ASSESSING THE EFFECTIVENESS OF COVID-19 MITIGATION STRATEGIES IN ARV SUPPLY CHAIN ON HIV PATIENT OUTCOMES AT CHUK, RWANDA by TUYITEGEREZE Adiel Student number: 220002895 A research proposal submitted in partial fulfillment of the Requirements for the Bachelor’s degree in CLINICAL PHARMACY AND PHARMACY PRACTICE in the DEPARTMENT OF PHARMACY SCHOOL OF MEDICINE AND PHARMACY COLLEGE OF MEDICINE AND HEALTH SCIENCES UNIVERSITY OF RWANDA Supervisor: Mr. Olivier clement MUBANO DECLARATION I declare that this report submitted in partial fulfillment of the requirements for the Bachelor’s degree with Honors in Pharmacy, at the University of Rwanda, College of Medicine and Health Sciences, School of Medicine and Pharmacy, Department of Clinical Pharmacy and Pharmacy Practice, is my original work and has not been previously submitted elsewhere. I also declare that a complete list of references indicates all sources of information cited. Student’s Name: Adiel TUYITEGEREZE Signature: Date: 24th January, 2025 DECLARATION BY THE SUPERVISOR Date: 06/02/2025 Name: Olivier Clément MUBANO ii ABSTRACT Background The COVID-19 pandemic significantly impacted healthcare systems, including the antiretroviral (ARV) supply chain, affecting the continuity of HIV treatment and patient outcomes. Objective This research aims to assess the effectiveness of mitigation strategies implemented to manage the disruptions caused by COVID-19 at CHUK. Methods A retrospective study will be conducted at CHUK HIV clinic, where the selected sample patient records and supply chain data will be studied, analyzing patient medical records and supply chain data from March 2020 to May, 2021. Key variables include ARV adherence rates, viral load suppression, stock-out durations, and the adoption of mitigation strategies such as multi-month dispensing. Findings The findings will quantify the impact of mitigation strategies on treatment continuity and clinical outcomes, providing evidence-based recommendations to enhance supply chain resilience and maintain HIV treatment access during future public health emergencies. This research contributes to strengthening healthcare systems in resource-limited settings. iii Contents ABSTRACT............................................................................................................................................ ii LIST OF ABBREVIATIONS.............................................................................................................. v CHAPTER 1. INTRODUCTION ........................................................................................................... 2 Background of the study ..................................................................................................................... 2 RESEARCH PROBLEM ........................................................................................................................ 3 1.5 RESEARCH OBJECTIVES ......................................................................................................... 5 1.5.1. GENERAL OBJECTIVES........................................................................................................ 5 1.5.2 SPECIFIC OBJECTIVES ...................................................................................................... 5 1.5.3 Research questions ..................................................................................................................... 6 1.8 Significance of the study ............................................................................................................... 6 CHAPTER 2: LITERATURE REVIEW................................................................................................. 7 CHAPTER 3. METHODS .................................................................................................................... 11 3.0 METHODOLOGY ..................................................................................................................... 11 3.1 study Area ................................................................................................................................... 11 3.2 Study design ................................................................................................................................ 11 3.3 Study Population ......................................................................................................................... 11 3.4 Sample size determination .......................................................................................................... 11 3.5 Data collection method ............................................................................................................... 12 3.5.1 Quantitative data collection ................................................................................................. 12 3.6 DATA ANALYSIS ...................................................................................................................... 12 3.7 Ethical considerations ................................................................................................................. 13 APPENDIX 1: WORK PLAN .............................................................................................................. 16 APPENDIX 2: BUDGET ..................................................................................................................... 17 References ............................................................................................................................................. 