Short Course in Research Methodology

Research title: PREVALANCE OF HEPATITIS B CO

INFECTION IN HIV POSITIVE PATIENTS
2023-2024

Title, initials and surname of student: Dr Nazima Latif

Student number: FPD018562
School: FPD
E-mail address of researcher: dr.nmlatif@gmail.com

Title, initials and surname of supervisor:

University or institution:
E-mail address of supervisor:

Date of submission: 29.08.2024

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1.Introduction:
Hepatitis B is a liver infection caused by the Hepatitis B virus (HBV), which is
transmitted through contact with blood, semen, or other bodily fluids from an
infected person (Trépo C et al, 2014). The risk of contracting hepatitis B
increases with unprotected sexual activity, particularly with multiple partners
or with someone infected with HBV, as well as through intravenous drug use
by sharing needles. (Spradling PR et al, 2010). The risk of contracting Hepatitis
B infection is higher in a male who engages in sexual activity with other men,
live with a person who is chronically infected with HBV, or a child born to an
infected mother, and a profession where there is contact with human blood.
(Platt L et al 2020). More-over, travel to areas like Asia, the Pacific Islands,
Africa, and Eastern Europe that have high prevalence of HBV infection also
increase the risk of Hepatitis B infection. (Patel EU et al, 2019)
Hepatitis B can be acute, typically lasting less than six months, or chronic,
persisting for longer. Chronic hepatitis B increases the likelihood of developing
severe liver complications such as liver cancer, liver failure, and cirrhosis,
which results in permanent liver scarring. (Thio CL et al 2002). Acute hepatitis B
may cause a range of symptoms from mild to severe, including fever, dark
urine, muscle and joint pain, nausea, vomiting, loss of appetite, fatigue, and
jaundice. Symptoms usually appear one to four months after infection,
although they can manifest as early as two weeks post-infection. In some
cases, particularly in young children, symptoms may not appear at all. Even
when symptoms are severe, most adults fully recover from hepatitis B, but
children and infants are particularly vulnerable. (World Health Organization)
Chronic HBV infection can lead to severe complications. The liver inflammation
caused by hepatitis B can result in cirrhosis, impairing liver function. In some
cases, acute liver failure may occur, necessitating a liver transplant for survival.
Individuals with chronic hepatitis B and a suppressed immune system, such as
those on immunosuppressive medications or undergoing chemotherapy, are at
risk of HBV reactivation, which can cause significant liver damage or failure.
Moreover, chronic hepatitis B may lead to liver cancer, kidney disease, or
inflammation of blood vessels.
2. Background and Literature review:

It has been estimated that globally there are about 35 million people living
with HIV and 360 million had chronic hepatitis B infection (World Health
organisation,2019). The global prevalence of prolonged hepatitis B infections,
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including both active and inactive chronic forms, is close to 360 million. (M.
Torbenson et al, 2002).
The prevalence of hepatitis B virus alone amongst South African population has
been reported in the pre-HIV era. It is estimated that the prevalence of
hepatitis B mono-infection in South Africa is about 10% in the rural population
and 1% in urban areas. (Burnett RJ et al 2005). Despite the high prevalence of
HIV that has been reported in the general population of South Africa as the
viruses have similar modes of transmission, the rate of HIV/HBV co-infection is
poorly reported.
Viral co-infection, particularly involving hepatitis B virus (HBV) and human
immunodeficiency virus (HIV), occurs frequently in various combinations
among patients, leading to heightened morbidity and mortality. (World Health
Organization 2022). The co-infection of HBV and HIV presents a significant
public health challenge, especially in regions where both viruses are highly
prevalent. Understanding such a scenario, concerning patient health and the
effective management strategies in improving patient outcomes by mitigating
further complications, is obligatory. Various studies have shown that the
prevalence of HIV in European countries is lower than African and Asian
countries. 15.4% (27 cases) out of 175 HIV positive Italian patients were co-
infected with HBV (Morsica G, et al.2009). Geographic HBV co-infection in
individuals infected with HIV varies. HBV-HIV co-infection is more common in
areas like sub-Saharan Africa and East Asia where there is a greater baseline
level of HBV infection. It has been estimated that 5–10% of all HIV-positive
individuals also have HBV chronically. (Firnhaber C., et al 2010) As a result, the
frequency of co-infection with these viruses via intravenous drug use, mother-
to-child transmission, and sexual contact complicates the extent of co-infection
even more.
Pathogenesis and Immunological Impact
The interaction between the two viruses creates a very complex natural
history. HIV increases HBV-related disorders, including cirrhosis, hepatocellular
cancer, and liver-related death. HIV-induced immunosuppression is related to
a worse immune response against HBV, which enhances chronicity and HBV
replication. Conversely, chronic HBV infection can accelerate the course of HIV
disease and affect the efficacy of ART.
Clinical Presentation

