Adherence to ready-to-use food and acceptability of outpatient nutritional therapy in HIV-infected undernourished Senegalese adolescents: research-based recommendations for routine care.

BACKGROUND: Ready-to-use food (RUF) is increasingly used for nutritional therapy in HIV-infected individuals. However, practical guidance advising nutrition care to HIV-infected adolescents is lacking, so that little is known about the acceptability of such therapy in this vulnerable population. This study assesses the overall acceptability and perception of a RUF-based therapy and risk factors associated with sub-optimal RUF intake in HIV-infected undernourished adolescents in Senegal. METHODS: Participants 5 to 18 years of age with acute malnutrition were enrolled in 12 HIV clinics in Senegal. Participants were provided with imported RUF, according to WHO prescription weight- and age-bands (2009), until recovery or for a maximum of 9-12 months. Malnutrition and recovery were defined according to WHO growth standards. Adherence was assessed fortnightly by self-reported RUF intake over the period. Sub-optimal RUF intake was defined as when consumption of the RUF provision was < 50%. RUF therapy acceptability and perceptions were assessed using a structured questionnaire at week 2 and focus group discussions (FGDs) at the end of the study. Factors associated with sub-optimal RUF intake at week 2 were identified using a stepwise logistic regression model. RESULTS: We enrolled 173 participants, with a median age of 12.5 years (Interquartile range: 9.5-14.9), of whom 61% recovered from malnutrition within the study period. Median follow-up duration was 66 days (21-224). RUF consumption was stable, varying between 64 and 57% of the RUF provided, throughout the follow-up. At week 2, sub-optimal RUF intake was observed in 31% of participants. Dislike of the taste of RUF (aOR = 5.0, 95% CI: 2.0-12.3), HIV non-disclosure (5.1, 1.9-13.9) and food insecurity (2.8, 1.1-7.2) were the major risk factors associated with sub-optimal RUF intake at week 2. FGDs showed that the need to hide from others to avoid sharing and undesirable effects were other constraints on RUF feeding. CONCLUSIONS: This study revealed several factors reducing the acceptability and adherence to RUF therapy based on WHO guidelines in HIV-infected adolescents. Tailoring prescription guidance and empowering young patients in their care are crucial levers for improving the acceptability of RUF-based therapy in routine care. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03101852, 04/04/2017.

Improving the informed consent process among HIV-infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal.

OBJECTIVES: Providing research information in a manner accessible to minors participating in biomedical research is a major challenge. Guidance is dramatically lacking regarding best practices for seeking informed consent among undisclosed minors enrolled in HIV-related research. We implemented an improved informed consent process (IICP) and identified factors associated with understanding of the information presented to HIV-infected minors prior to their enrolment in a study. METHODS: We enrolled study participants attending 12 paediatric HIV clinics in Senegal. Children ≥7 years were provided with standardised research information using the IICP, which involves viewing a video and taking part in extended group discussions. Understanding was assessed by seven basic questions scored 1 or 2 points, with a maximum score of 11 points. A score of 9 or more points was defined as satisfactory understanding. Factors associated with understanding were identified using a stepwise logistic regression model. RESULTS: Overall, 112 children, with a median age of 12.9 years (IQR: 10.2-15.0), participated in the IICP, of whom 37% were HIV disclosed. 71% achieved a satisfactory understanding score and all gave consent to participate in the research. HIV-disclosed children were more likely to demonstrate satisfactory understanding than undisclosed children (aOR = 3.2, 95% CI: 1.1-9.6). Age, study setting and education level were not associated with satisfactory understanding. CONCLUSION: These findings provide practical guidance for the development of improved and friendly informed consent processes in research involving minors. The implementation of the paediatric HIV research agenda will require a standardised and operational definition of informed consent, integrating the issue of HIV disclosure.

OBJECTIFS: Fournir des informations sur la recherche d'une manière accessible aux mineurs participant à la recherche biomédicale est un défi majeur. Les guidances font cruellement défaut en ce qui concerne les meilleures pratiques pour obtenir le consentement éclairé des mineurs non dévoilés, inscrits dans des recherches sur le VIH. Nous avons mis en place un processus de consentement éclairé amélioré (PCEA) et identifié les facteurs associés à la compréhension des informations présentées aux mineurs infectés par le VIH avant leur inscription à une étude. MÉTHODES: Nous avons recruté des participants à l'étude dans 12 cliniques pédiatriques de traitement du VIH au Sénégal. Les enfants de 7 ans et plus ont reçu des informations de recherche standardisées à l'aide du PCEA, qui consiste à visionner une vidéo et à participer à des discussions de groupe prolongées. La compréhension a été évaluée par 7 questions de base notées 1 ou 2 points, avec un score maximum de 11 points. Un score de 9 points ou plus a été défini comme une compréhension satisfaisante. Les facteurs associés à la compréhension ont été identifiés à l'aide d'un modèle de régression logistique par étapes. RÉSULTATS: Au total, 112 enfants âgés de 12,9 ans en moyenne (IQR: 10,2-15,0) ont participé au PCEA, dont 37% avaient leur statut VIH dévoilé. 71% ont obtenu un score de compréhension satisfaisant et tous ont consenti à participer à la recherche. Les enfants avec un statut VIH dévoilé étaient plus susceptibles de démontrer une compréhension satisfaisante que ceux avec un statut non dévoilé (aOR: 3,2; IC95%: 1,1-9,6). L'âge, le cadre de l'étude et le niveau d'éducation n'étaient pas associés à une compréhension satisfaisante. CONCLUSION: Ces résultats fournissent des guidances pratiques pour la mise au point de processus de consentement éclairé améliorés et conviviaux dans la recherche impliquant des mineurs. La mise en œuvre du programme de recherche pédiatrique sur le VIH nécessitera une définition normalisée et opérationnelle du consentement éclairé, intégrant la question de la révélation du VIH.