Context

Hepatitis C virus (HCV) infection is a major cause of liver diseases (including liver cancer) that lead to approximately 300,000 deaths annually. An estimated 58 million persons are chronically infected, with a disproportionately high burden in low- and middle-income countries (LMICs). People living with HIV are six times more likely to be infected with HCV than people who are HIV-negative, and chronic HCV infection rates are even higher in key populations such as people who inject drugs and prisoners.

HCV can be cured. The introduction of curative, short-course direct acting antiviral (DAA) therapy in 2014 has revolutionized the treatment of HCV, and WHO estimates that the number of people cured from HCV has increased from 1 million in 2015 to 9.4 million.[1] Despite this success, significant challenges remain; there has been insufficient progress on HCV testing and there has been no progress on prevention of HCV among key populations whose access to health services is limited. Prevention and diagnosis need to be scaled up to meet the 2030 elimination targets. This has become particularly urgent as COVID-19 has set back progress on viral hepatitis; according to WHO, viral hepatitis services are among the most frequently disrupted services due to COVID-19. [1]

Globally, despite their proven effectiveness, the availability and use of harm reduction services that can prevent HCV transmission is low. Key prevention interventions for people who inject drugs include the provision of clean needles and syringes, the provision of opioid substitution therapy (OST), and HCV testing and treatment. The provision of sterile injecting equipment is highly effective in reducing transmission of blood-borne infections such as hepatitis C and HIV, through reduction of the number of injections with unsterile or used equipment. However, the distribution of sterile needles and syringes is inadequate (around 17% of the target). OST is another critical component of harm reduction and is well-demonstrated to contribute to reducing incidence and prevalence of blood-borne infections like hepatitis C and HIV among PWID.[2] OST usually takes the form of a daily dose, which can present challenges to people who inject drugs when provided only under supervision or when a limited number of ‘take-home’ doses is provided, especially for those living in remote areas or far from OST centres.

The impact and reach of harm reduction services may be increased through the introduction of innovative or under-used products. For example, low-dead-space syringes reduce the risk of disease transmission in case of re-use or sharing. The option to use a long-acting formulation of buprenorphine may be able to reduce barriers to accessing OST (such as stigma, administrative hurdles and costs associated with travel and lost wages). By introducing such options, and offering people more choices, the uptake and effectiveness of services may increase.

Diagnosis and treatment of HCV infection is becoming more widely available in LMICs. However, services are not always offered or accessible to people who inject drugs and prison populations – despite the fact that they have a high risk of chronic HCV infection. UNODC and WHO have noted that HCV treatment is as effective among people who inject drugs as among other populations and should be offered without any discrimination.[3] HCV treatment can contribute significantly to a reduction of prevalence and incidence among people who inject drugs[4], and evidence is emerging from high-income countries that HCV treatment can also significantly reduce the prevalence and incidence of HCV in prison populations.[5]^,[6]

Without intervention, the uptake and availability of HCV prevention tools in low- and middle-income countries will remain low, which will hamper the achievement of HCV elimination targets. It will also continue to put populations that are already highly vulnerable and marginalized at risk of chronic HCV infection, liver cirrhosis and liver cancer. To redress this situation, there is a need to introduce a more expansive set of harm reduction tools to complement tools currently in use. Such additional tools are for example low dead-space syringes, HCV testing and treatment (‘treatment as prevention’ approach) and long-acting OST.  Work may also be required to accelerate uptake of these tools.

Through this call for proposals, Unitaid aims to catalyse access to and optimal introduction of additional, effective innovative and/or under-used tools for the prevention and treatment of hepatitis C infection in key populations.

[1] WHO. Progress report on HIV, viral hepatitis and sexually transmitted infections. 2021.

[2] WHO, UNODC, UNAIDS. Substitution maintenance therapy in the management of opioid dependence and HIV/AIDS prevention: position paper. 2004.

[3] UNODC. Implementing Comprehensive HIV and HCV Programmes with People Who Inject Drugs. 2017.

[4] AASLD, Key Populations: Identification and Management of HCV in People Who Inject Drugs, Sep 2021.

[5] Hajarizadeh et al. Evaluation of hepatitis C treatment-as-prevention within an Australian prison prospective cohort: The SToP-C study. Lancet Gastroenterology and Hepatology, 2021.

[6] Bartlett et al. Demonstration of Near-Elimination of Hepatitis C Virus Among a Prison Population: The Lotus Glen Correctional Centre Hepatitis C Treatment Project. Clinical Infectious Diseases, 2018.

