Since January 2018, iDSI has been working closely with the Global Fund to fight against AIDS, TB and Malaria (henceforth the Global Fund), the Kenyan Ministry of Health (National AIDS and STI Control Program -NASCOP- and the National AIDS Control Council -NACC) to assess the impact of implementation of Quality Improvement (QI) in support to differentiated care (DC) models on the quality of HIV care in Kenya. This was a unique project: the topic was scoped through lengthy consultations and was entirely led by local partners, the Global Fund and iDSI providing support on research methods, analysis and write-up. This modality of collaboration ensured that the study focus was aligned with future programming plans and strategic policy interests, and that the overall research being conducted with local ownership throughout.

Why is this important?

The study looks at the use of Quality Improvement to support the roll out of one of the most important changes in HIV/AIDs clinical guidelines in the country of the recent year. In 2016, the Ministry of Health issued comprehensive guidelines on Antiretroviral Therapy (ART), which introduced differentiated care (DC) pathways also known as “the DC ART model”. The DC ART model separated patients into different clinical groups demanding on their clinical needs, with specific differentiated patient pathways for each group so as to easily address their clinical needs. Prior to the introduction of DC, all patients were cared under one clinical pathway, e.g. whether they were stable or unstable (e.g. not virally suppressed or with a history of poor adherence). With the introduction of DC, stable patients (which represent > 75% of all patients) have fewer clinical visits and can pick up ART refills directly from pharmacies; freeing up resources (e.g., clinical staff time) to more intensive care for unstable patients with poor health outcomes.

There is a lot of interest and enthusiasm about DC globally, and it is seen as a means to achieve global HIV targets, especially in resource-constrained high prevalence settings[1]. However, there are anecdotal reports of barriers and challenges in implementation of DC pathways[2], including in Kenya where our study took place. As a result, the Kenya Ministry of Health and the Global Fund piloted early on a QI Program in support of DC implementation (with a focus on facilities where performance along HIV targets was not satisfactory). The intervention was implemented from December 2017 to May 2019, with 70 sites participating across 7 counties in the country. It followed a ‘Plan-Do-Act-Study’ process, whereby facilities diagnosed implementation barriers and developed with the support of NASCOP and other facilities local tailored solutions, testing change in real time. In addition, additional training and coaching on the new ART guidelines (including DC pathways) was provided in intervention facilities. There was some training to control sites, but it was far less intensive than in facilities receiving QI.

This is to our knowledge, the first comprehensive evaluation of a practical support program to DC pathway implementation. The study yields significant learnings for other countries looking to implement DC in their countries.

How was the study conducted?

The study followed a simple yet robust evaluation method relying on a single end-point evaluation between intervention and control facilities, identified through propensity score matching (PSM). PSM utilized data pre-intervention (June 2016) to ensure that intervention and control facilities were comparable prior to the implementation of QI. 70 intervention sites were matched with 193 sites based on facility level, volume of patients on ART, county epidemiological characteristics (e.g., HIV prevalence, population density) and proportion of patients with a viral load test in the last year (as an indicator of ‘performance’). Only the best 15 matches out of the 70 sites were selected for the study, for a final sample of 30 facilities. In all facilities, three survey instruments were used: (i) patient survey (coupled with chart abstraction for viral load and information on ARV regimens, weight, height etc.), (ii) facility costing tools (including time and motion survey administered to a sub-sample of patients) and (iii) provider survey (to measure satisfaction and knowledge of guidelines). Ethical clearance was granted by the Red Cross Ethical Review Committee.

Descriptive statistics were produced (means comparison between the two groups), and significance of the difference in means was tested using t-tests and Chi2 tests.

What have we learned?

Processes of care varied widely between facilities in both control (facilities implementing DC alone) and intervention (facilities implementing both QI and DC) groups. For instance, some facilities applied changes that improved service delivery, e.g. changes in opening times (e.g. ARV pick up organized from 6am) or appointment days (e.g., pediatric ART versus stable patient days) to implement DC pathways. Those innovations helped staff manage more complex care pathways and keep track of patient needs, although it is not clear whether they supported more effective implementation (not within the scope of this study). Another common theme across all sites was long waiting times for clinical appointments, especially in high volume facilities. Patients spent on average 92.8 minutes in facilities, and only 8.1 minutes were spent actively seeking services (e.g. clinical consultation, nutritional support, pharmacy time). Those results also support the overall rationale for DC: patients who were present for ARV pick up spent less than 25mins in total in the facility. This is in line with the global literature showing that DC models utilise health resources more efficiently, but may also align better with patient preferences given the otherwise long waiting times. It should be highlighted that waiting times in intervention facilities was lower than in control facilities.

