Nutritional Rehabilitation in Senegalese HIV-infected Children and Adolescents
Condition: Malnutrition; HIV/AIDS
MeSH terms: Malnutrition
Study type: Interventional

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.
    

Intervention name(s): Plumpy Nut; Plumpy Sup
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): ready-to-use therapeutic food; ready-to-use supplementary food
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe acute malnutrition; moderate acute malnutrition; HIV-infection; adolescents; antiretroviral; Africa; ready-to-use food; outpatient care