18 iv Data collection forms ............................................................................................................................ 20 LIST OF ABBREVIATIONS AIDS: Acquired Immunodeficiency Syndrome ARV: Antiretroviral ART: Antiretroviral Therapy ARVDR: Antiretroviral Drug Resistance CHUK: Kigali University Teaching Hospital COVID-19: Coronavirus Disease EWI: Early Warning Indicator GHSC-PSM: Global Health Supply Chain Program-Procurement and Supply Management HIV: Human Immunodeficiency Virus LMICs: low and middle-income Countries MMD: Multi Month Dispensing MoH: Ministry of Health PLHIV: People Living with HIV RBC: Rwanda Middle Center TLE: Tenofovir-Lamivudine-efavirenz TLD: Tenofovir-Lamivudine-Dolutegravir UNAIDS: Joint United Nations Program on HIV/AIDS VMI: Vendor-Management Inventory v CHAPTER 1. INTRODUCTION Background of the study Antiretroviral (ARV) therapy is critical for suppressing viral replication, improving quality of life, and preventing HIV transmission(1). In 2020, the coronavirus disease 2019 (COVID-19) pandemic emerged, disrupting global HIV-control efforts, and sidelining many routine HIV services to accommodate the response to the pandemic(2). COVID-19 pandemic posed unprecedented challenges to global health systems, including disruptions in ARV supply chains. Lockdowns, labor shortages, and transportation restrictions significantly hindered the delivery of life-saving medications in many low- and middle-income countries(3). Supply chain interruptions threatened consistent access to treatment, increasing the risk of treatment failure, drug-resistant HIV strains, and higher mortality rates. UNAIDS warned that a sixmonth disruption in ARV supply alone could result in severe patient outcomes in sub-Saharan Africa(4). Globally, 78 million people have been infected with HIV, and 35 million have died from AIDS-related illnesses since the epidemic’s inception 39 years ago (UNAIDS, Global AIDS Update)(5). Sub-Saharan Africa bears the highest burden, with an estimated 25.7 million people living with HIV (PLHIV) in 2018, of whom 16.4 million were receiving antiretroviral therapy (ART). Despite treatment advancements, the region experienced approximately 470,000 AIDS-related deaths in the same year. In Rwanda, the national HIV prevalence has remained stable at around 3% over the past decade, largely due to robust efforts led by the Ministry of Health (MoH)(6). Rwanda is also among the few African countries making significant progress toward achieving the UNAIDS 95-95-95 target. According to the UNAIDS 2023 EPP Spectrum, ART coverage in Rwanda reached 92.3% by June 2023, demonstrating the country’s commitment to universal access to HIV treatment. A total of 218,314 clients were enrolled in ART care, with females comprising 63.5% of patients and males 36.5%. Females were the most represented group across all age categories receiving ART.(7) Resilient supply chains—those capable of absorbing, adapting to, and recovering from disruptions—proved critical in mitigating the impact of the pandemic. Strategies such as localized ARV production, digital inventory tracking, and multi-sectoral coordination helped 2 maintain medication flow. The COVID-19 crisis emphasized the need for proactive, wellprepared healthcare systems capable of addressing future medical emergencies. Effective emergency response, as defined by Altay and Green (2006), involves systematic approaches to managing healthcare needs during disasters. Between 1998 and 2017, over 7,255 disaster events—including natural disasters, technological incidents, terrorism, and epidemics—were recorded, resulting in more than 1.3 million deaths and affecting 2.5 billion people globally(8). Healthcare institutions must develop contingency plans to ensure continuous medical supply and service delivery during emergencies to mitigate the impact on patient outcomes.(9) This research focuses on assessing the effectiveness of COVID-19 mitigation strategies within Kigali’s ARV supply chain. It will analyze supply chain functionality before, during, and after the pandemic, evaluating its resilience and impact on patient health. Recommendations will be provided to enhance the robustness and preparedness of ARV supply chain management for future emergencies. The findings aim to fill critical gaps in knowledge and offer actionable insights for strengthening healthcare systems against similar disruptions. RESEARCH PROBLEM The COVID-19 pandemic created unprecedented challenges for global healthcare systems, particularly affecting the management of chronic conditions such as HIV/AIDS. Access to antiretroviral (ARV) therapy, a cornerstone of HIV treatment, was severely threatened by disruptions in supply chains worldwide(10). Rwanda, where ARVs are primarily distributed through a government-led public health system, faced significant difficulties. Lockdowns, labor shortages, transportation restrictions, and the reallocation of resources toward addressing COVID-19 impacted the procurement, distribution, and delivery of ARVs (11). These disruptions placed people living with HIV (PLHIV) at risk of treatment interruptions, potentially leading to increased viral load, drug resistance, higher morbidity, and mortality (World Health Organization(12). The pandemic highlighted the critical need for resilient healthcare supply chains capable of withstanding crises to maintain continuity of care. ARVs are crucial for achieving viral suppression, preventing disease progression, and reducing the risk of HIV transmission. According to UNAIDS (2020), over 80% of 3 