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.: PACTR201903883154921 Date of Approval: 27/03/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Community directed interventions
Official scientific title Strengthening Primary Health Care in Rural Malawi using the Community-Directed Intervention Approach
Brief summary describing the background and objectives of the trial Based on a multi-country study which was conducted in areas that had experienced CDTi, it has been demonstrated that CDI can be feasible for integrated delivery of different health interventions in most rural African setting. However, limited knowledge is available about its added value for strengthening PHC services in geographical areas with no experience in CDTi. This proposal therefore attempts to study how best and in which way the CDI approach could be used to strengthen identified areas of PHC in a rural Malawian health district. Objectives are: 1. To assess acceptability of the CDI strategy for strengthening PHC to users and providers in Mangochi district. 2. To assess the effectiveness and efficiency of using the CDI strategy to strengthen PHC in Mangochi district. 3. To identify the critical factors that facilitate or hinder the implementation of the CDI strategy and ensures its sustainability in Mangochi district.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CDIPHC
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied Malaria,Urinary Schistosomisis, Anaemia
Purpose of the trial Public health service delivery strategy
Anticipated trial start date 01/06/2016
Actual trial start date 01/06/2016
Anticipated date of last follow up 31/05/2017
Actual Last follow-up date 30/08/2017
Anticipated target sample size (number of participants) 4500
Actual target sample size (number of participants) 4500
Recruitment status Completed
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Distribution of insecticide treated nets to under 5 children and pregnant women using the PHC system 1 net per participant in 1 year 12 months Insecticide treated nets for prevention against malaria in under 5 children and pregnant women attending health facility based services 2250 Active-Treatment of Control Group
Control Group Vitamin A to unde 5 children once per year 12 months Distribution of vitamin A to under 5 children for prevention against deficiency through the health system 2250 Active-Treatment of Control Group
Control Group home management of malaria every time a participant presents with fever 12 months Treatment against fever or malaria with drugs through the health system 2250 Active-Treatment of Control Group
Control Group Treatment with Praziquantel Every time a person complains or presents with urinary schistosomiasis symptoms or sign 12 months Treatment for urinary schistosomiasis using Praziquantel using the health system to both children and adults presenting with the problem 500 Active-Treatment of Control Group
Experimental Group Insecticide treated nets once in a year 12 months distribution of insecticide treated nets to under 5 children and pregnant women using the community volunteers through the CDI strategy 2250
Experimental Group Home management of malaria Every time a person has fever or malaria 12 months home treatment of people with fever or malaria in communities under CDI arm of the study 2250
Experimental Group Vitamin A Once per year to every under 5 child 12 months Distribution of Vitamin A to every under 5 child in CDI communities for prevention against deficincies 2250
Experimental Group Praziquantel Every time a person presents with urinary schistosomiasis signs 12 months Treatment for urinary schistosomiasis using Praziquantel using CDI volunteers in communities under CDI arm of study 500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All people living in the sampled communities during the study implementation duration who consented to participate in the study. People from outside the sampled communities and those who opted not to participate in the study during informed consent process at the beginning of data collection. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 7 Day(s) 80 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 17/08/2009 Malawi National Health Sciences Committee NHSRC
Ethics Committee Address
Street address City Postal code Country
Lilongwe Lilongwe 30377 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome No. of district, health centre and community based health workers actively involved in implementation of the CDI strategy in Mangochi district. End of project
Primary Outcome No. of community based implementers actively engaged in the CDI strategy implementation in Mangochi End of project
Primary Outcome Proportion of targeted population accessing health services through the CDI strategy in Mangochi district. End of project
Secondary Outcome Proportion of targeted population from community referred to health centre through the CDI strategy. End of project
Primary Outcome Cost per intervention of implementing the CDI strategy in the district. End of project
Secondary Outcome Enhanced capacity for implementation of the CDI strategy within community and health care delivery system in Mangochi district End of project
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mangochi District District Mangochi Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization Appia Street Geneva Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organization Appia Geneva Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Malawi College of Medicine Mahatma Ghandi Blantyre Malawi
Ministry of Health Mangochi Mangochi Malawi
Steno Diabetes Center Gentofe Copenhagen Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Makaula petmakau@yahoo.co.uk +265888850829 Mangochi
City Postal code Country Position/Affiliation
Mangochi Malawi Senior Researcher RHED Malawi
Role Name Email Phone Street address
Public Enquiries Peter Makaula petmakau@yahoo.co.uk +265888850829 Mangochi
City Postal code Country Position/Affiliation
Mangochi Malawi Senior Researcher RHED Malawi
Role Name Email Phone Street address
Scientific Enquiries Peter Makaula petmakau@yahoo.co.uk +265888850829 Mangochi
City Postal code Country Position/Affiliation
Mangochi Malawi Senior Researcher RHED Malawi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data base on coverage, costs Transcripts of KII and FGD Informed Consent Form,Statistical Analysis Plan,Study Protocol Any time upon request Upon request to the Principal Investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Access to health interventions continue to be a major challenge for many people in rural settings in low income countries of the world including Africa. The revitalization of Primary Health Care (PHC) was placed high on the agenda of several international fora, and was also highlighted in the 2008 World Health Report addressing issues of poverty, equity and access to health care in rural areas. Health systems in Sub-Saharan Africa continue to be weak and suffer from inadequate mechanisms for delivering PHC services to those in most need. This has maintained the high burden of infectious diseases prevalent among the rural population. A well-functioning health system is the backbone to supporting health programmes, and creating healthy populations. Health systems’ strengthening was recognized as a vital element in the global health agenda to achieve the Millennium Development Goals (MDG) and now evolved to Sustainable Development Goals (SDG). Community participation in health programmes has shown that it enhances their sustainability and affordability compared to non-participatory programmes. Initiatives such as community-directed interventions (CDI) the community takes charge of the process of planning and implementing the interventions. The CDI approach was used to distribute Vitamin A and insecticide treated nets (ITN) as well as in home management of malaria (HMM) by community volunteers in areas with prior experience with the community-directed treatment with ivermectin (CDTi) for onchocerciasis control. CDI has recently been used in control and treatment of schistosomiasis and soil transmitted helminths (STH) in rural Kenya. However, limited knowledge is available about its added value for strengthening PHC services in geographical areas with no experience in CDTi. This implementation research project was aimed to study how best and in which way the CDI approach could be used to strengthen identified areas of PHC in a rural setting. Designed as a comparative two-arm study, where intervention CDI/PHC strategy at community level in addition to EHP/PHC; and comparison EHP/PHC strategy only were respectively implemented and evaluated over a period of 12 months. The findings have shown that implementation of CDI strategy at community level in addition to EHP/PHC is both feasible and acceptable with no significant differences in intervention coverage between the arms. The CDI strategy can complement the regular EHP efforts especially where personnel and geographical barriers exist. Faced with acute shortage of trained health workers in many healthcare systems, CDI is a viable alternative for the delivery of essential health services in rural hard to reach areas. However, for maximum outcomes, the design and implementation of interventions have to take into consideration the critical factors and adapted to suit with local conditions. 27/03/2019 30/08/2017
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks www.whoafro.int
Changes to trial information