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Co-infected patients may manifest evidence of more aggressive liver disease
compared to those with HBV or HIV mono-infection. This is characterized by
asymptomatic to severe liver dysfunction, which manifests as jaundice,
hepatomegaly, and liver failure. Coinfection is linked with a higher incidence of
abnormal liver enzymes and more rapid progression to cirrhosis and liver
cancer.
Diagnosis
According to the South African HIV guidelines programme, a plan called the
Comprehensive Care, Management Treatment programme does not include
viral hepatitis studies (Tshabalala- Msimang ME, et al. 2003). Hepatitis B
serology is done only if serum aminotransferases are quite elevated in the
absence of another known cause like tuberculosis and concomitant
medications. Three studies documenting the South African prevalence of
HIV/HBV coinfection were a retrospective unmatched control laboratory-based
study by Mphahlele J et al. in 2006, a prospective study looking at patients
admitted to hospital (Lodenyo H et al. in 2000), and a retrospective study of a
cohort originating from the South African goldmines (Hoffman C et al. in 2007).
The co-infection rate varied from 6% to 17%. The diagnosis of HBV co-infection
in HIV patients is made using serology and molecular testing. HBsAg, anti-HBc,
and HBV DNA levels are some of the important markers. It is regular follow-up
for liver function tests and viral loads that remains the hallmark of maintaining
effective management of co-infected patients.
Treatment and Management
In patients co-infected with HBV and HIV, management against both viruses
must be complete. Drugs found to have activity against HBV are usually
included in ART for HIV, such as tenofovir and lamivudine. (Nunez M et
al,2003). Such dual activity against both viruses and possible drug-drug
interactions have to be considered when choosing ART. This treatment should
aim at the suppression of the virus, liver function betterment, and prevention
of the progression of liver disease.
Considerations and Challenges of Drug Resistance: The fear of drug resistance
is enormous, especially in lamivudine monotherapy, where the outstanding
risk of HBV resistance is already real. A combination with tenofovir is preferred
over monotherapy to reduce this risk.

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Hepatotoxicity Associated with ART: ART regimens may cause hepatotoxicity
and hence complicate the management of liver disease in co-infected patients.
(Hoffman C J)The need for frequent monitoring and therapy adjustment
cannot be overemphasized in mitigating these risks.
Vaccine response: The response of HIV-positive patients to the HBV vaccine
may be poor. Large doses or booster doses are necessary to achieve adequate
immunization.
Prevention
Preventive measures mainly include routine screening for HBV in HIV-positive
patients, vaccination against HBV in non-infected individuals, and harm-
reduction strategies in patients at risk of acquiring these infections. Notably,
education and counselling in using safe practices, such as safe sex and not
sharing injection equipment are other important part of prevention.
Conclusion

One of the most challenging aspects of Hepatitis B co-infection in HIV-positive

patients is associated with complex interactions between the two viruses,
coupled with an increased risk for serious liver disease. Early diagnosis,
appropriate antiretroviral therapy, regular monitoring by the multidisciplinary
team, and preventive measures are necessary. Continuous research and
optimal health care strategies are necessary if the burden of co-infection is to
be met and the lot of the patient

Taking these factors into account, the primary goal of this review article was to
compile and evaluate the most recent, pertinent research on the prevalence of
hepatitis B co-infection among HIV positive individuals globally.

3. Research Aim:

To study the Prevalence of Hepatitis B co infection in HIV positive patients

which can provide a comprehensive understanding of Hepatitis B co-infection
in HIV positive patients, clinical practices, informing public health policies and
future research directions.

4. Research objectives:

 To describe and determine the prevalence of HBV infection amongst

HIV-positive patients: To estimate the proportion of HIV positive

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 patients who are also infected with Hepatitis B in a specific population or
setting. Understanding the prevalence helps in gauging the extent of the
problem and planning appropriate healthcare responses
 To assess the clinical implications of HBV/HIV co-infection. This will
assist us to compare the clinical outcomes (e.g., liver-related morbidity
and mortality and progression to AIDS) between HIV positive patients
with and without Hepatitis B co-infection. This objective aims to
understand how co-infection affects disease progression and patient
health.
 To evaluate the current management strategies and their
effectiveness. To examine the impact of different ART regimens on the
control and progression of Hepatitis B infection in HIV positive patients
we need to evaluate the effectiveness of Antiretroviral Therapy (ART) on
Hepatitis B Co-Infection Management which focuses on optimizing
treatment strategies for co-infected patients. This can help in developing
targeted interventions for prevention and management.
5. Research questions:

 What is the prevalence and incidence of Hepatitis B co-infection among

HIV positive patients in the study population?
 What is the demographic, behavioural, and clinical risk factors for
Hepatitis B co-infection in HIV positive patients?
 What are the clinical outcomes and complications associated with
HBV/HIV co-infection?
 What are the current management strategies for HBV/HIV co-infection,
and how effective are they?
 What are the key challenges and gaps in research related to HBV co-
infection in HIV-positive patients?
6. Research Methods:

The purpose of research method is to familiarise the researcher in the processes

used during the data collection necessary for the research purposes and create a
better understanding of the topic when new information is uncovered. It allows us to
understand the approach taken and methods used to reach the conclusion (Brink et
al.,2016). For this study, the research methodology will be as follows:
6.1 Study Paradigm

