Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194545
Status:
COMPLETED
Last Update Posted:
2012-07-09
First Post:
2005-09-12
Brief Title:
Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 parentscaregivers 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 childrens 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 parentscaregiver 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 childs 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 months 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 parentcaregiver in the intervention study arm and address any issues raised about the diary use
At 36 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 procedures
Parents or caregivers of HIV-1 infected children discharged from the Kenyatta National Hospital KNH childrens 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 parentscaregiver 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 childs 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 months 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 parentcaregiver in the intervention study arm and address any issues raised about the diary use
At 36 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None