Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119093
Status:
TERMINATED
Last Update Posted:
2012-09-11
First Post:
2005-07-08
Brief Title:
Home-based AIDS Care Project
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Home-based AIDS Care Project Tororo Uganda
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by IRB for non-compliance with human subject regulations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Home-based AIDS care program pilot project delivers and monitors antiretroviral ARV and tuberculosis TB medications at the homes of 1000 people with HIV living in a rural area of Uganda This study is evaluating how well this program reduces illness and prolongs the life of participants changes sexual behavior influences levels of adherence to medication affects aspects of perceived stigma by participants and their communities and other operational components of the program including cost-effectiveness This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements
Detailed Description:
In Uganda the high cost and complexity of administering antiretroviral therapy is an obstacle to full implementation country-wide The Home-based AIDS care program HBAC pilot project was designed to deliver and monitor ARV and tuberculosis TB medications at the homes of 1000 people with HIV living in a rural area of Uganda In addition the cost and complexity of frequent laboratory monitoring of viral load and CD4 cell counts is a major impediment to widespread use of ARV therapies in Uganda and other resource-limited settings Nested within the Home-Based AIDS Care HBAC project is a randomized study of strategies for monitoring ARV therapy that involves 3 arms 1 Quarterly CD4 cell counts viral loads and home visits by trained lay persons 2 Quarterly CD4 cell counts and home visits and 3 Home visits alone
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