Prioritizing leprosy.

Participants explained that priority-setting for leprosy is globally guided by the WHO and ILEP through their published NTD Roadmap. However, the decision to implement the guidelines, and to what extent they are adopted ultimately lies with the respective country’s government and policy makers (B6). Due to its low endemic status, participants from all countries highlighted that policy makers often remain uninformed as to the consequences of leprosy and the resources needed by the healthcare system to effectively implement SDR-PEP. When there is a lack of awareness regarding leprosy’s ongoing public health impact, governments struggle to formulate an effective list of priorities. This, in turn, often results in inadequate resource allocation, impeding the scale-up of SDR-PEP implementation.

‘[Policy makers] can prioritize whether leprosy will be included and how much of those resources can be designated for leprosy. Some of them haven’t even seen or heard of leprosy at all in their lives. (…) And of course, this adds up to the problem of putting leprosy in the public health agenda.’ (C11)

In addition, participants highlighted that the low priority assigned to leprosy was attributed to its low national prevalence, despite the presence of disease hot-spots. It was asserted that with a low caseload, it is increasingly difficult to convince governments to consider leprosy as a priority and invest in preventative interventions such as SDR-PEP, particularly when other diseases are equally or more prevalent and destructive to population health overall (A4). Participants emphasized the pressing need to educate policy makers (e.g., Ministry of Health and the Ministry of Social Affairs) that a low case load does not mean that the disease does not hold significant health, economic and social consequences (S9).

Participants also expressed concern that without the ‘proper mainstreaming of leprosy’ in the public health agenda, healthcare workers lack a heightened awareness of the possibility of leprosy, facing the grave risk that it will be overlooked, and no effective treatment or control measures will be administered in sufficient time, even if SDR-PEP is fully operational (P1).

‘There are fewer and fewer cases, so there are fewer and fewer health personnel who know about leprosy, who know how to recognize a person with leprosy cases. It’s getting more and more difficult, more challenging. Putting leprosy on the public health agenda, keeping that as a priority, and above all, generating capacity and knowledge of the disease by health personnel is what we need [for the success of SDR-PEP].’ (C11)

In addition, participants discussed the risk of healthcare workers choosing to invest time, effort, and resources in other more ‘visible’ and ‘painful’ diseases, especially in the context of resource-tight settings.

‘The issue is that most people think that leprosy has been eradicated and this is not a common disease. And then the other thing is, which is very common, that since this is in the early stages a very painless disease, people take it very lightly. This is the reason that people, including healthcare workers, say leprosy is not a disease which we must put on our top priority.’ (P2)

Another challenge exacerbated by lowering endemicity, is the wider geographical spread of the remaining cases, with disease hot-spots remaining in remote, difficult to access locations. As described by participants from Afghanistan, Bolivia, and Pakistan, those living in these hot-spots are often from disadvantaged socio-economic backgrounds, hindering their access to medical care even when it may be available at a centralized location and free of charge (A4, B6). Investing in mobile health clinics and training in remote, hot-spot areas was one option proposed for diminishing access barriers for underserved groups to interrupt transmission in disease epicentres (C11).

Integration of leprosy into other health programmes.

WHO’s Roadmap to End NTDs by 2030 recommends the integration of several NTD interventions onto a single NTD platform allowing for centralized planning and shared case-finding [20]. Participants from Colombia, Togo, and Pakistan argued that integrating ACD and SDR-PEP with other diseases provided benefits in sharing resources in a flexible and quick manner. For example, Togo integrated ACD for leprosy with Buruli ulcer and yaws which has improved programme efficiency through joint interventions (T7). This combined approach has also garnered greater governmental awareness and funding for SDR-PEP implementation compared to when the leprosy programme functioned alone (T7).

Integration of leprosy control into other high priority public health programmes, such as that of TB, also proved effective in overcoming the lack of direct funding for SDR-PEP implementation by the government (C11, A4). Consequently, adopting a resource-sharing approach has allowed programme coordinators to access a common public health fund for SDR-PEP interventions when needed.

Integrating NTD training, including the basics of leprosy identification, into general medical training was proposed to strengthen ACD and PEP administration. Participants emphasized that by doing so, all healthcare professionals would be more effective sentinels for leprosy and would be able to refer cases more quickly, assisting in early diagnosis and treatment. In this context, leprosy control in Pakistan has collaborated with primary eye care services, resulting in the creation of ‘leprosy ophthalmic technicians’. This has extended leprosy screening and care to a broader population, including access to remote areas through the pre-existing care structure of primary eye care (P2).

