Sero-prevalence of Hepatitis B Among Health Facility Staff in Salima District – a Cross-sectional Study

doi:10.21203/rs.3.rs-4993403/v1

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Research Article

Sero-prevalence of Hepatitis B Among Health Facility Staff in Salima District – a Cross-sectional Study

https://doi.org/10.21203/rs.3.rs-4993403/v1

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Background and Aims

Hepatitis B (HBV) poses a significant public health challenge in Malawi, particularly among healthcare workers. This study aimed to determine the prevalence of HBV infection among healthcare workers in Salima District, Malawi, and assess the severity of positive cases.

Methods

A cross-sectional study was conducted in September 2020 across all public health facilities in Salima District. HBV screening using antigen point-of-care tests was performed on 854 healthcare workers, with data on demographics and risk history collected. Positive cases were linked to care, with subsequent assessments conducted by medical officers. Family members of positive cases were also screened or linked to care.

Results

The prevalence of HBV infection among healthcare workers was 2.93% (25 infections, 95% CI: 0.019–0.0429). Infections were more common among males, married individuals, and those unvaccinated against HBV. Environmental health personnel exhibited the highest chronic HBV prevalence. All positive cases were enrolled in the HBV clinic within two weeks of diagnosis, with no signs of severe liver disease.

Discussion

Despite lower prevalence than the general population, HBV infection rates remain concerning among healthcare workers, particularly those in non-clinical roles. The lack of vaccination history is a notable risk factor for infection.

Conclusion

The study underscores the elevated prevalence of HBV infection among healthcare workers in the Salima District, emphasizing the importance of vaccination and prompt linkage to care.

Hepatitis B infection

Healthcare workers

Prevalence

Hepatitis B (HBV) is a common communicable disease with a high prevalence in sub-Saharan Africa. The World Health Organization (WHO), estimates that 254 million people were living with chronic hepatitis B infection in 2022, with 1.2 million new infections each year [1]. HBV affects mostly the WHO African Region and the Western Pacific Region [2]. Sub-Saharan Africa has approximately 60 million chronically infected with HBV, and one of the highest mortality rates for the virus, estimated at 80,000 [2 – 6].

HBV infections are linked to various risk factors, such as occupational exposure for Healthcare Workers (HCWs), engaging in unprotected sex with multiple partners, sharing needles among drug users, and receiving blood transfusions [1,7]. HCWs and other staff members who work in healthcare settings are at increased risk of contracting HBV. HCWs are four times more likely to be infected with HBV compared to the general population, due to needle stick injuries and contact with infected blood or blood products [8 –12]. Furthermore, there is a low vaccination rate among healthcare workers in low-income countries, estimated at 2.3% [7,13,14]. In contrast, developed countries have implemented the same vaccination program to safeguard their healthcare workforce from HBV infection [10,11,14,15].

Malawi has a pooled prevalence of 8.1% (95% CI 6.1, 10.3) among adults in the general population [16]. Relatively. prevalence rates in neighbouring countries of Malawi show high numbers, with Mozambique at 12.2%, Tanzania at 7.2%, and Zambia at 6.5% [12,17,18]. To the best of our knowledge, there have been no published reports on the prevalence of HBV infection among healthcare workers in Malawi. However, a related study was conducted among medical students at Kamuzu University of Health Sciences (KUHeS), formerly the University of Malawi, College of Medicine, and it found a prevalence rate of zero [19]. In contrast, neighbouring countries such as Mozambique and Tanzania have documented prevalence rates among healthcare workers. In Beira City, Mozambique, the prevalence was 5.1%, while at a tertiary hospital in Tanzania, it was estimated to be 7.4% [12,20].

This study intended to determine the prevalence of HBV among all health facility staff, including both front-line healthcare workers (clinicians and nurses) and non-frontline healthcare workers (support staff) in all health facilities under the Salima District Health Office. Additionally, it examined the prevalence of HBV among different cadres of healthcare workers. Finally, we assessed the severity of HBV infections detected and ensured that those individuals received appropriate care and support.

Study design

A facility-based cross-sectional study was conducted involving all staff members at health facilities under the Salima District Health Office in September 2020. This study took place during a two-week HBV vaccination campaign organized by the Environmental Health Department at the Salima District Health Office. The campaign was part of a national immunization campaign led by the Viral Hepatitis Unit at the Ministry of Health. Its goal was to vaccinate all frontline and non-frontline healthcare workers. Participants underwent initial HBV screening. Those who tested negative received the HBV vaccine, while those who tested positive were referred for further tests, treatment, and screening of their household members. The investigations included Liver Function Tests, Full Blood Count, provider-initiated HIV testing and counselling (PITC), and a Liver Fibroscan. These tests were conducted to assess the severity of the disease.

Study setting

Salima is a lakeshore district and a popular tourist destination in Malawi. It is situated along a lakeshore road that connects the northern and southern parts of the country. At the time of the study, the district had a population of 473,554 [21]. The study was conducted in all 20 health facilities under the Salima District Health Office. These include 12 government-owned health facilities, 5 health facilities owned by the Christian Health Association of Malawi (CHAM), and 3 health facilities owned by non-governmental organizations (NGOs). The specific health facilities included in the study were ADMARC dispensary, Baptist, Chagunda, Chinguluwe, Chipoka, Chitala, Kaphatenga, Katawa, Khombedza, Lifeline, Lifuwu, Maganga, Makioni, Malawi Armed Forces College (MAFCO), Mary Lou, Mchoka, Ngodzi, Parachute Battalion, Thavite health centers, Ndimoyo Palliative Care Clinic, and Salima District Hospital (SDH).

Sample size and sample selection

Based on the records from the Human Resource Office of Salima District Health Office, it was found that there were a total of 1200 staff members employed across 20 health facilities in Salima District. The study included all staff members who met the following criteria: working in the 20 health facilities in Salima District and providing their consent to participate. A total of 854 staff members met these criteria and took part in the study. Staff members who were unavailable, or declined to participate were not included. No sampling was done.

Data collection

The screening took place at the SDH laboratory for staff based at the district hospital. Additionally, a team of laboratory scientists visited all health facilities to conduct the screening. At these other health facilities, a separate room was allocated for testing. The farthest health facility, Makioni Health Center, is located 75 kilometers away from SDH. After obtaining verbal informed consent, demographic data (age, gender, marital status, cadre), and additional details (years of service, number of household members, and history of prior HBV vaccination) were collected using a paper-based tool.

The study participants received pre-test counselling. A blood sample was collected through a finger prick for the HBV point-of-care test, using an aseptic technique. A one-step rapid immunochromatographic test (Right sign rapid diagnostic test by Hangzhou Biotest Biotech Co., Ltd, China) was conducted to detect hepatitis B surface antigen (HBsAg). The rapid diagnostic test has a sensitivity of 99.8% and a specificity of 99.6%. The test results were recorded as positive or negative and read after 15–20 minutes. Staff members who tested negative received their first HBV vaccine (rDNA hepatitis B vaccine) on the same day and were given appointments for the remaining two doses scheduled after one and six months. Those who tested positive received post-test counselling and were referred from the health centers to SDH to be reviewed by a senior medical officer. Counselling included advice on screening family members. At SDH, these participants received standardized and protocol-based care [22].

Based on the protocol, chronic HBV patients meeting certain criteria were started on a combination of Lamivudine and Tenofovir Sproxil Fumarate (TDF). The criteria for starting this treatment were as follows: criteria 1 - the risk of fibrosis (age > 30 years, Alanine Transaminase persistently above the upper limit of normal on 2 to 3 occasions over 6 to 12 months, and HBV DNA >20,000 IU/ml) or criteria 2 - evidence of cirrhosis (clinical evidence of cirrhosis, ultrasound features of cirrhosis, APRI score >1.5, or liver fibroscan >9.4 kPA). Due to resource constraints, HBV DNA testing was not performed on those who tested positive [22].

Data analysis

The data was later transferred from the paper-based tool to a Microsoft Excel spreadsheet for cleaning, and statistical analysis was conducted using STATA version 18. Descriptive statistics were used to describe the variables. We categorized healthcare workers (HCWs) into two broad professional categories based on their role in delivering healthcare services: frontline HCWs (clinicians - medical doctors, clinical officers, clinical technicians, and medical assistants; nurses - nursing officers, nursing technicians, and community midwife assistants) and support staff (pharmacists, pharmacy assistants, laboratory scientists, laboratory technicians, patient attendants, environmental health officers, health surveillance assistants, maids, administrative staff - human resource officers, accountants, drivers, guards, and ground laborers; biomedical engineering team).

