Impact of Enhanced Health Facility Care in Uganda
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ClinicalTrials.gov Identifier: NCT01024426 |
Recruitment Status :
Completed
First Posted : December 2, 2009
Last Update Posted : November 1, 2013
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Condition or disease | Intervention/treatment | Phase |
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Malaria | Procedure: Enhanced health facility-based care Other: Standard care | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Evaluating the Impact of Enhanced Health Facility-based Care for Malaria and Febrile Illnesses in Children in Tororo, Uganda |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
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Experimental: Health Facility intervention
In the clusters randomized to enhanced health facility-based care, the intervention is designed to address these barriers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs.
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Procedure: Enhanced health facility-based care
The intervention is designed to address barriers to delivering quality care at health centers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs.
Other Name: HFI |
Standard of care
In the clusters randomized to standard care, standard care will include services typically provided by government-run facilities; we will not provide any additional support to these facilities. Health care will be provided to patients attending these facilities according to the usual standards; in-charges will continue to manage the facilities using their standard approach, no additional training will be provided to the health workers stationed at these facilities; and no support for staffing or supplies will be provided beyond what is supplied by the district and MoH.
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Other: Standard care
In the clusters randomized to standard care, standard care will include services typically provided by government-run facilities; we will not provide any additional support to these facilities. Health care will be provided to patients attending these facilities according to the usual standards; in-charges will continue to manage the facilities using their standard approach, no additional training will be provided to the health workers stationed at these facilities; and no support for staffing or supplies will be provided beyond what is supplied by the district and MoH. |
- Prevalence of anemia in children under five in the cross-sectional surveys [ Time Frame: annually ]Proportion of hemoglobin measurements < 11.0 g/dL as measured in cross sectional surveys. Anemia will be classified according to severity: mild (Hb 8.0 - 10.9), moderate (Hb 5.0 - 7.9), severe (Hb < 5.0).
- Prevalence of parasitemia in children under five in the cross-sectional surveys [ Time Frame: annually ]Proportion of thick blood smears that are positive for asexual parasites
- All-cause mortality [ Time Frame: Annually ]Probability of dying between birth and five years of age, expressed per 1,000 live births
- Incidence of hospitalizations in children under five in the cohort study [ Time Frame: two years ]Overnight admission to a hospital or clinic
- Incidence of illness episodes in children under five in the cohort study [ Time Frame: Two years ]Episode of illness as reported by primary caregiver
- Incidence of febrile episodes in children under five in the cohort study [ Time Frame: Two years ]Episode of illness associated with fever as reported by primary caregiver
- Prompt effective treatment of fever in children under five in the cohort study [ Time Frame: Two years ]Proportion of children with fever treated within 24 hours of onset of symptoms with an ACT
- Incidence of serious adverse events in children under five in the cohort study [ Time Frame: Two years ]Any experience that results in death, life-threatening experience, hospitalization, persistent or significant disability or incapacity, or specific medical or surgical intervention to prevent one of the other serious outcomes
- Prompt effective treatment of malaria in children under five in the cohort study [ Time Frame: Two years ]Proportion of children with malaria (confirmed by a parasitological test) treated within 24 hours of onset of symptoms with an ACT
- Appropriate treatment of malaria in children under five in the Patient Exit Interviews [ Time Frame: Every six months ]Proportion of children under five with suspected malaria and a positive RDT result who are appropriately given an ACT + Proportion of children under five with suspected malaria and a negative RDT result who are not prescribed an ACT
- Inappropriate treatment of malaria in children under five in the Patient Exit Interviews [ Time Frame: Every six months ]Proportion of children under five with suspected malaria and a positive RDT result who are inappropriately given a non-ACT regimen
- Patient satisfaction with health care in caregivers of children under five in the Patient Exit Interviews [ Time Frame: Every six months ]Proportion of patients indicating they were satisfied with care provided at the health center in exit interviews
- Patient attendance in the Health facility surveillance [ Time Frame: Every two months ]Total number of patients attending health facilities and their characteristics, including age, sex,village of residence, and diagnosis
- Stock-outs of ACTs in the Health facility surveillance [ Time Frame: Every two months ]Days per month that AL supplied by NMS via the district is not available
- Knowledge questionnaire scores for Health workers [ Time Frame: Annually ]Proportion of questions answered correctly by clinicians following training in fever case management
- Prevalence of anemia in children aged 5-15years in the cross-sectional surveys [ Time Frame: annually ]Proportion of hemoglobin measurements < 11.0 g/dL as measured in cross sectional surveys. Anemia will be classified according to severity: mild (Hb 8.0 - 10.9), moderate (Hb 5.0 - 7.9), severe (Hb < 5.0).
- Antimalarial treatment incidence density for children under five in the cohort study [ Time Frame: 2 years ]Number of antimalarial treatments given for treatment of fever/malaria over the period of follow-up
- Inappropriate treatment of malaria in children under five in the Patient Exit Interviews [ Time Frame: Every six months ]Proportion of children under five with suspected malaria and a negative RDT result who are inappropriately given an ACT + Proportion of children under five with suspected malaria and a positive RDT result who are not prescribed an ACT.

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Ages Eligible for Study: | up to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
FOR THE COHORT STUDY
Inclusion Criteria:
- age < 5 years
- agreement of parents or guardians to provide informed consent
Exclusion Criteria:
1) intention to move during the follow-up period
FOR THE CROSS-SECTIONAL SURVEY:
Inclusion Criteria:
- age < 15 years
- agreement of parents or guardians to provide informed consent
- agreement of a child aged 8 years or older to provide assent.
Exclusion Criterion:
1) inability to locate the child.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024426
Uganda | |
Infectious Diseases Research Collaboration | |
Kampala, Uganda |
Principal Investigator: | Sarah G Staedke, MD, PhD | London School of Hygiene and Tropical Medicine |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sarah Staedke, Principal Investigator, Uganda Malaria Surveillance Project |
ClinicalTrials.gov Identifier: | NCT01024426 |
Other Study ID Numbers: |
ITGBVG01 |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | November 1, 2013 |
Last Verified: | October 2013 |
Uganda malaria enhanced health facility-based care febrile illnesses health services |
Malaria Protozoan Infections Parasitic Diseases |