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

Improving the informed consent process among HIV-infected undisclosed minors participating in a biomedical research: insights from the multicenter SNACS study in Senegal
Fabienne Hejoaka, Marie Varloteaux, Caroline Desclaux-Sall, Sidy Mokhtar Ndiaye, Karim Diop, Aminata DiackFatou Niasse, Cecile Cams
Tropical Medicine & International Health, 9 January 2019; 24(3) pp 294-303
Abstract
Objectives
Providing research information in a manageable way 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 informed consent process (IICP) and identified factors associated with the presentation of HIV-infected minors in their studies.
Methods
We enrolled study participants attending 12 pediatric HIV clinics in Senegal. Children ≥7 years were provided with standardized IICP, which involves viewing a video and taking part in extended group discussions. Was evaluated by seven basic questions scored 1 or 2 points, with a maximum score of 11 points. A score of 9 or more points. 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 and gave consent to participate in the research. HIV-infected children were more likely than children to be infected (aOR = 3.2, 95% CI: 1.1-9.6). Age, study and education level were not associated with satisfactory understanding.
Conclusion
These findings provide for guidance in the development of the business of business. The implementation of the pediatric HIV research agenda will require a standardized and operational definition of informed consent, integrating the issue of HIV disclosure.

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