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Objective: To systematically review and synthesize existing research on the
epidemiology, clinical outcomes, management strategies, and challenges related to
Hepatitis B (HBV) co-infection in HIV-positive patients.
The co-infection of hepatitis B virus (HBV) and human immunodeficiency virus (HIV)
presents significant clinical challenges and increases morbidity and mortality. This
systematic literature review aims to synthesize existing research on the prevalence,
clinical implications, and management of HBV co-infection in HIV-positive patients.
6.2 Study Design
1.Literature Search Strategy
 Databases:
 PubMed/MEDLINE
 Embase
 Cochrane Library
 Scopus
 Web of Science
 Search Terms:
 "Hepatitis B" OR "HBV"
 "HIV" OR "HIV-positive" OR "AIDS"
 "Co-infection" OR "coinfection"
 "Epidemiology" OR "prevalence" OR "incidence"
 "Clinical outcomes" OR "disease progression" OR "liver disease"
 "Management" OR "treatment" OR "antiretroviral therapy" OR "ART"
 "Challenges" OR "barriers" OR "gaps"
 Inclusion Criteria:
 Studies published in peer-reviewed journals.
 Studies focusing on HIV-positive patients with HBV co-infection.
 Articles published in English.
 Both observational and interventional studies.
 Exclusion Criteria:
 Studies not specific to HBV co-infection in HIV-positive patients.
 Case reports, editorials, and reviews not presenting primary data.
 Studies with insufficient data on co-infection outcomes or management.
2.Screening and Selection Process
Initial Screening:
 Titles and abstracts of all retrieved articles will be screened independently by
two reviewers.
 Articles that do not meet the inclusion criteria will be excluded at this stage.
 Full-Text Review:

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  The full text of potentially relevant articles will be reviewed
independently by two reviewers.
 Disagreements will be resolved through discussion or consultation with
a third reviewer.
 Data Extraction:
 A standardized data extraction form will be used to collect relevant information
from each study, including:
 Study design and setting
 Population characteristics (e.g., age, gender, HIV status)
 Prevalence and incidence of HBV co-infection
 Clinical outcomes (e.g., liver disease progression, mortality)
 Management strategies and ART regimens
 Challenges and barriers to care
 Key findings and conclusions
3. Quality Assessment
Assessment Tools:
 The quality of included studies will be assessed using appropriate tools based
on study design:
 Observational Studies: Newcastle-Ottawa Scale (NOS) for cohort and case-
control studies.
 Interventional Studies: Cochrane Risk of Bias tool for randomized controlled
trials (RCTs).
Criteria:
Studies will be evaluated based on criteria such as selection bias, confounding
factors, measurement of exposure and outcomes, and statistical analysis.
4. Data Synthesis and Analysis
Qualitative Synthesis:
 A narrative synthesis will be conducted to summarize the findings of the
included studies.
 Studies will be grouped based on research questions, such as epidemiology,
clinical outcomes, and management strategies.
 Quantitative Synthesis (Meta-Analysis):
 If the data allow, a meta-analysis will be conducted to estimate pooled
prevalence rates, relative risks, or odds ratios.
 Heterogeneity will be assessed using the I² statistic, and subgroup analyses
will be performed where appropriate.
 Publication bias will be assessed using funnel plots and Egger's test.
5. Discussion and Conclusion

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Interpretation of Findings:
The results will be discussed in the context of the existing literature, highlighting key
trends, patterns, and discrepancies.
The impact of HBV co-infection on HIV-positive patients, including the implications
for clinical practice and public health, will be explored.
Limitations:
Potential limitations of the review, such as publication bias, language bias, and
heterogeneity among studies, will be acknowledged.
Future Directions:
Gaps in the current research will be identified, and recommendations for future
studies will be made.
Strategies to improve the management and outcomes of HBV co-infection in HIV-
positive patients will be proposed.
6. Reporting
PRISMA Guidelines:
The systematic review will be conducted and reported in accordance with the
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
guidelines.
Registration:
The review protocol will be registered with PROSPERO, the international prospective
register of systematic reviews, to ensure transparency and reproducibility.
This study paradigm outlines a comprehensive approach to conducting a systematic
literature review on HBV co-infection in HIV-positive patients, ensuring a rigorous
and methodical analysis of the available evidence.

6.3 Study population and study setting

When conducting a systematic literature review on Hepatitis B co-infection in
HIV-positive patients, defining the study population and study setting is crucial
for establishing the scope and focus of the review.
1. Study Population
The study population refers to the specific group of individuals whose data will
be analysed in the systematic review. For a review on Hepatitis B co-infection
in HIV-positive patients, the study population would typically include:
 HIV-Positive Individuals: The primary population of interest consists of
individuals diagnosed with HIV.

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  Hepatitis B Virus (HBV) Co-infection: The review will focus on those HIV-
positive individuals who are also co-infected with Hepatitis B. This
includes both chronic HBV carriers and those with active HBV infection.
 Demographic Considerations: Depending on the scope of the review,
you might further specify subpopulations based on:
 Age: Adults, adolescents, or paediatric populations.
 Gender: Male, female, or other gender identities.
 Geographical Location: Populations from specific regions (e.g.,
Sub-Saharan Africa, Asia, or North America), depending on the
prevalence of HBV/HIV co-infection.
 Ethnicity/Race: Populations belonging to specific ethnic or racial
groups, if relevant to the study's aims.
 Clinical Status: Individuals at different stages of HIV infection (e.g.,
early-stage, late-stage) or with varying levels of immune
suppression (e.g., CD4 count).
2. Study Setting
The study setting describes the environments and contexts from which the
data on the study population are drawn. For this systematic review, the study
setting might include:
 Healthcare Settings:
 Hospitals: Data from inpatient and outpatient departments,
particularly infectious disease or hepatology units.
 Clinics: HIV treatment centres, liver clinics, and primary care
clinics providing services to HIV-positive patients.
 Specialized Care Centres: Centres focusing on the management of
viral infections, including co-infections.
 Geographical Scope:
 Global Perspective: A broad review may include studies from
multiple regions worldwide, comparing the burden of co-infection
across different healthcare settings.

