Severe acute malnutrition treatment delivered by community health workers in emergency settings of Mali (iCCM+ Project)

ISRCTN	ISRCTN60973756
DOI	https://doi.org/10.1186/ISRCTN60973756
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsors	Complutense University of Madrid, Institut National de Recherche en Santé Publique
Funders	Enhancing Learning and Research for Humanitarian Assistance, United States Agency for International Development

Submission date: 28/09/2020
Registration date: 15/10/2020
Last edited: 27/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Severe acute malnutrition (SAM) is the most extreme and visible form of undernutrition. Children with SAM have very low weight for their height and severe muscle wasting.
According to the latest estimates, 16.9 million children under-five worldwide suffer from SAM, making it a major public health concern. Over the past two decades, there have been significant shifts in how the world addresses SAM, changing from inpatient to outpatient treatment due to the development of Ready-to-Use Therapeutic Food (RUTF) and the Community Management of Acute Malnutrition (CMAM) protocol. However, a study in 21 low-and-middle-income countries showed that CMAM programmes reach less than 40% coverage due to critical barriers such as carers’ awareness of children’s conditions, awareness of programme existence, and high opportunity costs mainly due to distance from health centres.

These challenges are not unique to SAM, and public health services have sought ways of making critical child survival interventions more integrated and more accessible. The Integrated Community Case Management (iCCM) strategy is based on training non-medical Community Health Workers (CHWs) to provide selected curative services for high mortality infectious diseases. Given the influence of nutritional status on the recovery, this protocol also includes the identification and referral of SAM children. Thus, iCCM has been described as a logical platform and missed opportunity to increase the coverage of uncomplicated SAM treatment and prevent malnutrition. Along with this, there is a growing interest in exploring other alternative treatment protocols that will simplify managing the disease by making it easier for non-medical personnel.

Who can participate?
Children 6 to 59 months of age with uncomplicated severe acute malnutrition.

What does the study involve?
A cluster-randomized controlled trial with three arms has been designed to be put in place in the region of Gao in Mali. One arm will be the control by applying the current community program existing in the country. The first intervention arm aims to evaluate the individual effect of adding the CHWs as treatment providers outside the health facilities (closer to the communities) since they will apply the same protocol as in the control group. The second intervention arm aims to test the effectiveness of simplifying this protocol using the Mid-Upper Arm Circumference (MUAC) as the only diagnostic criterion for admission and discharge and giving a fixed dose of therapeutic food.

What are the possible benefits and risks of participating?
The main benefit is to bring nutritional treatment closer to children in remote or isolated rural villages. It is expected to reduce the dropout possibility and promote adherence to treatment by reducing the family's time and money to bring the child for treatment. Those children treated by the Community Health Workers will also receive nutritional treatment integrated with the most deadly infectious diseases.
The potential risks are that children treated by Community Health Workers may not receive a quality of care as good as that offered by health staff in health centers, which may negatively affect the speed of recovery or on their treatment outcomes.

Where is the study run from?
Health Facilities and Health huts (Community Health Workers) of the Gao Region in Mali, co-ordinated by Action Against Hunger (Action Contre la Faim, ACF), Mali

When is the study starting and how long is it expected to run for?
July 2019 to September 2021

Who is funding the study?
1. Elrha - Enhancing Learning and Research for Humanitarian Assistance (UK)
2. USAID/OFDA - Office of United States Foreign Disaster Assistance (USA)

