Clinical Trials

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Practice And Perceived Effectiveness of Ruta Chalpensisas for Infantile Colic by Parents or Caregivers of Infants in Addis Ababa, Ethiopia
(Addis Ababa University, 2025-11-01) Dureti Moti; Eyasu Makonnen; Abebaw Fekadu
Background: Infantile Colic, Also Known as Excessive Crying Is a Common Condition Affecting Infants During the First Months of Life and Also Have a Significant Impact on Parents or Caregivers, Leading to Increased Stress, Parental Distress, And Disrupted Family Dynamics. Though There Is Anecdotal Evidence and Traditional Knowledge Regarding the Use of R. Chalpensis for Infantile Colic There Is No Any Scientific Evidence. Therefore, This Study Aims to Investigate the Practice and Perceived Effectiveness of R. Chalpensis for Infantile Colic by Parents or Care Givers. Method: Facility Based Cross-Sectional Study Was Conducted on Randomly Selected 422 Parents or Caregivers of Infants Aged Between 1 And 6 Months Who Came for Immunization to Selected Health Centers in Addis Ababa City, Ethiopia, From February1 to February 30, 2024. The Data Were Collected Using Pre-Tested Semi-Structured Questionnaire by Trained Data Collectors Using ODK Collect V 2023.2.4. The Collected Data Were Exported to Statistical Package for Social Science Version 26 For Analysis. Descriptive Statistics Was Used to Calculate Prevalence of Practice of R. Chalpensis. Graphs, Charts, Statistical Tables and Texts Were Used to Present the Data. Result: Overall, 133(34.9%) Of the Study Participants Reported That Their Infants Had Infantile Colic. From Them 116(87%) Of the Participants Reported That They Administered Rc as a Therapeutic Intervention for Treating Colic Symptoms of Their Infants. Notably, 76(65%) Perceived the Remedy to Be Effective in Relieving Their Infants’ Colic Symptoms. Conclusion: While R.Chalpensis Is Perceived as Effective and Safe by Many Users, The Lack of Scientific Validation Highlights a Need for Caution. Further Scientific Research, Including Clinical Trials, Is Recommended to Validate the Safety and Efficacy.
Preparedness And Experience of Healthcare Professionals in Managing Acute Poisoning and Its Associated Factors at Kidus Petros Hospital, Addis Ababa, Ethiopia – A Facility Based Cross Sectional Study
(Addis Ababa University, 2025-10-01) Hana Mulat; Eyasu Makonnen; Solomon Mequanente
Background: Acute Poisoning Is a Significant Global Public Health Concern, Contributing Substantially to Morbidity and Mortality, Particularly Within Low- and Middle-Income Countries Including Ethiopia. Despite Its Recognition as a Priority by the Ethiopian Ministry of Health, Challenges in Healthcare Professionals' Preparedness and Experience in Managing These Emergencies Exists. Objective: To Assess the Overall Preparedness and Experience of Healthcare Professionals (Hcps) In Managing Acute Poisoning Cases and Identify Associated Factors at Kidus Petros Hospital, Addis Ababa, Ethiopia. Methods: A Cross-Sectional Study Was Conducted at Kidus Petros Hospital Between November 2024 and May 2025. The Study Targeted Hcps, Including Nurses, Physicians, And Clinical Pharmacists, Who Had Managed Poisoning Cases in the Past Three Years. A Department-Based Stratified Systematic Random Sampling Method Was Used. Data Were Collected Using a Self-Administered Questionnaire. Preparedness Was Defined as Achieving ≥75% In Both Knowledge and Practice. Experience Was Defined As ≥2 Years Managing Poisoning Cases. Data Were Analyzed Using Descriptive Statistics and Multivariate Logistic Regression to Identify Predictive Factors Using SPSS 23.0. Crude And Adjusted Odds 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: A Total Of 242 Healthcare Professionals Out Of 265 Invited Participants (91.3% Response Rate) Responded to the Survey. Only 36% Of Healthcare Professionals Were Classified as Well-Prepared for Managing Acute Poisoning. Approximately One Third (31%) Of Healthcare Professionals Reported More Than Two Years of Experience in Managing Poisoning Cases, The Number of Cases Managed Was Not Assessed Due To Data Limitations. Education Level Was Found to Be a Statistically Significant Predictor for Both Preparedness and Experience, With Nurses Having Significantly Lower Odds of Preparedness Compared to Specialists (AOR = 0.18, 95% CI: 0.04–0.829, P = 0.028). Conclusion: Low Preparedness (36%) And Experience (31%) Among Hcps, coupled with a Theory-Practice Gap, Highlight Critical Deficiencies, Especially in Nurses in Poisoning Management at Kidus Petros Hospital. This Highlights the Significance to Implement Focused Interventions, Such As High-Quality Training, Mentorship, And Ongoing Professional Development Targeted to Particular Professional Groups, In Order to Improve Patient Outcomes and Overall Preparedness in Ethiopia.
