Institutions/organizations that successfully carried out a stage 1 project were eligible to apply for a 3-year stage 2 grant. Stage 2 projects aim at further improving quality of care for people with HIV, viral hepatitis and tuberculosis through research that build on outcomes, insights and lessons learnt from the stage 1 pilot.
Following the stage 2 call for proposals launched in December 2021, three projects were selected for a stage 2 grant. Brief project summaries are available below.
Evaluation of integrated hepatitis C management in methadone clinics in Ukraine
Grantee: Ukrainian Institute on Public Health Policy (UIPHP), Kyiv, Ukraine
Project start: August 2022
Main applicant and principal investigator: Kostyantyn Dumchev, Scientific Director, UIPHP
Deputy applicant: Sergii Dvoriak, Director, UIPHP
1. Prof Frederick Altice, Yale University, USA
2. Dr Patrizia Carrieri, French National Institute of Health and Medical research (INSERM), France
Background: People who inject drugs (PWID) have a high burden of hepatitis C virus infection (HCV) but suffer from lower access to life-saving treatments because of stigma and low awareness. Enrollment into opioid agonist treatment (OAT), especially in integrated settings, improves the health of PWID through reducing drug use and increasing access to medical care. Integration of OAT with HIV and TB care is well studied, including in Ukraine, however, there are only a few studies of OAT and HCV treatment integration. About 17 000 patients receive opioid agonist treatment (OAT) in Ukraine among whom 83% are HCV-infected. Considering the increasing availability of DAA medications in Ukraine, this group can be efficiently covered with treatment using a simplified integrated HCV management (SHIM) care model, which minimizes the number of required assessments and costs. Building on the successful Stage 1 project, where we demonstrated feasibility of the applied SHIM care model and high cure rates in a small sample of OAT patients, we propose a rigorous evaluation using a hybrid type 2 implementation study design.
Objective: The goal of the proposed hybrid type 2 implementation study is to scale up and evaluate the effectiveness of the SHIM algorithm in improving the HCV treatment cascade outcomes in OAT clinics in Ukraine. We will strengthen the SHIM model implementation by an evidence-based ECHO (Extension for Community Healthcare Outcomes) intervention, a collaborative telehealth learning intervention that supports and empowers clinicians to develop knowledge and self-efficacy about HCV care, which has not traditionally been part of their clinical scope. Additionally, we will study the client, clinician and organizational factors that contribute to SHIM and ECHO adoption.
Methods: A hybrid type 2 implementation study design will be applied, combining a matched cluster-randomized trial and qualitative methods. 480 HCV-infected patients from 12 clinics with matching characteristics will be randomized to three arms: standard of care (N=160) versus SHIM with (N=160) or without (N=160) ECHO facilitation. We will assess and compare HCV cascade outcomes, including treatment uptake, completion and HCV cure. Client, clinician and organizational factors that contribute to SHIM and ECHO adoption will be assessed using a qualitative multi-level implementation science framework.
Output/impact: The results of SHIM evaluation, if shown effective, will enable formal endorsement by the Ministry of Health, paving the way for scale-up to OAT clinics and non-specialized clinics in Ukraine. The results of the study will strengthen the global evidence base on integration of HCV services for PWID, which currently lacks RCT data, particularly from low- and middle-income countries. Ultimately, this will result in improved access to HCV care, improved quality of life of the many people currently living with HCV and contribute to HCV elimination.
Improving management of non-AIDS comorbidities among people living with HIV in Georgia
Grantee: Infectious Diseases, AIDS and Clinical Immunology Research Center (IDACIRC), Georgia
Project start: August 2022
Main applicant and principal investigator: Prof. Tengiz Tsertsvadze, Director General, IDACIRC
Deputy applicant and deputy principal investigator: Nino Rukhadze, Infectious Diseases physician, IDACIRC
Background: Improvements in HIV treatment and care have resulted in increasing life-expectancy of people living with HIV (PLHIV) in Georgia which in turn is accompanied by increases in the prevalence of non-AIDS comorbidities (NACM). Patterns of cause-specific mortality have changed, with more persons dying from non-AIDS than AIDS related causes. The existing HIV care model has primarily focused on ART provision and management of infectious complications of HIV, provided in specialty clinics by infectious diseases physicians. While people are screened for NACMs in the HIV clinic, they may not always seek required NCD care (diagnostics and/or treatment) because of costs related to services outside of the HIV system or fear of disclosure of HIV status. The prior absence of national policies on the management of non-infectious co-morbidities among people living with HIV created a gap in the knowledge about the burden of NACM in the country. In the stage 1 project, a representative cohort was established to estimate the prevalence of cardiovascular disease (CVD), chronic kidney disease (CKD), diabetes mellitus (DM) and dyslipidemia. The stage 1 phase also facilitated the integration of EACS recommendations on the prevention and management of NACM into national guidelines. However, it remains critically important to better understand the magnitude of the problem and develop an appropriate care model.
Objective: The overall aim of the study is to improve the management of non-AIDS co-morbidities among people living with HIV in Georgia, focusing particularly on CVD, CKD and DM. The specific objectives are to 1) Expand the research cohort established in stage 1 and re-assess prevalence of NACM among PLHIV in Georgia; 2) Estimate incidence of NACM among PLHIV in the established cohort; 3) Implement a pilot integrated model of HIV/NACM care, seeking to remove barriers for patients and meet complex care needs; 4) Promote implementation of EACS recommendations on NACM prevention and management and assess the quality of service delivery in regional AIDS centers; 5) Disseminate study findings through policy recommendations for health decision-makers and a scientific publication.
