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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: Medication diaries
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • HIV-1 RNA [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Follow-up CD4% and adherence [ Time Frame: 6 months, 15 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2004
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194545

Locations
Kenya
University of Nairobi
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
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 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
  More Information

Publications:
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00194545     History of Changes
Other Study ID Numbers: 04-1519-D 02
Study First Received: September 12, 2005
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
HIV-1
pediatric adherence
medication diaries
HAART
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014