The Impact of Mode of Transport and Adequacy of Pre-Hospital Care Among Severely Injured Road Traffic Accident Patients in Addis Ababa, Ethiopia: A Retrospective Cohort Study
(Addis Ababa University, 2025) Aklile Habtemariam; Charlotte Hanlon
Background: Road traffic injuries (RTIs) are a major global health concern, particularly in low- and middle-income countries (LMICs) where over 90% of RTI deaths occur. Ethiopia has one of the highest RTI fatality rates in sub-Saharan Africa, with up to 37 deaths per 100,000 people. Contributing factors include poor road infrastructure, limited emergency medical services (EMS) and inadequate prehospital care. Despite EMS being crucial to reducing trauma mortality, Ethiopia lacks a formal prehospital care system, and most RTI victims are transported by informal means without emergency care. The impact of prehospital care and transport mode patient outcomes remains under-researched. Objective: This study investigated the impact of mode of transportation and adequacy of prehospital care on clinical outcomes—mortality, discharged with disability, and discharged without disability —among severely injured RTI patients admitted to Alert Hospital Trauma Center in Addis Ababa. Methods: A hospital-based observational study reviewed clinical records of RTI patients presenting to Alert Hospital Trauma center (2020-2023). The study included severely injured 449 adults (triaged red or orange by modified early warning score, MEWS) with recorded outcomes. Patients transported by ambulance were compared to those using non-ambulance means, and those receiving adequate pre-hospital care were compared to those with inadequate or no care. Data on demographics, clinical parameters, transport mode, provider type and outcomes were analyzed for association with RTI mortality and disability. Logistic regression was carried out to further examine significant associations to identify risk factors. Results: Out of 18,408 trauma cases seen at the institution during study period 2,946 (16%) were RTI. Of these, 449 records of severely injured patients were identified. Out of 449 patients. males made 70.8% with median age of 35 years and pedestrians accounted for 56.1%. Prehospital care was documented in half of the patients, though only 20% received adequate care. Prehospital care was mainly given health professional (95.5%). Mortality was 16.5%, with 39.4% discharged with disability and 44.1% without disability. Compared with private/public patients, patients arriving walking had twelve times more odds of death (AOR = 12.26, 95% CI: 2.47-60.89). Other predictors of death were age (AOR= 1.05, 95% CI: 1.03 – 1.07), female (AOR = 0.20 95% CI: 0.08-0.52) and higher systolic blood pressure (AOR xii = 0.98%, 95% CI: 0.97-0.99). Mode of transport and higher systolic blood pressure were found to be significant predictors of disability. Compared with private/public transport, patient transported by ambulance has twice odds of being disable (AOR = 2.36, 95% CI: 1.41-3.94). Conclusions: The study highlights a high rate of RTI in Ethiopia. Patients’ clinical outcome is significantly associated with mode of transport. Arrival on foot or carried was associated with higher mortality while arrival by ambulance increased the likelihood of disability. Although most prehospital care was provided by health professionals, only a small fraction was adequate. Strengthening EMS systems, improving timely quality prehospital care could substantially reduce death and disability among this population. Other key predictors of outcomes were age, sex and systolic blood pressure
Cardiovascular Efficacy and Safety of Calcium Channel Blockers, Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in Patients with Primary Hypertension: A systematic Review and Network Metanalysis
(Addis Ababa University, 2025-04-24) Anatia Kifle; Eyasu Makonnen; Anteneh Belete
Background: Cardiovascular disease (CVD), such as myocardial infarction (MI), stroke, and heart failure, are major global health concerns, with hypertension being a key risk factor. This study evaluates the efficacy and safety of three common antihypertensive drug classes—calcium channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACEi’s), and angiotensin receptor blockers (ARBs)—in preventing major cardiovascular events. These findings provide valuable information for clinicians in selecting appropriate treatment strategies for hypertensive patients who are at risk of cardiovascular complications, helping improve patient outcomes and reduce the global burden of CVD Methods: This systematic review and network meta-analysis was conducted following the PRISMA and PRISMA-NMA 2020 guidelines and registered on the PROSPERO database. Eligible studies included randomized controlled trials (RCTs) published between 2000 and 2024, with a minimum follow-up of three months, focusing on adults (≥18 years) with hypertension (BP 140/90–179/109 mmHg). Trials evaluating safety and efficacy of calcium channel blockers, angiotensin receptor blockers (ARBs), or angiotensin-converting enzyme inhibitors (ACEi’s) for cardiovascular outcomes (e.g., myocardial infarction, stroke, heart failure) were included. Studies with incomplete data or secondary hypertension were excluded. Data were sourced from PubMed, Embase, and Scopus using a detailed search strategy based on PICO criteria. Two independent reviewers screened the studies, and data were extracted using a structured format. The risk of bias was assessed using the Cochrane tool. Network meta-analysis was performed with a random-effects model using R Studio. Efficacy was measured by blood pressure reduction and cardiovascular events, while safety was assessed by adverse events (e.g., edema, syncope) observed. Results: This study evaluated the efficacy and safety of calcium channel blockers (Amlodipine), angiotensin-converting enzyme inhibitors (Enalapril, Ramipril, Lisinopril), and angiotensin receptor blockers (Losartan, Candesartan, Irbesartan, Valsartan) in hypertensive patients. Candesartan was 2.4 times more effective than Amlodipine in reducing systolic blood pressure and showed a 20% greater reduction in diastolic blood pressure. Amlodipine showed a 47% lower risk of myocardial infarction (MI) compared to Enalapril and a 62% lower risk compared to Irbesartan. However, there was no significant difference in death due to stroke and cardiovascular disorders across the drug classes. Amlodipine was associated with the lowest syncope incidence but the highest rates of edema. ARBs, particularly Valsartan, had the lowest edema incidence, while Enalapril had the smallest number of adverse events. Hospitalization rates for MI were lowest with Valsartan and Irbesartan. Conclusion: This study highlights the comparative cardiovascular efficacy and safety of calcium channel blockers (Amlodipine), angiotensin-converting enzyme inhibitors (Enalapril, Ramipril, Lisinopril), and angiotensin receptor blockers (Losartan, Candesartan, Irbesartan) in hypertensive adult patients. While ARBs were most effective in reducing blood pressure, no significant differences were found between drug classes for major cardiovascular events, like stroke, cardiovascular death, and hospitalization for heart failure. Amlodipine demonstrated the lowest incidence of myocardial infarction, while ARBs were most beneficial in reducing heart failure risk. Regarding safety, Amlodipine was associated with the lowest syncope incidence but the highest rates of edema, while Enalapril showed the smallest number of total adverse events. These findings suggest that treatment selection should be individualized based on both efficacy and safety profiles, considering patient-specific factors.