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  Regional Focus: Alternatively, the review could focus on specific
regions or countries with high prevalence rates of HIV and HBV,
such as Sub-Saharan Africa, Southeast Asia, or Eastern Europe.
 Healthcare Access:
 High-Income vs. Low- and Middle-Income Countries (LMICs): The
review could compare outcomes and healthcare challenges in
different income settings.
 Urban vs. Rural: Examining differences in access to care,
treatment adherence, and outcomes based on the urbanization
level of the study settings.
 Time Frame:
 Historical Data: Studies may span over different time periods to
observe trends in co-infection rates, treatment advancements, or
changes in clinical outcomes over time.
 Current Data: Focusing on more recent studies might be relevant
to understanding the impact of newer antiretroviral and antiviral
therapies on HBV/HIV co-infected patients.
 Healthcare Systems:
 Public vs. Private Healthcare: Studies from public health
institutions versus private healthcare settings may be considered
to understand differences in patient outcomes and access to
treatment.
 Resource Availability: The availability of diagnostic tools, antiviral
treatments, and regular follow-up care in different settings could
be a factor of interest.
6.4 Inclusion and exclusion criteria
Inclusion Criteria:
 Studies published in peer-reviewed journals.
 Studies involving HIV-positive patients co-infected with HBV.
 Studies reporting on prevalence, clinical outcomes, or management
strategies.
 Studies with a clear methodology and adequate sample size.

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 Exclusion Criteria:
 Non-English language studies (unless translated).
 Case reports, editorials, and reviews without original data.
 Studies without clear diagnostic criteria for HBV or HIV.
Variables
When conducting a study, it's essential to identify and define the key
variables that will be analyzed. Below is an outline of how you might
categorize and describe the variables for a systematic literature review
combined with meta-analysis on the prevalence of hepatitis co-infection
in HIV-positive patients.
1. Independent Variables (Explanatory Variables)
 HIV Status: Whether the individual is HIV-positive or not (though the
focus is on HIV-positive individuals).
 Type of Hepatitis Co-infection:
o Hepatitis B (HBV) Co-infection: Presence or absence of Hepatitis B
virus.
o Hepatitis C (HCV) Co-infection: Presence or absence of Hepatitis C
virus.
 Geographical Region: Region or country where the study was conducted
(e.g., Sub-Saharan Africa, Southeast Asia, North America).
 Demographic Variables:
o Age Group: Age range of the study participants (e.g., children,
adolescents, adults, elderly).
o Gender: Gender of the study participants (e.g., male, female,
other).
o Ethnicity/Race: Ethnic or racial background of the study
participants.
 Year of Study: The year or range of years during which the data was
collected.
 Study Design: Type of study (e.g., cross-sectional, cohort, case-control).
 Healthcare Setting: Type of healthcare facility where the data was
collected (e.g., hospital, clinic, community-based).
2. Dependent Variables (Outcome Variables)
 Prevalence of Hepatitis B Co-infection: The proportion of HIV-positive
patients who are also infected with Hepatitis B.
 Prevalence of Hepatitis C Co-infection: The proportion of HIV-positive
patients who are also infected with Hepatitis C.
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  Overall Prevalence of Hepatitis Co-infection: The combined prevalence
of either Hepatitis B or C in HIV-positive patients.
3. Control Variables (Covariates)
 CD4 Count: The immune status of the patient as measured by CD4 cell
count (e.g., <200 cells/µL, 200-499 cells/µL, ≥500 cells/µL).
 Antiretroviral Therapy (ART) Status: Whether the HIV-positive patients
are on ART or not, and the type of ART regimen.
 Liver Function Tests: Indicators of liver function (e.g., ALT, AST levels).
 Socioeconomic Status: Indicators such as income level, education level,
or employment status.
4. Moderator Variables
 Adherence to ART: The level of adherence to antiretroviral therapy,
which might moderate the relationship between HIV and hepatitis co-
infection.
 Vaccination Status: Whether the individual has been vaccinated against
Hepatitis B, which might influence the prevalence rates.
5. Confounding Variables
 Injection Drug Use: A known risk factor for both HIV and hepatitis, which
could confound the relationship between the two infections.
 Sexual Behaviour: Risky sexual behaviours that could increase the risk of
co-infection.
 Alcohol Use: Alcohol consumption, which can affect liver function and
might be associated with higher rates of hepatitis.
6. Outcome Measurement Variables
 Diagnostic Criteria for HIV: Methods used to diagnose HIV infection
(e.g., ELISA, Western blot).
 Diagnostic Criteria for Hepatitis: Methods used to diagnose Hepatitis B
or C (e.g., HBsAg, anti-HCV antibodies, PCR for viral load).
 Study Quality Assessment: A variable assessing the quality of the studies
included in the review, based on standardized criteria.
By carefully defining and measuring these variables, the study can
accurately estimate the prevalence of hepatitis co-infection among HIV-
positive patients and explore the factors that influence this prevalence
6.5 Measures to ensure data quality
To collect data according to the study protocol, ensuring consistency and
accuracy.

