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Title: Gateway to Care Campaign: A public health initiative to reduce the burden of hepatitis B
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in Haimen City, China
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Authors:
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Gang Chen, Hepatitis B Foundation, Doylestown, PA, USA, gang.chen@hepb.org
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Joan M. Block, Hepatitis B Foundation, Doylestown, PA, USA, joan.block@hepb.org
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Alison A. Evans, Drexel University, Philadelphia, PA and Hepatitis B Foundation, Doylestown,
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PA, USA, aae29@drexel.edu
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Peixin Huang, Haimen City Center for Disease Control and Prevention (HCCDC), Haimen City,
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China, email c/o gang.chen@hepb.org
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Chari Cohen, Hepatitis B Foundation, Doylestown, PA, USA, chari.cohen@hepb.org
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Correspondence to:
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Chari Cohen, 3805 Old Easton Road, Doylestown, PA 18902
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Phone: 215-489-4930, Fax: 215-489-4920, Email: chari.cohen@hepb.org
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Abstract
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Background An estimated one million people worldwide die each year from complications of
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chronic hepatitis B infection (CHB), including liver cancer. A disproportionate number of
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infections and deaths occur in China. The incidence and mortality of liver cancer in Haimen City
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is among the highest in China, and in the world. A multi-year citywide campaign was aimed at
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eliminating hepatitis B virus (HBV) infection and significantly reducing the number of liver
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cancer deaths due to CHB in Haimen City, China.
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Methods Strategies included a public health information campaign targeting the 1.03 million
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city residents; specialized health education for leaders and providers to increase adoption of
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evidence-based HBV management protocols; establishment of health care infrastructure and
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management systems; and increased prevention and care delivery to key subpopulations
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(especially pregnant women).
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Results The project developed and deployed broad-reaching public awareness and health
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education tools and modules to 280,000 households and at community-based events. More than
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90% of targeted healthcare providers and 80% of the community leaders/government officials
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attended educational seminars during the project period (1,441 health care providers; 1,883 local
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government officials). A centralized registration and management system for pregnant women
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was developed and instituted, 100% of pregnant women were enrolled (5,407 women over one
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year), and all infants born to HBV-infected mothers received one dose of HBIG and the first
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dose of HBV vaccine by 24 hours of birth.
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Conclusions Lessons from the implementation phase of the project include the importance of:
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gaining early and ongoing support from the local government and health bureau for success in
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reaching the targeted populations; and having project management by a local, experienced, and
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trusted health expert to navigate implementation and relationships, and help develop culturally
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and linguistically appropriate materials.
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Keywords: chronic hepatitis B infection; hepatocellular carcinoma; perinatal hepatitis B;
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prevention; health education campaign; hepatitis B screening; hepatitis B vaccination; Haimen
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City, China
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Ethics Statement
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This program was reviewed and approved by the Medical Ethics Review Committee of Haimen
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City. No identifying or individual level data were collected as part of the demonstration
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(education) component of the program, thus the ethics committee considered this component to
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be exempt from full review.
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Background
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The Burden of Chronic Hepatitis B Infection in China
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Worldwide, an estimated two billion people have been infected with the hepatitis B virus (HBV)
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and, of these, nearly 400 million remain chronically infected [1,2]. About one-third of those with
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chronic hepatitis B (CHB) infection live in China, where it is estimated that around 100 million
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people (about 10% of the Chinese population) are chronically infected, and around 500,000
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people die from CHB-related complications, including primary liver cancer (hepatocellular
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carcinoma, HCC) and cirrhosis, each year [3-6]. China has the highest age-adjusted incidence
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(new cases) of HCC due to CHB, and about 55% of liver cancer deaths worldwide occur in
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China [7]. Most of these deaths are men in their prime, between the ages of 30 and 65 years. Up
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to 9.5% of Chinese women of childbearing age have CHB [8]. Newborns infected perinatally
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have a more than 90% risk of developing CHB infection, and thus have an increased risk of
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premature death from end-stage liver disease or liver cancer [9,10]. Of babies born to HBV-
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infected mothers, 5% to 10% become chronically infected despite receiving immunoprophylaxis
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with Hepatitis B immune globulin (HBIG) and hepatitis B vaccine [11].