Treatment Outcomes of Patients With Visceral Leishmaniasis in Konso Zone, Southern, Ethiopia
(Addis Ababa University, 2023-10) Garra Geyeto; Hailu Asrat
Background: Visceral leishmaniasis is one of the most neglected tropical diseases caused byprotozoa of the genus Leishmania. Leishmaniasis is estimated to affect 0.7–1 million people,with 350 million people at risk, globally. It is characterized by a broad range of clinical andlaboratory findings like fever, cachexia, hepatosplenomegaly, pancytopenia, hypo albuminuria,anemia, leucopenia, polyclonal hyper gamma globulinemia, or lymph node enlargement. Sodiagnosis and treatment of visceral leishmaniasis is difficult and without appropriate treatment,an estimated 95 % of VL patients will die. Objective: This study aimed to analyze treatment outcomes of patients with visceralleishmaniasis in Konso Zone, Southwest, Ethiopia Methods: Health facility -based, Cross-sectional, retrospective study was conducted among VLpatients who were treated in Konso zone health facilities. Charts of all patients that have beentreated from 2007 to 2022 in the zone that fulfills the inclusion criteria were reviewed. The datawas entered and cleaned using SPSS 20 statistical packages and analysis was carried out usingthe SPSS 20 statistical packages. To identify factors associated with poor treatment outcomes,bivariate, and multivariable logistic regression were carried out. Result: A total of 381 patient's charts were reviewed. The overall level of poor treatmentoutcomes was 6.6%. The presence of sepsis (AOR=3.323%, 95% CI :(1.191-9.273) P=0.022,ascites (AOR=5.919%, 95% CI: (2.269-15.444) P< 0.001, lymphadenopathy (AOR=4.879%,95% CI:(1.875-12.694) P=0.001 and prolonged presentation to health facility of more than onemonth during illness (AOR= 0.366%,95% CI: (0.136-0.985) P=0.047 were found to be theindependent predictors of treatment outcomes. Whereas treatment with the combination of SSG& PM as antileishmanial was inversely related with the poor treatment outcomes (AOR=0.051%, 95% CI: (0.084-0.774) P=0.016. Conclusion and recommendation: Sepsis, ascites, lymphadenopathy, and prolonged duration ofillness at presentation were independent predictors of poor treatment outcomes, whereastreatment with the combination of SSG & PM as antileishmanial was inversely related with thepoor treatment outcomes. Awareness creation in the community on signs and symptoms of VLand scaling up the health-seeking behavior to enhance early presentation to health facilities andtraining of health care providers on complications of VL patients are some of the strategies to bepromoted in improving patient outcomes in VL control programs. Special attention and careshould be given to VL patients with sepsis, ascites, and lymphadenopathy.
Efficacy and Saftey of Artemether-Lumefantrine with Single Dose Primaquine for Treatment of Uncomplicated Plasmodium Falciparum Malaria in Arbaminch, Southwest Ethiopia
(Addis Ababa University, 2024-04-13) Bontu Abate; Eyasu Makonnen
Background: In Ethiopia, 60% of the population resides in areas prone to malaria infection. The first-line treatment for uncomplicated Plasmodium falciparum (P. falciparum) infection in Ethiopia is artemether-lumefantrine (AL), as outlined in the national malaria diagnosis and treatment guideline. The World Health Organization (WHO) recommends monitoring the efficacy of first-line antimalarial drugs at least once every two years post-implementations. Such information is crucial for assessing resistance levels and implementing timely interventions. Objective: To assess the therapeutic efficacy and safety of AL for the treatment of uncomplicated P. falciparum based on clinical, parasitological and hematological parameters. Methods: A prospective single-arm efficacy study was conducted among adults and children ≥ 6 months confirmed with uncomplicated P. falciparum and attending outpatient care at Shecha Health Center, Arbaminch, Southwest Ethiopia. The study took place from October 2023 to January 2024, during which the participants were enrolled and followed up for 28 days to evaluate clinical and parasitological responses. Enrolled participants were treated with the standard artemether 20mg + lumefantrine 120mg tablet, administered twice daily for three consecutive days and single dose primaquine given as 0.25mg/kg based on the national malaria treatment guideline of Ethiopia and the revised WHO protocol. Baseline assessments, including standard physical examinations and recording of medical history, were conducted on day 0 before dosing. Subsequent assessments were performed on days 1, 2, 3, 7, 14, 21, and 28. Thick and thin blood smears were taken at all time-points during the 28-day follow-up to detect parasites. Hemoglobin levels were measured from finger-prick blood samples on days 0, 14, and 28 to monitor changes and classify anemia severity. P. falciparum samples underwent polymerase chain reaction (PCR) testing for merozoite surface protein-1 (msp1), merozoite surface protein 2 (msp2), and glutamate-rich protein (glurp) to compare genotypic profiles pre- and post-parasite strains, distinguishing recrudescence from newly acquired infection. The primary outcome was the cure rate of AL measured by the adequate clinical and parasitological response (ACPR) on day 28. Secondary outcomes were parasite and gametocyte clearance, fever clearance, change in hemoglobin, and incidence of drug adverse events. Kaplan-Meier survival analysis and Per-protocol analysis were used to estimate primary and secondary outcomes, with statistical analysis conducted using SPSS version 25. One-Way ANOVA was used to compare baseline parasitemia between age groups, and a paired sample t-test was used to compare mean hemoglobin levels across follow-up dates. All comparisons were made at a 95% confidence interval (CI), with a significance level set at 0.05.