Patient satisfaction with HIV services overall was high across all facilities. Patients were most satisfied with drug availability, and the least satisfied with waiting times. Intervention sites scored higher than control sites along the following dimensions: waiting times, convenience of the appointment, time spent with the clinician and observation of privacy. It is worth noting that while the intervention involved coaching on DC guidelines, we found no statistical difference in provider knowledge of DC guidelines between control and intervention groups, and patient satisfaction with provider technical skills. However, 82% of providers in intervention sites reported that the intervention helped them improve their knowledge of DC pathways very much. Patients scored also higher in ‘knowledge questions’ in intervention sites compared to controls: for instance, to the question “what do you do if you have forgotten your medication?”, 70.6% of respondents in intervention sites answered correctly compared to 58.7% in control sites.

There were notable differences in patient outcomes between control and intervention sites. Patients cared for in intervention sites reported a lower incidence of opportunistic infections (9% compared to 12% in control), higher rate of viral suppression (92.7% compared to 89.4%) and higher quality of life as measured by EQ5D 5L instrument. All those differences were significant at the 5% level. This points to the fact that DC+QI did improve processes of care at the facility level, which resulted in greater patient health.

All in all, the costs of implementing DC+QI versus DC alone amounted to 516 KES  (or less than 5 dollars) per patient per year (a health systems perspective was adopted for costing). Overall costs varied significantly across facilities (e.g. based on facility size) and across different patient groups (e.g. between stable and unstable patients). Almost half of the DC+QI implementation costs (43%) were spent on organizing and learning sessions. Another 39% was attributed to administration and overheads.

A research collaboration led by local actors

This research was entirely driven by NASCOP and NACC, and the results of the report were used to discuss funding and modalities for scaling up the intervention in other counties. This is an example of a collaboration with academic partners, donors, led by country partners to ensure direct application into decision-making, as well as building awareness and capacity around project evaluation and costing methods.

Read the full report here

[1] El-Sadr WM, Rabkin M, DeCock KM. Population health and individualized care in the global AIDS response: synergy or conflict? AIDS. 2016;30(14):2145–8.

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738628/

The session brought together officials from Kenya, Zambia, Indonesia, Eswatini, Rwanda and Malawi representing ministries of health, national health insurers, a Prime Minister’s cabinet and academia to share practical experiences from health financing reforms, with a focus on priority-setting and strategic purchasing.

Dr Velphi Okello: “Weak links between budgets and supply chains often a challenge”

Dr Velphi Okello, Deputy Director of Clinical Health Services at the Eswatini Ministry of Health, shared her knowledge of the design of an essential Health Benefits Package and emphasised the importance of assessing the healthcare provision landscape. Dr Okello stated assessments carried out in 10 rural clinics in Eswatini revealed they were ready to scale up the National Essential Health Care Package (EHCP). However, through assessments at clinics and hospitals, bottlenecks in the supply chain were identified and efforts were made to ensure delivery of EHCP through improvements in the supply chain through budget processes. Political attention was also found to be focusing more on tertiary care than primary care; and there was room for improvement in cross-ministerial relationships. Dr Okello raised the need to mobilise resources to make these health landscapes ready and the need to maximise efficiency opportunities as much as possible.

Dr Solange Hakiba: “Rwanda is continuing to work on educating and engaging patients and the public more to emphasise primary care is just as crucial as tertiary care”

Dr Solange Hakiba, Deputy Director General in charge of Benefits at the Rwanda Social Security Board, highlighted the importance for low and middle-income countries (LMICs) to scope out opportunities to engage the private sector. Dr Hakiba detailed how Rwanda brought the private sector on board to help build infrastructure in partnership with nurses and the District Government, who provided buildings and furniture. Dr Hakiba explained how Rwanda experienced a lack of health workforce following genocide in 1994; as the country recovered its education system this meant more university graduates were coming through, however Rwanda still required non-university educated nurses and community health workers, thus set up ‘Health Posts’ which operate as entry-level clinics in the public sector and provide care for common conditions such as malaria and diarrhoea. Each post is run by an experienced nurse given access to financing and training in business, post-operations and clinical skills. The franchise approach allows the nurse operator to earn a living operating a small business while increasing access to essential medicines and basic healthcare for communities. After a short grace period, the Health Posts begin operating on a self-sustaining basis and can accept reimbursements through Rwanda’s community-based health insurance scheme, the Mutuelle de Sante, which covers approximately 90% of the population. Rwanda is continuing to work on educating and engaging patients and the public more to emphasise that effective and efficient primary care is just as crucial as tertiary care.