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  To monitor and supervise data collection activities to maintain quality
control.
 To enter data into a secure, standardized database.
 To perform regular data cleaning and validation to ensure accuracy and
completeness.
 To use unique identifiers to maintain participant confidentiality and
enable data linkage across different data sources.
6.6 Data Analysis Plan
A well-structured data analysis plan is essential to systematically address the
research objectives. The data analysis plan process involves Data Preparation
and Data Cleaning which identifies and correct errors, remove duplicates, and
handle missing data. Then data accuracy is verified by cross-checking with
source documents and statistical techniques are used to handle missing data
(e.g., imputation, exclusion). The categorical data is converted into numerical
codes for analysis by data coding and numerical codes are assigned to
categorical variables (e.g., gender: 1 for male, 2 for female). The thematic
analysis is a qualitative method for identifying, analysing, and reporting
patterns within data (Braun and Clarke 2006). It is widely used to provide a rich
and detailed account of the data.
7. Ethical considerations:

Listed here are some ethical considerations to consider when conducting a

systematic literature review on Hepatitis B co-infection in HIV-positive patients:

1. Confidentiality and Privacy

Protection of Data: This study must ensure that any information obtained from
patients used in the studies to be reviewed are anonymized to protect
individual privacy. Although a systematic review usually only uses aggregated
data, the reviewers must check that at least the original studies adhered to
privacy and confidentiality standards.

Responsible Data Use: Use the data responsibly, whereby the arrangement for
licensing and data use should ensure no derogatory inferences are drawn
regarding or that may stigmatize the population under study.

2. Bias and Integrity

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Provide No Selection Bias: Literature search needs to be full and without bias.
Exclusion on criteria such as language, publication, geography, and others must
be justified.

Transparency: Clearly document the search strategy, inclusion/exclusion

criteria, and reasons for study exclusion to maintain transparency in the review
process.

Conflict of Interest: State any likely conflict of interest that may influence the
interpretation of the results.

3. Respect for Research Participants

Ethical Approval of Original Studies: Ensure that studies included in the review
obtained ethical approval appropriate for the work and were conducted
ethically. Critical Appraisal by Reviewers: The original studies should be
critically appraised with respect to their ethical conduct.

Beneficence and Non-Maleficence: This is the point at which one begins to

assess the consequences of findings made in the review vis-à-vis public health
policies and clinical practices involving populations. The findings should show
benefits to the populations involved and not cause harm. In this category, one
needs to assess the impact of the findings from the reviews on public health
policies and clinical practices that involve populations. The aim should be to
bring out findings that will benefit concerned populations while preventing
harm.

4. Plagiarism and Proper Citation

Correct Citation: Accurately cite all sources of information and acknowledge

the authors conducting studies under review. One should avoid plagiarism,
including self.

Original Contribution: Ensure that the systematic review makes an original

contribution to the existing knowledge and not just a repeat of what has been
previously reviewed and published.

5. Cultural Sensitivity

Cultural Awareness: The emphasis here is to be culturally sensitive regarding

such issues as Hepatitis B and HIV, given the high stigma characterized by these
conditions in certain cultures.

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Language and Presentation: Use language that does not carry any stigmatizing
description while describing the population and conditions of interest.

6. Public Health Implications

Responsibility in Reporting: This is the responsibility to be careful with any

reporting of findings that may have major public health implications. It may
lead to misinterpretation of data, hence misguided policies or practices.

Balanced Representation: A balanced view should be presented of evidence

about potential risks versus benefits of any interventions discussed in a
manuscript; this avoids making flawed practices an established norm or
overlooking beneficial practices.

7. Access to Findings

Open Access Consideration: Consider submitting this systematic review to an

open access journal so findings can be accessed by all relevant stakeholders,
including researchers in resource-limited settings, health professionals, and
policy decision-makers. Dissemination: Plan for the dissemination of findings
appropriate for the target audience, including the community affected by HIV
and HBV, in a format that can be understood and accessed by them.

These considerations have to do with the ethics of the process for a coherent
integrity of the systematic review process and of findings that would ideally
make positive contributions to the fields and the concerned populations.

8. Logistics

In conducting a systematic literature review on Hepatitis B co-infection in HIV-

positive patients, several key logistics must be put in place to ensure the
project is completed efficiently and effectively. Some of these logistical features
are highlighted below:
1. Team coordination and roles
Team composition: Make sure that the review team includes members who
have diverse expertise in HIV and Hepatitis B research, methodology of
systematic reviews, data analysis, and medical ethics.