Adverse Drug Reactions and Associated Clinical Outcomes in Patients with Drug Resistant Tuberculosis: A Facility-Based Retrospective Cohort Study in Addis Ababa, Ethiopia
(Addis Ababa University, 2024-04-13) Solomon Bisrat; Manyazewal Tsegahun; Manyazewal Yimtubezinash
Background; Drug-resistant Tuberculosis (DR-TB) poses a significant global public health threat, with adverse drug reactions (ADRs) during treatment complicating medication outcomes and leading to substantial mortality. In Ethiopia, despite a high prevalence of DR-TB, there have been limited studies on ADRs during treatment and their effects on patient outcomes. Objective; This study aimed to assess the incidence, clinical outcomes, and risk factors associated with ADRs in the treatment of patients with DR-TB in Addis Ababa, Ethiopia. Methods: A facility-based, retrospective cohort study was conducted on patients with DR-TB who were followed up in two major DR-TB treatment sites, the St. Peter’s Specialized Hospital and the ALERT Comprehensive Specialized Hospital, in the years 01 January 2017 to 31 December 2023. Records of the patients were monitored throughout their treatment time. Information on ADR diagnosis, laboratory findings, clinical observations, type of second-line anti-TB regimen, type and nature of the DR-TB, presence of co-morbidities such as HIV, hypertension, diabetes mellitus, chronic obstructive pulmonary diseases, and asthma, and sociodemographic characteristics were abstracted from patients' charts and registries. The World Health Organization - Uppsala Monitoring Center (WHO-UMC) system was employed for standardized causality assessment of ADRs. Multivariate Cox regression analysis was employed to identify factors associated with ADRs. Survival among predictor variables was assessed using Kaplan-Meier (KM) curves. Adjusted hazard ratios (AHR) with their corresponding 95% confidence intervals (CI) were estimated, and statistical significance was declared for a p-value < 0.05. Result: A total of 292 patients with DR-TB were included, with a median age of 30 years [interquartile range (IQR) = 29–32], 161 (55%) male, and 113 (38%) had comorbidities. Cases were mainly rifampicin-resistant [281(96%)], pulmonary TB [225 (77%)], and on long-term regimens with new drugs [173 (59%)]. Drugs identified during treatment were Levofloxacin, Moxifloxacin, Bedaquiline, Linezolid, Clofazamine, Cycloserine, Caperomycin, Proteonamid, pyrazinamide, Ethambutol, Isonaizid, Ethionamide, and Kanamycin. The overall incidence of ADRs was 8.10 per 100 person-month (PM) (95% CI: 7.02-9.36) during a total follow-up time of xiv 2294 months. The most frequently reported ADRs were gastrointestinal disturbance (31.9%), followed by peripheral neuropathy (21.9%), and arthralgia (17.5%). Temporary and permanent drug discontinuation were noted in 17.1% and 21.9% of patients, respectively. Predictors of ADRs were hospitalization (AHR = 1.53, 95% CI: 1.10-2.13), baseline anemia (AHR = 1.58, 95% CI: 1.16-2.17), the age group of 25-49 years (AHR =1.53, 95% CI: 1.05-2.21), and older age above 50 years (AHR = 1.87, 95% CI: 1.19-2.93). Good treatment outcome was observed in 76% of cases, with no significant association found between ADRs and treatment outcomes. Conclusion: In this study involving patients with DR-TB, over half of the participants encountered at least one ADR. Patient admission, baseline anemia, and older age were identified as predictors of ADRs during MDR-TB treatment. Particular emphasis should be placed on these susceptible groups to facilitate early prediction, prompt management, and the formulation of appropriate treatment regimens that address ADRs effectively. Keywords: Adverse drug reaction, drug-resistant tuberculosis, treatment outcome, Ethiopia
Preparedness and Response to the COVID-19 Pandemic in a Hospital in Nairobi County, Kenya
(Addis Ababa University, 2022-06-05) Catherine Lydiah; Girmay Medhin
Background: Historically, pandemics and epidemics of infectious disease have caused devastating impacts in Sub Saharan Africa (SSA). In particular HIV/AIDS and Ebola Virus Disease (EVD) were associated with very high death rates. Knowing the extent to which previous experiences have equipped countries of SSA to prepare for and respond to the COVID-19 pandemic helps policy makers to make appropriate preparation for future pandemics. Objective: This study assessed preparedness for and response to the COVID-19 pandemic in a hospital in Nairobi County in Kenya at the start of the pandemic and the current status of preparedness and response. Methods: This case study was conducted in a level four private hospital located in an urban setting in Kenya with a catchment area population of 191,207 Kenyans in its catchment area. Data was collected using qualitative methods) that is observation, in-depth interviews, focus group discussions), a cross-sectional survey and a literature review. Data was collected from a total of seventy-two participants. The sample for the cross-sectional quantitative survey was fifty-one hospital employees. In-depth interviews were conducted with 17 participants (hospital managers, clinical services administrators, clinical department head of departments and public health staff). A focus group discussion was held with ten participants including the hospital management, consultant physicians, community health workers and a social worker. Observation was conducted in the hospital for a total of forty-five and a half hours to understand and to investigate implementation of COVID-19 prevention protocols in the hospital which were recommended by ministry of health. Qualitative data was coded and analyzed thematically while quantitative data were analyzed descriptively using SPSS software. Findings were triangulated across the data sources to address the research question. Prior permission and ethical clearance were obtained to conduct this study. Findings: In depth insight was gathered from the qualitative data on the initial lack of clarity around the COVID-19 case definition, inadequate resources including staff, medication and personal protective equipment at the onset of COVID-19. COVID-19 Protocols endorsed by the Ministry of health were implemented in the hospital, with some challenges. The response to COVID-19 greatly impacted delivery of other primary healthcare services. Quantitative data indicated that visual cautions about COVID-19 were adequate (100%) and a system response plan was implemented at a good