Clinical trial NCT03101852: Nutritional Rehabilitation in Senegalese HIV-infected Children and Adolescents
Official title: Effectiveness and Acceptability of Nutritional Rehabilitation Based on Ready-to-use Food in HIV-infected Children and Adolescents in Senegal: The Multicentre SNAC'S Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
HIV/AIDS
Keywords: severe acute malnutrition
moderate acute malnutrition
HIV-infection
adolescents
antiretroviral
Africa
ready-to-use food
outpatient care
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Global Fund
name: Sidaction
name: UNICEF
name: United Nations World Food Programme (WFP)
First posted: 2017-04-05
Enrollment: 185
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe (SAM, Body Mass Index-z \< -3) and moderate (MAM, -3 ≤ BMI-z \< -2) acute malnutrition, highly prevalent in HIV-infected children and adolescents, is an independent risk factor of death, even when antiretroviral treatment (ART) is initiated. The objectives of the SNAC'S study are to assess acceptability and effectiveness of outpatient nutritional rehabilitation, using ready-to-use food (RUF), elaborated in compliance with national and international recommendations and implemented in HIV-infected children and adolescents, under active follow-up in the 12 main pediatric HIV care sites in Senegal and presenting with SAM or MAM.

Detailed description: Background:

Severe (SAM, BMI-z \< -3) and moderate (MAM, -3 ≤ BMI-z \< -2) acute malnutrition, highly prevalent in HIV-infected children and adolescents, is an independent risk factor of death, even when antiretroviral treatment (ART) is initiated. Scaling-up of ART decreased morbimortality in children in low-income settings and thus allowed HIV-infection to become, to some extent, a chronic disease. However, appropriate and targeted nutritional interventions take a long time to be assessed with the aim of their integration in the "global care" of HIV infection, thus jeopardizing in these patients who go through adolescence the successes achieved so far. Many clinical trials reported a greater efficacy of the ready-to-use therapeutic foods (RUTF) in the nutritional rehabilitation compared with standard interventions, among up to five children, with or without HIV-infection. Since 2007, the United Nations recommend their use for the outpatient nutritional rehabilitation of severely malnourished children and since 2009, also in HIV-infected adolescents.

Objectives :

The objectives of the SNAC'S study are to assess acceptability and effectiveness of outpatient nutritional rehabilitation, using ready-to-use food (RUF), elaborated in compliance with national and international recommendations and implemented in HIV-infected children and adolescents, under active follow-up in the 12 main pediatric HIV care sites in Senegal.

Will be specifically assessed:

Effectiveness of nutritional rehabilitation in terms of catch-up weight growth, of immunologic status improvements, of muscular mass gain and of micronutrients status (including the correlation within these outcomes). Long-term (3 months and 6 months after discharge) weight growth and relapse will be assessed Acceptability of the intervention will be assessed using quantitative methods (observance to RUF prescription, feeding modalities, organoleptic appreciation, etc.) and qualitative methods (focus group and interviews about perceptions among children \> 7 years and health workers).

The SNACS study was carried out in Senegal from April 2015 to January 2017 in 12 public paediatric clinics: two in the Dakar district, the capital city, (Albert Royer National Paediatric Hospital and Roi Baudouin Hospital) and 10 in decentralized settings (Regional Hospitals of Saint Louis, Louga, Mbour, Kaoloack, Ziguinchor and Kolda; Health centres of Thiès, Nioro du Rip, Bignona and Kolda). Study implementation was gradual, starting with the central sites in April 2015 and ending with the Kolda sites in March 2016.

Methods:

This is an open cohort study (intervention/evaluation) conducted over 2 years. Children with SAM will be enrolled in a rehabilitation protocol, using Plumpy Nut until the target weight is reached, BMI-z \> -2. Children with MAM will be enrolled in a rehabilitation protocol, using Plumpy Sup. At enrollment and at discharge from the rehabilitation protocols, a blood sample will be collected for an immunovirological, biological and selected proteins and micronutrients assessment. At each visit, a clinical examination and anthropometric measurements will be performed.

At enrollment and after discharge, focus groups will be conducted with children \> 7 years about their understanding and perception of the study protocol and of the nutritional care. Before enrollments start and at the end of the study, interviews will be conducted with the health workers involved in the study to explore their understanding of the study and their perceptions about the acceptability, effectiveness and feasibility of the nutritional rehabilitation of HIV children. Overall acceptability of RUF will be assessed in children by questionnaires at 3 time points during the study follow-up.

Expected outcomes:

Implementation of the recent recommendations on early ART initiation in children should allow the integration of targeted and appropriate nutritional interventions. The SNAC's Study will disseminate the first scientific data on modalities, acceptability and efficacy of nutritional rehabilitation in HIV-infected older children and adolescents in Africa. As it complies with international and national recommendations, it will also provide programmatic data, with regards to feasibility of outpatient nutritional rehabilitation using RUTF in HIV-infected adolescents, to national stakeholders and decision makers. It is ultimately expected to facilitate effective integration of these vulnerable patients both in nutritional care guidelines and follow-up health structures.

Eligibility criteria: Inclusion Criteria:

* infected with HIV
* presenting with severe or moderate acute malnutrition
* followed-up in one of the 12 study sites
* written consent of the parent/legal guardian
* verbal assent of the child

Exclusion Criteria:

* pregnancy
* physical and/or mental disability incompatible with the study follow-up
* living far from the study site (about more than 50km)

Primary outcomes:
measure: Successful nutritional rehabilitation
timeFrame: up to 12 months
Secondary outcomes:
measure: long-term effectiveness
timeFrame: 3 months
measure: long-term effectiveness
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Division de Lutte contre le Sida et les IST, Dakar, Senegal
name: Karim Diop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Comité National de Lutte contre le Sida, Dakar, Senegal
name: Fatou Niasse-Traore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niasse F, Varloteaux M, Diop K, Ndiaye SM, Diouf FN, Mbodj PB, Niang B, Diack A, Cames C. Adherence to ready-to-use food and acceptability of outpatient nutritional therapy in HIV-infected undernourished Senegalese adolescents: research-based recommendations for routine care. BMC Public Health. 2020 May 15;20(1):695. doi: 10.1186/s12889-020-08798-z.
citation: Hejoaka F, Varloteaux M, Desclaux-Sall C, Ndiaye SM, Diop K, Diack A, Niasse F, Cames C. Improving the informed consent process among HIV-infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal. Trop Med Int Health. 2019 Mar;24(3):294-303. doi: 10.1111/tmi.13202. Epub 2019 Jan 24.