P11.04
Background: Informed consent comprehension is mandatory for individuals' decision to enrol and participate in clinical trials. Low literacy may be a barrier to consent. We report the relationship between volunteer literacy and comprehension of study information at entry into a fisher folk HIV vaccine preparedness cohort.
Methods: Community meetings were conducted at fishing sites along Lake Victoria to sensitize individuals to participate in HIV vaccine preparedness study. Interested individuals were provided HIV counselling and testing through which HIV uninfected volunteers were identified and invited to a study clinic located about 40km away. At the study clinic, written information on the study objectives, risks, benefits and procedures was read aloud and explained by a nurse to each individual. Those unable to read were requested to identify an independent witness to confirm provision of accurate information. Assessment of understanding (AoU) of study information was then done by a different study staff using 8 questions requiring “true” or “false” responses. Literacy was defined as the individuals' ability to read the study information in the local language and write their names. For the analysis scoring all 8 points correctly was considered as a pass.
Results: Of 584 (60% men) with mean age 28 years enrolled between Jan 2012 and Mar 2014, 122 (21%) were not literate. A total of 508 (87%) passed the AoU at first attempt. This did not differ by: literacy status (87% for literate and not literate), gender (86% men vs. 89% women, p=0.28) or other socio-demographic characteristics (age, occupation religion, marital status, number of dependants, tribe and parity) of the individuals.
Conclusions: Literacy status and other demographic factors may not affect individuals' comprehension of the informed consent process at study onset in these communities provided the investigator reads and explains the study information in the language understood by the individuals.
