Plain English Summary
Background and study aims
Tanzania is one of the countries devastated by dual burden of HIV/AIDS and child undernutrition. About 5.7 % of the general population in Tanzania is living with HIV/AIDS. Meanwhile, 47.8% of children suffer from stunting (reduction in growth rate), or a chronic form of undernutrition. Even under the treatment with antiretroviral therapy, undernutrition rates among HIV-positive children remains high. The country also suffers from a human resource for health crisis: it has a small number of qualified medical personnel. The doctor to patient ratio remains at 1:30,000. Therefore, less qualified health workers including mid-level providers (MLPs) are left to give health care to patients with high burden, especially in rural and suburban areas. These health workers are trained to treat only limited number of ailments and perform specific and less complex surgical procedures. They may not possess adequate skills to manage patients with complex health problems including HIV-positive children suffering from severe undernutrition. Previous studies have reported improvements on child undernutrition when the trained health providers give nutrition counseling to their caregivers. In Tanzania too, nutrition training for MLPs may improve their nutrition knowledge, counseling, and management skills of undernutrition among HIV-positive children. Successful transfer and translation of nutrition knowledge to caregivers through counseling and treatment may have a positive impact on HIV-positive childrens feeding practices and nutrition status. The aim of this study is therefore to examine the effectiveness of nutrition training of MLPs on feeding practices and nutrition status of HIV-positive children attending Care and Treatment Centers (CTCs) in Tanga, Tanzania.
Who can participate?
Mid-level providers working in CTC facilities for HIV/AIDS and pairs of mothers and their HIV-positive children attending such facilities in Tanga, Tanzania.
What does study involve?
Eight Care and Treatment Centers (CTCs) are randomly allocated to either the intervention or the control group. The nutrition training intervention is given to 16 MLPs in the intervention group. The training makes use of the specific local determinants of undernutrition. The trained MLPs provide the tailored nutrition counseling and nutrition follow up to caregivers of HIV-positive children attending the selected CTCs. The total of 400 pairs of caregivers and underfive children are assigned and followed up at the intervention group. Similar number and method are repeated for control group.
What are the possible benefits and risks of participating?
MLPs will have improved knowledge in nutrition, management of undernutrition, and counseling skills for caregivers of children at risk of undernutrition using a tailored approach. HIV-positive children with undernutrition will have better feeding patterns and nutrition status and may be sustained. There is no foreseen risk for participating in this study.
Where is the study run from?
The University of Tokyo, Japan in Collaboration with Dar es Salaam based Muhimbili University of Health and Allied Sciences and School of Public Health University of Massachusetts.
When is the study starting and how long is it expected to run for?
July 2013 to July 2014
Who is funding the study?
1. The University of Tokyo (Japan)
2. Muhimbili University of Health and Allied Sciences (Tanzania)
Who is the main contact?
Masamine Jimba
mjimba@m.u-tokyo.ac.jp
Trial website
Contact information
Type
Scientific
Primary contact
Prof Masamine Jimba
ORCID ID
Contact details
University of Tokyo
Graduate School of Medicine
Department of Community and Global Health
7-3-1 Hongo
Bunkyo-ku
Tokyo
113-0033
Japan
+81 (0)3 5841 3697
mjimba@m.u-tokyo.ac.jp
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of nutrition training for mid-level providers (MLPs) on feeding practices and nutrition status of HIV-positive children in Tanga, Tanzania: a cluster randomized control trial
Acronym
Study hypothesis
Undernutrition among Human Immune-Deficiency Virus (HIV)-positive children can be controlled if qualified medical personnel counsel caregivers frequently. Such counseling may be beneficial if they focus on local determinants of undernutrition and specific feeding patterns of locally available foods. However, the number of qualified medical personnel is limited especially in Human Resource for Health (HRH) crisis country like Tanzania. Nutrition training of the available mid-level providers (MLPs) mostly found in rural and suburban areas can help to provide such nutrition counseling. Trained MLPs may improve their own nutrition knowledge, management skills of child undernutrition, nutrition monitoring, and counseling skills for mothers of HIV-positive children attending their centers. Counseled mothers will improve feeding practices of their children. This includes feeding frequency, quality and quantity of diet consumed, and dietary diversity. Secondarily, HIV-positive children may have improved nutrition status, anti-retroviral therapy (ART) profile including adherence, CD4 counts, viral load, and general welfare.