Call scope

Unitaid is soliciting proposals that aim to catalyze the integration of HCV prevention and treatment in community harm reduction settings and prisons and that demonstrate a person-centered approach to the prevention of HCV for some of the most marginalized people, thereby reducing HCV incidence and prevalence and contributing to achieving the global targets for HCV elimination. Proposals’ scope should address the following objectives:

• Facilitating the introduction of innovative and under-used products for the prevention of HCV in community harm reduction settings or prisons. This should be done in a manner to increases options and choices for affected communities, and would include:
  • Assess user preferences and potential uptake of innovative and under-used products,
  • Pilot introduction, uptake and use of these products in different contexts,
  • Addressing supply side challenges, including affordability, of innovative and under-used products.
• Demonstrating integration of HCV prevention, testing and treatment in harm reduction services and/or prisons. This must include a clear plan of action for engaging with affected communities and other key stakeholders, and clearly explain how the intervention fits into or complements existing services for people who inject drugs or prisoners.
  • In addition to demonstrating feasibility, proposals should also aim to demonstrate impact of the intervention. 

Engagement with civil society and affected communities is a critical determinant for success. Proposals should clearly indicate the role of and collaboration with affected communities and civil society. Meaningful engagement with civil society and affected communities should be included across proposed activities, for example integration of community and civil society into project implementation or governance. 

Proposals should be carefully targeted, reflecting focused interventions to address key challenges with HCV prevention and care in community harm reductions settings and/or prisons. Proposals may target only harm reductions settings or only prison settings. Proposals targeting both prison and community harm reduction settings should clearly indicate the level of effort and budget for each type of settings and provide a rationale for it. The proposal budget should indicate the estimated amount for commodity procurement as a separate budget line.

Proposals should demonstrate value for money and measurable impact within the time frame of the grant. Proposals should also include analysis of the integration in or complementarity with existing services or settings. 

Areas out of scope for this Call include proposals: a) focussing on products that are still in development; b) aiming for full-scale implementation and/or delivery of products; c) aiming to deliver services without introducing any of the innovative or under-used commodities referred to above for the prevention and treatment of HCV infection.

Impact we are seeking

Through this Call for Proposals, Unitaid aims to catalyze HCV prevention among key populations in the following ways:

• Make innovative and/or under-used tools for the prevention of HCV more widely available as an option for key populations,
• Catalyze the integration of HCV prevention (incl. testing and treatment) in harm reduction settings and prisons,
• Reduce HCV transmission among some of the most marginalized and vulnerable people,
• Facilitate the expansion of integrated HCV prevention services for key populations in countries.

The objectives outlined above to prevent HCV infection will lead to (1) a reduction in HCV transmission among key populations, (2) an increase in the number of people tested, diagnosed and treated for HCV and an increase in the number of people cured, and (3) a reduction in HCV-related morbidity and mortality. The ultimate goal is to significantly contribute to progress against the WHO’s goal of elimination of HCV as a public health problem by 2030.

Process for proposal submission

When developing a proposal, please note the following resources:

• Answers to frequently asked questions relevant to proposal development (this document is regularly updated), please click here [PDF: 400 KB];
• Unitaid’s preliminary rationale for working in this area, please click here:
  • HCV prevention background note [PDF: 130 KB]
  • Our Impact stories: Paving the way to hepatitis C elimination [PDF: 300 KB]
  • HCV Disease Narrative 2020

Applicants should be clear about the underlying assumptions made in their proposed approach and should highlight any major risks or other factors that may affect the delivery of results. Finally, proposals are expected to outline a lean, concrete and clear pathway to results and impact.

After assessment of the proposals and endorsement by the Unitaid Board all applicants will be officially notified as to whether they will be invited to develop a full grant agreement for Unitaid funding.

Successful applicants should plan to be available for a face-to-face kick-off meeting with Unitaid, in the week 11-15 July 2022 (tbc). In addition, successful applicants should plan to have sufficient human resources available to advance a first draft of the project plan by 1^st September 2022.

Important dates

Submission and format of proposals

Proposals, including all annexes, should be submitted electronically to proposalsUnitaid@who.int. A full proposal consists of the following documents:

• Proposal form with scanned version of signed Front page template, [DOC: 170 KB]
• Annex 1: Log frame and GANTT chart template, [XLS: 278 KB]
• Annex 2: Budget details template, [XLS: 24 KB]
• Annex 3: Organizational details and CVs of key team members [no template]
• Annex 4: Country engagement support Letters [no template]
• Annex 5: Declaration of relevant interest template, [DOC: 21 KB]
• Annex 6: Applicable ethics, anti-discrimination and environmental policies template, [DOC: 21 KB]
• Annex 7: Declaration regarding tobacco entities template, [DOC: 24 KB]
• Annex 8: Anti-Terrorism Declaration template, [DOC: 30 KB]
• Annex 9: Audited financial statements for the past 3 years [no template]
• Guidance on Impact Assessment [PDF: 160 KB]
• Financial Guidelines for Unitaid Grantees [PDF: 1,2 MB]
• Unitaid Results Framework [PDF: 1.3 MB]
• Unitaid Scalability Framework [PDF: 466 KB]

If you have any questions about the application processes throughout any stage of the application review process, please send your queries to the Grant Application Manager:  proposalsUnitaid@who.int

You will find further guidance in the Unitaid proposal process document [PDF: 530 KB].

Webinar on this Call for Proposals: