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

Autor: Hejoaka F; Institut de recherche pour le développement, UMI233 TransVIHmi, U1175 INSERM, Université de Montpellier, Montpellier, France., Varloteaux M; Institut de recherche pour le développement, UMI233 TransVIHmi, U1175 INSERM, Université de Montpellier, Montpellier, France., Desclaux-Sall C; Institut de recherche pour le développement, UMI233 TransVIHmi, U1175 INSERM, Université de Montpellier, Montpellier, France., Ndiaye SM; Centre régional de recherche et de formation à la prise en charge clinique, Dakar, Sénégal., Diop K; Centre régional de recherche et de formation à la prise en charge clinique, Dakar, Sénégal.; Division de lutte contre le sida et les IST/Ministère de la santé et de l'action sociale, Dakar, Sénégal., Diack A; Centre hospitalier national d'enfants Albert Royer, Dakar, Sénégal., Niasse F; Conseil national de lutte contre le sida, Dakar, Sénégal., Cames C; Institut de recherche pour le développement, UMI233 TransVIHmi, U1175 INSERM, Université de Montpellier, Montpellier, France.
Jazyk: angličtina
Zdroj: Tropical medicine & international health : TM & IH [Trop Med Int Health] 2019 Mar; Vol. 24 (3), pp. 294-303. Date of Electronic Publication: 2019 Jan 24.
DOI: 10.1111/tmi.13202
Abstrakt: 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.
(© 2019 John Wiley & Sons Ltd.)
Databáze: MEDLINE
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