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Role Assignment: Clearly specify the roles of the team members, for example,
lead researcher, data extractor, quality assessor, statistician, or any other
person as noted.
Communication: Conduct the meetings regularly and let communication take
one way or another; for instance, through email or even project management
tools like Trello or Slack, which help in keeping the team updated and aligned.
2. Time Management
Chrono Development: The project timeline should be well defined in a chart
like the Gantt chart discussed above, through which the whole process, from
literature search to final submission, will be managed.
Milestones: Clearly indicate the milestones and deadlines for tasks. It will help
in tracking the progress and continuity of the project on time.
Buffer Time: Add on extra time to accommodate unexpected delays due to
some study that may not be easily available or some delay in data extraction.
3. Resource Allocation
Database access: Access to relevant databases to be used, including but not
limited to PubMed, Embase, Cochrane Library, and relevant journals. In case
any of these resources require subscription, include these in your budget.
Software Tools: Systematic review software tools, such as Covidence, Rayyan,
or RevMan, for screening, data extraction, and analysis. All team members will
receive training on these tools.
Funding and Budgeting: Ensure sufficient funding is supplied to the research
project, where costs will include database access, software tools, travel to
conferences, and publishing fees.
4. Data Management
Data Storage: Apply safe and dependable data storage tools in storing extracted
data, documents, and other materials. This involves the use of cloud storage
and institutional servers.
Version Control: Apply version control practices for managing document
versions and changes throughout the review process.

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Data Backup: Back up all data regularly to prevent loss and allow for continuity
in case of failure.
5. Full Text Articles
Procurement of Full-Text Articles: Lay down plans for procuring full-text
articles, either from institutional libraries, interlibrary loans, or even contacting
authors directly if necessary.
Organization of Document: Using reference management software like
EndNote, Zotero, or Mendeley, organize and manage citations and full-text
articles appropriately.
6. Compliance and Ethical Approval
Ethical Approval: Determine if ethical approval will be required based on the
scope and nature of the review, especially when the need is to collect or
analyse new data with sensitive information.
Compliance: Ensure compliance of the review with the governing principles
and guidelines. Among the applicable ones are PRISMA—Preferred Reporting
Items for Systematic Reviews and Meta-Analyses.
7. Collaboration and Partnerships
Institutional Support: One can approach academic institutions, research
centres, or professional bodies for their available resource facilities or
expertise.
External Help: External experts or institutes could be collaborated in need,
especially in specialized issues in the review, such as advanced statistical
analyses or rare data sources.
8. Dissemination Planning
Publication strategy: This concerns suitable planning of information
dissemination activities through peer-reviewed journals, conferences, and
presentations. This would guide one to consider his target audience and the
best channels that can communicate to them.
Public engagement: Here, the findings and implications for practice would need
to be shared with key stakeholders, such as healthcare professionals, policy
makers, and advocacy groups for patients.

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9. Risk Management
Risk Identification: Identify the risks that may act on the review, such as limited
access to data or availability of team members, or technological failures, and
develop mitigation strategies.
Contingency Planning: Have backup plans for the most critical component of a
project, such as obtention of data from alternative sources or people's
substitutes .
10. Reporting and Documentation
Detailed Reporting: It includes detailed records about all phases of review
process, including search strategies and actions, decisions related to study
inclusion and exclusion, data extraction forms.
Final Report Preparation: Allow adequate time and resources to ensure the
writing up of a comprehensive, well-organized final report that meets reporting
standards.
Through this effective management of these logistical aspects, the smooth
conduct of the systematic literature review with high quality is supposed to add
valuable insights to the field.
8.1 Project Timeline (Gantt chart)
To create a Gantt chart for the systematic literature review project, the tasks
involved need to be outlined along with their estimated durations and
dependencies. Here's a simple textual representation of the timeline:
1. Define the Research Questions and Objectives
 Start Date: Week 1
 Duration: 1 week
2. Literature Search Strategy
 Start Date: Week 2
 Duration: 1 week
3. Initial Screening of Titles and Abstracts
 Start Date: Week 3
 Duration: 2 weeks

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4. Full-Text Review of Selected Articles
 Start Date: Week 5
 Duration: 3 weeks
5. Data Extraction
 Start Date: Week 8
 Duration: 2 weeks
6. Quality Assessment of Included Studies
 Start Date: Week 10
 Duration: 2 weeks
7. Data Synthesis and Analysis
 Start Date: Week 12
 Duration: 3 weeks
8. Writing the Draft Report
 Start Date: Week 15
 Duration: 4 weeks
9. Review and Revision
 Start Date: Week 19
 Duration: 2 weeks
10. Final Report Submission
 Start Date: Week 21
 Duration: 1 week
11. Presentation and Dissemination of Findings
 Start Date: Week 22
 Duration: 2 weeks
This Gantt chart shows the various phases of the project along a timeline of 23
weeks. Each task is marked with a colour in the week(s) it will be active.

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 1. Preparation Phase:

 Literature Review and Protocol Development: This will take place in the
first two weeks.

2. Data Collection Phase:

 Data collection: Begins in the third and fourth week

 Data Extraction: Runs concurrently with data collection and continues
for 2 weeks

3. Data Analysis Phase:

 Data Cleaning and Validation: Begins once data collection starts winding
down and takes two weeks
 Data Analysis: Follows data cleaning and takes two weeks.

4. Report Writing and Dissemination Phase:

 Report Writing: Starts in the seventh and eighth week and overlaps with
data analysis.
 Manuscript Preparation: Takes place in the last two weeks.
 Dissemination of Findings: Includes presentations and publications in the
final two weeks

This Gantt chart provides a clear timeline for each phase of the study, ensuring
that tasks are well-organized and completed within the specified period.