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There are significant unmet needs for millions of individuals living with CHB, including
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a lack of screening and diagnosis, and limited access to appropriate medical care and treatment.
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The Hepatitis B Foundation (HBF) believes that the burden of CHB can be reduced, and lives
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saved, through improved public awareness, health education, and screening. To this end, HBF
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launched the “Gateway to Care Campaign: Haimen City Project” in August 2010, in
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collaboration with the Haimen City Center for Disease Control and Prevention (HCCDC). This
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three-year project consisted of a targeted citywide public health information campaign;
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specialized health education and training for providers; establishment of health care
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infrastructure and management systems; and increased screening, vaccination, treatment, and
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care management service delivery to key subpopulations (especially pregnant women and their
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infants and families).
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The Haimen City Cohort
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Haimen City is located in Jiangsu Province, approximately 60 miles northwest of Shanghai, with
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a total population of 1.03 million. HCC has been the leading cause of cancer death in this
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population since 1970 (when death registration began), and the incidence and mortality of HCC
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in Haimen City are among the highest in China, and in the world (Haimen City CDC Vital
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Statistics, unpublished data). A landmark study of this population published in 2006 clearly
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established a direct link between hepatitis B viral load and subsequent risk of liver cancer in
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chronically infected individuals [12]. This population-based prospective cohort study, begun in
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1992, enrolled more than 90,000 Haimen City residents aged 25 to 64 years old. Blood tests for
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the presence of the hepatitis B surface antigen (HBsAg) indicated a 13.7% HBV infection rate of
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the cohort. Intensive follow-up, including annual collection and validation of vital statistics of
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each cohort member, has been conducted since 1994. Between 1994 and 2007, there were 7,468
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deaths in the cohort, of which 1,717 (23%) were due to HCC.
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Critical Gaps in Knowledge and Practice
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Previously published findings from this cohort have contributed to global knowledge regarding
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the outcome of chronic HBV infection. Although evidence-based HBV prevention, treatment,
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and management protocols have been published [13-17], evidenced-based guidelines have not
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been implemented in Haimen City. Huge gaps in knowledge and practice persist in the general
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population, among patients, and at every level of health care providers in Haimen City. City
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public health officials estimate there are approximately 80,000 people between the ages 25 to 64
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years in Haimen City with CHB. Thousands will likely die from HCC and other chronic liver
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diseases within the next ten years if no appropriate actions are taken towards the prevention and
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control of HBV in this population.
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Methods
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Project Location and Collaborators
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Over the past two decades, Haimen City residents have had high rates of participation in
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epidemiologic studies of the impact of HBV on their population [12, 18-19]. However, Haimen
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City (and much of China) still suffers the stigma, loss of productivity, and death resulting from
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hepatitis B. HBF saw a critical need to address the significant burden of CHB through
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community-based education and the creation of sustainable public health services that could
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serve as a model for implementation in other areas of China, and other high HBV-endemic areas
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around the world. Excellent working relationships between HBF and the HCCDC, the Haimen
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City Health Bureau, Haimen City Center for the Health of Women and Children (HCHWC), and
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the Haimen City Municipal Government, made Haimen City an appropriate site for this
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demonstration project. The HCCDC has an excellent track record in public health awareness
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programming; the recruitment and retention of study subjects; the collection of high quality data
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and biological samples; and the training of doctors and other public health professionals whose
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participation is needed to implement the project activities.
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Specific benefits of conducting the campaign in Haimen City included: immediate start-
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up of the project due to existing infrastructure and relationships; timely government approval of
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the program; comprehensive, well-organized health care infrastructure; cooperation of healthcare
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officials; local experience in working with U.S. collaborators; accurate data collection and
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credible results; and the potential for the transferability of the program to other small city and
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rural populations.
