The ACT Malaria Treatment Policy Change in Kenya

Objectives of the national Antimalarial treatment policy: •Enable population at risk access safe, good quality, effective, affordable & acceptable antimalarial drugs •Ensure rapid and long lasting clinical cure •Prevent progression to severe disease •Reduce the incidence of anaemia •Reduce consequences of placental malaria infection •Delay development of resistance to antimalarial drugs Key specific issues: •Limited data available on safety of ACTs in young infants (use of coartem <5kgs) •Lack of adequate safety and efficacy data on drug combinations in pregnant women (safety of lumefantrine in pregnancy) •Improving systems of forecasting of drug needs •Strengthening the management and drug supply system (procurement, distribution and use) according to the specificities of the new drugs (shorter shelf life and the course-of-therapy packs) •Complex treatment schedules poses challenge for ensuring compliance •Need for more friendly paediatric formulation

The challenges of changing national malaria drug policy to artemisinin-based combinations in Kenya

Backgound: Sulphadoxine/sulphalene-pyrimethamine (SP) was adopted in Kenya as first line therapeutic for uncomplicated malaria in 1998. By the second half of 2003, there was convincing evidence that SP was failing and had to be replaced. Despite several descriptive investigations of policy change and implementation when countries moved from chloroquine to SP, the different constraints of moving to artemisinin-based combination therapy (ACT) in Africa are less well documented. Methods: A narrative description of the process of anti-malarial drug policy change, financing and implementation in Kenya is assembled from discussions with stakeholders, reports, newspaper articles, minutes of meetings and email correspondence between actors in the policy change process. The narrative has been structured to capture the timing of events, the difficulties and hurdles faced and the resolutions reached to the final implementation of a new treatment policy. Results: Following a recognition that SP was failing there was a rapid technical appraisal of available data and replacement options resulting in a decision to adopt artemether-lumefantrine (AL) as the recommended first-line therapy in Kenya, announced in April 2004. Funding requirements were approved by the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) and over 60 million US$ were agreed in principle in July 2004 to procure AL and implement the policy change. AL arrived in Kenya in May 2006, distribution to health facilities began in July 2006 coincidental with cascade in-service training in the revised national guidelines. Both training and drug distribution were almost complete by the end of 2006. The article examines why it took over 32 months from announcing a drug policy change to completing early implementation. Reasons included: lack of clarity on sustainable financing of an expensive therapeutic for a common disease, a delay in release of funding, a lack of comparative efficacy data between AL and amodiaquine-based alternatives, a poor dialogue with pharmaceutical companies with a national interest in antimalarial drug supply versus the single sourcing of AL and complex drug ordering, tendering and procurement procedures. Conclusion: Decisions to abandon failing monotherapy in favour of ACT for the treatment of malaria can be achieved relatively quickly. Future policy changes in Africa should be carefully prepared for a myriad of financial, political and legislative issues that might limit the rapid translation of drug policy change into action

Costs and cost-effectiveness of delivering intermittent preventive treatment through schools in western Kenya

BACKGROUND: Awareness of the potential impact of malaria among school-age children has stimulated investigation into malaria interventions that can be delivered through schools. However, little evidence is available on the costs and cost-effectiveness of intervention options. This paper evaluates the costs and cost-effectiveness of intermittent preventive treatment (IPT) as delivered by teachers in schools in western Kenya. METHODS: Information on actual drug and non-drug associated costs were collected from expenditure and salary records, government budgets and interviews with key district and national officials. Effectiveness data were derived from a cluster-randomised-controlled trial of IPT where a single dose of sulphadoxine-pyrimethamine and three daily doses of amodiaquine were provided three times in year (once termly). Both financial and economic costs were estimated from a provider perspective, and effectiveness was estimated in terms of anaemia cases averted. A sensitivity analysis was conducted to assess the impact of key assumptions on estimated cost-effectiveness. RESULTS: The delivery of IPT by teachers was estimated to cost US$1.88 per child treated per year, with drug and teacher training costs constituting the largest cost components. Set-up costs accounted for 13.2$ 0.25 per child) whilst recurrent costs accounted for 86.8% (US$1.63 per child per year). The estimated cost per anaemia case averted was US$ 29.84 and the cost per case of Plasmodium falciparum parasitaemia averted was US$5.36, respectively. The cost per case of anaemia averted ranged between US$ 24.60 and 40.32 when the prices of antimalarial drugs and delivery costs were varied. Cost-effectiveness was most influenced by effectiveness of IPT and the background prevalence of anaemia. In settings where 30% and 50% of schoolchildren were anaemic, cost-effectiveness ratios were US$ 12.53 and 7.52, respectively. CONCLUSION: This study provides the first evidence that IPT administered by teachers is a cost-effective school-based malaria intervention and merits investigation in other settings

Evaluating Different Dimensions of Programme Effectiveness for Private Medicine Retailer Malaria Control Interventions in Kenya

