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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00194545
First received: September 12, 2005
Last updated: July 5, 2012
Last verified: July 2012

September 12, 2005
July 5, 2012
July 2004
November 2006   (final data collection date for primary outcome measure)
HIV-1 RNA [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 1. Adherence
  • 2. Follow-up CD4% and change in CD4%
  • 3. Follow-up HIV-1 RNA and change in HIV-1 RNA
Complete list of historical versions of study NCT00194545 on ClinicalTrials.gov Archive Site
Follow-up CD4% and adherence [ Time Frame: 6 months, 15 months ] [ Designated as safety issue: No ]
1. Correlates of adherence
Not Provided
Not Provided
 
Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children
Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children

Following significant reduction in antiretroviral drug prices over the past two years, more HIV-1 infected African adults and children are gaining access to treatment. However, due to complex drug regimens that have to be taken continuously, suboptimal adherence is likely to be a formidable challenge. As programs providing antiretroviral drugs in Africa scale up, achievement of excellent adherence is a high priority as this will result in maximum benefits from the drugs and forestall development of resistant virus. A better understanding of predictors of pediatric HAART adherence in African children is essential in order to formulate feasible, culturally appropriate, strategies to monitor and enhance adherence. There is also urgent need to evaluate simple, inexpensive interventions that are widely applicable in the African setting. The medication diary has been used empirically among HIV infected adults and children in Western countries, mainly as a tool for monitoring and to a lesser extent improving HAART adherence. Literacy levels have risen significantly in most African regions over the past few years, and the diary can also be further modified using pictures to suit parents of different literacy levels. We propose to conduct a randomized control trial to determine the effect of medication diaries and counseling versus counseling alone on HAART-adherence in HIV-1 infected children and their parents/caregivers in Nairobi Kenya.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Behavioral: Medication diaries
Caregivers expected to complete medication diaries daily
  • Experimental: 1
    Medication diary
    Intervention: Behavioral: Medication diaries
  • No Intervention: 2
    Caregivers only receive counseling which is the standard of care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • parents/caregivers planning to reside in Nairobi for at least one year after initiation of antiretroviral therapy
  • HIV-1 infected children between ages 18 months to 12 years with symptomatic disease (WHO stage II or III) and/or CD4 <20% [where CD4 counts available]

Exclusion Criteria:

  • previous use of antiretroviral drugs by the child apart from drugs taken as part of prevention of mother to child transmission of HIV
  • children with end-stage AIDS including widespread disseminated malignancy, and generalized severe encephalopathy
Both
18 Months to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00194545
04-1519-D 02
No
University of Washington
University of Washington
National Institutes of Health (NIH)
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
University of Washington
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP