Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259142
Status:
TERMINATED
Last Update Posted:
2015-05-13
First Post:
2005-11-25
Brief Title:
Acceptability and Cost Effectiveness of Home Based Management of Fever Different Strategies
Sponsor:
DBL -Institute for Health Research and Development
Organization:
DBL -Institute for Health Research and Development
Study Overview
Official Title:
Community Acceptability and Cost-effectiveness of Two Drug Distribution Methods for Home Based Management of Fevr in Kayunga District Uganda
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Malaria remains a major cause of morbidity and mortality particularly among children 5 years in Uganda Due to inaccessibility many children die before they reach the health facility The Home Based Management of Fever HBMF strategy was adopted in Uganda as a mean to improve access to early and appropriate treatment of fever at community level Pre-packed chloroquine with sulphadoxine-pyrimethamine HOMAPAK is provided through Community Drug DistributorsCDDs Initial evaluation showed underutilization of the CDDs 15 This cast doubt on community acceptability accessibility as well as its feasibility and cost effectiveness This 3-year project intends to compare community acceptability and cost effectiveness of two HOMAPAK distribution methods The current CDD-based HOMAPAK distribution versus home-based HOMAPAK distribution The study hypothesis is that home-based HOMAPAK distribution is more acceptable to the community and more cost effective than the CDD based HOMAPAK A non randomised community study will be conducted in two sub-counties of Mukono district In the control arm HOMAPAKs will be distributed through the CDDs while in the intervention arm HOMAPAKs will be directly distributed to the caretakers in the homes The study population are caretakers and their children 5 years At baseline a survey Phase 1 with a sample size 657 in each study area will assess the common drugs stocked at home to treat malaria and the health seeking behaviour for malaria for children 5 years and to determine the prevalence of malaria parasitaemia and anaemia among children 5 years Phase 2 includes the intervention The villages will be assigned to either the control or intervention arm Anaemia and malaria parasitaemia among children with fever will be assessed through active case finding The impact of either distribution system on accessibility acceptability sustainability compliance cost effectiveness and malaria morbidity will be assessed during the evaluation phase Health education messages on malaria prevention and treatment will be given to both communities Drug misuse will be limited by distributing HOMAPAKs according to the number of children 5years in each household HOMAPAK will only be replenished after the caretaker returns a used packet to the CDD
Detailed Description:
The hypothesis is that distributing HOMAPAK directly to caretakers is more acceptable to the community cost effective and results in reduced malaria morbidity among children 5 years than distribution through CDDs
General Objective
To compare the communities malaria seeking behaviour in the two drug distribution methods of HOMAPAK in order to provide information that can be used to enhance the HBMF strategy
Specific Objectives
1 To assess trends in the types and numbers of antimalarials stocked for use among children 5 years in the two study areas
2 To assess the patterns of health seeking behaviour in the community for fever among children under five years of age
3 To assess the incidence of malaria and the associated morbidity anaemia in the two study areas
4 To compare community acceptability of the two drug distribution methods of HOMAPAK in the aspects of utilisation of the services drug compliance coverage and accessibility
5 To assess the cost and compare cost effectiveness of the two drug distribution methods of the HOMAPAK on malaria morbidity in the community
Study area and population
The study will be conducted in Kayunga district located 80 km northeast of Kampala with a total population of 800000 Uganda Housing and Population Census 2002 of which 20 is 5 years It is hyperendemic for malaria The study population will consist of the children 5 years and their caretakers The study areas will be those without HOMAPAK being distributed at all
Study design
Household based intervention study Two drug distribution methods of HOMAPAK will be compared In the Control arm HOMAPAKs will be distributed through the conventional HOMAPAK distribution method ie through the CDDs while in the Intervention arm HOMAPAKs will be distributed directly to the caretakers
A Baseline survey will assess the patterns of health seeking behaviour for the 5 children with fever Types of antimalarials stocked in homes will be established The prevalence of malaria and anaemia among children 5 years will be established In the intervention phase the two different HOMAPAK distribution methods will be implemented and monitored Active case finding of malaria cases will be combined with passive surveillance A structured questionnaire will be administered to the caretakers and a finger prick blood sample for Hb and malaria parasitaemia will be drawn from the children Malaria records at the health facility will be reviewed for number of malaria cases seen and their clinical outcome In the evaluation phase the impact of the drug distribution methods on antimalarials stocked in the homeshealth seeking behaviour and other outcome measures
Sample size
Baseline and evaluation phase The sample size n has been estimated according to Kirkwood and Sterne 2003 for comparing of two means The required sample size is 597 per group To cater for loss of follow up 10 of the sample size will be added thus giving a total of 657 per group