individuals on HIV treatment in low- and middle-income countries rely on first-line regimens such as tenofovir-lamivudine-dolutegravir (TLD) or tenofovir-lamivudine-efavirenz (TLE)(13). Delays in the availability of these medications due to global supply chain constraints posed significant risks to HIV treatment programs. In Rwanda, where ART coverage has reached 92.3% (UNAIDS, 2023), ensuring a continuous supply of ARVs is critical for maintaining this progress. However, the pandemic tested the country’s supply chain resilience, raising questions about the effectiveness of mitigation strategies deployed to sustain medication availability and patient outcomes. Several measures were implemented in Rwanda to mitigate the impact of COVID-19 on the ARV supply chain. These included the introduction of multi-month dispensing (MMD) policies, enhanced stock-level monitoring, and improved coordination among healthcare stakeholders(14). The MMD strategy aimed to reduce the frequency of clinic visits by providing patients with up to six months of ARV supplies(15). This approach sought to limit exposure to COVID-19 while ensuring continued treatment adherence. Additionally, digital inventory tracking systems were strengthened to monitor stock levels and prevent shortages. However, despite these efforts, gaps remain in understanding how effectively these strategies addressed supply chain disruptions and whether they equitably benefited all population groups, particularly rural and underserved communities. Rwanda’s progress toward achieving the UNAIDS 95-95-95 targets underscores the importance of maintaining a stable ARV supply chain. By 2023, 95% of people living with HIV knew their status, 92.3% were on ART, and 91.5% had achieved viral suppression(16). However, the pandemic-induced disruptions risked reversing these gains. Previous studies have shown that even brief interruptions in ARV therapy can result in significant health consequences, including virologic failure and increased HIV-related mortality(17). Furthermore, extended stock-outs and supply chain failures could exacerbate healthcare inequities, disproportionately affecting vulnerable populations with limited access to healthcare services(18). Although global reports highlight the overall impact of COVID-19 on HIV care, limited empirical evidence is available on how supply chain mitigation strategies were operationalized at the country and regional levels, particularly in Kigali. Key questions remain regarding the extent to which Rwanda’s ARV supply chain adapted to the pandemic’s challenges, how mitigation measures influenced supply chain functionality, and the overall 4 impact on patient health outcomes. Evaluating these factors is critical for identifying strengths, weaknesses, and lessons learned to improve future preparedness for health emergencies. This research aims to assess the effectiveness of COVID-19 pandemic mitigation strategies in Kigali’s ARV supply chain. Specifically, it seeks to examine supply chain performance before, during, and after the pandemic, focusing on medication availability, distribution efficiency, and patient access to treatment. The study will evaluate the impact of multi-month dispensing policies, stock-level management systems, and cross-sectoral coordination on ensuring treatment continuity for PLHIV. Additionally, it will investigate disparities in access to ARVs between urban and rural populations, highlighting any inequities exacerbated by the pandemic. By addressing these gaps, the findings will provide actionable insights for strengthening supply chain resilience and enhancing Rwanda’s healthcare system’s ability to respond to future global health crises. 1.5 RESEARCH OBJECTIVES 1.5.1. GENERAL OBJECTIVES To assess the effectiveness of COVID-19 pandemic mitigation strategies (existed contingency plans and emergency protocols) on the antiretroviral (ARV) supply chain in Kigali. in ensuring ARV availability by analyzing disruptions and response strategies. The impact of ARV supply chain resilience on patient outcomes, including treatment adherence, viral suppression, and overall health indicators. 1.5.2 SPECIFIC OBJECTIVES 1. To analyze the impact of COVID-19-related supply chain disruptions on the availability, distribution efficiency, and stock management of ARVs in Kigali. 2. To evaluate the effectiveness of multi-month dispensing (MMD) policies in ensuring treatment adherence and access to ARVs for people living with HIV(PLHIV) during pandemic. 3. To assess the role of digital inventory management and stock-level monitoring systems in mitigating ARV shortages. 5 1.5.3 Research questions 1. How effective were the COVID-19 mitigation strategies in maintaining a resilient antiretroviral (ARV) supply chain at CHUK? 2. What impacts did COVID-19-related supply chain disruptions have on the availability and distribution of ARVs in Kigali? 3. How did the implementation of multi-month dispensing (MMD) policies influence treatment adherence and access to ARVs for people living with HIV (PLHIV) during pandemic? 1.8 Significance of the study This study is significant as it addresses critical gaps in understanding how healthcare supply chains can be managed effectively during global health crisis, specifically focusing on the antiretroviral (ARV) supply chain in Kigali during the COVID-19 pandemic. The findings will contribute to enhancing the resilience and adaptability of healthcare systems in Rwanda and similar contexts, offering a strategy for mitigating future disruptions. 