Furthermore, integrating leprosy awareness into broader NTD campaigns enabled countries such as Senegal to broaden the coverage and dissemination of leprosy information while simultaneously avoiding the potential for increased stigmatization that might result from having a separate campaign for leprosy.

‘There have been mass campaigns for NTDs and other diseases, and it’s important that the preventive program against leprosy becomes an integral part of any national campaign. There have been youths in the villages who said, look, there are mass campaigns about various diseases, why on earth does leprosy have its own campaign, which of course makes it more susceptible to being stigmatized.’ (S9)

On the other hand, some participants held the viewpoint that if leprosy was fully integrated into a shared monitoring structure with other NTDs it could hinder timely leprosy case reporting due to bureaucratic delays. In this case, participants advocated for a vertical system for leprosy case reporting, where cases are monitored separately, allowing SDR-PEP implementation efforts to target hot-spots, using limited resources efficiently (A13). These participants remained open to the idea of total integration only if clear policy from the WHO was provided and disseminated to public health surveillance and monitoring services.

In addition, a lack of clear policy from the WHO regarding rifampicin supply was also identified as a barrier when integrating leprosy control with other skin related NTDs that require a treatment regimen also including rifampicin, such as Buruli ulcer and TB. Participants expressed that exchanging medication (in this case rifampicin) between disease programmes, as a form of disease integration, could foster medication availability and thus PEP upscaling in leprosy control.

‘I always complain to WHO saying that; you guys are promoting the use of single dose rifampicin to prevent transmission. Yet, you don’t provide rifampicin on a routine basis for leprosy. But at the same time, we have rifampicin for tuberculosis, for Buruli ulcer, but you are not allowed to use tuberculosis rifampicin to treat leprosy patients. We are not allowed to use Buruli ulcer rifampicin to treat leprosy. (…) I’m asking loudly to whoever would want to hear, the WHO or ILEP members, are we really promoting integration just on paper? And in practice does it happen? Nobody seems to provide a clear guideline on how.’ (T7)

In summary, promoting integration of SDR-PEP into other public health programmes encourages resource sharing and ensures the long-term sustainability of the intervention. However, integration needs to be implemented effectively with clear unified aims.

Procurement of rifampicin.

As mentioned in the previous section, one of the key resources necessary for the full and effective functioning of SDR-PEP is the constant availability of sufficient MDT to treat leprosy patients as well as single-dose rifampicin for PEP. Many participants expressed concerns about the procurement of rifampicin, noting that the drug is not produced in sufficient quantity to ensure a constant and adequate supply for SDR-PEP, particularly in low endemic settings. This was attributed to administrative obstacles (rifampicin not being registered for leprosy prevention by the regulatory authorities), lack of political advocacy for drug procurement to international pharmaceutical companies, unfavourable demand for pharmaceutical companies to produce rifampicin in larger quantities for low endemic areas, concerns about rifampicin resistance, and competition with other disease programmes over the available supply of the drug, for example for rifampicin reserved for TB treatment, which is more endemic than leprosy.

‘A big challenge is that we don’t have rifampicin on a routine basis, the rifampicin for SDR-PEP. Even though global partnership for leprosy is promoting the administration of single dose of rifampicin to prevent the transmission, and WHO is promoting it, but where are we getting the rifampicin?’ (T7)

Participants emphasized the need to develop ‘high-quality affiliation’ with pharmaceutical companies to produce sufficient supplies of rifampicin if SDR-PEP is to be implemented as a routine intervention (A4). This is particularly important as rifampicin is used for both the prevention and treatment of the disease, so relying upon disease burden alone may not encourage sufficient production of the drug, especially in low endemic settings.

A potential solution for low endemic settings that struggle to procure rifampicin is to consider local production of the drug (A13, B6). This would provide greater control over its production and cost. Yet, most countries do not have the resources to produce rifampicin locally under franchise agreements, or the quality of the local rifampicin is unclear.

‘Even if I can find rifampicin here in the country, I will not be allowed to purchase any medicine which does not have quality certificate. (…) If quality certificate is not available, as a WHO partner, I will not be allowed to purchase such medicine. So, I will need to have procurement from international market.’ (A13)

Currently, the provision of rifampicin for SDR-PEP in most low endemic countries relies on charitable institutions. Participants expressed growing concern that this creates a dependence upon outside charitable assistance, which if lost, will result in SDR-PEP programme collapse. Some participants added that this dependency reduces pressure on governments to introduce their own nationally funded schemes.