Participant’s demographic characteristics

Out of the 854 staff members who took part in the study, 457 (53.5%) were male. We categorized the participants into two age groups: 20–49 years old, which accounted for 774 (90.6%) participants, and over 49 years old, which accounted for 80 (9.4%) participants. The majority of the study participants, 636 (74.47%), were married. In terms of cadre, the study included a significant number of environmental health personnel, totaling 250 (29.27%) participants. The majority of participants, 370 (37.47%), were from SDH. Participants' years of service were divided into two categories: less than 10 years (416 participants, 48.7%) and 10 years or more (438 participants, 51.3%). Only 283 (33.14%) participants had a prior vaccination history at the time of the study (Table 1). Due to the unavailability of vaccination records for previous vaccinations, we asked participants about this during data collection. Although some participants remembered being vaccinated in the past, they were unsure if their previous vaccinations were complete.

Table 1

demographic characteristics of study participants
Characteristics	Frequency	Percentage (%)
Sex
Female	397	46.5
Male	457	53.5
Age (years)
20–49	774	90.6
> 49	80	9.4
Facility
ADMARC	14	1.6
Baptist	57	6.7
Chagunda	19	2.2
Chinguluwe	24	2.8
Chipoka	37	4.3
Chitala	17	2.0
Kaphatenga	34	4.0
Katawa	22	2.6
Khombedza	50	5.9
Lifeline	47	5.5
Lifuwu	24	2.8
MAFCO	28	3.3
Maganga	26	3.0
Makioni	28	3.3
Mchoka	38	4.5
Ngodzi	19	2.2
Parachute	11	1.3
SDH	320	37.5
Thavite	39	4.6
Cadre: frontline healthcare worker
Clinician	95	11.1
Nurses	125	14.6
Cadre: non-frontline healthcare workers
Administrative personnel	30	3.5
Attendant	188	22.0
Environmental Health Personnel	250	29.3
Ground labourer	23	2.7
Guard	29	3.4
Health Management Information System personnel	23	2.7
Health Technical Support Personnel	70	8.2
Laboratory personnel	21	2.5
Marital Status
Divorced	9	1.1
Married	636	74.5
Widow	14	1.6
Single	195	22.8
Previous Hepatitis B Vaccination
No	571	66.9
Yes	283	33.1
Years of service
< 10 years	416	48.7%
> 10 years	438	51.3%

Prevalence of HBV among staff members

The overall prevalence of chronic HBV infection (HBsAg+) was 2.93% (25 infections, 95% CI: 0.019–0.0429). In terms of demographics, HBV infection was more common among males (17 infections, 95% CI: 0.81–5.98) and those who were married (18 infections, 95% CI: 0.13–1.07). When looking at different cadres, the highest prevalence of chronic HBV infection was found among environmental health personnel (11 infections, 95% CI: 0.78–69.46) and hospital attendants (6 infections, 95% CI: 0.46-182.78). Out of the 25 positive cases, 6 participants (3 frontline and 3 non-frontline healthcare workers) had a history of previous HBV vaccination. It is worth noting that there were no participants with indeterminate results (Table 2).

Table 2

Prevalence rates of HBV among Health facilities staff members
Participant's characteristics	n	Hepatitis B status		Fisher's exact	p-value
		Positive	Negative
Sex
Female	397	8(2.0)	389(98.0)	0.158	0.14
Male	457	17(3.7)	440(96.3)
Cadre: front-line health worker
Clinician	95	2(2.1)	93(97.9)
Nurse	125	1(0.8)	124(99.2)
Cadre: non-frontline healthcare worker
Administrative Personnel	30	1(3.3)	29(96.7)	0.55	0.893
Attendant	188	6(3.2)	182(96.8)
Environmental Health Personnel	250	11(4.4)	239(95.6)
Ground labourer	23	1(4.4)	22(95.7)
Guard	29	2(6.9	27(93.1)
HMIS	23	0(0.0)	23(100)
Health Technical Support Personnel	70	1(1.4)	69(98.6)
Lab personnel	21	0(0.0)	21(100)
Marital Status
Divorced	9	0(0.0)	9(100.0)	0.155	0.081
Married	636	18(2.8)	618(97.2)
Widow	14	2(14.3)	12(85.71)
Single	195	5(2.6)	190(97.4)
Prior HBV Vaccination
No	571	20(3.5)	551(96.5)	0.197	0.157
Yes	283	5(1.8)	278(98.2)

