Find the Missing Millions: Malaysia’s experience with nationwide hepatitis C screening campaign in the general population

Approximately 2.5% of the Malaysian population is currently living with hepatitis C virus (HCV) infection. Yet, the public awareness of the disease is limited and under‐screening remains a major challenge. With the support of international non‐for‐profit organizations, the Ministry of Health in Malaysia recently launched a one‐week nationwide hepatitis C screening campaign in conjunction with the World Hepatitis Day. For the first time, the rapid diagnostic test (RDT) for HCV screening was introduced in public health institutions. This campaign involved 49 hospitals and 38 health clinics across the country, targeting the adult general population with unknown HCV infection status. Of the 11 382 participants undergoing the RDT, 1.9% were found to be positive for hepatitis C antibody (anti‐HCV) and were referred to on‐site medical departments or nearby hospitals for confirmatory testing and treatment. Men, the Malay ethnic group, intranasal and injection drug users and ex‐prisoners were shown to have higher odds of being positive for anti‐HCV. In addition to serving as a model to educate the general population about the disease, this campaign demonstrates the feasibility of decentralizing HCV screening, particularly by promoting the use of RDT, and linking the HCV‐infected patients to care in Malaysia.

Following the advent of the highly effective treatment with direct-acting antivirals (DAAs), the World Health Organization (WHO) has set a goal for the elimination of hepatitis C by 2030. 8 As a country with approximately 2.5% of its population infected with HCV, 9 Malaysia has been actively taking steps towards achieving this goal. Together with the Foundation for Innovative New Diagnostics (FIND) and the Drugs for Neglected Diseases initiative (DNDi), the Ministry of Health (MOH) in Malaysia is currently working on decentralizing HCV screening using a pre-qual- Despite all the efforts made, the awareness of hepatitis C is still considerably lacking and under-screening remains a major challenge in Malaysia. 11,12 Therefore, in collaboration with the FIND and DNDi, the MOH recently launched a one-week nationwide hepatitis C screening campaign. In addition to promoting the public awareness of the disease, this campaign aimed to provide insight into the effectiveness of a population-based screening programme in identifying HCV-infected individuals and the associated factors for HCV infection in the country.

| MATERIAL S AND ME THODS
The screening campaign was conducted between 15 and 21 July 2019 in conjunction with the World Hepatitis Day. Forty-nine public hospitals and 38 public health clinics located in all the 14 states in the country participated in this campaign.
The SD Bioline HCV rapid test kits (sensitivity = 99.3%; specificity = 98.1%) used in this campaign were provided by the FIND in support of the country's efforts to upscale the screening and treatment for hepatitis C. 13 All the screening activities were performed in the existing health facilities by medical staff, including doctors, nurses and medical assistants, who had received training on the use of rapid test kits prior to the campaign. The adult population (≥18 years of age) with unknown HCV infection status was the main target of the campaign. The involved hospitals and clinics were also encouraged to reach out to at-risk groups in need of screening by engaging civil society organizations (CSOs).
Pre-test counselling was given to the individual participants who consented to be enrolled in the campaign, with the aim to inform them of the purpose of the screening, the data collection procedures and the measures taken to ensure confidentiality.
Their information regarding sociodemographic characteristics and the exposure to risk factors of hepatitis C was gathered through an anonymous survey. The participants were required to complete a structured, self-administered questionnaire, which consisted a list of risk factors of hepatitis C adopted from the Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) project (Table 1). 14 The survey was conducted in a designated area in each centre, and only trained medical staff were involved in the data collection.
The presence of hepatitis C antibody (anti-HCV) was mainly confirmed through the RDT, using capillary blood collected by finger-pricking with a lancet. Alternatively, venous blood was used as a sample for the RDT in the participants who required laboratory assessments for other medical conditions at the same time. Posttest counselling was also given to all the participants, mainly to inform them of the screening results and educate them about healthy lifestyle. Those who were positive for anti-HCV were subsequently referred to on-site medical departments or nearby hospitals for confirmatory testing and further management.
The data analysis was performed using the R-3.5.1 for Windows. All the categorical variables were summarized as frequencies and percentages. The backward stepwise multiple logistic regression analysis was applied to determine the factors associated with the anti-HCV status of the participants. This was preceded by the simple logistic regression analysis to identify the potential significant factors. It was ensured that multicollinearity and interaction were not present in the final model. The finding of the Hosmer-Lemeshow goodness-of-fit test, the overall correctly classified percentage and the area under the receiver operating characteristic curve were also used to confirm the model fitness.
The final results were presented as crude and adjusted odds ratios (ORs), along with their corresponding 95% confidence intervals (CIs) and P-values.

| RE SULTS
Of the 11 382 participants undergoing the RDT, nearly half were in the age range of 30-59 years. More than 60% of them were female and of Malay ethnicity. Having a history of invasive medical procedures (17.3%) and body piercing (12.4%) was found to be the most common risk factor of hepatitis C among the participants (Table 1).
A total of 11,523 tests, including 141 (1.2%) repeated for invalid results, were performed. The majority (99.2%) of the participants provided a finger-prick sample for the RDT, while the rest were screened using their venous blood.  (Table 2).

| D ISCUSS I ON
This campaign represents the first time that a highly sensitive and specific rapid test kit was introduced for HCV screening in public It is also noteworthy that this campaign went beyond screening.
Over the one-week period, all the anti-HCV-positive patients iden- Administration. 21 Moreover, it is important to acknowledge the contributions of CSOs in this campaign. Consistent with the previous findings, 22 CSOs were found to play an active role in increasing the screening uptake among high-risk groups, particularly PWID and persons living with HIV. It is noted that the hospitals and clinics engaging CSOs were more likely to capture high-risk groups for HCV screening in this campaign. Again, this implies that multi-organizational participation is of great significance in pushing the agenda of hepatitis C elimination in Malaysia.
The major limitation of this screening campaign lies in its coverage, as the screening services might not be accessible to those who were unaware of this campaign or unable to make a visit to public health institutions. Therefore, the MOH has a plan to expand the screening services to community-based outreach agencies and private health institutions in the second phase of the campaign. It was also challenging to have all the high-risk behaviours truthfully reported by using a self-administered questionnaire. Hence, in the next phase of the campaign, a one-to-one session in a private area could be introduced to obtain the history of high-risk behaviours of participants.
In conclusion, this nationwide HCV screening campaign represents a successful collaborative initiative between the MOH in Malaysia and international non-for-profit organizations. In addition to getting the general population acquainted with the disease and identifying more than 200 potentially HCV-infected individuals, this campaign demonstrates the feasibility of decentralizing HCV screening, especially by promoting the use of RDT, and linking the HCV-infected patients to care in Malaysia.

ACK N OWLED G EM ENTS
We would like to thank Datuk Dr Noor Hisham bin Abdullah, the Director-General of Health, Malaysia, for his support and advice throughout the conduct of the screening campaign. We would also like to thank the FIND and Unitaid for providing us with the rapid diagnostic kits. The DNDi and Pharmaniaga are also acknowledged for their contribution to the transportation and distribution of the rapid diagnostic kits. We also appreciate all the assistance we received from the staff in the Ministry of Health, Malaysia.