Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134602
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-08-24
Brief Title:
Pediatric Impact Promoting Adherence to Medications Among HIV-infected Children
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
An Intervention to Promote Adherence to Antiretroviral Medications Among HIV-infected Children 5-12 Years of Age
Status:
COMPLETED
Status Verified Date:
2012-09
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:
The purpose of the study is to develop and evaluate an intervention to promote adherence to HIV medications among children 5-12 years of age It compares changes in antiretroviral ARV adherence between the EIG enhanced intervention group and an MIG minimal intervention group from baseline to 4 months post-intervention
Secondary outcomes include examining whether improvement in adherence to a medication regimen is associated with improved health outcomes ie viral load CD4 counts etc identifying and evaluating predictors andor mediators of adherence studying the feasibility of electronic recording in measuring adherence in an HIV-infected pediatric population and evaluating the relationship between the amount of intervention received ie number of hoursnumber of sessions and changes in adherence
Secondary outcomes include examining whether improvement in adherence to a medication regimen is associated with improved health outcomes ie viral load CD4 counts etc identifying and evaluating predictors andor mediators of adherence studying the feasibility of electronic recording in measuring adherence in an HIV-infected pediatric population and evaluating the relationship between the amount of intervention received ie number of hoursnumber of sessions and changes in adherence
Detailed Description:
The objective of this research is to develop and evaluate an intervention to promote adherence to HIV-medications among children aged 5-12 years The research will be conducted at Jacobi Medical Center in the Bronx NY Childrens National Medical Center in Washington DC and at Howard University Hospital in Washington DC The research will employ a randomized case control study design Participants dyads composed of an HIV-infected child and hisher primary caregiver will be recruited from eligible families within each sites HIV clinic After the study is explained and informed consent and assent where applicable are obtained participants will be randomly assigned to either the enhanced intervention group cases or the minimal intervention group controls Participants assigned to the enhanced intervention group will receive a multi-component intervention specifically tailored to their familys needs which includes a maximum of 24 hours of contact conducted over a period of up to 12-weeks and a 1-3 hour booster session approximately six weeks after the intervention phase is completed
The enhanced intervention will be coordinated by an onsite Adherence Coordinator AC and implemented primarily by the AC or another member of the study staff Participants assigned to the comparison group will receive a minimal intervention that will consist of an educational video and health education pamphlets about general health All participants will continue to receive the standard-of-care at their respective sites during the study period Assessments of all participants will be done at baseline Assessment A 1 month Assessment B and 4 months Assessment C following the intervention Each assessment will include an interview to collect the following information from families
socio-demographic data
parentalchild report of childs medication taking or adherence self-reported adherence
mental health functioning of parents and child using standardized measures
HIV of parents and medication knowledge of parents and child
medical review of childs hospital chart
The baseline assessment of adherence to medications will include electronic recording of medication taking via a MEMS cap done over a four-week period Ongoing electronic assessment of adherence will occur for the duration of the study Pharmacy refill data will also be obtained for a portion of the study participants for whom data are available
The enhanced intervention will be coordinated by an onsite Adherence Coordinator AC and implemented primarily by the AC or another member of the study staff Participants assigned to the comparison group will receive a minimal intervention that will consist of an educational video and health education pamphlets about general health All participants will continue to receive the standard-of-care at their respective sites during the study period Assessments of all participants will be done at baseline Assessment A 1 month Assessment B and 4 months Assessment C following the intervention Each assessment will include an interview to collect the following information from families
socio-demographic data
parentalchild report of childs medication taking or adherence self-reported adherence
mental health functioning of parents and child using standardized measures
HIV of parents and medication knowledge of parents and child
medical review of childs hospital chart
The baseline assessment of adherence to medications will include electronic recording of medication taking via a MEMS cap done over a four-week period Ongoing electronic assessment of adherence will occur for the duration of the study Pharmacy refill data will also be obtained for a portion of the study participants for whom data are available
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U64CCU319449 | None | None | None |
| U64CCU219540 | None | None | None |