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.: PACTR202306638003501 Date of Registration: 06/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of education on linear programmed dietary plan using locally available food on energy intake among HIV- infected children aged 2-5 years in Simiyu region: A cluster randomized control trial protocol
Official scientific title Effectiveness of education on linear programmed dietary plan using locally available food on energy intake among HIV- infected children aged 2-5 years in Simiyu region
Brief summary describing the background and objectives of the trial In sub–Saharan Africa, the under-five mortality rate of HIV infected children is high by 76 deaths per 1000 live birth. Despite the mortality of children from HIV, poor nutrition particularly low energy intake has been shown to impair immune responses, accelerate the progression of HIV/AIDS and can lead to mortality. This study aims to test the effectiveness of education on linear programmed dietary plan using locally available food on energy intake of HIV infected children in Tanzania mainland. The study will be a cluster randomized control trial study designed with both intervention and control arms and will use quantitative approach. CTC will be the unit of randomization. The study will involve 212 asymptomatic HIV infected children aged 2 – 5 years. The children will be randomly allocated into the intervention and control arm. The intervention will be implemented once monthly for three months. Participants from all groups will be assessed nutrition knowledge and attitude as well as 24 hours recall at baseline and endline. Education on how to use the energy dense dietary plan developed by using linear programming technique will be provided to the intervention group. The main outcome measures will be change in knowledge, attitude and energy intake in the intervention group compared with the control group. Unpaired t -test will be used to establish effectiveness of intervention. P-value of less than 0.05 will be considered statistically significant.
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 HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 22/05/2023
Actual trial start date 22/05/2023
Anticipated date of last follow up 18/08/2023
Actual Last follow-up date 25/08/2023
Anticipated target sample size (number of participants) 212
Actual target sample size (number of participants) 212
Recruitment status Not yet recruiting
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 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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine nutrition education which is provided from health facilities Three months Control arm - The control group will not be provided with intervention and will continue with the normal routine which are provided by the health facilities. 106 Active-Treatment of Control Group
Experimental Group education on linear programmed dietary plan Three months Intervention arm - Education on the use of a dietary plan developed by linear programming will be given to caregivers. During development of dietary plan, common locally available food which are mostly consumed by HIV infected children will be used. The implementation of the intervention will be done by Konga. These are people living with HIV and their health status are known within the community. The intervention will be community based where caregivers from intervention group will be arranged in five groups and education will be provided. The intervention will be provided once a month for three months. The education will base on energy dense food which will help to improve the energy intake of HIV infected children 106
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A pair of asymptomatic HIV-infected children aged 2-5 years and their caregivers attending the selected CTCs and willing to participate will be included in the study. Asymptomatic HIV-infected children aged 2-5 years, whose caregivers refuse to participate will be excluded in the study. Preschool Child: 2 Year-5 Year 2 Year(s) 5 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 24/05/2023 INSTITUTIONAL RESEARCH REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
BENJAMIN MKAPA STREET,BENJAMIN MKAPA BUILDING,41107 DODOMA DODOMA 259 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome These are variables that is the most relevant to answer the research question. The variables will be changes of knowledge and attitude of caregivers on feeding HIV infected child The primary outcome will be measured at baseline and after intervention
Secondary Outcome These are outcome variables which expected to be affected by primary outcome. In this study change in energy intake of HIV infected children is expected. The secondary outcome will be measured at baseline and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Simiyu region Simiyu Simiyu P.O BOX 4 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Dodoma Dodoma 395 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Individual Dodoma Dodoma 259 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heriet Carin carinharriet@gmail.com +255787917273 1 TIBA STREET
City Postal code Country Position/Affiliation
Dodoma 41218 United Republic of Tanzania Student
Role Name Email Phone Street address
Scientific Enquiries Leonard Katalambula katalambula@gmail.com +255758921000 1 TIBA STREET
City Postal code Country Position/Affiliation
DODOMA 41218 United Republic of Tanzania SENIOR LECTURER
Role Name Email Phone Street address
Public Enquiries Mageda Kihulya mageda121@gmail.com +255757600426 1 TIBA STREET
City Postal code Country Position/Affiliation
DODOMA 41218 United Republic of Tanzania LECTURER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data that underlie the results that will be reported from this study, after the deidentification of identifiers in text and tables, will be shared. I will first share with the Council Health management team (CHMT) and Regional Health management team (RHMT) in the Simiyu region. I will further share the report with higher authorities, such as the President’s Office, the Regional Administrative Secretary and Local Government (PORALGT), and the Ministry of Health. Lastly will be publicly available at Figshare repository. Informed Consent Form After 12 months OPEN
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.udom.ac.tz 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