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.: PACTR201901856648139 Date of Approval: 04/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of Screening and Treatment of Children with Severe Acute Malnutrition by Community Health Workers in Simiyu Region, Tanzania
Official scientific title Effectiveness of Screening and Treatment of Children with Severe Acute Malnutrition by Community Health Workers in Simiyu Region, Tanzania: A Quasi-Experimental Pilot Study
Brief summary describing the background and objectives of the trial Background: In Tanzania, treatment of children with SAM is hampered by problems in accessing SAM treatment units, weak links with the facilities in referring malnourished children, indirect costs, and health system constraints. This has resulted in low coverage of SAM services and poor treatment outcomes. Well trained and supervised community health workers (CHWs) can cost-effectively screen and treat children with SAM without complications at home. However, there is no study that has evaluated the effectiveness of this strategy in Tanzania. As to whether such a strategy can achieve high coverage of SAM treatment and is cost-effective in the Tanzanian context also remain unknown. Objectives: 1) To assess the effectiveness of treatment of SAM by CHWs compared with the standard treatment model; 2) to assess the cost-effectiveness of treatment of SAM by CHWs compared with the standard treatment model; and 3) to assess whether the treatment of SAM by CHWs compared with the standard treatment model leads to a higher coverage of SAM services.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/09/2017
Actual trial start date 01/09/2018
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 27/03/2020
Anticipated target sample size (number of participants) 258
Actual target sample size (number of participants) 364
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
Parallel: different groups receive different interventions at same time 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 Treatment of SAM without complications using ready to use therapeutic food by CHWs 3 months Children with SAM without complications will be seen weekly at home by a CHW and treated with RUTF. 201
Control Group Treatment of SAM without complications in OTC 3 months Standard care which involves treating children with SAM without complications in OTC by formal health care workers 201 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children aged 6-59 months with SAM without medical complications from the study area. Those for whom consent is not provided Children who need admission for any reason at recruitment Preschool Child: 2 Year-5 Year 6 Month(s) 59 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 04/07/2017 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar Es Salaam 11101 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recovery defined as MUAC ≥12.5 cm 3 months
Primary Outcome Treatment coverage 1 year
Primary Outcome Cost-effectiveness 1 year
Secondary Outcome Default rate 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bariadi District Bariadi District Bariadi Tanzania
Maswa District Maswa District Maswa Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Doctors with Africa CUAMM via San Francesco 126 Padova Italy
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Childrens Investment Fund Foundation 7 Clifford Street W1S 2FT London United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Giulia Segafredo New Plot n.14, Bagamoyo Rd Dar es salaam Tanzania
Giovanni Putoto via san Francesco 126 Padova 35121 Italy
Joyceline Kaganda 22 Barack Obama Avenue Dar es Salaam Tanzania
Vincenza Lorusso New Plot n.14, Bagamoyo Rd Dar es Salaam Tanzania
Calistus Wilunda 5-1-1 Tsukiji, Chuo Tokyo Japan
Fortihappiness Gabinus Mumba New Plot n.14, Bagamoyo Rd Dar es Salaam Tanzania
Fabio Manenti via san Francesco 126 Padova Italy
Touma Ngwanakilala New Plot n.14, Bagamoyo Rd Dar es Salaam Tanzania
Bupe Abel Ntoga 22 Barack Obama Avenue Dar es Salaam Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Calistus Wilunda calisrtuswilunda@yahoo.co.uk +813354475201 5-1-1 Tsukiji, Chuo-ku
City Postal code Country Position/Affiliation
Tokyo Japan Researcher
Role Name Email Phone Street address
Public Enquiries Giulia Segafredo g.segafredo@cuamm.org +255752681768 New Plot n.14, Bagamoyo Rd
City Postal code Country Position/Affiliation
Dar es salaam Tanzania Program Director The Next Generation Program
Role Name Email Phone Street address
Scientific Enquiries Calistus Wilunda calistuswilunda@yahoo.co.uk +81335475201 5-1-1 Tsukiji
City Postal code Country Position/Affiliation
Tokyo Japan Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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