Evaluation of Home-Based Management of Fever in Urban Ugandan Children
Condition: Malaria; Anemia
MeSH terms: Malaria
Study type: Interventional

Summary: 
      The purpose of this study is to see if providing effective antimalarial treatment at home for
      parents/guardians to treat their children for malaria will lead to an improved health outcome
      compared to conventional healthcare.
    

Detailed description: 
      Population: Representative sample of Ugandan children aged 1 to 5 years from 400 households
      (approximately 540 children).

      Clinical Site: The study will be conducted in the Mulago III parish community of Kampala,
      Uganda.

      Study Duration: 13 months

      Study Intervention: *Pilot period: After enrollment, households will participate in a one
      month pilot period to test the household pictorial diaries. At the end of the pilot period,
      households will be randomized to participation in the home-based management of fever (HBMF)
      arm or standard care arm for the remainder of the study (12 months). *HBMF arm: Households
      randomized to the HBMF group will be provided with pre-packaged coartemether to keep at home.
      Primary caregivers will be instructed to treat children participating in the study
      empirically with coartemether at home when the child develops fever. Study personnel will
      distribute drugs and educate the caregivers about administration of drugs, recognition of
      danger signs of fever/malaria, and when to seek additional care. *Standard care: Households
      randomized to the standard care arm will be asked to continue their current behaviour and to
      manage fever in their children as they would normally.

      Measurements: Household diaries and monthly visits. Primary caregivers will be asked to keep
      a diary regarding the health of study participants for the duration of the study (13 months).
      Information on illnesses, treatments given, visits to health care facilities, and health care
      expenditures will be collected. Study personnel will visit the households monthly to collect
      completed diaries. At each visit, questionnaires will be administered to gather additional
      data on the health of the participants and treatment seeking behaviour.

      Clinical and laboratory evaluations: Temperature, height, weight, mid-upper arm
      circumference, spleen size, haemoglobin, and thick blood smear will be assessed at
      enrollment, and at the beginning and end of the intervention period.

      Study Objectives: 1. To measure the impact of home-based management of fever with
      coartemether on malaria-related morbidity compared to the current standard of care in the
      community.

      2. To measure the impact of home-based management of fever with coartemether on economic
      measures compared to the current standard of care in the community.

      Primary outcome: Treatment incidence density (treatments per time at risk) for each treatment
      arm

      Secondary clinical outcomes: 1) mean days of fever; 2) incidence of febrile episodes; 3) mean
      haemoglobin at study end; 4) change in mean haemoglobin; 5) prevalence of splenomegaly; 6)
      prevalence of parasitaemia; 7) incidence of visits to health care facilities, and
      hospitalizations; 8) mortality rate; 9) anthropometric measurements; 10) proportion of
      "appropriate" treatments; 11) proportion of delayed treatments; 12) treatment incidence
      density of treatments given at >50% and at full dose

      Economic outcomes: 1) household cost/febrile episode; 2) household costs for treatment of
      febrile episode/month; 3) provider cost/child for delivery of HBMF; 4) estimated provider
      facility cost/patient for uncomplicated fever, and for severe disease; 5) total net
      cost/child/year; 6) net cost/additional child appropriately treated; 7) net cost/day of fever
      averted
    

Intervention name(s): Provision of antimalarial treatment at home
Intervention type(s): Behavioral
Intervention MeSH terms: Antimalarials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Home-based care; Malaria; Africa