level (72.6%). However, resources were quite constrained 11 (staff (62.7%), medication (60.8%) and Personal Protective Equipment’s (PPEs) (66.7%)). Overall, the hospital was not prepared to respond to COVID-19 (66.7%). More than half of the respondents (66.7%) said that infection control was implemented in the hospital premises and wards. Resources for COVID-19 response were constrained in the hospital (64.7% of participants) and the hospital did scarce resource allocation in response to COVID-19. Finding from the observation of service delivery and the hospital compound during the data collection showed that staff were in personal protective equipment, isolation protocols were displayed, personal protective equipment precautions were displayed, sanitizers were available and COVID-19 testing was outsourced. The literature review highlighted the need for strengthening of the healthcare system in relation to pandemic preparedness. A pandemic preparedness response plan was lacking. COVID-19 majorly impacted maternal and child health due to reduced clinic attendance and the cost of COVID-19 management was a burden to the healthcare infrastructure. Conclusion: At the onset of the pandemic the hospital was not prepared to respond to COVID 19 in terms of space, staff, (resources) and system coordination. However, capacity has been built and structures implemented over the pandemic period. Hence, the hospital is currently more prepared and well equipped to respond to COVID-19 pandemic. Findings from the primary quantitative study we have learned how pandemics overwhelm the healthcare system by creating an increased demand for medical supplies and the unforeseen increased costs to meet healthcare needs. Policy Implications: This study showed that hospital preparedness and response relied heavily on the country’s healthcare infrastructure, human resource capacity, medical supply, surveillance information and pandemic preparedness and response plans that the country should put in place before a pandemic hits. All these pillars form the backbone for adequate pandemic preparedness and response. The results from this study have a potential of informing policies on contagious disease outbreak surveillance by emphasizing the need for adequate health system preparedness for potential outbreaks through adequate resource mobilization and implementing a working pandemic response plan in Kenya’s healthcare system. Extrapolation of the lessons in this study’s findings to Sub Saharan Africa should take the country into account.
Setting up Contract Research Organizations in Sub-Saharan Africa: Challenges, Opportunities, and Prospects; A Qualitative Study
(Addis Ababa University, 2024-10-15) Shiferaw Tesfaye; Abebaw Fekadu
Background: A Contract Research Organization (CRO) is a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. Africa, emerging as a powerhouse of clinical research, presents significant opportunities for CROs. Despite the benefits of CROs, there is a lack of understanding of the challenges, opportunities and prospects of setting up CROs in sub-Saharan Africa. Objective: To explore the setting up, challenges, opportunities and prospects of CROs in sub Saharan Africa and to suggest the way forward for improved practice. Methods: This qualitative research used a phenomenological study design. A semi-structured interview guide was used for the in-depth interviews with 13 CRO participants from nine sub Saharan African countries, both face-to-face and virtually. Combination of purposive sampling procedure using criterion and snowball sampling were employed for study participant selection. Data collection took place from July 2023 to June 2024. Data was analyzed using thematic analysis, performed with ATLAS. ti version 8.4.24 Results: Five themes were identified: setting up of CROs, challenges of CROs, strategies used to overcome challenges, opportunities of CROs, and prospects of CROs in sub-Saharan Africa. To establish a CRO workforce and infrastructures are needed. Lack of regulations and bureaucratic challenges were the major identified challenge in homegrown CROs. Collaboration, partnerships, community engagement and creation of a strong networking platform were used to overcome their challenges. Opportunities like market potential and untapped industry were reported. Based on these findings, participants recommended that all regulatory bodies in their respective countries establish clear requirements and standards for setting up CROs. Conclusion: Challenges faced by CROs reveals essential strategies that sponsors, regulatory bodies, and new CROs can adopt to understand how established CROs navigate and overcome operational difficulties. Countries should support emerging CROs due to the significant opportunities and needs in this field. Furthermore, collaboration among stakeholders is essential to leverage this opportunity and foster the expansion of the CRO sector in sub-Saharan Africa. Key-words: Challenges, Opportunities, Prospects, CRO, sub-Saharan Africa
Patient-Health Care Interaction in Care Plan and its Associated Factors in Public Hospitals in Addis Ababa, Ethiopia: a Facility-Based Cross-Sectional Study
(Addis Ababa University, 2024-06-13) Tigist Mesfin; Anteneh Belete
BACKGROUND: Chronic diseases, also known as Noncommunicable diseases (NCDs), account for 71% of deaths globally with the majority occurring in Low-and middle-income countries (LMICs). More than one-third of all deaths in Ethiopia are due to NCDs. As per the World Health Organization (WHO), better clinical outcome of NCDs was strategized to be achieved through engaging and empowering individuals in their care, i.e., activating patients to have the necessary knowledge, skill, and willingness to self-manage, and promoting healthy behavior through different interventions. The health care approach in the in-patient setup creates an intimidating environment for patients to have an effective patient-health care interaction. OBJECTIVE: The aim of the study was to assess patient-health care interaction in care plan and associated factors contributing to poor patient-health care interaction among patients with NCDs admitted to public hospitals in Addis Ababa, Ethiopia. METHODS: A facility-based cross-sectional study was conducted in randomly selected public hospitals in Addis Ababa. A systematic sampling method was used to recruit 372 adult patients who had the main types of NCDs receiving in-patient medical service from five selected