Medication diaries do not improve outcomes with highly active antiretroviral therapy in Kenyan children: a randomized clinical trial

Citation:
Wamalwa DC, Farquhar C, Obimbo EM, Selig S, Mbori-Ngacha DA, et al. "Medication diaries do not improve outcomes with highly active antiretroviral therapy in Kenyan children: a randomized clinical trial ." Journal of the International AIDS Society Research. 2009.

Abstract:

Abstract
Background: As highly active antiretroviral therapy (HAART) becomes increasingly available to African children,
it is important to evaluate simple and feasible methods of improving adherence in order to maximize benefits of
therapy.
Methods: HIV-1-infected children initiating World Health Organization non-nucleoside reverse transcriptaseinhibitor-
containing first-line HAART regimens were randomized to use medication diaries plus counselling, or
counselling only (the control arm of the study). The diaries were completed daily by caregivers of children
randomized to the diary and counselling arm for nine months. HIV-1 RNA, CD4+ T cell count, and z-scores for
weight-for-age, height-for-age and weight-for-height were measured at a baseline and every three to six months.
Self-reported adherence was assessed by questionnaires for nine months.
Results: Ninety HIV-1-infected children initiated HAART, and were followed for a median of 15 months
(interquartile range: 2–21). Mean CD4 percentage was 17.2% in the diary arm versus 16.3% in the control arm at
six months (p = 0.92), and 17.6% versus 18.9% at 15 months (p = 0.36). Virologic response with HIV-1 RNA of
<100 copies/ml at nine months was similar between the two arms (50% for the diary arm and 36% for the control,
p = 0.83). The weight-for-age, height-for-age and weight-for-height at three, nine and 15 months after HAART
initiation were similar between arms. A trend towards lower self-reported adherence was observed in the diary
versus the control arm (85% versus 92%, p = 0.08).
Conclusion: Medication diaries did not improve clinical and virologic response to HAART over a 15-month
period. Children had good adherence and clinical response without additional interventions. This suggests that
paediatric HAART with conventional counselling can be a successful approach. Further studies on targeted
approaches for non-adherent children will be important.

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