Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Medication diaries
Intervention type(s): Behavioral
Intervention description(s): Caregivers expected to complete medication diaries daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; pediatric adherence; medication diaries; HAART; Treatment Naive