We included these independent variables (Table 3) based on previous research [12, 20]. All individuals who tested positive were connected to medical care. None of them had a severe form of HBV (APRI Score ranged from 0.5–1), and chronicity was confirmed after another positive HBsAg + test at 6 months.

Table 3

Univariate analysis of independent variables
Characteristic	Unadjusted OR (95% CI)	Adjusted OR (95% CI)
Marital status
Unmarried	Reference	Reference
Married	0.87(0.36–2.13)	0.37(0.13–1.07)*
Age category
20–49	Reference	Reference
>49	1.33(0.38–4.55)	0.99(0.27–3.63)
Sex
Female	Reference	Reference
Male	1.88(0.80–4.40)	2.21(0.81–5.98)
Administrative worker
No	Reference	Reference
Yes	1.15(0.15–8.79)	4.52(0.23–86.54)
Patient attendant
No	Reference	Reference
Yes	1.12(0.44–2.85)	6.31(0.68–58.39)
Clinician
No	Reference	Reference
Yes	0.69(0.15–2.97)	32.98(0.25–35.09)
Environmental health worker
No	Reference	Reference
Yes	1.94(0.87–4.33)	7.37(0.78–69.46)
Ground labour
No	Reference	Reference
Yes	1.53(0.20-11.81)	9.13(0.46-182.78)
Security guard
No	Reference	Reference
Yes	2.58(0.58–11.52)	13.97(1.0-194.76)
HIV Testing Counselors
No	Reference	Reference
Yes	0.46(0.06–3.44)	2.57(0.15–44.24)
Years of Service
More than 10 years	Reference	Reference
Less than 10	0.49(0.21–1.14)*	0.49(0.18–1.33)
Previous vaccination
No	Reference	Reference
Yes	0.50(0.18–1.33)	1.02(0.27–3.93)

32 household contacts of those who tested positive were screened, 18 (56.25%) were females and ages ranged from 5 years to 54 years. None of the household contacts tested positive, and they all received HBV Vaccine.

The Viral Hepatitis Unit at the Ministry of Health is striving to align its objectives with the WHO's global health sector strategy on viral hepatitis for 2016 to 2022. As part of this initiative, the unit is deploying evidence-based strategies aimed at eradicating viral hepatitis by 2030 [2]. A key strategy involves screening and vaccinating frontline healthcare workers and health facility staff, who are considered to be at professional risk [22].

Our study revealed that males constitute the majority of our healthcare workforce, a trend that mirrors the broader pattern observed across Africa [23]. This predominance of male healthcare workers is consistent with regional data, highlighting a gender imbalance in the healthcare sector on the continent.

The prevalence is lower than that of the general population, despite the participants belonging to a high-risk group. This can be attributed to several factors: a proportion of the study participants had previously been vaccinated against HBV, and there was strict adherence to infection prevention measures among this group. These preventative actions likely contributed to the reduced prevalence observed in the study.

Furthermore, the prevalence is particularly high among lower cadres, especially support staff. It should be noted that medical and nursing schools provide vaccinations to students before their clinical years [19]. In contrast, other personnel who have not attended these training institutions often miss out on this critical preventive measure. This disparity in vaccination coverage likely contributes to the higher prevalence observed among support staff and other lower-level cadres within the healthcare workforce.

We did not observe any discernible relationship between HBV positivity and demographic characteristics in our study. This finding aligns with similar observations reported in studies conducted in Tanzania and Nigeria [12, 24, 25]. Despite examining various demographic factors such as age, gender, and socioeconomic status, no significant correlations with HBV positivity were identified. These consistent findings across different geographical regions underscore the complex nature of HBV transmission and the need for multifaceted approaches to its prevention and control.