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Target Populations
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The public awareness component of the campaign was designed to reach as many city residents
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as possible (total 1.03 million population, 280,000 households). A more targeted educational
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outreach was directed toward city and township government officials; school nurses;
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obstetricians and nurse assistants; public health officials and physicians from 23 townships;
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village physicians from 239 villages; and community leaders from 239 villages. In addition,
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because transmission of HBV from mother to child during the perinatal period remains a serious
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medical problem in China, the campaign sought to reach all pregnant women over a one-year
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period; HBV-infected pregnant women and their newborns over a one-year period; and spouses
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and first-degree relatives of HBV-infected pregnant women.
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Program Goals and Activities
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The Gateway to Care Campaign has three primary goals focused on public awareness, provider
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and leader education, and elimination of perinatal transmission of HBV (Figure 1). Multi-
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platform educational campaigns for the general public were developed and deployed,
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highlighting the importance of being tested for HBV (see Additional file 1). Specialized
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educational seminars were developed for government officials, community leaders, and
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healthcare providers to increase their knowledge about HBV infection and HCC, and foster
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appropriate testing and referral to care. Finally, the project sought to increase uptake by Chinese
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obstetrical and perinatal care providers of improved, evidence-based methods to prevent and
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manage perinatal HBV infection (see Figure 1 for details on strategies and targets). The
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educational materials, training modules, survey questionnaires, and comprehensive, multi-modal
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outcome evaluation plan were developed together with the local project manager who is on staff
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at the HCCDC (author PH).
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Results and Discussion
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The implementation phase of the Haimen City project concluded in July 2013. Figure 2
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summarizes the outreach activities and results for the three goals of public awareness, provider
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and leader education, and elimination of perinatal transmission. Overall, more than 90% of
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targeted healthcare providers and 80% of the community leaders/government officials attended
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educational seminars during the project period (1,441 health care providers; 1,883 local
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government officials; see figure 2 for details).
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A centralized registration and management system for pregnant women was developed
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and instituted, and 5,407 pregnant women were registered and screened for hepatitis B between
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July 1, 2011 and June 30, 2012 (see figure 2). A total of 266 women (4.9%) were confirmed
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positive for HBsAg, and all 246 infants (100%) born to these HBV-infected mothers received
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one dose of HBIG and the first dose of HBV vaccine by 24 hours of birth. For comparison, an
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associated retrospective survey found that, of 180 infants born to HBV-infected mothers in
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Haimen City in 2010, 178 (98.9%) had received the first dose of HBV vaccine after birth, but
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only 128 infants (71.1%) had received HBIG (Haimen City CDC unpublished data).
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Hepatitis B-related knowledge change in health care providers, health officials, and
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community leaders who attended educational events will be evaluated using data from pre- and
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post-tests conducted before and immediately after educational events, and two years after the
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launch of the campaign (to determine sustainability of change). The long-term impact of the
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project overall (sustainability of knowledge improvements, behavior change, systemic effects of
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the program/ policy changes in Haimen City) will be assessed via focus groups, interviews, and
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surveys conducted at 1 and 3 years post-project completion. Data collection from the prospective
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study to evaluate perinatal prophylaxis failure is ongoing, and will be analyzed according to the
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approved study protocol.
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Conclusions
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To our knowledge, this citywide awareness campaign designed to reach all 1.03 million Haimen
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City residents and their healthcare providers is the first of its kind addressing hepatitis B in
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China. Through its Gateway to Care initiative, HBF hopes to increase public awareness and
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health care provider knowledge about HBV prevention, screening, and care; expand HBV
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screening of pregnant women and ensure post-exposure prophylaxis of newborns; and foster
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adoption of evidence-based HBV management protocols. The HBF and HCCDC will continue to
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monitor the effects of the program for the next ten years, tracking expected reductions in deaths
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from CHB and HCC in the population of Haimen City. It is expected that increasing public
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awareness about hepatitis B will also help to dispel myths, and decrease the stigma and
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discrimination associated with this chronic and highly prevalent disease. The research findings
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about HBV knowledge and practices will contribute to the development of effective educational
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strategies for target audiences. These findings will also inform policy changes toward the
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improvement of health care outcomes in individuals with CHB, and the elimination of new HBV
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infections in China and other areas of the world where HBV is endemic. Deployment of the tools
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developed for this project, including the educational materials and the database system for
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registration and management of pregnant women, can also be expanded to other regions where
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HBV is endemic.