6 CHAPTER 2: LITERATURE REVIEW The COVID-19 pandemic posed unprecedented challenges to global health systems, affecting the supply chain for essential medicines, including antiretroviral therapy (ARV) for people living with HIV(PLHIV). The pandemic underscored vulnerabilities in supply chain systems, highlighting the need for resilient healthcare logistics. This literature review examines previous research on supply chain disruptions and their effectiveness, focusing on ARV supply chain management during health emergencies. 1. HIV/AIDS and ARV supply chain in sub-Saharan Africa HIV/AIDS remains a significant public health challenge globally, with sub-Saharan Africa bearing the highest burden. According to UNAIDS (2019), 25.7 million people in subSaharan Africa were living with HIV, and approximately 16.4 million were on antiretroviral therapy (ART) (13).ART is vital for achieving viral suppression and preventing HIV-related mortality. However, access to consistent medication is dependent on efficient supply chain systems(19). Weaknesses or disruptions in antiretroviral (ARV) supply chains are frequently underestimated contributors to the development of human immunodeficiency virus (HIV) and drug resistance (HIVDR) particularly in low- and middle-income countries (LMICs)(20). Although stock-outs are recognized as a contributor to HIVDR, stock shortages (when a site has a limited a limited quantity of a product, causing healthcare workers to either dispense a smaller amount than prescribed or temporarily substitute components of ARV regimens) are also programmatically relevant, yet rarely reported in peer literature. Most patients in LMICs have initiated HIV treatment using nonnucleoside reverse-transcriptase inhibitor (NNRTI)based regimens, which are particularly susceptible to emergent HIVDR from stock interruption due to their long half-lives. HIVDR appears to be increasing in sub-Saharan Africa. Early warning indicator (EWI) surveys, performed by countries to identify risk for emergent HIVDR, demonstrated higher rates of drug stock-outs (percentages of sites with greater than or equal ARV drug out of stock in the reporting year) in LMIC settings, particularly Eastern (33.1%), western (23.9%), and central Africa (21.9%), compared with 2.9% in all other global regions(20). Before COVID-19, studies on ARV supply chains focused on routine operational challenges, including stock-outs, procurement delays, and inadequate distribution systems(21). These issues were compounded during the pandemic, affecting treatment adherence and increasing 7 the risk of drug resistance(22). Addressing these challenges requires a resilient supply chain capable of absorbing shocks while maintaining continuity in service delivery. 2. Impact of COVID-19 on healthcare supply chain The Supply chain process is the vital link in the delivery of healthcare services. The supply chain is a life-saving, crucial factor fostering the delivery of services and goods to the enduser, which in healthcare is the patient. To a certain extent, managing the healthcare supply chain is difficult due to healthcare systems becoming more uncertain and sophisticated. Each step of the healthcare decision-making process includes a component of uncertainty and risks. Inefficient healthcare supply chain management may induce negative impacts on the healthcare system The COVID-19 pandemic disrupted global supply chains through transportation restrictions, border closures, and labor shortages. Pandemics pose risks to supply chain, causing demand and supply disruptions. The COVID-19 pandemic has resulted in an increased demand for health commodities used to manage COVID-19-related conditions, which may shift the supply chain, affecting the availability and prices of essential health commodities including ARVs(22). The study done in Tanzania revealed that COVID-19 pandemic reduced the availability of health commodities in the community. A total of 216(89%) out of 242 retail community pharmacy workers reported that COVID-19 reduced the availability of health commodities in the market(23). ARV supply chains in low- and middle- income countries (LMICs) were particularly affected due to dependency on international suppliers. Research by Dada et al. highlights that a six-month disruption in ARV supply could result in 500,000 excess deaths in sub-Saharan Africa. Rwanda experienced similar risks, necessitating prompt mitigation strategies(24). 3. Mitigation strategies for ARV Supply Chain Management Various strategies have been implemented to mitigate ARV supply chain disruptions during health crisis: Multi-Month Dispensing (MMD): MMD allows patients to receive several months’ supply of ARVs in a single visit, reducing the frequency of clinic visits and enhancing treatment adherence during lockdowns. During COVID-19 pandemic, it was important to keep people living with HIV away from health-care settings in order to avoid COVID-19 transmission. The pandemic increased the urgency around scaling MMD to reduce the patients’ trips to 8 health facilities while preventing gaps in treatment. GHSC-PSM procured and delivered 90and -180-count bottles of TLD by October 2020, the project rapidly scaled MMD and delivered more than 13 million bottles of TLD to 20 countries. To help countries plan their MMD needs, GHSC-PSM created a dashboard so countries can enter and test scenarios to determine an optimal strategy to accelerate MMD. At the same time there was a need to manage actual dispensing in the coming months depending on the stock and supply of medicines. Rwanda adopted MMD to mitigate COVID-19’s impact, showing promise in maintaining adherence rates (Rwanda Biomedical Center [RBC], 2023). 