- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024426
Impact of Enhanced Health Facility Care in Uganda
Evaluating the Impact of Enhanced Health Facility-based Care for Malaria and Febrile Illnesses in Children in Tororo, Uganda
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study overview:
We are proposing to evaluate enhanced health facility-based care for malaria and febrile illnesses in children in Tororo district using a cluster randomized design. The health facility intervention (HFI) will aim to address barriers to achieving good quality health care that were identified in our formative research. The focus of our intervention will be providing RDTs and training health workers in management of both malaria and non-malarial febrile illnesses.
Study site:
The study will be conducted in Tororo district, an area with very high malaria transmission intensity. The estimated entomologic inoculation rate (EIR) in Tororo is 562 infective bites per person-year, and the prevalence of parasitemia among children aged 5-9 years is 63.5%. The five sub-counties of West Budama North Health Sub-district (Nagongera, Paya, Kirewa, Kisoko, and Petta), and two sub-counties of West Budama South Health Sub-district (Mulanda and Rubongi) will be included in the study population.
Study population:
Within the seven sub-counties, there are 22 lower-level government run health facilities, including 17 level II health centers (HC), and 5 level III HCs; 20 will be included in the randomization scheme.
Randomization:
The lower-level government-run health facilities in the study area will be the unit of randomization. Clusters will be defined as the catchment areas of the health centers, including households located within a 2km radius of the facilities. The clusters will be defined prior to randomization using the full census survey database. Households will be excluded from our sampling frame if they are > 2km from any health facility. The randomization will be conducted by an investigator who is not directly involved in the project. Health facilities will be stratified by level (HC IIs and HC IIIs). Because of the uneven numbers of HC IIs and IIIs, one of the HC IIIs without a laboratory will be 'demoted' and paired with a HC II to ensure even numbers. Restricted randomization will be employed to ensure balance on geographical location. Specifically, restrictions will be applied that exclude the allocation of all clusters originating from a single sub-county, or that are otherwise in close geographical proximity from being allocated to the same arm of the trial.
The Health Facility Intervention:
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.
Training in-charges:
All in-charges of health centers randomized to the HFI will be trained in health center management. The purpose of this training is to equip in-charges with the skills and tools required to effectively and efficiently manage their health center. The training will include three components: (1) financial management, (2) supply management, and (3) information management.
Health worker training:
A)Training in fever case management and use of RDTs All clinical staff will receive training in fever case management. Training will be based on the Integrated Malaria Management training package developed by the Joint Uganda Malaria Training Program (JUMP) team, and the RDT training guidelines which have been adopted and implemented by Uganda's MoH 'User's manual: Use of Rapid Diagnostic Tests (RDTs) for malaria in fever case management in Uganda'. The training program will be conducted by the JUMP training team over two weeks; the first two days will focus on theory, and will be followed by support supervision at the health facilities the next week. The training will be conducted in Tororo at a local health facility, and health workers will be trained in two small groups to ensure that work at the health facilities continues alongside the training. The impact of training on knowledge will be assessed using a pre-and post-training evaluation administered by the JUMP team. Additional support supervision will be conducted at 6 weeks and 6 months after the initial training and refresher training will be provided as needed.
B)Training in patient-centered services The purpose of the Patient-Centered Services (PCS) training module is to identify and improve interpersonal interactions between health workers and patients. The module builds on the results of our formative research which identified several barriers to proving good quality health care at health facilities, including poor interpersonal interactions between health workers and community members resulting from poor communication skills, discriminatory behaviors of health workers, poor health worker motivation, and lack of patient-centered thinking. Through the PCS module, health workers will learn to recognize these challenges and develop skills for communicating and interacting with patients. The PCS module training will be implemented in a tiered approach to (1) all clinical staff, and (2) all health center support staff. All clinical staff, including in-charges, will receive the full PCS training package which includes self-observation tasks and specific emphasis on clinical and patient interaction challenges. Support staff including volunteers will receive a scaled-down PCS training package with specific emphasis on welcoming and guiding patients at the health facility. All training activities and workshops will be led by study personnel and trainers with experience in adult learning methodology.