In many of the countries in this study, where leprosy is present, TB is also endemic. The rifampicin used to treat TB, as well as leprosy, comes in combination tablets/capsules or in combined blister packs. However, for PEP, loose rifampicin is needed. This is further challenging SDR-PEP scale-up as rifampicin itself may be available on the market, but the type might not be suitable.

‘It is very difficult to find plain rifampicin because it was a drug that was normally used in the treatment for tuberculosis, so it comes with several combinations. (…) Now we try to manage by placing orders from the pharmaceutical companies that we want to arrange this drug for specifically this use and then they will make the availability for that hopefully.’ (P2)

Participants were deeply concerned about the ethical dilemma of carrying out contact screening without rifampicin being available when contacts were identified.

‘Contact tracing and PEP should go hand in hand. Because if you go and trace contacts and then you don’t have anything to provide (…) is it really necessary to go for contact tracing? (…) We ultimately should have a procurement for rifampicin on a routinely basis. (…) Because if I have a leprosy case and then I have a contact and then you ask me, what next? I should have rifampicin. So they go hand in hand.’ (T7)

Yet, one participant acknowledged that even if the drug is not currently available for widespread PEP use, unless screening and diagnosis takes place, the extent of the burden of the disease will not be recognized and there will be no pressure upon pharmaceutical companies to produce the drug at an affordable price and in an accessible way for low endemic countries (T7).

Regulatory authorities responsible for rifampicin access, along with advocacy efforts directed at pharmaceutical companies and governments, need to be at the forefront of SDR-PEP implementation strategies. Unless rifampicin is readily available, no prevention programme can be fully effective, however well planned.

Human resources and training.

There were two main challenges identified by participants in relation to human resources. The first was the shortage of leprosy specialists, such as dermatologists or expert NTD doctors, and the second was the shortage of female health workers. Furthermore, the low prevalence of leprosy in these countries has been seen as a reason not to invest additional funds in specialist training. This has resulted in leprosy being misdiagnosed or SDR-PEP being incorrectly prescribed due to the lack of familiarity and expertise with the disease, particularly in remote hot-spots (A4, S9, T8). All participants stressed the critical need to have adequate numbers of well-trained leprosy staff to diagnose and refer cases to specialists and implement SDR-PEP safely, with investment in training prioritizing difficult to reach, hyper-endemic areas of leprosy.

Another challenge is the shortage of female health workers, particularly at ground-level. Participants from Afghanistan, Pakistan, and Togo explained how male health professionals are forbidden from examining a female patient for contact screening as it would be considered culturally insensitive within the context of those communities.

“Men are considered the head of the family and would not like you [as a male healthcare worker] to have access to their women. You are obliged to explain at length that his wife was in contact with leprosy. The difficulty is that you cannot have access directly to the woman without going through the man. The man has to give you the authorization to be able to question the woman. This causes an ethical problem.” (T8)

Participants expressed the need to empower and train more female workers to ensure there is equal access to both genders when carrying out contact screening and SDR-PEP administration (A13, P3, T7 & T8).

To ensure the success of SDR-PEP implementation, investment into capacity building and training of more healthcare workers is essential, taking extra effort to address rural areas and the shortage of female health workers.

Surveillance and monitoring systems.

All participants agreed that monitoring systems are essential for improving SDR-PEP implementation in the long-term. Due to the low caseload, participants emphasized the need for effective mapping strategies to assist in finding and analysing disease hot-spots, particularly when forced with limited financial resources. One challenge identified was fragmentation among different monitoring systems within a country for ACD and disease prevalence, in addition to issues regarding the poor functioning of already present leprosy control data systems (C12, C11).

One participant pointed out that vital time is often lost between data collection (e.g., incidence levels) and analysis, which delays SDR-PEP administration to contacts, and consequently increases transmission rates (C12). In addition, the information stored in the database can also serve as a valuable tool for assessing progress and fine-tuning SDR-PEP implementation to provide more effective delivery of leprosy care (C11). This is of particular importance for low resource, low endemic settings due to funding and resource constraints.

Participants suggested that data related to ACD and PEP should be combined with, and collected at the same time and level as other national leprosy reports, to ensure all data are collated. Furthermore, participants from South America and West Africa believed that a unified national reporting system will further emphasize the increasingly routine nature of SDR-PEP to policy makers and the health system at large.

Local alignment of policy.

Currently the guidelines for leprosy control, including ACD and SDR-PEP implementation, are provided by the WHO in the NTD Roadmap [20]. These guidelines are primarily directed at high endemic settings but serve as overarching guidance for all settings irrespective transmission rates. Most participants agreed that the WHO guidelines for SDR-PEP were clear, however, they also emphasized that without the inclusion of local decision makers in adapting the policy to local settings, there is little hope that implementation will be successful. Participants reiterated that it is not just a question of involving the local decision makers in the implementation, but prior to that, involving them in discussions regarding the design of the SDR-PEP implementation plan, to best align with the local context (T7).