Dr Gerald Manthalu: “Multiple sources of funding for health are often not used efficiently as many have different priorities and plans – pooling of funds where possible can help with challenges of fragmentation of financing”

Issues surrounding the fragmentation of financing was raised by Dr Gerald Manthalu, Deputy Director of Planning at Malawi’s Ministry of Health. Dr Manthalu explained how Malawi had over 190 different sources of funding for health, however their use was not always efficient as many had different priorities and plans in place. Dr Manthalu specified Malawi was tackling this specific challenge by aiming to carry out more detailed resource mapping; and encouraging the pooling of funds where possible, especially from donors. Dr Manthalu mentioned the importance of potential revisions of Essential Medicines Lists and also the need to make citizens more aware and encouraging nationwide discussions. The last revision of Malawi’s Essential Medicines List included the addition of antenatal corticosteroids, chlorhexidine, injectable contraceptives and contraceptive implants – increasing commodity access for women and newborns who need lifesaving interventions.

Remaining on the topic of Essential Medicines Lists, Pak Budi Hidayat, Professor of Health Economics and Health Insurance at the University of Indonesia and a member of the national Health Technology Assessment (HTA) Committee, announced at the satellite session the decision by Indonesian authorities to delist certain medicines deemed to be cost-ineffective from the national formulary. Professor Hidayat stated that Badan Penyelenggara Jaminan Sosial, the social insurance agency responsible for administering the Jaminan Kesehatan Nasional (JKN), the world’s largest single national health insurance scheme for Universal Health Coverage, will no longer reimburse cetuximab and bevacizumab for certain colorectal cancers. iDSI core partner HITAP was instrumental in the economic evaluation of the two medicines which led to the policy decision. The costs of these drugs are strikingly high with only marginal benefits for patients, so much so that they are considered poor value for money and not advised as first-line treatment options even in high-income countries.

Dr Henry Kansembe: “G2G funding can result in one strategic plan and a country’s strategic purchasing formula can be applied to a larger amount”

Chief Planner at Zambia’s Ministry of Health (MoH) Dr Henry Kansembe gave examples of how strategic thinking can improve health indicators in a space where fiscal expansion is limited. Dr Kansembe explained how Zambia’s MoH were aware they would unlikely get increased funding from their country’s treasury, so created incentives for providers to perform better. Results-based financing was on five key performance indicators and led to 30% of the allocation being invested more strategically. Zambia has also explored ‘G2G’ funding, where government funds are pooled with donor funds – meaning one strategic plan can be put together and a country’s strategic purchasing formula can be applied to a larger amount of funding.

Practicalities surrounding health financing towards UHC discussed ranged from data constraints to political challenges, such as how to engage civil society. Professor Tony Culyer highlighted the importance of the education of and understanding from all stakeholders, including the public; and used examples of where blood pressure control methods had received public ‘buy in’ after they were successfully communicated, by both health ministries/departments and the media.

Professor Kalipso Chalkidou emphasised the need for LMICs to have more access to data on costs/prices of essential medicines, as high mark-ups are often charged on medicines in LMICs. This could be due to historical practices, or a result of public services buying medicines in the private sector. Professor Chalkidou used the Congo as an example, where the cost of essential medicines is four times higher than the international average; and stressed that the impact is often on individuals, given the high percentage of out-of-pocket payments in LMICs.

The need for integration and transparency with regards to priority-setting; and ensuring policy-makers are on the same page as academics was also high on the agenda during the session.  All agreed academics are habitually signed up to the process of priority-setting for decision making. Decision making however doesn’t always follow through with the priority-setting process. Being transparent when engaging with stakeholders and citing what options were and who was consulted was highlighted as the only way to defend difficult decisions. The value of having a legal and governance framework to link priority-setting and decision making was a theme that was frequently raised throughout the session.

On the topic of Health Technology Assessment (HTA) infrastructure, the UK and Sweden were hailed as success stories, as a drug is not approved for reimbursement before the HTA process (including health economic analyses) has occurred. In contrast, the HTA process happens far too infrequently in LMICs. All concurred it could be challenging to replicate the same structure the UK and Sweden has elsewhere, however a strategy to collaborate internationally – such as via universities’ economics departments – could be a promising way forward to foster HTA within LMICs.

