17SERVICE DELIVERY APPROACHES FOR VIRAL HEPATITIS TESTING – examples from the field

17.1. Health-care facility-based testing and provider-initiated testing and counselling

Health facility-based viral hepatitis testing refers to testing provided in a health facility or laboratory setting. There are several approaches to facility-based testing.

Provider or practitioner-initiated testing and counselling (PITC) denotes testing that is routinely offered at a health facility (411), as well as for persons who request testing or who exhibit clinical signs, symptoms or laboratory results that could indicate HBV or HCV infection. It includes provision of pre-test information and obtaining consent, with the option for individuals to decline testing. Although voluntary counselling and testing (VCT) in stand-alone facilities was an early model for delivering HIV testing, it was recognized that offering testing in clinical sites as part of general medical care through PITC (411) resulted in increased HIV testing uptake, coverage and case detection. It also helped normalize testing by removing the potential reluctance of clients to request a test (11, 411). PITC for hepatitis can be implemented and integrated in a number of clinical settings, as summarized below, and these represent major opportunities for scaling up viral hepatitis testing.

HIV clinics. In many populations and high-risk groups, prevalence of HIV and HBV or HCV is high, and there are also high rates of HIV/HBV or HIV/HCV coinfection (88). Existing HIV and ART programmes provide an important opportunity to integrate testing for viral hepatitis with that for HIV (see Box 17.1).

Box 17.1

Integrated HIV/hepatitis testing.

TB clinics. Some populations who are at high risk for HBV and HCV infection are often also at risk for TB, e.g. PWID, prisoners, migrants and persons coinfected with HIV. WHO already recommends routine HIV testing for all TB patients (both active and presumptive cases) (412), and this has proven highly acceptable (413). Integrating HBV and HCV testing as part of a comprehensive package of care for TB patients should be both feasible and acceptable, particularly in settings and populations where the prevalence of TB and viral hepatitis is high.

STI clinics. HBV and HIV, and to a lesser extent HCV, are all sexually transmissible infections, and services providing care for STIs are therefore a key entry point for both HIV and viral hepatitis prevention and treatment services. New acquisition of STIs, such as gonorrhoea and syphilis, indicate recent unprotected sex and can help identify people at a heightened risk of acquisition of HIV and viral hepatitis. WHO already recommends routinely offering HIV testing for persons diagnosed with other STIs (414), with a high uptake of testing (415, 416). Extension to include targeted HBV and HCV testing is also likely to be feasible and acceptable.

Drug treatment and harm reduction services. Many innovative models of care to provide integrated hepatitis and OST services for PWID in community drug treatment services have been developed and effectively implemented, mostly in developed countries (196, 362, 377, 417–419). Many of these programmes provide additional interventions, including education, harm reduction, mental health services, other general medical services, and direct provision of referrals to care and treatment. These models can provide a framework for lower-income countries to expand viral hepatitis testing and treatment for at-risk populations.

Inpatient and outpatient hospital settings present a further opportunity for testing in patients with symptoms or laboratory test findings, such as unexplained abnormal liver function tests that may be indicative of viral hepatitis infection. Testing in hospitals, particularly in low- or concentrated-epidemic settings, has proven effective in HIV case-finding in Europe (420). Testing in hospital emergency departments has also been recently piloted in Europe and the United States (see Box 17.2) (421).

Box 17.2

Using emergency departments to promote testing.

Primary-care settings may be more accessible and less stigmatizing than hospital-based clinics, particularly for high-risk and vulnerable populations such as PWID. Targeted case-finding of people with a history of injecting drug use can increase the number of people who are offered and accept HCV testing (422). Studies also show that multidisciplinary care with integration of other services (e.g. drug and alcohol support, psychiatric services) at the same primary-care setting are acceptable and particularly effective for these populations, who often have multiple health comorbidities and complex needs (417, 423–425). Peer-led models, or provider-led models with peer support, can be particularly effective in enabling integration of services in one place in a way that is acceptable to certain high-risk groups such as PWID. Electronic medical records (EMR) have been successfully used to identify and flag higher-risk patients for viral hepatitis testing in several primary-care clinic and hospital-based programmes (see Box 17.3).

Box 17.3

Use of electronic medical records (EMRs) to flag higher-risk primary care patients for testing.