4. Digital Inventory Management Systems Effective inventory management at different levels of supply chain is an essential strategy to build supply chain resilience. Research by Remko reveals that since the onset if COVID-19, 47% of respondents are considering holding more inventory, and 58% intend to diversify their sourcing strategies to mitigate supply chain risks. When the demand surges occur, inventory provides immediate availability to fill the need. Similarly, in the event of supply disruptions, on-hand inventory serves as a buffer to continue serving the demand. To hedge against demand-side disruptions, firms often employ pre-positioning of emergency supplies. This strategy enables immediate response to demand surges, significantly reducing shortages impact on customer service. Ergun et al. note that pre-positioned inventories are particularly effective in mitigating frequent, large demand surges, as they substantially decrease the response time needed. Conversely, to guard against supply-side disruptions, hospitals and supply chain organizations adopt multiple sourcing strategies. This approach ensures that hospitals can maintain health care commodities inflows even if some supplies face disruptions. However, relying solely on inventory pre-positioning or multiple sourcing has its limitations in managing disruption risk. For instance, while pre-positioning can hedge against demand-side disruptions, maintaining large stockpiles is often costly. Alternative like reserving capacities-referred to as virtual inventory- can be more cost-effective. This approach, complimented by sharing inventory data, implementing Vendor-Managed Inventory (VMI) programs or engaging in collaborative inventory planning. Real-time inventory tracking enhances supply chain visibility and reduces stock-outs. A study demonstrated that digital tools improved ARV availability during COVID-19(25). Similar systems have been used in Kigali to enhance data accuracy and stock management. 9 5. Gaps in literature While various studies have explored ARV supply chain challenges and COVID-19 mitigation strategies, few have conducted a comprehensive evaluation of their effectiveness in Rwanda. Specifically, there is limited empirical evidence on the impact of mitigation strategies on patient adherence, viral suppression, and long-term health outcomes. 10 CHAPTER 3. METHODS 3.0 METHODOLOGY This chapter describes the methods and procedures that will be used to collect and analyze the research data for this study. It consists of different parts including study area, study design, study population, sample size, analysis and, ethical considerations. 3.1 study Area This study will be carried out at CHUK, which is one of the referral hospitals in Rwanda with first HIV clinic Rwanda. The data will be collected from the ARV dispensing services in HIV clinic. The data related to ARV supply chain will be collected from CHUK Central pharmacy which deals with procurement and logistics. 3.2 Study design This study will adopt retrospective research to analyze the effectiveness of mitigation strategies and identify improvement areas, with a focus on comparing existing ARV supply chain data across different phases of the pandemic with patient ARV program data to see the correlation between COVID-19 mitigation strategies in ARV supply chain and patient’s adherence and viral suppression. 3.3 Study Population A simple random sampling method will be used to select 514 adult HIV-positive patients form the whole population on ART from March, 2020- May, 2021. Patients will be assigned with coded IDs for confidentiality. The inclusion criteria include: adult patients (over 18 years), on ART at CHUK during pandemic and after, records available on viral load and refill history. And for the ARV supply chain data from the pharmacy, we will select the most used ARV regimen. 3.4 Sample size determination The number of patients included in the study was determined using Cochran’s formula below: 𝑍 2 𝑝𝑞 𝑛0 = 2 𝑒 11 Where: n = the desired sample size, z = set at 1.645, assuming a confidence interval of 95% p = population proportion, set at 50% q = 1 – p, and e = margin of error, set at 5%. The minimum study sample size is 514. STUDY VARIABLES. Independent variables These are the COVID-19 mitigation strategies or interventions introduced to sustain ARV supply chain and service delivery during the pandemic and after pandemic. These variables are expected to influence HIV patient outcomes. These variables include Multi-Month Dispensing (MMD), and stockout frequency. Dependent variables These are the outcomes that the mitigation strategies in ARV supply chain aim to influence. Patient-level clinical outcomes indicators includes viral suppression rate, missed refills, CD4 count. 