- Supply of AL and RDTs for malaria If the amount of AL provided to the intervention health centers by NMS is not adequate to meet demand, or if the procurement of AL fails, the project will supply supplemental AL. In addition, we will ensure adequate supplies of RDTs at all intervention health centers.
Evaluation procedures:
Outcomes will be measured in three distinct populations: (1) cross-sectional surveys of children under 15 years randomly selected from households within the clusters; (2) a cohort of children under five randomly selected from households within the clusters and followed for 2 years; and (3) patients attending all government-run health facilities, including children under five and their caregivers participating in exit interviews on selected days every six months.
- Cross-sectional surveys will be conducted in randomly selected children under-five, and those between the ages of 5-15 years of age. The number of children sampled will be weighted according to the total population of each cluster to achieve a harmonic mean of 200 for each age category. A total of 8766 children will be sampled in each survey. Surveys will be conducted at baseline and then annually for each year; new populations of children will be selected for each survey. The survey will include a structured questionnaire administered to the primary caregiver, and a clinical and laboratory assessment of each child.
- A Cohort of children under five will be enrolled from 25 households randomly selected from each cluster, for a total of 500 households. The cohort will be dynamic, in that all children within a household, who are under the age of five and who meet selection criteria, will be included. A household survey will be conducted at the start of the study. Children will undergo clinical and laboratory assessments at baseline and then every six months. Primary caregivers will be asked to prospectively collect information on the clinical symptoms of participating children and expenditures for health care using pictorial diaries. Study personnel will visit the households monthly to collect the diaries and administer a monthly questionnaire. Participants will be followed for approximately 18 months in total, the equivalent of approximately 12 months following roll-out of the intervention.
- Patient Exit Interviews will be conducted with children under five and their caregivers at all health facilities. The purpose of the interviews is to evaluate for rational prescribing of ACTs, and to determine the level of satisfaction with the health facility visit. Three rounds of surveys are planned. In the first two surveys, 10 patients will be selected by convenience sampling from each facility to participate in the interviews (200 total per survey). In the final survey, 50 patients will be recruited to participate (1000 total in survey). In total, 1400 patients will participate in the interviews.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Kampala, Uganda
- Infectious Diseases Research Collaboration
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
annually
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
annually
|
All-cause mortality
Time Frame: Annually
|
Probability of dying between birth and five years of age, expressed per 1,000 live births
|
Annually
|
Incidence of hospitalizations in children under five in the cohort study
Time Frame: two years
|
Overnight admission to a hospital or clinic
|
two years
|
Incidence of illness episodes in children under five in the cohort study
Time Frame: Two years
|
Episode of illness as reported by primary caregiver
|
Two years
|
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
|
Two years
|
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
|
Two years
|
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
|
Two years
|
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
|
Two years
|
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
|
Every six months
|
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
|
Every six months
|
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
|
Every six months
|
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
|
Every two months
|
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
|
Every two months
|
Knowledge questionnaire scores for Health workers
Time Frame: Annually
|
Proportion of questions answered correctly by clinicians following training in fever case management
|
Annually
|
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).
|
annually
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
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.
|
Every six months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarah G Staedke, MD, PhD, London School of Hygiene and Tropical Medicine
Publications and helpful links
General Publications
- Staedke SG, Mwebaza N, Kamya MR, Clark TD, Dorsey G, Rosenthal PJ, Whitty CJ. Home management of malaria with artemether-lumefantrine compared with standard care in urban Ugandan children: a randomised controlled trial. Lancet. 2009 May 9;373(9675):1623-31. doi: 10.1016/S0140-6736(09)60328-7. Epub 2009 Apr 9.