Paediatric and adolescent clinics may be important settings for identifying cases of previously undiagnosed hepatitis B or C infections, particularly in high-prevalence countries. Offering testing to all children whose mother or father has either HBV or HCV infection, and to those with symptoms or laboratory findings that could be indicative of viral hepatitis infection may identify many infections. This could be integrated in clinics where PITC for HIV is already provided.

Routine testing in antenatal clinics (ANC) is a key opportunity to reduce the global burden of HBV disease, which is primarily propagated through ongoing MTCT in high-prevalence resource-limited settings. Testing for HBsAg enables women to have knowledge of their HBV serostatus for their own health, and for their offspring to benefit from interventions to prevent MTCT, including birth dose and infant HBV vaccination, use of hepatitis B immune globulin (HBIG), and antiviral therapy. PITC for HBV offered routinely in ANC has proven feasible and acceptable in several settings. However, although many countries recommend routine screening, the proportion actually screened in many high-burden LMICs remains low (157). The additional cost of also testing pregnant women for HCV alongside HIV and HBV is likely to be low (see Box 17.4).

Box 17.4

Antenatal clinic testing for hepatitis B infection.

17.2. Community-based testing

Community-based testing can complement facility-based approaches, which may fail to reach certain high-risk populations, especially PWID, who are often marginalized because of stigma and discrimination or legal sanctions, as well as those in remote or rural areas, including pregnant women with limited access to facility-based testing. There is some evidence that offering hepatitis testing in community settings may increase testing acceptance and uptake, achieve earlier diagnosis, reach first-time testers and people who seldom use clinical services (194, 422). However, the same barriers encountered in ensuring linkage to HIV prevention, care and treatment services will need to be addressed. Such outreach methods aimed at HIV prevention have been shown to be particularly effective in engaging with hard-to-reach PWID populations, and decreasing injection and sexual risk behaviours (426) (see Box 17.5).

Box 17.5

Reaching people who inject drugs.

Mobile/Outreach testing approaches include outreach to community sites through mobile vans or tents, at community sites such as churches, mosques or other faith settings, in places of entertainment such as bars and clubs, at cruising sites. Such services may be offered on a regular schedule, at night (“moonlight testing”), or as a one-time or occasional promoted event, linked to public events, such as sports events, music performances, theatre, agricultural fairs and holiday festivals.

Door-to-door/home-based testing takes place in the home. There are two main models: (i) testing that is offered door to door and provided to all consenting individuals, couples or families in a geographical area; and (ii) testing that is offered to households with an index patient (i.e. persons known to have HIV, viral hepatitis or active or presumptive TB), with consent obtained from the index patient before the home visit. Door-to-door testing during the daytime may reach only people who are not working and younger children, while services during the evening or on weekends may increase uptake among others, such as men.

National testing campaigns are nationwide efforts to increase access to and uptake of testing. Some have focused on testing in facilities while others have used a community-based approach or a combination of the two. Outcomes have varied with regard to coverage of different population groups, linkage and cost-effectiveness. A national or regional hepatitis testing campaign has the potential to reach a significant proportion of the population, which includes both those known to be at risk as well as those not at risk for HBV or HCV infection (see Box 17.6). However, experience with national HIV campaigns has shown that they can be expensive, and that a substantial number of people with HIV remain undiagnosed. In addition, linkage to care and treatment from campaigns has been problematic.

Box 17.6

Reaching general populations through community-based and primary clinic testing.

Mass media and social media. Knowledge of hepatitis testing and availability is limited in many countries, and there is a need for promotion and awareness campaigns in the general population. Some countries and programmes promote viral hepatitis testing and education through the mass media, including radio, television, billboards and posters, the Internet and electronic social media (see Box 17.7). This approach has also been used to facilitate more targeted and efficient screening in regions of low prevalence. This also applies to testing in health facilities, in the community and through mobile services (see Box 17.7).

Box 17.7

Use of Internet and social media to promote testing in the general population.

Workplace testing provides employed men and women access to testing, who otherwise might have limited access to clinical services because they need to take time off work to seek health care. Concerns with workplace testing include the potential for coercion, breaches in confidentiality, and weak linkages to services, and care must be taken that this approach is not promoted where it is likely to be abused. For example, 60% of HIV testing in the Middle East and North Africa region is undertaken through workplace testing and work visa procedures, and is generally mandatory (427). It should not therefore be considered an effective model for scale up of hepatitis testing. However, workplace testing for HIV and TB with onward linkage to HIV and TB services has been successfully implemented in several high-burden settings (428–430). Many workplace health programmes do not include hepatitis programmes, creating an opportunity for expanding workplace testing (see Box 17.8).

