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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201706002335281 Date of Registration: 01/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Process evaluation on task-shifting of administration of Vitamin A supplement for children 6-59 months to include village health workers in Zimbabwe
Official scientific title Process evaluation on task-shifting of the administration of Vitamin A supplement for children 6-59 months to include village health workers in Zimbabwe
Brief summary describing the background and objectives of the trial Vitamin A supplementation (VAS) among children enhances resistance to disease and can reduce all-cause childhood mortality by approximately 23%. Based on large-scale Vitamin A supplementation community trials; the minimum coverage at which countries can expect to begin observing reductions in child mortality is 70%. Zimbabwe¿s national target for VAS is 85%, but current coverage appears to be substantially lower than this target. In 2014, the Multiple Indicator Cluster Survey (MICS) estimated VAS coverage in Zimbabwe to be 33%. At the same time, the DHS 2015 estimated VAS coverage to be 67%. While estimates are inconsistent from various data sources, the country still remains among countries classified as high impact countries for vitamin A supplementation based on high under five mortality rate and the Ministry of Health and Child Care (MoHCC) has made it a priority to improve Vitamin A coverage nationally. The MoHCC in Manicaland province was tasked to undertake a pilot exercise to inform national scale-up of VAS administration by VHWs. The results from an initial pilot were promising, but further documentation and process learning are needed to information national roll-out. Specifically, evidence is needed at a wider scale, for a longer period, involving a training component for facility nurses, and with enhanced standardization and documentation to comprehensively inform the development of national guidelines. The Clinton Health Access Initiative (CHAI) will support the evaluation of this process, while MCHIP is supporting the implementation of this pilot scale-up. This study will evaluate VHWs` capabilities, identify challenges, mitigation measures, and best practices in task-shifting VAS to VHWs, and the assessment will involve the VHWs, professional health workers, caregivers and also review of relevant documents and data reported into the routine health information systems. Mixed methods will be used in this evaluation.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutrition - Administration of Vitamin A,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2017
Actual trial start date 03/04/2017
Anticipated date of last follow up 30/12/2017
Actual Last follow-up date 30/12/2017
Anticipated target sample size (number of participants) 450
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MRCZ-A-2196 MRCZ
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Village Health Worker Training to administer Vitamin A 6 months The aim of the study is to assess the process of task-shifting administration of the VAS to include VHWs so as to inform the optimal way to operationalize the national scale-up of this intervention. This study will evaluate VHWs` capabilities, identify challenges, mitigation measures, and best practices in task-shifting. 3033 Uncontrolled
Experimental Group Village Health Worker training to administer Vitamin A 6 months The aim of the study is to assess the process of task-shifting administration of the VAS to include VHWs so as to inform the optimal way to operationalize the national scale-up of this intervention. This study will evaluate VHWs` capabilities, identify challenges, mitigation measures, and best practices in task-shifting. 450
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children between the ages of 6 and 59 months. Children under 6 months and over 60 months. 18 Month(s) 150 Month(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 10/10/2017 Chesapeake IRB
Ethics Committee Address
Street address City Postal code Country
6940 Columbia Gateway Drive, Suite 110 Columbia 21046 United States of America
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 02/06/2017 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Cnr Josiah Tongogara / Mazowe St. Harare Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Village Health Worker knowledge and attitudes June 2017 October 2017
Secondary Outcome Caregiver knowledge and attitudes October 2017
Secondary Outcome Health worker attitudes June 2017
Secondary Outcome VHW documentation and reporting June 2017 Feb 2018
Secondary Outcome Supply security June 2017
Secondary Outcome VHW workload June 2017 October 2017
Secondary Outcome Program coverage and feasibility June 2017 Feb 2018
Secondary Outcome Vitamin A coverage June 2017 Feb 2018
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chimanimani District Office Chimanimani DHO Manicaland Province Zimbabwe
Chipinge Urban District Office Chipinge Urban DHO Manicaland Province Zimbabwe
Makoni district office Makoni District Manicaland Province Zimbabwe
Mutasa District Office Mustasa District Manicaland Province Zimbabwe
Mutare Urban District Office Mutare District Manicaland Province Zimbabwe
Mutare Rural District Office Mutare Rural Health Office Manicaland Province Zimbabwe
Nyanga District Office Nyanga District Health Office Manicaland Province Zimbabwe
Buhera District Office Buhera District Health Office Manicaland Province Zimbabwe
Chipinge Rural District Office Chipinge DHO Manicaland Province Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development Abercrombie House Eaglesham Road East Kilbride United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinton Health Access Initiative Block 4 Arundel Office Park, Mt Pleasant Harare Zimbabwe Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Zimbabwe Ministry of Health and Child Care 2nd Floor Kaguvi Building Corner Central Avenue and Fourth Street Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alec Mkwamba amkwamba@clintonhealthaccess.org +263785701786 Block 4, Arundel Office Park, Mt Pleasant
City Postal code Country Position/Affiliation
Harare Zimbabwe Senior Evaluation Manager
Role Name Email Phone Street address
Public Enquiries Makaita Gombe mgombe@clintonhealthaccess.org +263774305424 Block 4, Arundel Office Park, Mt Pleasant
City Postal code Country Position/Affiliation
Harare Zimbabwe Senior Project Coordinator
Role Name Email Phone Street address
Scientific Enquiries Marta Prescott mprescott@clintonhealthaccess.org +17036157008 383 Dorchester Ave
City Postal code Country Position/Affiliation
Boston MA United States of America Senior Technical Advisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information