Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children|
- HIV-1 RNA [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Follow-up CD4% and adherence [ Time Frame: 6 months, 15 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Study Completion Date:||December 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Behavioral: Medication diaries
Caregivers expected to complete medication diaries daily
No Intervention: 2
Caregivers only receive counseling which is the standard of care
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194545
|University of Nairobi|
|Study Director:||Carey Farquhar, MD, MPH||University of Washington|
|Principal Investigator:||Dalton Wamalwa, MBChB, MPH||University of Nairobi|
|Study Director:||Grace John-Stewart, MD, PhD||University of Washington|
|Study Director:||Dorothy Mbori-Ngacha, MBChB, MPH||University of Nairobi|
|Study Director:||Barbra Richardson, PhD||University of Washington|
|Study Director:||Grace Wariua, MBChB, MPH||University of Nairobi|
|Study Director:||Julie Overbaugh, PhD||Fred Hutchinson Cancer Research Center|
|Study Director:||Elizabeth Obimbo, MBChB,MPH||University of Nairobi|
|Study Director:||Christine Gichuhi, MBChB,MMed||University of Nairobi|
|Study Director:||Ruth Nduati, MBChB,MPH||University of Nairobi|