BACKGROUND: Private medicine retailers (PMRs) are key partners in the home management of fevers in many settings. Current evidence on effectiveness for PMR interventions at scale is limited. This study presents evaluation findings of two different programs implemented at moderate scale targeting PMRs for malaria control in the Kisii and Kwale districts of Kenya. Key components of this evaluation were measurement of program performance, including coverage, PMR knowledge, practices, and utilization based on spatial analysis. METHODOLOGY/PRINCIPAL FINDINGS: The study utilized mixed quantitative methods including retail audits and surrogate client surveys based on post-intervention cross-sectional surveys in intervention and control areas and mapping of intervention outlets. There was a large and significant impact on PMR knowledge and practices of the program in Kisii, with 60.5% of trained PMRs selling amodiaquine medicines in adequate doses compared to 2.8% of untrained ones (OR; 53.5: 95% CI 6.7, 428.3), a program coverage of 69.7% targeted outlets, and a potential utilization of about 30,000 children under five. The evaluation in Kwale also indicates a significant impact with 18.8% and 2.3% intervention and control PMRs selling amodiaquine with correct advice, respectively (OR; 9.4: 95% CI 1.1, 83.7), a program coverage of 25.3% targeted outlets, and a potential utilization of about 48,000 children under five. A provisional benchmark of 7.5 km was a reasonable threshold distance for households to access PMR services. CONCLUSIONS/SIGNIFICANCE: This evaluation show that PMR interventions operationalized in the district level settings are likely to impact PMR knowledge and practices and lead to increased coverage of appropriate treatment to target populations. There is value of evaluating different dimensions of public health programs, including quality, spatial access, and implementation practice. This approach strengthens the potential contribution of pragmatic study designs to evaluating public health programs in the real world

Patient adherence to prescribed artemisinin-based combination therapy in Garissa County, Kenya, after three years of health care in a conflict setting.

BACKGROUND: Current day malaria cases and deaths are indicative of a lack of access to both methods of prevention, diagnosis, and treatment; an important determinant of treatment efficacy is adherence. This study is a follow up to the baseline study of adherence to artemether-lumefantrine (AL) carried out in Garissa District in 2010. The study presented evaluates any changes in adherence levels which may have occurred in the area during this period and after nearly three years of sustained use of ACT across the public health sector. METHODS: The study was carried out in Garissa County in the North Eastern Province of Kenya and included patients fitting the suspected malaria case definition and having been prescribed AL, regardless of confirmatory diagnosis. A questionnaire assessed the intake of AL via both self-reporting by the participant and observation of blister packs by the interviewer. On separate occasions exit interviews with patients and observations of prescribers were also carried out. RESULTS: Of the 218 participants enrolled, 195 were successfully followed up. 60% of participants were found to be adherent to the three-day AL regimen, this is 4.7% lower than the proportion of participants adherent in 2010; the result of a two-sided z-test was not significant (p = 0.23). The odds of the patient being adherent to AL increased by 65% with each additional correct statement regarding how to take AL that a patient could recall (between zero and four statements), this was the only variable significantly associated with patient adherence (p = 0.01). CONCLUSION: Sustaining the ACT adherence rates at the 2010 levels, through 2.5 years of insecurity in the study area is an achievement and suggests that if security can be improved barriers to improving health service quality and patient adherence to AL would be removed. This study, by looking specifically at anti-malarial adherence over a prolonged period and in a setting of severe conflict, provides a valuable and rare insight in to the challenges and barriers to ACT adherence in such settings

Possible Interruption of Malaria Transmission, Highland Kenya, 2007–2008

Annual insecticide spraying and artemisinin combination therapy may stop transmission

Importance of strategic management in the implementation of private medicine retailer programmes: case studies from three districts in Kenya

BACKGROUND: The home-management of malaria strategy seeks to improve prompt and effective anti-malarial drug use through the informal sector, with a potential channel being the Private Medicine Retailers (PMRs). Previous evaluations of PMR programmes focused on their impact on retailer knowledge and practices, with limited evidence about the influence of implementation processes on the impacts at scale. This paper examines how the implementation processes of three PMR programmes in Kenya, each scaled up within a district, contributed to the outcomes observed. These were a Ministry of Health programme in Kwale district; and two programmes supported by non-governmental organizations in collaboration with government in Kisii Central and Bungoma districts. METHODS: The research methods included 24 focus group discussions with clients and PMRs, 19 in-depth interviews with implementing actors, document review and a diary of events. The data were analysed using the combination of a broad policy analysis framework and more specific scaling up/diffusion of innovations frameworks. RESULTS: The Kisii programme, a case study of successful implementation, was underpinned by good relationships between district health managers and a "resource team", supported by a memorandum of understanding which enabled successful implementation. It had flexible budgetary and decision making processes which were responsive to local contexts, and took account of local socio-economic activities. In contrast, the Kwale programme, which had implementation challenges, was characterised by a complex funding process, with lengthy timelines, that was tied to the government financial management system which constrained implementation Although there was a flexible funding system in Bungoma, a perceived lack of transparency in fund management, inadequate management of inter-organisational relationships, and inability to adapt and respond to changing circumstances led to implementation difficulties. CONCLUSIONS: For effective scaling up of PMR programmes, the provision of technical support and adequate resources are vital, but not sufficient on their own. An active strategy to manage relationships between implementing actors through effective communication mechanisms is essential. Successful outcomes may be realised if a strong and transparent management system, including management of financial resources, is put in place. This study provides evidence of the value of assessing implementation processes as part of impact evaluation for public health programmes