- Hopkins H, Talisuna A, Whitty CJ, Staedke SG. Impact of home-based management of malaria on health outcomes in Africa: a systematic review of the evidence. Malar J. 2007 Oct 8;6:134. doi: 10.1186/1475-2875-6-134.
- Chandler CI, DiLiberto D, Nayiga S, Taaka L, Nabirye C, Kayendeke M, Hutchinson E, Kizito J, Maiteki-Sebuguzi C, Kamya MR, Staedke SG. The PROCESS study: a protocol to evaluate the implementation, mechanisms of effect and context of an intervention to enhance public health centres in Tororo, Uganda. Implement Sci. 2013 Sep 30;8:113. doi: 10.1186/1748-5908-8-113.
- Staedke SG, Chandler CI, DiLiberto D, Maiteki-Sebuguzi C, Nankya F, Webb E, Dorsey G, Kamya MR. The PRIME trial protocol: evaluating the impact of an intervention implemented in public health centres on management of malaria and health outcomes of children using a cluster-randomised design in Tororo, Uganda. Implement Sci. 2013 Sep 30;8:114. doi: 10.1186/1748-5908-8-114.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITGBVG01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malaria
-
University of California, San FranciscoCenters for Disease Control and Prevention; University of Massachusetts, Amherst and other collaboratorsRecruitingPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaLao People's Democratic Republic
-
Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis Ababa... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaEthiopia, Bangladesh, Indonesia
-
University of OxfordWellcome Trust; Ministry of public Health AfghanistanCompletedVivax Malaria | Uncomplicated Falciparum MalariaAfghanistan
-
Medicines for Malaria VentureAsociacion Civil Selva AmazonicaCompletedPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaPeru
-
Gadjah Mada UniversityMenzies School of Health Research; Eijkman Institute for Molecular Biology; Timika...Completed
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
London School of Hygiene and Tropical MedicineWorld Health Organization; United Nations High Commissioner for Refugees; HealthNet... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaPakistan
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
University of IbadanShin Poong Pharm Co Ltd 161 yoksam-ro, Gangnam-Gu Seoul 135-925, Korea; Institute...CompletedPlasmodium Falciparum Malaria | Uncomplicated Malaria | Malaria FeverNigeria
-
Research Institute for Tropical Medicine, PhilippinesWorld Health OrganizationCompletedTES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014 (TES)Malaria | Vivax Malaria | Falciparum Malaria | Malaria Recrudescence
Clinical Trials on Enhanced health facility-based care
-
University of LeedsUniversity of Nottingham; World Health Organization; The Regional Government...CompletedTuberculosis, Pulmonary | Quality of Health Care | Community Health Care | Volunteer Health Workers | Tuberculosis Treatment EffectivenessEthiopia
-
VA Office of Research and DevelopmentCompleted
-
Noctem, LLCRecruiting
-
Aga Khan UniversityThe Hospital for Sick Children; Bill and Melinda Gates FoundationActive, not recruitingNewborn Morbidity | Maternal Complication of Pregnancy | Perinatal ProblemsPakistan
-
Glasgow Caledonian UniversityUniversity of Edinburgh; University of Glasgow; NHS Lanarkshire; Nursing Midwifery... and other collaboratorsCompletedStroke | Cerebrovascular Disorders | Pneumonia | Oral HygieneUnited Kingdom
-
Health Resources in Action, Inc.Methodist Healthcare Ministries of South Texas, Inc.; Social Innovation FundCompletedDepression | Hypertension | Obesity | Diabetes | Chronic Disease | Hypercholesterolemia
-
Brigham and Women's HospitalRecruitingHypertensionSouth Africa
-
University of Southern CaliforniaPatient-Centered Outcomes Research InstituteTerminatedCancer | Chronic Obstructive Pulmonary Disease | Congestive Heart FailureUnited States
-
London School of Hygiene and Tropical MedicineAddis Ababa UniversityCompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorder | Schizophrenia Spectrum DisorderEthiopia
-
University of RochesterNational Heart, Lung, and Blood Institute (NHLBI)Completed