Box 17.8

Workplace testing.

Testing in schools, colleges or other educational establishments can facilitate access to testing among sexually active young persons by bringing services to students who may find it challenging to seek HIV or hepatitis testing during school hours, and be otherwise hard to reach, as they do not use health services or community services. The service may also provide sexual health education and counselling on risk reduction. In South Africa, a national campaign provides HIV testing to students aged 12 years and older in schools (431). However, school-based HIV testing remains controversial, and few countries have established such programmes. Further evaluation is needed to understand issues of confidentiality, linkage to care and adolescents' experiences with and expectations of school-based testing for both viral hepatitis and HIV, as well as the impact and acceptability of testing among university students.

Testing in prisons and other correctional system settings is a potentially effective way to expand testing uptake among high-risk populations, as many prisoners are at increased risk of acquiring hepatitis B and C infection. There are also additional ethical and regulatory procedures involved in establishing testing programmes in prison settings. Several effective case studies demonstrate how hepatitis testing can be undertaken in prison and justice system settings (see Box 17.9).

Box 17.9

Prison and correctional hepatitis testing.

17.3. Good practices for delivery of effective viral hepatitis testing services

17.3.2. Integration of viral hepatitis testing with other services

Integration involves not only providing related services in a single setting, but also linking recording and reporting systems to share information and referrals between settings and providers. There is already a range of clinical services for which WHO recommends the integration of HIV testing, and this may also apply to hepatitis testing in some settings (see Table 17.1). These include clinical services for TB, HIV, maternal and child health, sexual and reproductive health (STI clinics), mental health and harm reduction programmes for PWID, migrant and refugee services, and persons in prisons (5, 6, 25, 28, 432). Integration with HIV testing and treatment services will be particularly appropriate in HBV and HCV epidemic settings where the HIV prevalence is also high.

Table 17.1

Potential populations and programmes for integration to promote hepatitis testing.

The primary purpose of such integration is to make HBV, HCV and HIV testing more convenient for people coming to health facilities for other reasons, and so expand the reach and uptake of viral hepatitis testing. For the patient, integration of hepatitis testing into other health services may facilitate addressing other health needs at the same time, saving time and money. For the health system, integration may reduce duplication of services and improve coordination, for example, in stock management, overall efficiency and cost–effectiveness.

The goal of programme collaboration is to create integrated delivery systems that best facilitate access to and increase the impact of hepatitis testing, treatment and other health services. Aspects of coordination across programmes that need consideration include: mobilizing, allocating and sharing resources (including multitasking and task-shifting of human resources to increase the availability of highly skilled workers); training, mentoring and supervising health workers; procuring and managing medicines, test kits and other medical supplies; maintaining the quality of testing; and reducing stigma and discrimination (433).

17.3.3. Decentralization of hepatitis testing services

Decentralization of services refers to delivery of services provided in peripheral health facilities, community-based venues and locations beyond urban hospital sites, nearer to patients' homes. This may reduce transportation costs and waiting times experienced in central hospitals and, therefore, improve uptake of testing. Decentralization of HIV treatment services, in high-burden LMICs was a key component of the global scale up of HIV services and successfully improved uptake of testing and reduced loss to follow up (402). To date, delivery of viral hepatitis testing and treatment has in general relied on specialist-led centralized models of care in hospital settings (432). Currently, there are only a few successful models of decentralized viral hepatitis testing and treatment for hard-to-reach populations and general populations at high risk (see Box 17.10). With the development of simpler diagnostic tests for HBV and HCV, and simpler and more effective treatment regimens for HCV, decentralization has the potential to also increase the uptake of hepatitis testing.

Box 17.10

Decentralization.

Decentralization of services, however, may not always be appropriate for or acceptable to potential users. In some settings, centralized viral hepatitis services can provide greater anonymity than neighbourhood services for high-risk populations or others who fear stigma and discrimination. Also, in some low-prevalence settings, decentralizing hepatitis testing may be inefficient and costly. Context, needs, access to laboratory infrastructure and tests, and overall costs and benefits should inform decisions about where hepatitis testing should be decentralized. Decentralization of testing services will also require access to quality-assured RDTs, and DBS specimen collection and analysis.

