title: Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India.
abstract: BACKGROUND
  Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India.
  
  
  METHODS
  As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the 'optimal comprehension group', whilst those scoring 80-89% were categorised into the 'lower comprehension group'. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension.
  
  
  RESULTS
  The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71-11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42-28.55), illiteracy (AOR= 1.65, 95% CI 1.19-2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12-2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01-1.82) were more likely to have lower consent comprehension.
  
  
  CONCLUSIONS
  We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.
authors.affiliation: National AIDS Research Institute, Indian Council of Medical Research, Pune, India.
authors.forename: Neelam S
authors.initials: NS
authors.lastname: Joglekar
authors.forename: Swapna S
authors.initials: SS
authors.lastname: Deshpande
authors.forename: Seema
authors.initials: S
authors.lastname: Sahay
authors.forename: Manisha V
authors.initials: MV
authors.lastname: Ghate
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bollinger
authors.forename: Sanjay M
authors.initials: SM
authors.lastname: Mehendale
mesh_terms: D000328:Adult; D015331:Cohort Studies; D032882:Comprehension / Q000502:physiology*; D032984:Ethics, Research; D005260:Female; D015658:HIV Infections / Q000453:epidemiology*; D006801:Humans; D007194:India / Q000453:epidemiology; D007258:Informed Consent / Q000706:statistics & numerical data*; D008297:Male; D016017:Odds Ratio; D035842:Research Subjects; D017678:Sex Distribution; D012959:Socioeconomic Factors
keywords: Comprehension; Consent comprehension tool; Illiteracy; India; Informed consent process; Study related risks
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