Malawi has one of the lowest ratios of healthcare providers per 1000 citizens [15]. Specifically, there are only 0.019 physicians and 0.283 nursing and midwifery personnel for every 1000 people, which falls below the recommended ratio set by the WHO [15]. This leads to task shifting to support staff [26, 27]. While training institutions for clinicians and nurses do vaccinate their students before they start clinical rotations, non-frontline healthcare workers do not have this privilege. The HCWs found positive might have acquired HBV from other non-occupational sources.

Worse still, in Malawi's Extended Program on Immunization, hepatitis B vaccination for children was introduced as part of the pentavalent vaccine, which also protects against diphtheria, pertussis, tetanus (DPT), hepatitis B (HBV), and Haemophilus influenza type B [28]. This comprehensive vaccine has significantly enhanced protection for children against these diseases since its implementation. However, this initiative primarily benefits younger populations, meaning that elderly individuals did not receive the hepatitis B vaccine during their childhood. As a result, older generations remain at a higher risk of hepatitis B infection due to the lack of vaccination during their formative years [29].

Several studies have demonstrated that hepatitis B virus (HBV) is endemic in Malawi [16, 30–33], suggesting that non-occupational acquisition of HBV is a significant possibility. In regions with high endemicity, the virus can spread through various routes beyond occupational exposure. One notable route of transmission is perinatal transmission from mother to child, which remains a critical concern [29, 33]. This mode of transmission highlights the importance of comprehensive HBV vaccination and prevention strategies to address both occupational and non-occupational risks.

The Ministry of Health's Viral Hepatitis Unit has implemented vaccination programs, but it is essential to reinforce these initiatives through the human resource office to ensure compliance during medical check-ups and recruitment processes. While the Ministry of Health has made significant strides forward, it is crucial to establish comprehensive policies for individuals who test positive for hepatitis. These policies should outline how affected individuals can safely continue their duties without risking transmission to others, including their immediate family members. By integrating these measures, the Ministry can enhance the effectiveness of its vaccination programs and ensure a safer, healthier environment for all.

Limitations

Despite having a large sample size, the small number of positive cases (25) could limit the reliability of these subgroup analyses. This limited number of positive cases may result in reduced statistical power, making it challenging to draw definitive conclusions about the prevalence and characteristics of hepatitis B within different subgroups. Additionally, this constraint may affect the ability to identify significant trends or associations, underscoring the need for caution when interpreting the results and for considering further studies with larger numbers of positive cases to validate these findings.

Due to resource limitations, we were unable to conduct additional laboratory tests to accurately distinguish between acute and chronic HBV infections. Such tests, including anti-HBs (Hepatitis B surface antibody) and anti-HBc (Hepatitis B core antibody), would typically employ enzyme-linked immunosorbent assay (ELISA) techniques. These assays would have been invaluable in assessing natural immunity to HBV and providing deeper insights into infection resolution rates. It's worth noting that factors such as the timing of HBV acquisition and HBV genetic variations can significantly influence the course of infection resolution.

In our study, individuals who tested positive for HBV were vaccinated, albeit without accounting for the possibility of a window period. This period refers to the interval between HBV exposure and the time when the test reliably detects HBV in the body [1, 34]. The duration of this window period varies depending on the type of HBV test employed. The incubation period for hepatitis B spans from 30 to 180 days, with detection typically feasible within 30 to 60 days post-infection [34]. If acquired during infancy or childhood, HBV infection may progress to chronic hepatitis B [29, 33].

Furthermore, our study could not perform HBV DNA testing, leaving us reliant solely on clinical assessments and various haematological (Full Blood Count) and biochemical laboratory tests (Liver Function Test) to gauge the disease's severity in positive cases. It's pertinent to acknowledge that parameters measured in these tests, such as Aspartate Aminotransferase and Platelet Count, may be influenced by factors beyond HBV infection alone.