Who is the main contact?
Noemí López-Ejeda, PhD, noemilop@ucm.es

Contact information

Dr Noemi Lopez-Ejeda
Scientific

Action Against Hunger Spain
C/ Duque de Sevilla 3. C.P.
Madrid
28002
Spain

ORCID ID	0000-0003-1310-0134
Phone	+34 91 391 53 00
Email	noemilop@ucm.es

Study information

Primary study design	Interventional
Study design	Cluster randomized controlled non-inferiority trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Effectiveness, cost-effectiveness, and coverage of the treatment of severe acute malnutrition delivered by community health workers through a protocol based on simplified approaches in emergency settings of Mali
Study acronym	iCCM+ Project
Study objectives	The decentralization of treatment through Community Health Workers with a modified protocol will increase coverage and cost-effectiveness while maintaining quality standards in the outcomes
Ethics approval(s)	1. Approved 03/09/2019, Clinical Research Ethics Committee of the Hospital Clínico San Carlos (Comité de Ética de Investigación Clinica del Hospital Clínico San Carlos, Madrid, Spain; +34 91 330 34 13; ceic.hcsc@salud.madrid.org), ref. 19/363-R_X_BC 2. Approved 07/01/2020, National Institute of Public Health (Institut National de Sante Publique, Route de Koulikoro, rue 235, porte 52, BP 1771, Bamako, Hippodrome, Mali; +223 66766337; no email provided), ref. 35/2019/CE-EX-INRSP
Health condition(s) or problem(s) studied	Uncomplicated severe acute malnutrition of children 6 to 59 months
Intervention	The study design includes three arms: - Control arm: treatment is provided only in health centers following the national protocol. Admission criteria: Edema +/++ and/or WHZ <-3 z-score and/or MUAC <115mm. Treatment: RUTF according to weight (170 Kcal/kg/day). Discharge criteria: WHZ >-1.5 z-score or MUAC >=125 mm. - Intervention Arm 1: treatment is provided in health centers and outside by community health workers following national protocol. Admission criteria: Edema +/++ and/or WHZ <-3 zscore and/or MUAC <115mm. Treatment: RUTF according to weight (170 Kcal/kg/day). Discharge criteria: WHZ > -1.5 zscore or MUAC >=125 mm. - Intervention arm 2: treatment is provided in health centers and outside them by community health workers following a modified protocol. Admission criteria: Edema +/++ and/or MUAC <115mm. Treatment: fixed amount of 2 sachets of RUTF /day (1000 Kcal/day) except children under 5Kg who will receive 1 sachet/day (500Kcal/day). Discharge criteria: WHZ >-1.5 z-score or MUAC >=125mm. All children in the three study arms will receive a weekly follow-up until meeting a discharge criterion. Each cluster will correspond to one treatment provider (health centre or its group of CHWs) which means that there will be 6 groups of providers by arm. However, in order to avoid final real imbalance in cluster size, the unit of randomization will be the health centre with a block allocation ratio of 2:1:1.
Intervention type	Supplement
Primary outcome measure(s)	Data will be extracted directly from the patient records existing in the health centers and health huts at the end of the study: 1. Recovery rate: proportion of children achieving and maintaining the discharge criteria during two follow-up visits (two consecutive weeks) 2. Default rate: proportion of children absent of two follow-up visits (two consecutive weeks) 3. Decease rate: proportion of children who die during treatment or in transit to inpatient care 4. Referral rate: proportion of children referred to inpatient care due to the appearance of medical complications or nutritional treatment failure (non-response considered as oedema still present after 21 days, weight loss for two consecutive visits, not weight gain in 14 days, or failure in the appetite test)
Key secondary outcome measure(s)	1. Coverage compared at baseline and end-line from two population-based surveys conducted at the beginning and end following the standardized SLEAC methodology 2. Cost-effectiveness: cost per child treated and cost per child recovered. Financial information for the cost-effectiveness analysis will be taken towards the middle of the recruitment period using as a source the logistics and financial records of the Action Against Hunger offices and the health district authorities Obtained monthly from the patient records: 3. Severity at admission (MUAC and WHZ measurements and oedema proportion) 4. Recovery time: time spent in treatment until being discharged as cured 5. Number of follow-up visit absent in those children recovered 6. Number of RUTF sachets consumed by those children recovered 7. Average weight and MUAC gain of those children recovered 8. Number of cases treated for other non-severe common diseases in an integrated manner (diarrhea, malaria, acute respiratory infection)
Completion date	27/09/2021

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	All
Target sample size at registration	1728
Total final enrolment	1244
Key inclusion criteria	1. Children from 6 to 59 months of age 2. Diagnosed with uncomplicated severe acute malnutrition 3. Positive appetite test result 4. Without any medical danger sing (severe oedema, unable to drink or suck, severe vomit, convulsing, non-response to external stimuli, severe palmar pallor, severe difficulty breathing, spontaneous bleeding, dark urine, unable to sit/stand, severe diarrhea/dehydration)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/07/2020
Date of final enrolment	31/08/2021

Locations

Countries of recruitment

Mali

Study participating centre

Action Against Hunger (Action Contre la Faim, ACF)

Rue 254
Porte 637
Quartier Hippodrome
Bamako
BP E 2562
Mali

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/02/2024	17/04/2024	Yes	No
Other publications	Economic evaluation	20/01/2025	27/01/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file		03/09/2019	05/09/2022	No	No
Protocol file		14/01/2020	05/09/2022	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN60973756_Protocol_in English_03Sep2019.pdf: Protocol file
ISRCTN60973756_Protocol_in French_14Jan2020.pdf: Protocol file

Editorial Notes

27/01/2025: Publication reference added.
17/04/2024: Publication reference added.
15/02/2023: The following changes have been made:
1. Total final enrollment number added.
2. The overall trial end date has been changed from 30/10/2021 to 27/09/2021.
3. The intention to publish date has been changed from 31/03/2023 to 31/07/2023.
05/09/2022: The following changes have been made:
1. Protocol files uploaded.
2. The intention to publish date has been changed from 31/05/2022 to 31/03/2023.
3. The scientific contact's details have been updated.
01/10/2020: Trial’s existence confirmed by Clinical Research Ethics Committee of the Hospital Clínico San Carlos.