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

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.

Conditions

• HIV Infections

Interventions

BEHAVIORAL

Medication diaries

Caregivers expected to complete medication diaries daily

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Carey Farquhar, MD, MPH · University of Washington

• Dalton Wamalwa, MBChB, MPH · University of Nairobi

• Grace John-Stewart, MD, PhD · University of Washington

• Dorothy Mbori-Ngacha, MBChB, MPH · University of Nairobi

• Barbra Richardson, PhD · University of Washington

• Grace Wariua, MBChB, MPH · University of Nairobi

• Julie Overbaugh, PhD · Fred Hutchinson Cancer Center

• Elizabeth Obimbo, MBChB,MPH · University of Nairobi

• Christine Gichuhi, MBChB,MMed · University of Nairobi

• Ruth Nduati, MBChB,MPH · University of Nairobi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Months

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-07-31

Primary Completion

2006-11-30

Completion

2006-12-31

Countries

• Kenya

Study Locations