3.5 Data collection procedure 3.5.1 Quantitative data collection Secondary data will be collected retrospectively from CHUK HIV clinic patients records and CHUK Pharmacy. Data on stock levels, stock out frequencies will be obtained from supply chain management databases at CHUK pharmacy. Patient adherence data including: ART coverage, adherences rates, and viral suppression outcomes will be collected from CHUK HIV/AIDS clinic. Monthly reports documenting ARV availability and distribution patterns. Confounders: o Age, gender, baseline CD4, ART regimen, duration on ART 3.6 DATA ANALYSIS This research will use Linear regression method of data analysis to understand the relationship between the Supply chain parameters during COVID-19 (independent variables), 12 and patient outcomes (dependent variables). SPSS software will be used to analyze the collected data. 3.7 Ethical considerations The study involves the collection highly sensitive data or information from patient medical records. This requires the informed consent from the patients. However, this is retrospective review of existing records and programmatic data related to antiretroviral (ARV) supply chain performance and patient health outcomes, and involves minimal risk to participants. Hence, obtaining the informed consent from individual patient is impracticable because they will be no contact with the patients, many of whom may no longer receiving care at CHUK and finally for the confidentiality of the patient, avoiding the face to face contact with individual patients is the priority. For that reason, I will request the consent waiver the IRB committee of CHUK before data collection process justifying the reason for the request of the waiver. 13 CONSENT WAIVER REQUEST LETTER Adiel TUYITEGEREZE Pharmacy Department On 3rd, July 2025 The chairperson CHUK Institutional Review Board (IRB) Kigali, Rwanda Subject: request for waiver of informed consent research on COVID-19 Mitigation Strategies and ARV Supply Chain Resilience at CHUK. Dear CHUK IRB committee, I am writing to respectfully request a waiver of informed consent for my research study titled: “ASSESSING THE EFFECTIVENESS OF COVID-19 MITIGATION STRATEGIES IN ARV SUPPLY CHAIN ON HIV PATIENT OUTCOMES AT CHUK, RWANDA.” This study involves a retrospective review of existing records and programmatic data related to antiretroviral (ARV) supply chain performance and health outcomes during and after the implementation of COVID-19 mitigation strategies at CHUK. Justification for Waiver Request This request is made in accordance with ethical guidelines and regulatory provisions that allow for a waiver of informed consent under the following criteria, which this study meets: 1. Minimal Risk to participants. The study involves no more than minimal risk as it uses only routinely collected de-identified data from hospital records and supply chain reports. There will be no direct contact with patients, no intervention, and no collection of new personal data. 2. Impractically of conducting the research without the waiver 14 Obtaining individual consent form for a large number of patients, many of whom may no longer be receiving care at CHUK or may not be reachable, would be impracticable and could introduce selection bias that compromises the validity of the study. 3. De-identified Data (Data anonymization) Only de-identified data will be analyzed. Patients names, medical record numbers, and other direct identifiers will not be recorded in the data abstraction process. Conclusion Given the above points, I kindly the CHUK IRB to grant a waiver of informed consent for this study. This waiver of informed consent for this study. The waiver will enable timely and ethical execution of the study that has the potential to contribute to better preparedness and resilience in Rwanda’s healthcare system. Thank you for consideration. Sincerely 15 APPENDIX 1: WORK PLAN This table represents the timeline in research proposal writing to the final dissertation presentation. ACTIVITY 2025 May June July August September October Final draft of research proposal ready X Submission of Research Proposal for Review in the department Proposal defense Final Proposal Ready X Submission to Ethics Committee X Getting ethical approval X x Data collection X Data analysis Writing dissertation X Submission of a dissertation Defense X 16 APPENDIX 2: BUDGET ACTIVITIES QUANTITY UNIT TOTAL (RWF) PRICE(RWF) Printing and 60 pages 100 6000 1 50,000 50,000 2 50,000 100,000 Internet 10 5000 50,000 voice call 10 1000 10,000 3000 60,000 10000 10,000 Miscellaneous 30,000 30,000 Total 149,100 316,000 photocopying Data analysis software Data collection labor Transport Report cover 1 17 References 1. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-treatment-basics [Internet]. HIV Treatment: The Basics | NIH. 2. Jardim CGR, Zamani R, Akrami M. Evaluating the Impact of the COVID-19 Pandemic on Accessing HIV Services in South Africa: A Systematic Review. Vol. 19, International Journal of Environmental Research and Public Health. MDPI; 2022. 3. Unaids. The impact of the COVID-19 response on the supply chain, availability and cost of generic antiretroviral medicines for HIV in low- and middle-income countries. 4. UNAIDS data 2020. 5. https://www.unaids.org/en/resources/fact-sheet [Internet]. Global HIV & AIDS statistics — Fact sheet. 6. COUNTRY PROGRESS REPORT RWANDA. 2012. 7. UNAIDS data 2020. 8. Galindo G, Batta R. Review of recent developments in OR/MS research in disaster operations management. Eur J Oper Res. 2013 Oct;230:201–11. 9. Hospital Preparedness for Epidemics [Internet]. 2014. Available from: www.who.int 10. https://www.who.int/news/item/06-07-2020-who-access-to-hiv-medicines-severelyimpacted-by-covid-19-as-aids-response-stalls [Internet]. WHO: access to HIV medicines severely impacted by COVID-19 as AIDS response stalls. 11. Unaids. The impact of the COVID-19 response on the supply chain, availability and cost of generic antiretroviral medicines for HIV in low- and middle-income countries. 12. https://www.who.int/publications/i/item/9789240038608 [Internet]. HIV drug resistance report 2021. 13. https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/202 18 4/june/20240614_day-african-child [Internet]. UNAIDS urges sub-Saharan African countries and global partners to ensure children living with HIV are on life-saving treatment and to stop new infections. 