Parents’ attitudes to their HIV-infected children being enrolled into a placebo-controlled trial: the PENTA 1 trial. Paediatric European Network for Treatment of AIDS
Authors: Paediatric European Network for Treatment of AIDS (PENTA)
Published in: HIV Med. 1999;1(1):25-31
Objective The study aimed to explore the experience of parents/care-givers to their child’s participation in a European randomized trial of immediate (zidovudine) with deferred (placebo) antiretroviral treatment in asymptomatic children with vertically acquired HIV infection (PENTA 1 trial).
Design One hundred and thirty-three questionnaires were distributed to parents/care-givers (68% of children in the trial) through their paediatrician prior to unblinding the individual child’s therapy (zidovudine/placebo) and 84 (63% response rate) were returned.
Methods & Results Thirty-six (43%) parents described moderate (n = 30) or great (n = 6) interference with everyday life. This was more frequent among parents of children whose HIV disease progressed (P = 0.03, Fisher’s exact test) but was unrelated to ethnicity, country of origin, treatment allocated or adverse events. Invited comments suggested that concern about forgetting doses and the taste/volume of the trial medication contributed to interference with everyday life. Seventy-six (90%) parents considered information received during the trial adequate. The eight expressing dissatisfaction were recruited in the same country and five of them were among the eight (10%) who stated that they would not want to enroll their child in another trial.
Conclusions There is a need for adequate ongoing feedback about trial progress to participating families. With increasing use of complex antiretroviral regimens, innovative ways of helping families with adherence issues require development and evaluation