A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya

<p>Abstract</p> <p>Background</p> <p>Artemether/lumefantrine (AL) has been adopted as the treatment of choice for uncomplicated malaria in Kenya and other countries in the region. Six-dose artemether/lumefantrine tablets are highly effective and safe for the treatment of infants and children weighing between five and 25 kg with uncomplicated <it>Plasmodium falciparum </it>malaria. However, oral paediatric formulations are urgently needed, as the tablets are difficult to administer to young children, who cannot swallow whole tablets or tolerate the bitter taste of the crushed tablets.</p> <p>Methods</p> <p>A randomized, controlled, open-label trial was conducted comparing day 28 PCR corrected cure-rates in 245 children aged 6–59 months, treated over three days with either six-dose of artemether/lumefantrine tablets (Coartem^®) or three-dose of artemether/lumefantrine suspension (Co-artesiane^®) for uncomplicated falciparum malaria in western Kenya. The children were followed-up with clinical, parasitological and haematological evaluations over 28 days.</p> <p>Results</p> <p>Ninety three percent (124/133) and 90% (121/134) children in the AL tablets and AL suspension arms respectively completed followed up. A per protocol analysis revealed a PCR-corrected parasitological cure rate of 96.0% at Day 28 in the AL tablets group and 93.4% in the AL suspension group, p = 0.40. Both drugs effectively cleared gametocytes and were well tolerated, with no difference in the overall incidence of adverse events.</p> <p>Conclusion</p> <p>The once daily three-dose of artemether-lumefantrine suspension (Co-artesiane^®) was not superior to six-dose artemether-lumefantrine tablets (Coartem^®) for the treatment of uncomplicated malaria in children below five years of age in western Kenya.</p> <p>Trial registration</p> <p>ClinicalTrials.gov NCT00529867</p

Malaria in Kakuma refugee camp, Turkana, Kenya: facilitation of Anopheles arabiensis vector populations by installed water distribution and catchment systems

<p>Abstract</p> <p>Background</p> <p>Malaria is a major health concern for displaced persons occupying refugee camps in sub-Saharan Africa, yet there is little information on the incidence of infection and nature of transmission in these settings. Kakuma Refugee Camp, located in a dry area of north-western Kenya, has hosted ca. 60,000 to 90,000 refugees since 1992, primarily from Sudan and Somalia. The purpose of this study was to investigate malaria prevalence and attack rate and sources of <it>Anopheles </it>vectors in Kakuma refugee camp, in 2005-2006, after a malaria epidemic was observed by staff at camp clinics.</p> <p>Methods</p> <p>Malaria prevalence and attack rate was estimated from cases of fever presenting to camp clinics and the hospital in August 2005, using rapid diagnostic tests and microscopy of blood smears. Larval habitats of vectors were sampled and mapped. Houses were sampled for adult vectors using the pyrethrum knockdown spray method, and mapped. Vectors were identified to species level and their infection with <it>Plasmodium falciparum </it>determined.</p> <p>Results</p> <p>Prevalence of febrile illness with <it>P. falciparum </it>was highest among the 5 to 17 year olds (62.4%) while malaria attack rate was highest among the two to 4 year olds (5.2/1,000/day). Infected individuals were spatially concentrated in three of the 11 residential zones of the camp. The indoor densities of <it>Anopheles arabiensis</it>, the sole malaria vector, were similar during the wet and dry seasons, but were distributed in an aggregated fashion and predominantly in the same zones where malaria attack rates were high. Larval habitats and larval populations were also concentrated in these zones. Larval habitats were man-made pits of water associated with tap-stands installed as the water delivery system to residents with year round availability in the camp. Three percent of <it>A. arabiensis </it>adult females were infected with <it>P. falciparum </it>sporozoites in the rainy season.</p> <p>Conclusions</p> <p>Malaria in Kakuma refugee camp was due mainly to infection with <it>P. falciparum </it>and showed a hyperendemic age-prevalence profile, in an area with otherwise low risk of malaria given prevailing climate. Transmission was sustained by <it>A. arabiensis</it>, whose populations were facilitated by installation of man-made water distribution and catchment systems.</p