14. https://www.kff.org/report-section/covid-19-pepfar-implications-for-the-future-issuebrief/ [Internet]. COVID-19 & PEPFAR: Implications for the Future - Issue Brief 9471 | KFF. 15. Mantell JE, Zech JM, Masvawure TB, Assefa T, Molla M, Block L, et al. Implementing six multi-month dispensing of antiretroviral therapy in Ethiopia: perspectives of clients and healthcare workers. BMC Health Serv Res. 2023 Dec;23. 16. https://www.unaids.org/en/resources/fact-sheet [Internet]. Global HIV & AIDS statistics — Fact sheet. 17. Foka FET, Mufhandu HT. Current ARTs, Virologic Failure, and Implications for AIDS Management: A Systematic Review. Vol. 15, Viruses. Multidisciplinary Digital Publishing Institute (MDPI); 2023. 18. https://www.who.int/news/item/01-06-2020-covid-19-significantly-impacts-healthservices-for-noncommunicable-diseases [Internet]. COVID-19 significantly impacts health services for noncommunicable diseases. 19. document. 20. Minior T, Douglas M, Edgil D, Srivastava M, Crowley J, Firth J, et al. The Critical Role of Supply Chains in Preventing Human Immunodeficiency Virus Drug Resistance in Low-And Middle-Income Settings. Journal of Infectious Diseases. 2017;216:S812– 5. 21. Aloqab A, Hu W, Abdulraqeb OA, Mohammed O, Raweh B. The Impact of the Corona Virus on Supply Chains: Opportunities and Challenges. Review of Economic Assessment. 2024 Jan;2:37–48. 22. Bwire G, Sack DA, Almeida M, Li S, Voeglein JB, Debes AK, et al. Molecular characterization of Vibrio cholerae responsible for cholera epidemics in Uganda by PCR, MLVA and WGS. PLoS Negl Trop Dis. 2018 Jun;12. 19 23. Ipagala P, Mlugu EM, Mwakalukwa R, Kagashe GA. Impact of COVID-19 on the supply chain of essential health commodities: a mixed method study, in Dar es Salaam, Tanzania. J Pharm Policy Pract. 2023 Dec;16. 24. Jewell BL, Mudimu E, Stover J, ten Brink D, Phillips AN, Smith JA, et al. Potential effects of disruption to HIV programmes in sub-Saharan Africa caused by COVID-19: results from multiple mathematical models. Lancet HIV. 2020 Sep;7:e629–40. 25. Guo Y, Liu F, Song JS, Wang S. Supply chain resilience: A review from the inventory management perspective. Fundamental Research. KeAi Communications Co.; 2024. 20 Data collection forms HIV patient data collection form 1. Demographics Age: Below 20 21-35 Gender: Male 36-50 above 50 Female Marital status: Single Married divorced widow Duration on ART: 2. ARV ADHERENCE Variable Data Number of missed doses (COVID-19 period) Number of missed clinics visit due to COVID19 Was the patient stopped refilling ARVs at CHUK due to COVID-19 Frequency of medication pick-up o Every 1 month o Every 3 months o Every 6 months 3.CLINICAL OUTCOMES Variable Data Last viral load measurement during (COVID19) Date of last load test Viral suppression status CD4 count o Suppressed (<200 copies/mL) o Not suppressed (≥ 200 copies/mL) ……………. Cells/𝑚𝑚3 21 ARV SUPPLY CHAIN DATA COLLECTION 1. ARV supply chain and availability Variable Data Stock-out occurrences during COVID-19 Yes No Duration of stock-outs ……… days Frequency of multi-month dispensing 22 o Monthly o 2-months o 3-months o 6 months COVER LETTER Huye, Rwanda 24th January,2025 The chairperson of UR-CMHS Institutional Review Board Dear sir, Re: Application for ethical clearance of research proposal titled: ASSESSING THE EFFECTIVENESS OF COVID-19 MITIGATION STRATEGIES IN ARV SUPPLY CHAIN ON HIV PATIENT OUTCOMES AT CHUK, RWANDA. I am a final year pharmacy student at university of Rwanda and we’re obligated to carry out a research project that’s why I am writing to formally request an ethical clearance for research proposal with the title mentioned above. I have attached essential documents for approval by your committee. While I’m waiting for your positive feedback, Thank you! Sincerely, Adiel TUYITEGEREZE 23 CURRICULUM VITAE Personal identifications Name: Adiel Surname: TUYITEGERERE Father: MUHAYIMANA Eliezel Mother: NYIRANGENDAHAYO Donathile Gender: male Nationality: Rwandan Marital status: Single Date of birth: 24/12/1997 E-mail: adieltuyitegereze@gmail.com Phone number: +250780444931 Place of birth: RUSIZI District, western province Education Level Institution Year of study Primary school Groupe scolaire Kagugu 2007-2012 Ordinary level College 2013-2015 INYEMERAMIHIGO Advanced level Groupe Scolaire JANJA 2016-2018 2019 to now: currently studying in University of Rwanda in Bachelors of Clinical Pharmacy and Pharmacy Practice. 24 Employment Nursey school teacher at IRERERO Nursery school from 2018 to 2019 Experience Intern at Butare University Teaching Hospital (CHUB) for 2 months in 2024 Intern at RMS HUYE Branch for 2 weeks in 2024 Intern at UNIPHARMA Ltd 3 months in 2024 Senior clerkship at KIGALI University Teaching Hospital for 4 months from mid-September, 2024 to mid-January, 2025 Languages English: fluently Kinyarwanda: fluently French: Beginner Hobbies Playing guitar Playing football Running REFERENCES 1. Evariste RUBOHA, RMS HUYE branch Director Phone number: +250783816887 2. Phn Ariella MANIRAMBONA, UNIPHARMA KAGUGU branch Phone number: +25078345205 3. Mr. Olivier clement MUBANO Email: mubocbenii@gmail.com 25 PROTOCOL SUMMARY FORM SECTION A: Project Information Project title: ASSESSING THE EFFECTIVENESS OF COVID-19 MITIGATION STRATEGIES IN ARV SUPPLY CHAIN ON HIV PATIENT OUTCOMES AT CHUK, RWANDA Investigator: Adiel TUYITEGEREZE Student No. 220002895 Co-Investigators (if applicable): Supervisor/s: (if applicable) Mr. Olivier clement MUBANO Contact details of Phone Investigator: +250780444931 Fax E-mail adieltuyitegereze@gmail .com Degree enrolled in Bachelor’s with honor in pharmacy (if applicable): Project location: NYARUGENGE, KIGALI Project duration: 5 months SECTION B: Ethical Review Application (To be filled by Applicant (s)) Please answer all of the following questions 26 1. Who are the research participants and how will they be recruited? The study will include only the data of ARV supply chain at CHUK during and after COVID-19 pandemic and the data of patients who has been taking Antiretroviral medications at CHUK during, and after C OVID-19 pandemics from February 2020 to May 2021. 