hospitals. Patient activation measure-22 tool was used to assess the level of patient-health care interaction in care plan. Patient satisfaction was measured using the Picker Patient Experience Questionnaire-15. Pre-test was done involving 5% of the sample size calculated prior to the actual data collection. Data were collected using face-to-face interview through interviewer-administered structured questionnaire. Collected data were entered to Epi Info and exported to SPSS version 26 for data cleaning and analysis. Descriptive and logistic regression analysis methods were carried out to compute frequency and identify factors associated with patient-health care interaction. RESULTS: 80% of the patients had high activation with median Patient Activation Measure (PAM) of 63 (IQR 57- 66). On bivariate logistic regression analysis, factors significantly associated with patient activation were age, gender, marital status, educational background, employment status, monthly income, NCD type, and patient satisfaction. Multivariate logistic regression analysis showed the odds of a patient with no formal education having high activation was 73.8% less than a patient with higher education (AOR=0.262 , 95% CI: 0.069 - 1.001). Similarly, the odds of a patient with no monthly income having high activation level was 68.2% less when compared to a patient having monthly income of >2500 ETB (AOR=0.318, 95% CI: 0.11 - 0.87). Patients who had good satisfaction with the health care viii provided were 2 times more likely to be activated than patients with poor satisfaction (AOR= 2.34, 95% CI:1.32 - 4.15). CONCLUSION Most patients in the study were beginning to engage in recommended health behaviors, i.e., attained level 3 of activation with some patients already being proactive about their health and engaged in most recommended health behaviors (level 4) thus showing a good patient-health care interaction with care plan. Having higher education and higher income as well better satisfaction with provided care are strong predictors of having higher patient activation. Recognizing determinants of patient activation will help promote better health outcomes for individuals with NCDs and encourage health care providers to focus on tailoring a personalized care plan for their patients.
Effects of Comorbid Non-Communicable Diseases on Tuberculosis Treatment Outcomes in Ethiopia: A Retrospective Cohort Study
(Addis Ababa University, 2024-02-13) Hanna Melesse; Tsegahun Manyazewal
Background: The intersection of tuberculosis (TB) and non-communicable diseases (NCDs) presents a major challenge in achieving global health targets, including the WHO’s End TB 2030 strategy. In countries like Ethiopia where the TB burden is particularly high, the impact of NCDs on TB treatment remains insufficiently explored, limiting the development of informed interventions. Therefore, this study aimed to assess the effect of comorbid NCDs on TB treatment outcomes and identify underlying factors in Ethiopia. Methods: This was a retrospective cohort study that utilized secondary data from the EXIT TB project - an evidence-based, multiple-focus integrated intensified TB screening package. Participants were individuals with acute respiratory symptoms seeking outpatient care at four healthcare facilities in Ethiopia selected using stratified random sampling that account for urban and rural differences. Of these, all patients confirmed positive for TB and tested for NCDs were included. The patients were divided into two exposure groups: the exposed group, consisting of patients diagnosed with TB and one or more NCDs, and the non-exposed group, consisting of patients diagnosed with TB but without any NCDs. Their data were extracted from the EXIT-TB database, focusing on four key categories: sociodemographic variables, TB diagnosis and risk factor, NCD diagnosis, and TB treatment outcomes, classified as cured, treatment completed, treatment failure, loss to follow-up, transferred out, not assessed and death. The data were analyzed using SPSS version 20. A Chi-square (X2) test was used to compare the baseline and clinical characteristics between the NCD-TB comorbid and TB-only patients groups, with a significance level of p≤0.05. Multiple logistic regression was used to investigate the association between independent and dependent variables. Results: A total of 356 participants were included in the analysis, with 198 (55.6%) men, and the largest age group was between 15 and 30 years. The overall treatment success rate was 95.2%, with an unsuccessful treatment outcome of 4.8%. Patients with TB-NCD comorbidities had a higher rate of unsuccessful treatment outcome, with 27.3% for those with TB-NCD comorbidity, compared to 4.0 % for those with TB only, resulting in an incident rate ratio of 6.8 (95% CI 2.4-19.5). Male gender (AOR=4.4 (CI 1.1-18.4)) and NCDs (AOR=8.9(CI (1.5 52.9)) were identified as significant risk factors for unsuccessful treatment outcomes. Conclusion: The findings show that the incidence of unsuccessful treatment outcomes was nearly seven times higher in patients with TB-NCDs comorbidity compared to TB-only. This study underscores the importance of screening for and addressing NCD comorbidities in TB management. Healthcare systems should prioritize integrating TB care with the management of comorbid conditions to ensure patients receive comprehensive and coordinated treatment and better treatment outcomes. Keywords: TB, NCD, Comorbidity, Tuberculosis, Non communicable diseases
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.
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 DarNorthwest 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.
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 ; Fekadu Abebaw ; Assefa Mathewos
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 amongadult 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 toappropriate treatment. Furthermore, expanding more treatment centers andimplementation of advanced Technology like Linear accelerator, rachytherapy and PET-scan needs urgent attention.
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 anddepends 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 thevaccines 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 aregiven 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 allAfrican 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 controlledenvironment i.e., for a long term effect and the issues seen in general populations.