The satellite session received funding from the Swedish International Development Cooperation Agency (Sida), working on behalf of the Swedish Parliament and Government; and was co-hosted by the Clinton Health Access Initiative, Sida and iDSI. We have made all presentations from the session available for download.

 Ahead of the event iDSI caught up with Patric Landin, regional advisor for Sida’s Sexual and Reproductive Health and Rights team; and Dr Yogan Pillay, Deputy Director-General for Communicable and Non-communicable Disease, Prevention, Treatment and Rehabilitation in the National Department of Health in South Africa.

 Read our 60 seconds interview with Patric Landin here.

Read our 60 seconds interview with Yogan Pillay here.

The workshop was attended by 23 delegates representing NACC and NASCOP, as well partners from the Global Fund to fight against AIDS, Tuberculosis and Malaria; the Centre for Disease Control; USAID, Kenya Institute for Public Policy Research and Analysis; and the National Treasury.

The first day kicked off with presentations and case study exercises by the iDSI team, including an introduction to economic evaluation and to fundamentals of costing; as well as a session on valuing and measuring costs. The HIV programmes in the country highlighted the need to develop a standard framework for costing work in Kenya, given that several costing studies are on-going in the country.

Participants spent the morning of day two discussing the evidence needs for the HIV programme. NASCOP presented the on-going work on the piloting of differentiated care pathways coupled with a quality improvement intervention (DCM+QI) in seven counties. DCM+QI recognises that the change from a single guideline to a differentiated pathways requires up-front investment and training to support providers. As a result, NASCOP has worked for almost two years with facilities in the intervention counties to develop locally relevant solutions to support DCM implementation.

In-country partners, the Global Fund and iDSI, will form a technical working group to support NASCOP and NACC in generating the evidence relating to the pilot. This workshop demonstrated the importance of consultation, especially between external partners and local partners working on the ground in Kenya.

Over the last two decades access to treatment has also risen significantly. At present approximately one million people are living with HIV in Keyna are on antiretroviral therapy (ART – the use of HIV medicines to treat HIV infection); and the country’s national strategy includes plans to increase coverage rates to 90%.

These plans could create new challenges for Kenya’ health system by increasing the pressure on the already overstretched human resources and infrastructure for ART delivery. To further compound matters, external funding for HIV/AIDS has been declining globally (-7% between 2015 and 2016). In Kenya, such a decline is likely to be felt in the coming years, especially as Kenya is now categorised as a lower middle income country and will be increasingly requested to co-finance its HIV response (at least by the Global Fund).

Against this backdrop, Kenya plans to implement differentiated care to generate efficiencies and improve quality of ART delivery. Differentiated care seeks to develop standardised evidence-informed clinical pathways for different groups of people living with HIV on ART that share similar needs in terms of ARV follow-up, laboratory testing, clinical examinations and counselling services. Instead of a guideline applied for all, DC defines guidelines for different patient groups depending on their common needs.

Members of iDSI visited Kenya and met with representatives of the National AIDS and STI Control Program (NASCOP), the National AIDS Control Council (NACC), members of the Ministry of Health and various academics to hear about current HIV efforts; the evidence gap on costing of ART delivery and differentiated care; and data gaps for economic evaluation of HIV interventions.

The visit was an opportunity to get to know in country-partners and learn about the implementation of differentiated care. The overarching aim of the trip was to understand how economic evaluation can inform the country’s HIV response and help meet the coverage target.

• The take home messages for IDSI as a result of the Kenya visit were:
• There is a need to understand the cost structure and cost drivers of ART delivery – the last extensive costing in the country occurred in 2011.
• There is significant interest in real-life evidence around the costs and cost-savings of differentiated care in Kenya and globally.
• Non-communicable diseases (NCDs) have become a growing source of morbidity and mortality in people living with HIV in Kenya. Future work should aim to document the costs associated with the rising NCD burden. Kenya also needs to experiment with approaches to integrating HIV and NCD care.
• Kenya’s strategy to combat HIV is extremely progressive. Earlier this year the country was the first in Sub-Saharan Africa to receive and start delivering a new generic first line ART.

iDSI hopes to follow up this visit with a workshop to assess how iDSI can contribute to evidence needs.