Participants noted that lack of implementation research in low endemic countries limits evidence-based decisions on choosing the best suited SDR-PEP implementation approach. Some countries (Bolivia, Colombia, Senegal, and Togo) have previously run or are currently undertaking pilot studies to identify challenges and enablers unique to implementing SDR-PEP as a routine intervention in low endemic settings. For example, pilot studies in Colombia revealed that case identification and SDR-PEP acceptance improved when door-to-door contact screening was carried out by a specialist dermatologist and a person with experience of leprosy (C12).

Currently, pilot studies are not officially part of the SDR-PEP implementation process. Yet, this pro-active approach allows for fine-tuning of national/regional guidelines and the adaption of ACD and SDR-PEP approaches to fit the local context, thereby improving implementation outcomes (T7).

Establishing focal points.

Participants emphasized that the success of SDR-PEP programme implementation was reliant on the capacity and performance at the national level, for example within the Ministry of Health, often through an established focal point with defined roles and responsibilities. For example, participants from Afghanistan highlighted the importance of establishing a national focal point to act as a bridge between WHO, who supports funding, medication availability, and resources (e.g., training) for the programme, and with the workforce, who are the backbone of the public health system and ground-level leprosy control. Additionally, as illustrated by a participant from Afghanistan, establishing an official administrative-level focal point increases unified dedication to implementing SDR-PEP, ensuring that someone within the government is responsible for the programme, thereby preventing the neglect of leprosy control due to its low endemicity. However, one challenge raised by participants was the difficulty of securing permanent funding for a key focal person responsible for SDR-PEP implementation and resource procurement within the government.

‘They [the MoH] are not reluctant actually they are saying there are financial limitations, we cannot recruit some specific person, we do not have finances, we do not have resources to cover salary for such a person.’ (A13)

Afghanistan has overcome this by assigning LEPCO, a leprosy NGO working within the country, as a temporary focal point for the advocacy of the programme’s needs. Although effective for the time being, concerns were expressed around the lack of influence a charitable NGO holds to advocate for the country’s needs within the international public health world. As this was not an official position, it was felt that leprosy control did not have a voice at international forums such as WHO meetings. This puts low resource settings at a greater disadvantage, as they are unable to advocate for funding and support for leprosy control irrespective of their level of endemicity (A4).

Another enabler that was put forward by participants is the value of setting up regional and local focal points alongside national ones. These focal points, such as regional programme coordinators or public health officers, will act as leprosy control strong-holds by taking ownership of any interventions implemented in their locality. Participants hoped that by being able to operate ACD and SDR-PEP successfully through a network of local focal points, a more robust foundation is laid for the long-term implementation of routine leprosy control and disease monitoring (B6, S9).

Fostering trust and addressing stigma.

The theme of building trust emerged inductively during the analysis of the data based on discussions around stigma, acceptance of treatment, and the socio-cultural and political context in general. Many of the participants referred to the ‘myths’, ‘beliefs’, and ‘rumours’ surrounding leprosy and the stigma attached to the disease and anyone suffering from it (B6, T8). These varying understandings of leprosy and its association with criminality or social disobedience were reported to adversely affect disclosure of contacts for ACD and the acceptance of preventative treatment (T8).

“Leprosy is considered a curse in some communities, because he [the leprosy patient] has sinned. (…) Someone with leprosy is considered a thief. They say that is why you lose your fingers. There is this cultural connotation of leprosy that causes problems for contact tracing and accepting any treatment.” (T8)

This was seen as a considerable challenge for SDR-PEP in some low endemic areas, particularly due to the lack of awareness of leprosy due to low national prevalence (S9, T7, T8). Participants suggested that adopting a hybrid approach to ACD, combining door-to-door visits and community skin screening events (for multiple skin-NTDs), would facilitate access for all groups of people regardless of the prevailing levels of stigma and awareness in the area (B6, P1).

“Where there is more stigma, we have found it is better to do general skin camps because in every community, in every family, you have persons who have skin problems. And that is something which helps in overcoming stigma around leprosy as it is not singled out. (…) This is something which helps you to get a relationship with the communities and the trust of the community so that they say okay if you find a patient with any skin problem we will come to your centre for treatment” (P1)

These community clinics also hold the advantage of providing an opportunity for providing health education and destigmatising information about leprosy and other NTDs.