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Several practical elements of the development and implementation phases of this project
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were contributors to its success thus far. Involving key stakeholders, including the Haimen City
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municipal government, the health bureau, and prominent physicians, at the beginning of the
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project was critical for success in reaching out to the targeted population in a project of this
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scale. HBF has established and maintained communication with the Chinese Foundation for
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Hepatitis Prevention and Control, in partnership with Haimen City government and public health
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officials, to pave the way for policy changes based on current and forthcoming project data.
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Project management conducted at the local level by an experienced and trusted member of the
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local health care community was extremely helpful for navigating implementation in Haimen
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City and its villages. (In this case the Deputy Director at the HCCDC was recruited as the project
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manager.) The onsite project manager oversaw the health educators and case managers, assured
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that milestones were met in a timely fashion, oversaw data collection and evaluation, worked
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with media outlets to promote the campaign, and interacted with the city public health and
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government leaders. Also essential was the development of culturally and linguistically
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appropriate, relevant, and potentially effective educational materials, training modules, and
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survey questionnaires. The local project manager and other key local experts are important
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resources for this task.
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List of Abbreviations
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chronic hepatitis B infection (CHB); hepatitis B virus (HBV); Hepatitis B Foundation (HBF);
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Haimen City Center for Disease Control and Prevention (HCCDC); hepatitis B surface antigen
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(HBsAg); Haimen City Center for the Health of Women and Children (HCHWC); hepatocellular
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carcinoma (HCC); hepatitis B immune globulin (HBIG)
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Competing Interests
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The authors have declared that no competing interests exist.
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Author Contributions
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All authors contributed significantly to the study. GC participated in study design, served as
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U.S.-based project director, participated in analysis and interpretation, and provided manuscript
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content and edits. JMB participated in study design, and provided substantial manuscript content
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and edits. AAE participated in study design, led data analysis and interpretation, and provided
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substantial manuscript content and edits. PH participated in study design, served as Haimen City-
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based project director, and provided manuscript review/edits. CC participated in study design,
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participated in analysis and interpretation, and provided substantial manuscript content and edits.
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All authors gave final approval of the manuscript, and agree with the manuscript results and
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conclusions. The ICMJE criteria for authorship has been read and met by all authors.
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Acknowledgement
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The authors acknowledge independent science writer, Theresa M. Wizemann, for assistance with
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preparation of the draft under contract with the Hepatitis B Foundation.
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Funding
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The authors acknowledge funding support for the project from the Bristol-Myers Squibb
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Foundation. This funder had no role in study design, data collection and analysis, decision to
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publish, or preparation of the manuscript. The authors also thank the Haimen City Centers for
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Disease Control and Prevention for their contribution of funds to cover the cost of viral DNA
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testing, and the HBV vaccine and HBIG. (Author P. Huang is on staff at HCCDC)
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Figures
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Figure 1. Gateway to Care Campaign: Haimen City Project goals, srategies and targets. An
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overview of the three main goals of the project, along with specific strategies used during the
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implementation phase of the project.
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Figure 2. Overview of outreach activities. Numbers and proportion of Haimen city residents,
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city leaders, health care providers, and pregnant women reached during the implementation
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phase of the project.
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Additional Files
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Additional file 1. Community awareness events and campaign logo. Residents and patients in
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Haimen City received free hepatitis B consultations at community awareness events on April 8
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and May 19, 2011. Three hepatologists from the Infectious Disease Department of Haimen City
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People’s Hospital and three project staff from the HCCDC answered questions and distributed
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educational give-away items at the event, including the brochure seen here (front and back). Key
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messages included in the logo and brochure are “Right Knowledge, Right Action” and “Stopping
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Liver Cancer Starts from Prevention and Treatment of Hepatitis B.” [link to be created to access
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file with graphics]
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