Method: The cohort will be expanded from 1200 to 2000 people living with HIV for the estimation of CVD, CKD, DM and dyslipidemia prevalence and incidence (twice per year). Data on clinical events, appropriately documented in accordance with national regulations on medical recordkeeping, will be extracted from the medical charts. In addition, a patient survey will collect information from enrolled patients about awareness of NACM, risk factors, and self-reported history of NACM and treatment. For the integrated HIV/NACM care model, three NCD physicians (a cardiologist, an endocrinologist, and a nephrologist) will be consulting patients in the HIV clinic. NCD screening and diagnostics will be covered through the national AIDS treatment program within allocated funding, and NCD physician consultations will be reimbursed through funds requested from WEEPI according to scales used within the national AIDS treatment program. Quality of service delivery, including impact of the stage 1 project activities, and implementation of EACS recommendations will be assessed via audits conducted in regional AIDS centers. Leading non-communicable diseases specialists will be involved in the planning and implementation of a national training-workshop on the management of NACM in PLHIV.
Output/impact: The study will facilitate adoption of an effective and patient-centered model of care to ensure appropriate management of NACMs integrated within HIV clinic settings, and will create a solid basis for building a sustainable care model for the prevention and management of NACM, both programmatically and financially. Such a model will improve the quality of care for people living with HIV and NACM and improve access to NCD treatment. The project will also expand the partnerships between local, national and international experts that were founded in the stage 1 project and thereby contribute to strengthening the capacity of Georgian healthcare providers.
Implementation of programmatic management of latent tuberculosis infection in HIV-infected people in Lithuania
Grantee: Vilnius University, Vilnius, Lithuania
Project start: March 2023
Main applicant and principal investigator: Prof. Raimonda Matulionyte, Vilnius University
Deputy applicant and project coordinator: Elzbieta Matulyte, PhD student, Vilnius University
- Edvardas Danila, Head of Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos; Vilnius University, Faculty of Medicine, Institute of Clinical Medicine, Clinic of Chest Diseases, Immunology, and Allergology
- Robertas Badaras, Head of Toxicology centre, Republican Vilnius University Hospital; Vilnius University, Faculty of Medicine, Clinic of Anaesthesiology and Intensive Care
- Giedrius Likatavicius, Head of Vilnius Branch of Republican Centre for Addictive Disorders
- Rasa Girdziuniene, Head of Infectious Diseases Unit, Department of Infectious Diseases, Klaipeda University Hospital
- Aidas Kausas, Head of Adult Infectious Diseases Unit, Clinic of Conservative Medicine, Republican Siauliai County Hospital.
Background: Tuberculosis (TB) continues to be a serious public health problem in Lithuania and is the leading cause of death among people living with HIV (PLHIV). It is the most common AIDS-indicative disease (>50% in 2019), more common than in any other EU/EEA country. Prevention of active TB disease by treatment of latent TB infection (LTBI) is a critical component of the WHO End TB Strategy. Since mid-2018, interferon gama release assay (IGRA) testing has been included into Lithuanian HIV management guidelines, but no further steps after positivity detection are described. Given the complicated epidemiological TB situation, Lithuania urgently needs a policy for programmatic management of LTBI among PLHIV. The WEEPI stage 1 project clearly demonstrated that injecting drug use is a common driver of the HIV, TB and HCV syndemic in Lithuania, similarly to other Eastern European countries.
Objective: This stage 2 project will identify the required components for programmatic LTBI control, develop national guidelines and implement programmatic management of LTBI among PLHIV in Lithuania, taking into account country-specific factors defined during the stage 1 WEEPI project. The project aims at enabling better identification of at-risk populations for LTBI testing and treatment and define the best interventions to ensure timely linkage to care following an HIV, HCV and LTBI diagnosis, develop a comprehensive and systematic strategy for LTBI management, prepare national guidelines for programmatic LTBI control among PLHIV in Lithuania and develop methods and material for the information and education strategy for different levels of society.
Methods: The study will be conducted at seven distinctive sites: four infectious diseases departments, a Toxicology centre; Centre for Addictive Disorders and a Hospital Dermatovenerology Centre. A cross-sectional study will assess population groups who are at increased risk for LTBI in Lithuania; explore the best pathways to enhance linkage to care and treatment among individuals screened positive for LTBI, HIV and/or HCV; and assess prevalence and associated risk factors for LTBI among PLHIV (N=250) and HIV uninfected individuals (N=1080) in Lithuania. A cohort of 20 to 40 PLHIV screened positive for LTBI during the WEEPI stage 1 and 2 projects combined will be established to describe and compare clinical and diagnostic work-up algorithms for LTBI. An expert group of national and international experts will develop a comprehensive and systematic strategy for programmatic LTBI control in PLHIV in Lithuania and draft the national guidelines based on the project findings. The group will also develop materials for dissemination and education of various groups, including patient groups, community workers, healthcare workers and policy makers.
Output/impact: The project will serve as a base for the comprehensive programmatic management of LTBI among people living with HIV in Lithuania. Based on this strategy, national recommendations for programmatic management of LTBI will be created and harmonized with other activities in the area of TB elimination in response to the WHO End TB Strategy and the next national Action plan for HIV/AIDS and STI Prevention and Control. It will be integrated into the existing Lithuanian HIV/AIDS guidelines, and a long-term benefit to individual and public health is expected. The WEEPI stage 1 clearly demonstrate that injecting drug use is a common driver of the HIV, TB and HCV epidemics in Lithuania. This is a strong argument supporting the need for integrated HIV, TB, HCV and substance abuse treatment services to provide person-centered rather than disease-centered care. The project will enable implementation of educational activities, reduce barriers to testing for LTBI and HIV/HCV, raise the awareness about LTBI and active TB among patient population and health care providers. It will also facilitate interdisciplinary collaboration and the partnership with other geographically distinct centres and facilitate knowledge and better equity in quality of care across the country.