Comparison of home-based management of fever/malaria to enhanced health facility-based care in Tororo, Uganda

West Budama North Health Sub-district, Tororo District, Uganda

Dr. Sarah Staedke, LSHTM

Sarah Staedke, MD, PhD is a clinical senior lecturer at LSHTM based in Uganda where she is a co-investigator of the Uganda Malaria Surveillance Project. She is an Infectious Disease clinician with 10 years of experience researching malaria in Uganda, focusing on the efficacy, safety, and delivery of antimalarial treatment. From 2005 to 2007 she led an evaluation of home-based management of fever in urban Ugandan children, which serves as the pilot study for this project. The Uganda Malaria Surveillance Project is a collaborative group linking academic researchers with the Ministry of Health, which strives to generate evidence to inform policy and to contribute to malaria control in Uganda. 

Co-Investigators:

• Prof Moses Kamya, Professor, Makerere University, Uganda
• Dr Grant Dorsey, Associate Professor, University of California, San Francisco
• Prof Philip Rosenthal, Professor, University of California, San Francisco
• Dr Clare Chandler, Lecturer, LSHTM

Collaborators:

• Dr Ambrose Talisuna, Medicines for Malaria Venture (MMV) Representative in Africa
• Dr Fred Wabwire-Mangen, Associate Professor, School of Public Health, Makerere University
• Dr Heidi Hopkins, FIND Diagnostics, Uganda

Early effective antimalarial treatment is one of the key strategies for reducing the burden of malaria. However, few African children benefit from such treatment. Health facilities may be few and far between, and often lack staff, essential drugs, and other resources. Home-based management of fever/malaria (HBMF or HMM) is a major strategy which aims to improve access to antimalarials in Africa. HBMF programmes bypass health facility care; instead, members of the community are trained to provide effective antimalarial treatment to febrile children at or near their home. Although HBMF promotes prompt treatment of malaria, providing treatment without an established diagnosis may have negative consequences. Treating all febrile episodes as if they are malaria may delay treatment of other illnesses (such as pneumonia), waste valuable drugs, and potentially contribute to the spread of drug resistance. The optimal approach to delivering drugs and health services to ensure that antimalarials reach those in greatest need is unclear. Whether resources should be put into home- or community-based programmes or towards improving quality and delivery of health care through existing public facilities is a critical question.

In this study, we plan to compare home-based management of fever/malaria to enhanced health facility-based care in Tororo, a rural area with very high malaria transmission, using a cluster randomized design. We will compare the impact of the two interventions on key health indicators, assess the safety and tolerability of antimalarials when dosed repeatedly, and evaluate the cost-effectiveness of the interventions.

This study is being conducted in two phases.

• Phase I, which included the census and mapping of the study area, a survey of existing health services focusing on the public health facilities and Uganda's home-based management of fever program, and a qualitative study involving focus group discussions with community members and health workers was conducted from October 2009 to September 2010. The data collected in Phase I has been used to define the clusters for randomization, establish the sampling frame for the main trial, and inform the study interventions.
• We are currently conducting Phase II, the main cluster-randomized trial (the ACT PRIME Study).  We plan to evaluate enhanced health facility care using a cluster-randomized design in Tororo, Uganda. Twenty lower-level government-run health facilities in the area have been randomly assigned to the health facility intervention (HFI) or to standard care.  The HFI is designed to address barriers to providing good quality care and focuses on (1) improving health centre management, (2) providing health worker training, and (3) ensuring adequate malaria diagnostics and drug supplies. To evaluate the impact of the intervention, cross-sectional surveys will be conducted at baseline in randomly selected children from each cluster, and will be repeated annually.  A sub-cohort of children will be recruited from households randomly selected per cluster at the start of the intervention, and will closely followed for 2 years.  All health facilities in the area will also be assessed using patient exit interviews conducted every 6 months in patients attending each health facility.  The PRIME study started in December 2010.