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