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; Makonnen Eyasu; Abay Solomon
Background: Polypharmacy is one of the major concerns in the healthcare sector as it has astrong 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 acuteillnesses that lead to polypharmacy. In Ethiopia, there is a dearth of studies exploring theprevalence and associated factors of polypharmacy in elderly patients. Objective: To determine the prevalence of polypharmacy and its associated factors amongelderly patients admitted to Federal Police Referral Hospital (FPRH) in Addis Ababa, Ethiopia. Methods: A healthcare facility-based, retrospective cross-sectional study was carried out inFPHR, one of the two federal-level military hospitals in Addis Ababa. Medical charts of elderlypatients who were admitted to the hospital in the period 01 January 2019 to 01 January 2020were reviewed for polypharmacy. Using an adapted and structured data extraction tool, data wereabstracted on patient characteristics, diseases encountered, co-morbidities, and the type andcategories 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 acorresponding 95% confidence interval (CI) was used. Results: A total of 376 medical charts were reviewed, of which five or more drugs wereprescribed in 180 (47.9%) charts, with a mean of 4.57. This indicated the occurrence ofpolypharmacy 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, andcomorbidity with one to three diseases were themajor predictors of polypharmacy. We recommend that medication practices for elderly patientsneed to be improved through training of clinical practitioners, regular review of patients’medication charts, particularly patients with cardiovascular disease and endocrine disorders, andfurther ingagement of clinical pharmacists in elderly care and treatment.
Treatment Outcome of Drug-resistant Tuberculosis and Associated Factors at St.peter Specialized Hospital Addis Ababa, Ethiopia.
(Addis Abeba University, 2021-08) Abebe Mekdelawit; Hailu Asrat; Woldeamanuel Yimtubezenash
INTRODUCTION:Drug Resistant Tuberculosis is defined as tuberculosis that does not respondto antituberculosis agent. Data on the outcome of MDR/RR-TB and associated factors is highlyneeded to evaluate the efficiencies of the MDR/ RR-TB treatment program. However, Thetreatment 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-resistanttuberculosis from January 2015 - December 2020 at St. Peter specialized hospital. This studyincluded 335 patients treated for multidrug resistant or rifampicine-resistant tuberculosis. Themain outcome variable was overall MDR/RR-TB treatment outcome classified as successful andpoor. Data were collected by trained nurses. Data entry and analysis were performed using Exceland SPSS. The relationship between MDR/RR-TB treatment outcome and associated factors wasevaluated by fitting logistic regression. The final multivariable logistic regression model was agood fit for the data and had no multicollinearity issue. Statistical significance was considered atp<0.05. RESULTS: Treatment success was achieved in 71.3% of the patients. The adjusted odds of poortreatment 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 2foldshigher in patients who had a positive result for HIV test. Concerning mortality, thelikelihood 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-TBpatients co-infected with HIV (AOR=3.81, p<0.001). CONCLUSION: In this study, the overall treatment success was consistent with studies carriedout in different regions of Ethiopia. Again, a higher danger of poor treatment outcome and deathwas observed among people who drink alcohol, co-infected with HIV/AIDS, and theelderly.Patents with MDR/RR-TB patients, use alcohol and are co-infected with HIV/AIDSshould be given greater attention during therapy. More studies should be done to generate dataon the factors affecting the treatment of MDR/RR-TB patients to improve the outcome oftreatment.
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 ; Manyazewal Tsegahun; Woldeamanuel Yimtubezinash
Background: Digital Health Interventions (DHIs) such as electronic health (eHealth) and mobilehealth (mHealth) are emerging as promisingtechnologies to advance clinical care and treatment.However, many of these breakthroughs have not reached the people most in need to tackle therising 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 livingin other regions while having the least access to such technologies. There is a high level of concernthat low-income countries lack the infrastructure and human resource capacity needed toeffectively adopt, implement, and scale up DHIs. Being one of the top 30 high TB and HIV burdencountries globally, Ethiopia exerts efforts to meet the global targets to End TB by 2035 and EndHIV/AIDS by 2030. DHIs could transform TB and HIV clinical care and treatment services inEthiopia. However, the country needs an in-depth assessment of the healthcare system’s capacityand readiness to absorb and implement DHIs. Objective: This study aimed to assess the capacity and readiness of healthcare facilities to adoptand implement DHIs for TB and HIV care and treatment. Method: This study was a multi-center, facility-based, mixed-method, cross-sectional study. Thestudy included 14 government healthcare facilities: 10 health centers and four hospitals with highTB/HIV clients load in Addis Ababa, Ethiopia. The participants were healthcare providers whoprovide TB and HIV clinical care and treatment services in the study facilities. With a purposivesampling method, two healthcare providers have participated from each included site. Using aquestionnaire framed by the Technology Readiness and Acceptance Model, data were collectedfrom the participants that assessed their experience using digital health technologies and thepotential readiness of their healthcare facilities to implement DHIs. Using a tool framed by theunified theory of acceptance and use of technology (UTAUT) model, data were collected fromparticipants who hold a solid prior experience of using DHIs to understand further the level ofacceptability of such digital health technologies. A multiple linear regression model to determinethe relationship between dependent and independent variables. Cronbach’s alpha test wasperformed to evaluate the internal consistency and reliability. Using an adapted checklist, thehealthcare facilities were assessed to investigate their infrastructure and human resource capacityto adopt and implement DHIs. Result: There were 76 healthcare providers actively engaged in HIV/TB clinical care services inthe 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 10years of working experience, 65% of them held a minimum of BSc degree, 60% were female, and42% were aged between 31-40 years. According to the responses, 80% of the healthcare providers had the experience of using DHIs tofacilitate their healthcare delivery. Most of them had internet access and computers in theirfacilities. Seventy-five percent of the participants found the technologies advantageous than thetraditional system and the majority preferred to use the DHIs in their healthcare facility. The majorfactors that influence healthcare providers’ willingness to use different technologies wereeducational 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 remotemonitoring of medication adherence benefits both patients and providers. Similarly, respondentswho had experience using smart care technology for HIV felt that the technology helps to retrievepatients’ data easily and simplify their work. The strongest facilitator of their acceptance and theuse 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 ahigh level of internal consistency and reliability of related items. The majority of respondentsreported the absence of regulatory policy and guidelines as the major gap to adopt and use DHTsin their facilities. The correlation between technological readiness and organizational culturalreadiness was considered to being significant (r = 0.8). Thirty-one percent of the healthcare facilities had prior needs assessments made to make their sitesready for new DHIs. The data showed that 57.1% of facilities had skilled staff on payroll formaintaining computers and other dysfunctions related to technologies. The average number ofcomputers 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 toestablish a functional Local Area Network for interconnectivity to give better services. Conclusion: The present data confirm that many public healthcare facilities in Addis Ababa havealready begun implementing various DHIs/e-Health systems for TB/HIV services and the level ofacceptability of these technologies by healthcare providers was noticeablygood. Thus, there is anexcellent opportunity for DHIs to be integrated into the healthcare system in tertiary healthfacilities in Ethiopia with appropriate training and education. However, most of the availabledigital health technologies in the facilities were utilized without reliable DHIs/eHealth regulatorypolicy in place. Thus, there is a critical need for DHIs/e-Health regulatory policies and someimprovement is needed in DHIs/e-Health strategic planning (core readiness). There should be aprior need assessment and proper training given to healthcare providers to properly adopt andimplement new DHIs in healthcare facilities.