17.3.4. Task-shifting or -sharing in delivery of hepatitis testing

Many countries, including those affected by HBV, HCV and HIV epidemics, continue to face shortages of trained health workers. Task-shifting is a pragmatic response to health workforce shortages. It seeks to increase the effectiveness and efficiency of available personnel and so enable the existing workforce to provide testing services to more people.

Several systematic reviews from different areas of health care support the general conclusion that good health outcomes can be achieved by devolving tasks to nurses and lay or community health workers (435–438), with appropriate training and supervision. Task-shifting has been adopted for over a decade to expand HIV testing across the Americas (441), Europe (442, 443), sub-Saharan Africa (444–449) and Asia (450), especially in resource-limited settings where there is a shortage of health-care professionals (438). WHO now recommends that lay providers who are trained and supervised can independently perform HIV counselling and testing using RDTs (11, 439). HIV testing in pregnancy can also be promoted through prescription of ART by nurses (440).

In a similar way, task-shifting may also be important for scale up of hepatitis testing, particularly in settings with high HBV or HCV prevalence in the general population or subpopulations (see Box 17.11). Incorporation of viral hepatitis testing into existing task-shifting models of care providing HIV services could be an effective and cost–effective means of fulfilling these objectives. Peer-led interventions have also been effective in increasing viral hepatitis testing, care and treatment for marginalized groups of PWID. In addition to providing services, peers can act as role models and offer non-judgemental and respectful support that may contribute to reducing stigma, facilitating access to services and improving their acceptability (25). However, increasing task-shifting and broadening the scope of responsibilities of trained lay providers will not alone fully rectify staff shortages and poor-quality services.

Box 17.11

Task-shifting.

17.4. Diagnostic innovations to promote access to testing

Advances in hepatitis virus detection technology have created new opportunities for enhancing hepatitis testing, as well as monitoring the response to treatment. Future directions and innovations in testing include simplified single virological assay testing algorithms, near patient or POC assays for NAT and core antigen, DBS sampling (Chapter 13), multiplex/polyvalent platforms, and self-testing.

Simplified testing algorithms. Simplifying testing algorithms will be critical to ensuring affordability and the success of scaling up testing. Potential future testing approaches for HCV infection are the adoption of a less expensive and more manageable single virological test for both diagnosis and confirmation of viraemia (453). However, this may only ever be cost–effective in high-prevalence settings and high-risk populations.

Near patient or POC testing. The development of reliable, accurate, practical and affordable near patient tests will be crucial for expanding hepatitis testing services, especially in community-based settings. POC technologies for viral hepatitis include molecular NAT-based tests for diagnosis and treatment monitoring. These emerging POC devices are able to perform conventional laboratory molecular testing (qualitative and quantitative) in field settings; are easier to use than the laboratory-based NAT assays, as they require minimum training and hands-on time; can be operated on battery or conventional power source; do not require phlebotomy; and provide a result within 2 hours. They include cartridge-based HCV RNA assays, which can be used with existing diagnostic platforms developed for TB or HIV early infant diagnosis and viral load monitoring, but HCVcAg POC platforms are also in development. They offer the possibility of a same-day diagnosis of viraemic infection, either alone or when combined with an HCV antibody RDT, as well as test of cure.

Multiplex and multi-disease analysers. Multiplex or multi-disease analysers allow for integrated testing of hepatitis B and C alongside other pathogens, e.g. HIV and syphilis, and can leverage technology developed for other infectious disease programmes. Key advantages include the requirement for lower specimen volume, improved client flow with results for multiple pathogens available at the same time, and so fewer patient visits and transport costs. Multiplex RDTs are in development for anti-HIV/anti-HCV, anti-HIV/syphilis/anti-HCV, anti-HIV/syphilis/HBsAg and anti-HIV/anti-HCV/HBsAg. Data on their diagnostic accuracy and impact on patient-important outcomes are required before adoption.

Self-testing. Self-testing is a process in which an individual, who wants to know his or her status collects a specimen, performs a test and interprets the result themselves, often in private. HIV self-testing (HIVST) is now being conducted in many settings. Most studies report that HIVST is highly acceptable across a variety of populations (454–456), and has increased uptake of testing among people not reached by other existing HIV testing services, many of whom are first-time testers (21, 457). The experience with hepatitis self-testing is currently very limited, but it represents a potentially important approach to expand access to testing in the future.