Authors: Shafic Makumbi, Abbas Lugemwa, Deborah Ford, Anna Turkova, Francis Bajunirwe, Victor Musiime, Diana Gibb, Imelda K Tamwesigire
Introduction: Voluntariness among parents consenting for research in their children is hard to assess and there have been few studies undertaken. This study assessed the voluntariness of consent in on-going Paediatric HIV clinical trials and the associated factors.
Methods: We conducted a mixed methods cross-sectional study among parents of children starting first or second line treatment in two paediatric HIV clinical trials. Data were collected using in-depth interview guide and an interviewer administered tool consisting of the voluntariness ladder (1-10), items adopted from the Survey of influences questionnaire and items assessing the consent process. Data were triangulated at interpretation. The scores were dichotomised to facilitate analysis.
Results: Of the 151 parents approached, all consented and were enrolled. 84% were female. Median age 40 years. Most respondents (95%) reported that they received enough information about the study. When asked whether they took time to read consent documents on their own or with help from family and friends, 39% reported reading the entire documents, 50% read part and 11% did not read. Whereas 47% fully understood the trial, 48% understood some parts and only 5% did not understand most about the trial. Most respondents (67%) gave a fully voluntary decision with a score of 10 on the voluntariness ladder whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 3% scored 4. Trust in medical researchers [aOR=10.41(1.15-93.91), p=0.037], male parent [aOR=3.82(1.05-13.87), p=0.042] were significantly associated with voluntariness of consent. Prior Research experience and consulting others were negatively associated with voluntariness [aOR=0.32(0.13-0.77), p=0.011 and aOR=0.25(0.11-0.58), p=0.001 respectively)]. Consultation and advice came from several sources: referring health-workers (36%), spouses (29%), other family member (27%), friends (15%) and researcher (7%). Most respondents reported feeling pressure to consent because of the child’s health.
Conclusions: This study, with 100% participation, demonstrated a relatively high voluntariness of consent, which was enhanced in those with trust in medical researchers. Female parents/guardians and parents of children with prior research experience may benefit from additional interventions to support voluntary participation. The content of the consent documents need to be reviewed to improve their readability and understanding.