Assessment of Capacity for Conducting Drug Trials in Ethiopia: a Cross-Sectional Situation Analysis
(Addis Abeba University, 2021-07) Amano Aliyi; Hanlon Charlotte; Medhin Girmay
Background: Several development organizations have argued that clinical trials (CTs) inLMICs are crucial for advancing public health and development. In order to ensure thatclinical trials facilities (CTFs) can respond to this demand, it is vital that a country hassufficient 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 orprogrammes and does not build on systematic baseline data and conceptual frameworks.Furthermore, CTs funders are increasingly looking for evidence that investigators are linkedto CTFs with sufficient expertise and infrastructure, so it is critical that the prevailingcapacity of this resource is assessed and the need for any further capacity strengthening isidentified. Objective: To assess existing capacity of conducting clinical trials, perceived gaps andpriorities for capacity strengthening for CTFs in Ethiopia. Methods: An institutional-based cross-sectional situational analysis was carried out usingmixed methods approaches: online semi-structured interviews with key informants, documentreview, and an email-based, self-administered checklist of key domains of CTs infrastructureand capacity. The data was collected from September-November 2020. Descriptive statisticalmethods were used to summarize quantitative data. Qualitative data were transcribedverbatim and analyzed using a framework approach. NVivo software version 12 (QSRInternational Pty Ltd.) was used to manage qualitative data Findings from quantitative andqualitative 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 tothe quantitative questionnaire and 3 responded only to qualitative interview. The results frothe 10 CTFs who responded to the quantitative assessment indicated that they had 159 stafflinked to the CTF, comprising 112 (70.4%) of the scientific staff and 47 (29.6%) supportstaff. Among the 10 leading causes of death in Ethiopia, only two were included in the trialportfolio of the CTFs. A total of 35 CTs had been conducted in the 10 CTFs, with 46% ofthese being locally developed protocols and phase III trials. Two CTFs reported ownership ofresearch laboratory and data management units with external certification. Onsite monitoringwas 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 fundsand the sustainability of CTFs infrastructure. Conclusions: This study has identified that Ethiopian CTFs have limited capacity toconduct CTs due to a lack of physical infrastructure, workforce, CTs experiences, and datamanagement, 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.
A systematic Review and Meta-analysis of Antimicrobial Prescriptions in East Africa
(Addis Abeba University, 2021-06) Joan Acam; Medhin Girmay; Makonnen Eyasu; Otiku Paul
Background: Antimicrobial resistance is one of the major global health problems that has beenworsened due to poor antibiotic stewardship by health workers and improper use ofantimicrobial by the patients among other factors. Quality data representative of the extent ofpoor antimicrobial stewardship in low- and middle-income countries is scanty, but highincidences of antimicrobial resistance are increasingly reported in many settings across theglobe. The objective of the present study was, therefore, to evaluate prescriptions forantimicrobials in East Africa. Methods: A comprehensive literature search strategy that includes text words and medicalsubject headings was developed and applied to predefined electronic databases. Tworesearchers independently screened the titles and abstracts of the outputs of the literaturesearch. Full texts were then independently reviewed by the two researchers. Extracted datafrom included studies were pooled using meta-analysis. Results: Majority of the included studies (30.8%) were retrieved from Ethiopia, followed bySudan, Kenya and Tanzania each contributing 19.2%. The overall proportion of encounter withantimicrobials reported was 57% (95%CI 42%; 73%). Ethiopia had an overall patient encounterwith antimicrobials of 63% [95%CI: 50%, 76%] followed by Sudan with an overall encounterwith antimicrobials of 62% [95%CI: 34%, 85%]. Studies included from Kenya reported theoverall encounter with antimicrobials of 54% [95%CI: 15%, 90%], whereas studies fromTanzania reported an overall patient encounter with antimicrobials of 40% [95%CI: 21%,60%]. Conclusion: Prescription patterns demonstrated in this review significantly deviate from WHOrecommendations suggesting inappropriate antimicrobial use in the East African countries.Considering the global threat posed by antimicrobial resistance, perhaps countries with fewresearch being carried out on antimicrobial use patterns and resistance should focus moreresources on this important research agenda as a matter of public health priority.

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