Clinical trial NCT04072211: Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District
Official title: Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Virus
Health Care Associated Infection
Keywords: Hepatitis B Virus
Vaccination
Health Personnel
Lead sponsor: Centre for Infectious Disease Research in Zambia
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2019-08-28
Enrollment: 641
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants will be screened for Hepatitis B Virus and those eligible for vaccination will receive the vaccine. Those already infected will be linked to care and those with a protective level of anti-HBs will not receive the vaccine.
Primary purpose: PREVENTION

Brief summary: Hepatitis B virus (HBV) has infected over one third of the world's population; of these about 350 million go on to be chronic carriers. Infection with HBV can be self-limiting depending on age and immunity status of the infected person. Acute infection with HBV is cleared within six months of initial infection while chronic infection can last longer than six months. HBV can be transmitted perinatally, sexually, horizontally, through direct contact with infectious body fluids or blood, being pricked with an infected needle and injury from instruments contaminated with infectious body fluid or blood. Certain population groups are at higher risk of infection with HBV. Among these populations is that of health care workers (HCWs). In this population, HBV infection can occur through occupational exposure. In fact, the hepatitis B virus is more contagious than human immunodeficiency virus (HIV) during a needle stick injury (30% versus 0.5%). It is therefore imperative that HCWs are highly knowledgeable about HBV and how they can prevent transmission. Protection from HBV infection can be achieved by means of vaccination after which the HBV vaccine has been shown to be 90-100% effective.

Detailed description: Hepatitis B virus (HBV) has infected over one third of the world's population; of these about 350 million go on to be chronic carriers. In adults, infection with HBV can be self-limiting in up to 95% of those infected and the most common route of infection is sexual transmission. HBV can also be transmitted perinatally, horizontally, through direct contact with infectious body fluids or blood, being pricked with an infected needle and injury from instruments contaminated with infectious body fluid or blood.

Certain population groups are at higher risk of infection with HBV. Among these populations is that of health care workers (HCW). In this population, HBV infection can occur through occupational exposure. It is therefore imperative that HCWs are highly knowledgeable about HBV and how they can prevent transmission.Protection from HBV infection can be achieved by means of vaccination after which the HBV vaccine has been shown to be 90-100% effective.

Despite availability of these vaccines, studies have shown low rates of vaccination against HBV amongst HCW in different countries. However, in countries where there is a deliberate policy to vaccinate HCW, the rates of HBV vaccination are over 90%. In Zambia, this rate has been reported to be as low as 19.3%.

This project will demonstrate an approach to reduce HCW risk of HBV through increasing knowledge and awareness of HBV among HCWs, providing vaccination to HCWs and linking those already carrying HBV infection to care and treatment. The study will also investigate the cost of vaccinating HCWs against HBV and evaluate feasibility, acceptability and implementation factors to inform possible scale-up of this approach throughout Zambia.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* Willing to consent and meet project requirements for training and follow-up.

Exclusion Criteria:

* Kidney disease or renal failure
* Pregnant
* History or current neurological condition
* Express refusal to consent

Primary outcomes:
measure: Demonstrate attainment of protective Hepatitis B surface antibody (anti-HBs) levels in their serum
timeFrame: Eight Months
Secondary outcomes:
measure: Demonstration of attained cell-mediated protection against Hepatitis B surface Antigen after vaccination.
timeFrame: Eight Months
measure: Linkage of health care workers with chronic Hepatitis B virus infection to treatment and management
timeFrame: One Month
measure: Cost and cost-effectiveness analysis of a universal Hepatitis B Virus vaccination strategy targeted at healthcare workers in Kalulushi district
timeFrame: Eighteen months
Other outcomes:
Locations:
city: Kalulushi
country: Zambia
facility: Kalulushi district all facilities
state: Copperbelt
Study officials:
References: