AN ASSESSMENT OF UNDERSTANDING OF INFORMATION PROVIDED IN GENETIC RESEARCH AMONG PEOPLE LIVING WITH HIV AT THE INFECTIOUS DISEASES INSTITUTE (IDI)

Abstract

Introduction Obtaining informed consent is essential for biomedical research; and for informed consent to be valid, it is imperative that participants understand all the information disclosed to them before making voluntary decisions. A number of studies reveal poor understanding of genetic research by participants in developing countries; with a high propensity to therapeutic misconception. The study aimed to assess the understanding of information provided in genetic research among people living with HIV at a single research institution. Methods This was a cross sectional study that employed both qualitative and quantitative data collection and analysis approaches. An assessment of understanding of informed consent by 206 participants of five pharmacogenetic studies was done using the Quality of Informed Consent questionnaire. Fifteen in-depth interviews with study nurses, counsellor, doctors and principal investigators were conducted. Quantitative data was summarized using descriptive statistics. Inferential statistics were done using the chi-squared test and logistic regression analysis. Qualitative data was analyzed using thematic analysis. Results Among the research participants enrolled, 138 (67%) were female with a median age of 32 years and 137 (66.5%) had at least attained post-primary education. Majority 8(53.3%) of key informants were highly educated and 11(73%) of them had a research experience of more than 5 years. Only 47(22.8%) of 206 participants had adequate understanding of the information provided during genetic research. Understanding of informed consent was influenced by level of education (OR 3.29, CI 1.25-8.69 p=0.01), being employed (OR 2.45, CI: 1.04-5.78 p=0.009), and participation in more than one study (OR 3.59, CI 1.48- 8.67 p=0.02). Other facilitators of adequate understanding identified from the interviews included the use of experienced nurses to obtain informed consent; establishing conducive social and physical environment; translation of consent documents into local languages; use of simplified language; and assessment of comprehension before final decision-making.

Conclusion Only 47 (22.8%) out of 206 participants in this study had adequate understanding of the information disclosed to them in genetics research. The factors identified that influence adequate understanding include the level of education, being employed and having prior exposure to genetic research and concepts. Several facilitators that enhance participants’ understanding of genetic research information were suggested by the research team members. The results of this study can be used to inform researchers on the appropriate strategies of improving participants’ understanding of information provided to them in genetic research.