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8.2 Project budget
This comprehensive budget ensures the study can be conducted efficiently and
effectively while maintaining high standards of data integrity and ethical
compliance.
In conducting the systematic literature review for Hepatitis B co-infection
among HIV-positive patients, several things must be considered so that the
project could be finished both expeditiously and effectively. Among the
logistical issues that must be addressed would be the following:
1. Coordination of the Review Team and the Roles
• Team Members: The review team should have a mixture of multidisciplinary
expertise in HIV and Hepatitis B research, systematic review methodology,
analysis of data, and medical ethics.
• Role Assignment: Clearly outline the roles and responsibilities of each
member of your team
• Communication: Time of regular meetings and communication channels for
updates and alignment within the team.
2. Time management
• Timeline Development: Develop an elaborate project timeline (based on the
Gantt chart above) for use in controlling every stage from the searching of
literature to submission of the final report.
• Milestones: Formulate milestones for each work assignment and their
respective due dates for controlling and ensuring focused progress as planned
and that the review will not surpass the designated timelines.
• Buffer Time: To cater for activities that may lag behind schedule, such as in
data extraction, or delay in access to some targeted studies.
3. Resource Allocation
• Databases. Access to supportive databases like PubMed, Embase, and
Cochrane Library. In addition, subscriptions in relevant journals if available
• Software for Systematic Review. Software is applied in systematic reviews,
including Covidence, Rayyan, or RevMan upon screening and in extraction of
information. All members must have to ascertain training in the application of
these software programs.

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• Funding and Budgeting: Secure adequate funding for the project.
Considerations should be made on database access, software tools, travel
expenses such as for conferences, publication charges.
4. Data Management
• Data Storage: To store the extracted data, documents, and any other project
material, trustable means of data storage mechanisms shall be applied, for
example in the cloud or institutional servers.
• Version Control: I have the necessary policies to my use version control
mechanisms over the versions of documents involved as well as the changes
associated with the review process.
• Data Back-Up: Back up data regularly to avoid the loss and work to continue
in cases of the failure of the system.
5. Full Text Articles
• How to Get Full Articles: Obtain a strategy to access the full text of articles,
institutional or organizational access, inter-library loan request, or contacting
the author(s) to provide the required information.
• Documents Citation: Use bibliographic management software tools like
EndNote, Zotero, Mendeley for citation and publication.
6. Evidence and Compliance
• Ethical approval: The scope and nature of the review will determine whether
the review will require ethical approval, particularly if it involves new data
collection and or analysis of sensitive information.
• Adherence to guidelines: Ensure that the review is conducted following
relevant guidelines and standards. For example: PRISMA (Preferred Reporting
Items for Systematic Review and Meta-Analysis)
7. Collaboration and Partnerships
• Institutional Support: Involves seeking support from academic institutions,
research centres, or professional organizations able to afford appropriate
resources or expertise.
• External Collaboration: May involve collaboration with external experts or
institutions, especially in the case of specialized aspects of the review, such as
advanced statistical analysis or access to rare data sources.

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8. Dissemination Planning
• Publication Strategy: Plan how findings will be disseminated through articles
in peer-reviewed journals and at conferences and through presentations.
Determine the most effective media of dissemination keeping in view the
target audience.
• Public Dissemination: Disseminate findings and implications for practice to
relevant policy makers, health professionals and patient advocacy groups.
9. Risk Management
• Risk Identification: Identify potential risks to affect the review; for instance,
restricted access of data, likely unavailability of some members of the team, or
technological issues, and plan for mitigation of those risks.
• Contingency Planning: Plan for potential alternatives for essential aspects of
the project; for instance, sources of data, and backup human resources
10. Reporting and Documentation
• Detailed Reporting: document all processes of the review such that it is
possible to trace steps in the actual review process. Such steps would involve
search strategies, process of inclusion and exclusion, as well as extraction of
data.
• Final Report Preparation: Sufficient time and money to be invested into
preparing the final report, which must be exhaustive and logically organized
and must conform to the rules of reporting.
With these logistic details sorted, the implementation of the systematic
literature review can be smoothed with high quality results that will contribute
useful knowledge to the field.
Project Budget
A project budget for conducting a systematic literature review on Hepatitis B
coinfection in HIV positive should describe the general cost estimates within
different domains of the research process. The common components of the
budget are usually:
1. Personnel
• Research technicians/students

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Stipend/Salary: This is commonly the salary or stipend paid to the person or
persons spearheading the project.
Cost estimate: R2,000 (hourly or FTE estimate over the lifetime of the project).
• Research Assistant/ Associative Member:
Salary/Stipend: Payment involved in the data extraction, literature searching,
and quality assessment being done by the research assistants.
Estimated Cost: 3,000.
• Statistician/Data Analyst
Salary/Stipend/: Payment involved in the data analysis and synthesis by the
statistician or data analyst.
Estimated Cost: 2,000.
• Administrative Support
 Salary/Stipend: Remuneration for management or administrations like
scheduling, document management, communication, etc.
 Estimated Cost: 2,000
2.Software and tools
Software Licenses: These entail software license costs for tools that relate to
bibliographies, such as EndNote, Zotero, or Mendeley.
 Estimated Cost: R2000.
• Data Analysis Software
 Software Licenses: Software license costs that relate to statistical
software application. Examples in this case include SPSS, Stata, or R.
 Estimated Cost: R3000.
3. Database Access and Literature Acquisition
 Database Subscription Fees
 Cost: Subscription fees to a range of academic databases. This may
include, but not be limited to PubMed, Embase, and the Cochrane
Library.
 Estimated Cost: R3,000.