1.1. Etc 2. Provide a brief summary of the project: This cross-sectional retrospective study aims to assess the effectiveness of C0VID-19 mitigation strategies on the ARV supply chain and its patients’ outcomes in Kigali. Conducted at CHUK HIV Clinic and pharmacy, the study will analyze patient medical records and supply chain data from March 2020, to May, 2021. Key variables include ARV adherence rates, viral load suppression, stock-outs durations, and the implementation of strategies such multi-month dispensing. Statistical methods will evaluate the impact of these interventions on treatment continuity and outcomes. 3. Outline the research plan: After the finalizing the research and submit to the university for the ethical clearance, I’ll submit to the CHUK Institutional Review Board for the ethical approvals. After getting ethical approval from CHUK, the following month is for data collection: patients’ records and pharmacy data. Third month: Data arrangement and validation, cross-checking data and missing values. Fourth month: Data analysis, perform statistical analysis using SPSS and correlate mitigation strategies with key variables. Fifth month: report writing and dissemination, prepare research report, including results and recommendations. 4. How will informed consent and assent (where applicable) be obtained from participants? 5. Provide details of procedures for establishing confidentiality and protecting privacy of participants. Personal information will remain confidential and will not be linked to the extracted data. All data will be anonymized and stored securely No identity details will be shared in reports and publications 6. Provide details of data collection, security and storage This study will collect retrospective data from CHUK HIV clinic and pharmacy, focusing on ARV 27 adherence, viral suppression, and stock-out trends. Data will be anonymized during collection, with personal identifiers removed. Collected data file will be restricted with password which can be opened by researcher and supervisor only. 7. Give details of whether and/or how feedback will be available to participants: Not applicable 8. Does the project involve any of the following procedures? a) The possibility of physical or psychological injury, stress and/or discomfort? (If YES, give details No b) Participant involvement by any “vulnerable groups.” (If YES, give details) No c) Does the project involve any other disciplines and/or Ethics Committees? (If YES, please state which and what approval has already been obtained - attach documentation.) CHUK Institutional Review Board for the ethical approvals, not yet available. d) Will payments to participants be made? (If YES, state amount and whether payment is for out-ofpocket expenses, or a fee.) No e) Will the project receive financial support? (i) If YES, specify the nature and source of the support (ii) If YES, have any restrictions been imposed upon the conduct of the research? (If YES, specify the nature of the restrictions) No 28 f) Will any restrictions be placed on the publication of results? (If YES, please state the nature of the restrictions) No g) Are there any other points you wish to make in justification of the proposed study? No h) Please complete the items on the checklist shown below. (Write either YES or YES/NO NO in the box following each item) i. Have you completed all the questions on this form that are applicable to your YES project? ii. Have you attached a covering letter? YES iii. Have you attached the full protocol? YES iv. Have you attached a letter of recommendation from the school /department NO (for students)? v. Have you attached an informed consent form and Assent form (for NO children between 7-20 years, if applicable) in both English and Kinyarwanda (see below)? vi. Have you attached a sample questionnaire or interview schedule, data YES capture sheets for lab work (if applicable) in English and Kinyarwanda? vii. Have you attached a draft material transfer agreement (if applicable, in case NO you expect to transfer samples outside the country)? 29 viii. Have you attached the Curriculum vitae (CVs) of all investigators to also YES include email address, phone contacts, affiliation, academic background, research publications and research projects undertaken? ix. Have you attached Certificate of research ethics training and/or GCP YES (Good Clinical Practice)/RCR (Responsible Conduct of Research) course from the Principal Investigators? x. Have you attached the budget? YES xi. Have you attached the progress report and the previous ethical clearance NO (for amendment of protocol or renewal of ethical clearance)? xii. Have you attached receipt of payment of submission fee (also applicable to protocol amendment or renewal of ethical clearance)? Signature of Proposer: date: 03/02/2025 30 NO 31
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