The prevalence of Hepatitis B infections among healthcare workers, encompassing both frontline and non-frontline personnel, remains largely unknown across numerous healthcare facilities. Despite available findings from pooled studies, the majority of healthcare facilities in Sub-Saharan Africa lack localized data on this matter. Concurrently, the WHO is fervently advocating for governments, through their ministries of health, to combat and eradicate HBV by 2030. The workforce spearheading this endeavor must be adequately equipped and safeguarded. Analogous to soldiers donning bulletproof vests on the battlefield, frontline healthcare workers require protection through vaccination and access to personal protective equipment. Given their collaborative work environment, support staff also necessitate protection.

Moreover, individuals diagnosed with the disease must be promptly linked to care to enhance their quality of life and prevent potential transmission to colleagues and family members. The commendable efforts of the Ministry of Health's Viral Hepatitis Unit in Malawi, which is currently implementing screening and vaccination initiatives for HBV across all healthcare facilities, merit recognition. Sustaining and expanding these efforts to encompass future recruits is essential. Additionally, further research is warranted to ascertain the efficacy of these interventions and devise tailored implementation strategies for diverse healthcare settings.

APRI

Aspartate to Platelet Ratio Index

Anti-HBc

Hepatitis B core antibody

DNA

Deoxyribonucleic acid

DPT

Diphtheria, Pertussis, Tetanus

CHAM

Christian Health Association of Malawi

ELISA

Enzyme-linked immunosorbent assay

HBs

Hepatitis B surface antibody

HBV

Hepatitis B

HCW

Healthcare workers

HBsAg

Hepatitis B surface antigen

KUHeS

Kamuzu University of Health Sciences

MAFCO

Malawi Armed Forces College

WHO

World Health Organization

NGOs

Non-governmental organizations

NHSRC

National Health Sciences Research Committee

PITC

Provider-initiated HIV testing and counselling

SDH

Salima District Hospital

TDF

Tenofovir Sproxil Fumarate

Ethics approval and consent to participate

Ethical clearance was obtained from the Salima District Health Research Committee and the Institutional Review Board of Malawi National Health Science Research Committee (NHSRC). Clinical trial number not applicable.

Consent for publication

All authors have approved the publication of this research.

Availability of data and material

All data and materials in this article are included in the manuscript.

Competing interests

All authors would like to declare no competing interests.

Funding

Not applicable

Authors' contributions

GDL: Conceptualization, designed experiments, data curation, formal analysis, methodology, writing – original draft, writing – review & editing.
YN: Conceptualization, designed experiments, data curation, formal analysis, methodology, writing – original draft.
KM: Data curation, formal analysis, writing – review & editing.
YM: Conceptualization, data curation, writing – review & editing.
MMC: Conceptualization, designed and performed laboratory tests, data curation.
LNA: Conceptualization, designed and performed experiments, data curation, formal analysis, writing – original draft, writing – review & editing.
VC: Formal analysis, writing – original draft, writing – review & editing.
MC: Formal analysis, writing – original draft, writing – review & editing.
DK: Writing – original draft, writing – review & editing.
FN: Formal analysis, writing – original draft, writing – review & editing.
CM: Conceptualization, funding acquisition, writing – original draft, writing – review & editing.
YC: Conceptualization, formal analysis, funding acquisition, writing – original draft, writing – review & editing.

Acknowledgements

We extend our heartfelt gratitude to Baylor College of Medicine Children's Foundation for generously procuring the HBV test kits utilized in this study. Their invaluable contribution facilitated the smooth execution of our research endeavors. We would also like to express our sincere appreciation to the dedicated team at the Viral Hepatitis Unit for their unwavering support throughout this project. Their guidance and expertise have been instrumental in ensuring the success of our study.

Furthermore, we extend our thanks to the research team at the Salima District Health Office for graciously permitting us to conduct this study within their jurisdiction. Their cooperation and collaboration have been essential in navigating the logistical challenges inherent in conducting research within a healthcare setting. We are deeply grateful for their assistance and facilitation of our research activities.

Last but not least, we extend our heartfelt thanks to the study participants for their invaluable contribution to this research endeavor. Their willingness to participate and provide crucial insights have been pivotal in advancing our understanding of hepatitis B infection within the community. We are truly grateful for their time, cooperation, and willingness to engage in this important study.

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Sero-prevalence of Hepatitis B Among Health Facility Staff in Salima District – a Cross-sectional Study

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