Methods The Intervention Phase The study populations will consist of the caretakers and children under five years of age in the Control and the Intervention arms Two CDDs in each village will be trained and given HOMAPAKs In the Control Arm the CDDs will keep the HOMAPAKs and will only be distributed when the caretakers seek care for their children In contrast in the intervention area the CDDs will distribute the drugs to all homes with children 5 years of age The CDDs will only act as RELAY POINTS for the HOMAPAKs All villages of the study parishes in either arm will be included
Activities
Community sensitisationselection of the CDDs Through village meetings the community will be informed about the project and be requested to select two people for training as CDDs Two district trainers will conduct a training workshop Item included the roles of the CDD issues about malaria its importance cause clinical presentation case management prevention HOMAPAK dosage counselling preventive compliance referral of cases record keeping HMIS drug stocks recognition of a child with fever and what to do for herhim determining what pre-pack to give recording the treatment and drug storage
Procurement and distribution of HOMAPAK HOMAPAKs will be procured through the MoH and supplied to all CDDs in both study communities The CDDs in the control arm will only give the drugs when the caretakers seek care while those in intervention arm will distribute the appropriate HOMAPAKs to all HH with children 5 years In order to prevent drug misuse the CDDs in the intervention group will be instructed to only replenish the stocks in the household after the caretaker produces the used packet of HOMAPAK
Monitoring cases of malaria Three field assistants FAs will be stationed in the community and will do weekly surveys in households with children with either malaria or history of fever in the previous 7 days A case of malaria will be any child who either currently has a fever axillary temperature 375 C and any parasitaemia or has a history of fever in 48 hours prior to the survey plus any parasitaemia Information regarding health-seeking behaviour by the caretaker for the child with fever and related costs will be obtained by use of a questionnaire Finger prick blood samples for Hb and malaria parasitaemia will be taken from the child The Hb will be obtained by use of a portable haemoglobin photometer HemoCue while a thick malaria slide will be examined under a microscope The FAs will give appropriate information regarding malaria control and treatment to the caretakers
Monitoring and Supervision of project activities Project activities will be monitored and supervised by the project staff the district health team and the community themselves The project staff will join the district team during their quarterly support supervision visits The PI and the district supervisor will do fortnightly supervision in the study area During the supervisory visits meetings with the CDDs and community leaders will be held to discuss the progress of the project activities Meetings will also be held with the FAs and Field Supervisors Patient records and drug stock cards at both the health facility and CDDs will be reviewed
The Evaluation Phase
To assess the impact of the distribution methods on patterns of health seeking behaviour of the caretakers for fever among children 5 years acceptability and related costs for the household and government antimalarials stocked in the homes malaria morbidity among children 5 years a second KAP Survey will be conducted 2 years after the implementation of the project in the same villages on a comparable sample of 657 caretakers and children 5 years in each study area using the same structured questionnaire and FGD guide
Sampling
Two sub counties SC in the district with similar demographic and socio-economic characteristics will be purposely selected 50 of the parishes in each SC will then be randomly selected
Baseline and Evaluation phase
In order to have at least 30 households HH in a village a total of 17 villages will be selected from the sampled parishes in each sub county using probability proportionate to size sampling At village level the list of all the HH in the village will be obtained from the chairman of the village The 30HH will be selected randomly Appointments will be made with the caretakers to agree on the time for the interview In case the caretakers refuse to participate she will not be replaced In case the selected HH does not have a child 5 years it will be replaced by one in the neighbourhood with such a child In case there is more than one eligible caretaker in the selected HH like in polygamous homes then one respondent will be selected by use of the ballot method A similar procedure will be applied in case there is more than one eligible child in the HH After seeking an informed consent from the respondent an interview will be conductedParticipants for the FGDs will be purposely selected from the parishes HH that will not be part of the structured questionnaire Two FGDs for men and Two for women will be conducted separately
Intervention phase
All households with children 5 years in the study villages in both the control and intervention arm
Outcome Measures
Patterns of health seeking behaviour
Types of health services used factors affecting utilisation of the formal health services individual community health system based etc
Utilisation of antimalarial in the community
Types of antimalarial drugs used for the malaria among the under five children
Number of antimalarial drugs used to treatment an episode of fever
change in types and number of antimalarial drugs stocked in the homes
Acceptability
Proportion of under-five children with fever that are given HOMAPAKS