Ethics approval
1. Research Ethics Committee of the Graduate School of Medicine of the University of Tokyo, ref: 1007-(1)
2. Research Ethics Committee of Muhimbili University of Health and Allied Sciences in Tanzania, 11/02/2013, ref: MU/DRP/AEC/Vol.XVI/88
Study design
Cluster randomized control trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Child nutrition/HIV/AIDS
Intervention
In-service training will be conducted on prevention, diagnosing, and management of undernutrition based on the identified local determinants of undernutrition at the formative research. The training method will be adopted from the standard IMCI nutrition module and Nutrition Assessment and Counseling (NACs) modules. The trained MLPs will provide tailored nutrition counseling and management of undernutrition to HIV-positive children attending the CTCs intervention sites. After the completion of the study, a similar intervention will be made available for the control group after evaluation of results.
The tailored nutrition counseling and management of undernutrition will be provided by MLPs when patients attend CTCs on a monthly basis. Such intervention will continue and be monitored for the entire study duration.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Feeding practices of HIV-positive children attending CTC in Tanga, Tanzania. This includes:
1. Feeding frequency
2. Dietary diversity
3. Quality, and quantity of diets fed to children
Measured at baseline, and monthly for one year
Secondary outcome measures
1. Nutrition status (weight, height, and mid upper arm circumference)
2. ART profile (adherence, viral load, CD4 count, opportunistic infections)
Measured at baseline, and monthly for one year
Overall trial start date
01/07/2013
Overall trial end date
30/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 16/07/2013:
Children:
1. Aged 6 months to 14 years, either sex
2. Diagnosed of HIV / acquired immune deficiency syndrome (AIDS); registered at Care and Treatment Centers (CTC) for treatment or care
Caregivers:
Who takes care of the child on a routine basis
MLP; classified as Assistant Medical Officers (AMO), Clinical Officers (CO), Nurse assistant
Previous inclusion criteria:
Children:
1. Aged 6 months to 5 years, either sex
2. Diagnosed of HIV / acquired immune deficiency syndrome (AIDS); registered at Care and Treatment Centers (CTC) for treatment or care
Caregivers:
Who takes care of the child on a routine basis
MLP; classified as Assistant Medical Officers (AMO), Clinical Officers (CO), Nurse assistant
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
A total of 400 pairs of caregivers and their HIV-positive children attending CTC for intervention and 400 pairs for control group.
Participant exclusion criteria
1. Children too sick to participate in the interview
2. Refusal to participate by caregiver
3. MLP who are not under formal WHO classification
Recruitment start date
01/07/2013
Recruitment end date
30/07/2014
Locations
Countries of recruitment
Tanzania
Trial participating centre
University of Tokyo
Tokyo
113-0033
Japan
Sponsor information
Organisation
University of Tokyo (Japan)
Sponsor details
Department of Community and Global Health
Graduate School of Medicine
7-3-1 Hongo
Bunkyo-ku
Tokyo
113-0033
Japan
+81 (0)3 5841 3697
mjimba@m.u-tokyo.ac.jp
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Tokyo
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Japan
Funder name
School of Public Health and Social Sciences of Muhimbili University of Health and Allied Sciences (Tanzania)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24156500
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28376725
Publication citations
-
Protocol
Sunguya BF, Poudel KC, Mlunde LB, Urassa DP, Jimba M, Yasuoka J, Efficacy of in-service nutrition training for mid-level providers to improve feeding practices among HIV-positive children in Tanga, Tanzania: study protocol for a cluster randomized controlled trial., Trials, 2013, 14, 352, doi: 10.1186/1745-6215-14-352.