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  Article Procurement
 Interlibrary Loans/Document Delivery: Cost involved in the process of
acquiring the full text
 Registration: Participants will be required to register to attend system
reviews methodologies or data analysis workshops.
 Estimated amount to be charged: R2000.
4. Training and Professional Development
• Online courses and webinars.
 Registration: Participants will be contracted to take part in online studies
to do with systematic review, fair/meta-analysis or research ethics.
 Estimated amount to be charged: R2500.
5. Ethics and Compliance
• Ethical clearance
 Application: Pay for the institutional ethical review board application if
there is one.
 Amount to be charged: R2500.
• Compliance and reporting
 Fees: Pay for your contribution to the compliance for reporting
standards, maybe PRISMA or compliance for PROSPERO registration.
 Amount to be charged: R2000
6. Publication and Dissemination
• Open Access Charges
 Publication Fees: Charges for publication in open access journals so that
the findings are widely disseminated.
 Estimated Cost: R2,000.
• Conference Charges
 Registration and Transportation: Charges associated with presenting and
taking the results to various academic conferences.
 Estimated Cost: R1500.
• Printing and Circulation

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  Charges: These will be the charges related to printing hard copies of the
final report or any different reports or materials, for example.
 Estimated Cost: R2000.
7. Legacy
• Unallocated Fund
 Reserve: Such will be a reserve for any unplanned eventuality in the
project.
 Estimated Cost: R2,000.
• Office.
 estimated Cost: R2000.
8. Total Estimated Budget
Personnel Costs: R9000
Software and Tools: R5000
Database Access: R5000
Training: R2,500
Ethics and Compliance: R4500
Publication and Dissemination: R5500
Miscellaneous: R4000
Grand Total: R35,500
This would be the final budget, pending the details of the project regarding its
duration, the size of the working team, and the resources that would be
required.

References:

1.Askari, A., Hakimi, H., Behzad Nasiri Ahmadabadi, Gholamhossein

Hassanshahi and Mohammad Kazemi Arababadi (2014). Prevalence of Hepatitis
B Co-Infection among HIV Positive Patients: Narrative Review Article. DOAJ

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(DOAJ: Directory of Open Access Journals), 43(6), pp.705–12.(Accessed on 24th
June 2024)

2. El-Serag, H.B. (2012). Epidemiology of Viral Hepatitis and Hepatocellular

Carcinoma. Gastroenterology, [online] 142(6), pp.1264-1273.e1.
doi:https://doi.org/10.1053/j.gastro.2011.12.061.(Accessed on 28th June,2024)

3.Hawkins, C., Christian, B., Ye, J., Nagu, T., Aris, E., Chalamilla, G., Spiegelman,
D., Mugusi, F., Mehta, S. and Fawzi, W. (2013). Prevalence of hepatitis B co-
infection and response to antiretroviral therapy among HIV-infected patients in
Tanzania. AIDS, 27(6), pp.919–927.

(doi:https://doi.org/10.1097/qad.0b013e32835cb9c8.(Accessed on 27th
June,2024)

4.King, J. and Hagemeister, D.T. (2016). Hepatitis B co-infection in HIV-infected

patients receiving antiretroviral therapy at the TC Newman Anti Retroviral
Treatment Clinic in Paarl, Western Cape. Southern African Journal of HIV
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on 26th June 2024)

5.kye-Duodu, G., Nortey, P., Malm, K., Nyarko, K.M., Sackey, S.O., Ofori, S. and
Afari, E.A. (2016). Prevalence of hepatitis B virus co-infection among HIV-
seropositive persons attending antiretroviral clinics in the Eastern Region of
Ghana. Pan African Medical Journal, 25.
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June,2024

6.Moher, D. (2009). Preferred Reporting Items for Systematic Reviews and

Meta-Analyses: The PRISMA Statement. Annals of Internal Medicine, 151(4),
p.264.(Accessed on 2nd July 2024)

7.Platt L, French CE, McGowan CR, Sabin K, Gower E, Trickey A, McDonald B,

Ong J, Stone J, Easterbrook P, Vickerman P. Prevalence and burden of HBV co-
infection among people living with HIV: A global systematic review and meta-
analysis. J Viral Hepat. 2020 Mar;27(3):294-315. doi: 10.1111/jvh.13217. Epub
2019 Dec 22. PMID: 31603999; PMCID: PMC7383613. .(Accessed on 2nd July
2024)

8.Setia, M.S. (2016). Methodology Series Module 3: Cross-sectional Studies.

Indian Journal of Dermatology, [online] 61(3), pp.261–264.
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9.Sud A, Singh J, Dhiman Rk, Wanchu A, Singh S and Chawla Y (2001). Hepatitis
B virus co-infection in HIV infected patients. PubMed, 22(2), pp.90–2.
(Accessed on 28th June,2024)

10.Yemane Mengsteab Hagos et al. (2024) ‘Hepatitis B and C viral coinfection

and associated factors among HIV-positive patients attending ART clinics of Afar
regional state, northeast Ethiopia’, PLoS ONE, 19(5), pp. e0302453–e0302453.
Available at: https://doi.org/10.1371/journal.pone.0302453. (Accessed on 28th
June,2024)

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