Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311542221577 Date of Approval: 28/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Community Health Volunteers’ Role in Control of Paediatric Infections: Experimental Evidence on Impact of Health Insurance Cover in Kenya
Official scientific title Community Health Volunteers’ Role in Control of Paediatric Infections: Experimental Evidence on Impact of Health Insurance Cover in Rarieda and Seme Sub-Counties of Kenya
Brief summary describing the background and objectives of the trial In this project, we shall conduct a field experiment to evaluate the impact that health insurance interventions will have on the roles of CHVs in supporting the control of paediatric infections in the study area. This will be a two-arm experiment involving a treatment arm evaluated against the control arm. A control group T0 (Routine) will continue to perform their routine roles without receiving any incentives. Treatment group T1 (Health insurance incentive) will continue to perform their routine roles while enjoying a FHI cover as an incentive in line with the project protocol. The CHV will be awarded a monthly premium of USD 5 for six months to provide his /her family health insurance cover with the National Hospital Insurance Fund (NHIF), a public corporation. This amount will be paid directly to the NHIF, upon the CHV achieving pre-established health goals at the local health area. Under the Supa Cover Scheme, the NHIF provides medical insurance cover to all its members and their declared dependents (spouse and children). The Benefits of this scheme include outpatient, inpatient, surgical, emergency, maternity, radiology and pharmacy services. The specific objectives of this study will include, to: (1) assess the socio-demographic characteristic of the CHVs in Rarieda and Kombewa Sub-Counties; (2) evaluate how much the family health insurance cover will incentivize the performance of CHVs in the control of paediatric infections; and (3) evaluate the extent to which the incentivized CHV performance will increase quality of care of under-5 children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Pediatric infectious diseases including malaria, diarrheal and respiratory
Purpose of the trial Supportive care
Anticipated trial start date 15/03/2023
Actual trial start date 01/08/2023
Anticipated date of last follow up 31/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 312
Actual target sample size (number of participants) 305
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://orcid.org/0000-0002-9135-3930
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No intervention A control group T0 (Routine) will continue to perform their routine roles without receiving any incentives. 6 Months A control group T0 (Routine) will continue to perform their routine roles without receiving any incentives. 256 Historical
Experimental Group Treatment Group Treatment group T1 (Health insurance incentive) will continue to perform their routine roles while enjoying a FHI cover as an incentive in line with the project protocol. The CHV will be awarded a monthly premium of USD 5 for six months to provide his /her family health insurance cover with the National Hospital Insurance Fund (NHIF), a public corporation. This amount will be paid directly to the NHIF, upon the CHV achieving pre-established health goals at the local health area. Under the Supa Cover Scheme, the NHIF provides medical insurance cover to all its members and their declared dependents (spouse and children). The Benefits of this scheme include outpatient, inpatient, surgical, emergency, maternity, radiology and pharmacy services. 6 months Treatment group T1 (Health insurance incentive) will continue to perform their routine roles while enjoying a FHI cover as an incentive in line with the project protocol. The CHV will be awarded a monthly premium of USD 5 for six months to provide his /her family health insurance cover with the National Hospital Insurance Fund (NHIF), a public corporation. This amount will be paid directly to the NHIF, upon the CHV achieving pre-established health goals at the local health area. Under the Supa Cover Scheme, the NHIF provides medical insurance cover to all its members and their declared dependents (spouse and children). The Benefits of this scheme include outpatient, inpatient, surgical, emergency, maternity, radiology and pharmacy services. 256
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included in the study, participants will have to be: 1. Currently registered to work as community health volunteers in Seme and Rarieda Sub-counties; 2. Have been actively working as a CHV for the previous one (1) year. 3. They will be adults of 18 years and above; regularly submit reports to their supervisors; 4. Will be residents of their current sub-locations for the next six (6) months; 5. Are willing to provide consent for participation; and 6. Have access to a phone. Those who will be excluded from the study will be: 1. Those who are currently not registered to work as community health volunteers in Seme and Rarieda Sub-counties; 2. Have not been actively working as a CHV for the previous one (1) year. 3. Below 18 years of age; 4. Already having health insurance; 5. Not regularly submit reports to their supervisors; 6. Unlikely to be residents of their current sub-locations for the next six (6) months; 7. Unwilling to provide consent for participation; and 8. Having no access to a phone. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/06/2023 MASENO UNIVERSITY SCIENTIFIC ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
BUSIA ROAD, MASENO MASENO 40105 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/09/2023 NATIONAL COMMISSION FOR SCIENCE TECHNOLOGY INNOVATION
Ethics Committee Address
Street address City Postal code Country
OFF WAIYAKI WAY, UPPER KABETE NAIROBI 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The number of under-5 children referred, using prescribed tools, for further treatment for infectious diseases Baseline and endline 6 months
Secondary Outcome - Number of household (hh) visits by the CHV - Number of village health activities organized and led by the CHV - Maintenance of household register by the CHV - Number of households registered as per policy guidelines - Maintenance of records of community health related events - Number of CHA/CHC monthly feedback meetings attended - Implementation of Integrated Community Case Management (iCCM) of Childhood diseases - CHV kit satisfactorily stocked with health supplies (at least 50% of defined kit content) - Community disease identification and treatment Baseline and endline 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MASENO UNIVERSITY BUSIA ROAD, MASENO MASENO 40105 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
CENTER FOR EFFECTIVE GLOBAL ACTION THROUGH FUNDING FROM THE NATIONAL INSTITUTES OF HEALTH 207 GIANNINI HALL, BERKELEY BERKELEY CA 94720 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CEGA 207 GIANNINI HALL BERKELEY CA 94720 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator APOLLO MAIMA apollomaima@gmail.com +254722753156 BUSIA ROAD, MASENO
City Postal code Country Position/Affiliation
MASENO 40105 Kenya ASSOCIATE PROFESSOR
Role Name Email Phone Street address
Public Enquiries APOLLO MAIMA apollomaima@gmail.com +254722753156 BUSIA ROAD, MASENO
City Postal code Country Position/Affiliation
MASENO 40105 Kenya ASSOCIATE PROFESSOR
Role Name Email Phone Street address
Scientific Enquiries APOLLO MAIMA apollomaima@gmail.com +254722753156 BUSIA ROAD, MASENO
City Postal code Country Position/Affiliation
MASENO 40105 Kenya ASSOCIATE PROFESSOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes CONFIDENTIALITY Before collecting any data, the researchers and enumerators will inform participants about the study, concepts of confidentiality and dignity. During data collection and analysis, identification codes will be used to replace personal and identifying information such as names and contacts. The codes will also be used in the intervening publications and final report. Tools that have been used to collect data will be stored securely in locked cabinets and access to master code lists or key codes will be limited to the PI and Co-PI only. We have adopted the MUSERC’s Guidance on Research Project Participants Rights. INFORMED CONSENT Consent is an essential element of the rights and dignity of the subject that must be preserved during study. The respect of rights and dignity contribute to avoid harm and ensure privacy and respect of the participant. These key ethical issues will be considered when conducting the study by ensuring participants sign the consent form after clearly understanding their roles in the study. Study Protocol 31 MARCH 2024 This research will be conducted in a transparent way. We have developed pre-analysis plans, documenting all procedures for data collection, processing and analysis. All the research outputs are fully computationally reproducible. There will be unrestricted access to, and reuse of, all publications and research outputs resulting from the project through use of open access publication.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx?TrialID=27037 No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information