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.
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).


METHODS
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.


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.
D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D017028:Caregivers; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology* / Q000821:virology; D015497:HIV-1; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D010290:Parents; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires; D020458:Third-Party Consent; D015215:Zidovudine / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D015215:Zidovudine