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

July 5, 2012 updated by: University of Washington
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • University of Nairobi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Medication diary
Behavioral: Medication diaries
Caregivers expected to complete medication diaries daily
No Intervention: 2
Caregivers only receive counseling which is the standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV-1 RNA
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Follow-up CD4% and adherence
Time Frame: 6 months, 15 months
6 months, 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)

Investigators

  • 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 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

July 9, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-1519-D 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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