Proportion of caretakers that use HOMAPAKS as their first choice of treatment for fever
Proportion of caretakers that are able to correctly use HOMAPAKs
Accessibility
- Proportion of children that get treatment with HOMAPAK within 24 hours of onset of fever
of weeks in the year without stock-outs of HOMAPAKs
of drug distributors that are always available
of households with HOMAPAKS for future episodes of fever
FeasibilitySustainability
- of distributorshouseholds with satisfactory drug storage of households with expired HOMAPAK
Compliance
Proportion of febrile under-five children that get appropriate treatment
of caretakers that show correct dosage for the child
of under-five children that are given HOMAPAK for only fevermalaria
proportion of under five that get appropriate referral
Coverage
- Proportion of under five children with fever that get treatment with HOMAPAK
Cost cost-effectiveness
- Average costs incurred by MoH to deliver HOMAPAK up to HH level
- Average costs incurred by MoH in treatment of a severe malaria case in a health facility
- Average Costs incurred by a house hold level to seek care for a case of malaria
- Average cost by a household to treat a case of severe malaria at a health facility
- Cost effective ratio for a case of severe malaria averted at health facility level
- Cost effective ratio for a case of blood transfusion averted at health facility level
Malaria morbidity
increase in mean Hb levels
decrease in prevalence and intensity of parasitaemia
decrease in severe malaria cases HIS
General Objective
To compare the communities malaria seeking behaviour in the two drug distribution methods of HOMAPAK in order to provide information that can be used to enhance the HBMF strategy
Specific Objectives
1 To assess trends in the types and numbers of antimalarials stocked for use among children 5 years in the two study areas
2 To assess the patterns of health seeking behaviour in the community for fever among children under five years of age
3 To assess the incidence of malaria and the associated morbidity anaemia in the two study areas
4 To compare community acceptability of the two drug distribution methods of HOMAPAK in the aspects of utilisation of the services drug compliance coverage and accessibility
5 To assess the cost and compare cost effectiveness of the two drug distribution methods of the HOMAPAK on malaria morbidity in the community
Study area and population
The study will be conducted in Kayunga district located 80 km northeast of Kampala with a total population of 800000 Uganda Housing and Population Census 2002 of which 20 is 5 years It is hyperendemic for malaria The study population will consist of the children 5 years and their caretakers The study areas will be those without HOMAPAK being distributed at all
Study design
Household based intervention study Two drug distribution methods of HOMAPAK will be compared In the Control arm HOMAPAKs will be distributed through the conventional HOMAPAK distribution method ie through the CDDs while in the Intervention arm HOMAPAKs will be distributed directly to the caretakers
A Baseline survey will assess the patterns of health seeking behaviour for the 5 children with fever Types of antimalarials stocked in homes will be established The prevalence of malaria and anaemia among children 5 years will be established In the intervention phase the two different HOMAPAK distribution methods will be implemented and monitored Active case finding of malaria cases will be combined with passive surveillance A structured questionnaire will be administered to the caretakers and a finger prick blood sample for Hb and malaria parasitaemia will be drawn from the children Malaria records at the health facility will be reviewed for number of malaria cases seen and their clinical outcome In the evaluation phase the impact of the drug distribution methods on antimalarials stocked in the homeshealth seeking behaviour and other outcome measures
Sample size
Baseline and evaluation phase The sample size n has been estimated according to Kirkwood and Sterne 2003 for comparing of two means The required sample size is 597 per group To cater for loss of follow up 10 of the sample size will be added thus giving a total of 657 per group
Methods The Intervention Phase The study populations will consist of the caretakers and children under five years of age in the Control and the Intervention arms Two CDDs in each village will be trained and given HOMAPAKs In the Control Arm the CDDs will keep the HOMAPAKs and will only be distributed when the caretakers seek care for their children In contrast in the intervention area the CDDs will distribute the drugs to all homes with children 5 years of age The CDDs will only act as RELAY POINTS for the HOMAPAKs All villages of the study parishes in either arm will be included
Activities
Community sensitisationselection of the CDDs Through village meetings the community will be informed about the project and be requested to select two people for training as CDDs Two district trainers will conduct a training workshop Item included the roles of the CDD issues about malaria its importance cause clinical presentation case management prevention HOMAPAK dosage counselling preventive compliance referral of cases record keeping HMIS drug stocks recognition of a child with fever and what to do for herhim determining what pre-pack to give recording the treatment and drug storage
Procurement and distribution of HOMAPAK HOMAPAKs will be procured through the MoH and supplied to all CDDs in both study communities The CDDs in the control arm will only give the drugs when the caretakers seek care while those in intervention arm will distribute the appropriate HOMAPAKs to all HH with children 5 years In order to prevent drug misuse the CDDs in the intervention group will be instructed to only replenish the stocks in the household after the caretaker produces the used packet of HOMAPAK
Monitoring cases of malaria Three field assistants FAs will be stationed in the community and will do weekly surveys in households with children with either malaria or history of fever in the previous 7 days A case of malaria will be any child who either currently has a fever axillary temperature 375 C and any parasitaemia or has a history of fever in 48 hours prior to the survey plus any parasitaemia Information regarding health-seeking behaviour by the caretaker for the child with fever and related costs will be obtained by use of a questionnaire Finger prick blood samples for Hb and malaria parasitaemia will be taken from the child The Hb will be obtained by use of a portable haemoglobin photometer HemoCue while a thick malaria slide will be examined under a microscope The FAs will give appropriate information regarding malaria control and treatment to the caretakers
Monitoring and Supervision of project activities Project activities will be monitored and supervised by the project staff the district health team and the community themselves The project staff will join the district team during their quarterly support supervision visits The PI and the district supervisor will do fortnightly supervision in the study area During the supervisory visits meetings with the CDDs and community leaders will be held to discuss the progress of the project activities Meetings will also be held with the FAs and Field Supervisors Patient records and drug stock cards at both the health facility and CDDs will be reviewed
The Evaluation Phase
To assess the impact of the distribution methods on patterns of health seeking behaviour of the caretakers for fever among children 5 years acceptability and related costs for the household and government antimalarials stocked in the homes malaria morbidity among children 5 years a second KAP Survey will be conducted 2 years after the implementation of the project in the same villages on a comparable sample of 657 caretakers and children 5 years in each study area using the same structured questionnaire and FGD guide
Sampling
Two sub counties SC in the district with similar demographic and socio-economic characteristics will be purposely selected 50 of the parishes in each SC will then be randomly selected
Baseline and Evaluation phase
In order to have at least 30 households HH in a village a total of 17 villages will be selected from the sampled parishes in each sub county using probability proportionate to size sampling At village level the list of all the HH in the village will be obtained from the chairman of the village The 30HH will be selected randomly Appointments will be made with the caretakers to agree on the time for the interview In case the caretakers refuse to participate she will not be replaced In case the selected HH does not have a child 5 years it will be replaced by one in the neighbourhood with such a child In case there is more than one eligible caretaker in the selected HH like in polygamous homes then one respondent will be selected by use of the ballot method A similar procedure will be applied in case there is more than one eligible child in the HH After seeking an informed consent from the respondent an interview will be conductedParticipants for the FGDs will be purposely selected from the parishes HH that will not be part of the structured questionnaire Two FGDs for men and Two for women will be conducted separately
Intervention phase
All households with children 5 years in the study villages in both the control and intervention arm
Outcome Measures
Patterns of health seeking behaviour
Types of health services used factors affecting utilisation of the formal health services individual community health system based etc
Utilisation of antimalarial in the community
Types of antimalarial drugs used for the malaria among the under five children
Number of antimalarial drugs used to treatment an episode of fever
change in types and number of antimalarial drugs stocked in the homes
Acceptability
Proportion of under-five children with fever that are given HOMAPAKS
Proportion of caretakers that use HOMAPAKS as their first choice of treatment for fever
Proportion of caretakers that are able to correctly use HOMAPAKs
Accessibility
- Proportion of children that get treatment with HOMAPAK within 24 hours of onset of fever
of weeks in the year without stock-outs of HOMAPAKs
of drug distributors that are always available
of households with HOMAPAKS for future episodes of fever
FeasibilitySustainability
- of distributorshouseholds with satisfactory drug storage of households with expired HOMAPAK
Compliance
Proportion of febrile under-five children that get appropriate treatment
of caretakers that show correct dosage for the child
of under-five children that are given HOMAPAK for only fevermalaria
proportion of under five that get appropriate referral
Coverage
- Proportion of under five children with fever that get treatment with HOMAPAK
Cost cost-effectiveness
- Average costs incurred by MoH to deliver HOMAPAK up to HH level
- Average costs incurred by MoH in treatment of a severe malaria case in a health facility
- Average Costs incurred by a house hold level to seek care for a case of malaria
- Average cost by a household to treat a case of severe malaria at a health facility
- Cost effective ratio for a case of severe malaria averted at health facility level
- Cost effective ratio for a case of blood transfusion averted at health facility level
Malaria morbidity
increase in mean Hb levels
decrease in prevalence and intensity of parasitaemia
decrease in severe malaria cases HIS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None