return into a pre-antibiotic era. The antibiotic crisis has rekindled the interest in phage therapy approaches that were developed in Eastern Europe, one of the alternatives recently regaining interest, which was first introduced by Felix d’Herelle at the beginning of the 20th century. Objectives: The main objective of this study was to quantify the pooled therapeutic efficacy and safety status of Bacteriophage for bio-control of nosocomial infections associated with but not limited to multidrugresistant “Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species pathogens” (ESKAPE) bacteria in humans based on available studies. Methods: In this review, the study protocol was submitted for registration in PROSPERO and eligible studies involved prospective interventional studies with patients infected with one or all the six pathogens and who were treated with bacteriophages or a phage cocktail specific to the pathogen, regardless of the year of publication up to December 2019. We searched the PubMed/Medline, Embase and Web of science databases for articles on phage therapy. 14 studies were included in the review with six considered for metaanalysis to quantify the therapeutic efficacy based on available studies on phages that may prevent and eradicate infections associated with but not limited to “Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species pathogens” in humans for control of Nosocomial infections. In addition current gaps in the literature that would prompt further research on bacteriophage in the fight against antibiotic resistance were identified. Results: Phage safety was sufficiently reported in that all studies showed no side effects related to phage administration. A moderate pooled effect size was obtained with a high evidence of heterogeneity (SMD = 0.52, (C.I. = -1.18, 2.22), P< 0.00001, I 2 = 96%). Most studies were pointing towards the overall effect size with one study regarded as an outlier. However, there was no significant treatment difference between the two therapeutic arms as observed in the forest plots. Moreover, the therapeutic efficacy of bacteriophage is inconclusive due to the few available randomized phage studies found with even few sample sizes. Hence more streamlined phage clinical trials with large sample sizes are needed to detect sufficient effect sizes.