Trial Information

Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children

Study design: This is a randomized trial comparing adherence to antiretroviral drugs and
clinical outcomes between 50 HIV-1 infected Kenyan children randomized to a simple
medication diary plus standard counseling with a similar group of children randomized to
counseling alone.

Study procedures:

Parents or caregivers of HIV-1 infected children discharged from the Kenyatta National
Hospital (KNH) children's wards or seen in pediatric outpatient clinics will be invited to
participate in the study by nurse counselors. Informed written consent will be obtained
from those who meet eligibility criteria and agree to participate. The consenting process
will be done by the principal investigator in a confidential area. A baseline questionnaire
will be administered to obtain socio-demographic information and previous medical history of
the parents/caregiver and child. All those enrolled will undergo three sessions of
counseling conducted by a trained nurse counselor regarding antiretroviral therapy over a
two-week period.

After successful completion of the counseling process, 8 mls of blood will be drawn from
each child for liver function tests, urea, blood count including hemoglobin, CD4 cell count
and HIV-1 viral load.

After receiving results of the laboratory tests, children will be randomized to two groups.
Those in the first group will be given a medication diary in which caregivers will record
the child's daily intake of antiretroviral drugs. Those in the second group will be
followed up without a diary. Children in both groups will be started on three
antiretroviral drugs: zidovudine, nevirapine, and lamivudine. Caregivers will be requested
to bring to the next clinic appointments drug containers for the past month's prescriptions.
Those in the intervention arm will be requested to carry the medication diaries to all
appointments.

Follow-up: Clinic appointments will be planned for 2 weeks after initiating antiretroviral
therapy and at monthly intervals thereafter. At each visit, adherence will be monitored
using self report using the pediatric adherence questionnaire. Pill counts will be
performed at 3-monthly intervals. A study nurse will review the medication diary with each
parent/caregiver in the intervention study arm, and address any issues raised about the
diary use.

At 3,6, and 9 months after initiation of antiretroviral therapy, 8 mls of blood will be
drawn from each child for liver function tests, urea, blood count including hemoglobin, CD4
cell count and HIV-1 viral load, and antiretroviral drug resistance.

In-depth interviews will be conducted with caregivers to cover a broad range of experiences.

The second two aims of this study are summarized below:

Aim 2): Define correlates of adherence measured by self report to specific components of a
pediatric HAART regimen in HIV-1 infected children initiating therapy in Nairobi, Kenya.

Aim 3) Identify behavioral and social problems experienced by caregivers in relation to
paediatric HAART adherence and define mechanisms to improve adherence.