Viewing Study NCT00144365



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00144365
Status: COMPLETED
Last Update Posted: 2012-09-11
First Post: 2005-09-02

Brief Title: Comparison of Facility and Home-based ART Delivery Systems in Uganda
Sponsor: Centers for Disease Control and Prevention
Organization: Centers for Disease Control and Prevention

Study Overview

Official Title: Comparison of Facility and Home-based ART Delivery Systems in Uganda
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 study is a 3-year randomized trial to compare ART delivery through two different models a ART delivered through health facilities by clinically qualified staff and b home-based care in which lay workers ie non-medically qualified people play a major role in the ART delivery and clients are followed up at health facilities less frequently The primary objective is to measure the effects of these strategies on HIV viral load We will also examine the effects on treatment failure disease progression survival adherence family member HIV testing sexual behavior and cost-effectiveness
Detailed Description: The study is a randomized trial to compare ART delivery through two different models a ART delivered through health facilities by clinically qualified staff and b home-based care in which lay workers ie non-medically qualified people play a major role in the ART delivery and clients are followed up at health facilities less frequently The primary objective is to measure the effects of these strategies on plasma HIV viral load We will also examine the effects on treatment failure disease progression survival adherence family member HIV testing sexual behavior and cost-effectiveness

The trial is conducted with The AIDS Support Organization TASO clinic in Jinja Uganda Randomization is conducted through geographic clusters defined using sub-counties in the district and stratified by distance from fixed health facilities and urbanrural Just over 800 participants living in 40 clusters will be recruited over a period of 3-6 months and followed-up over a period of 3 years

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
1U01PS000065-01 NIH None httpsreporternihgovquickSearch1U01PS000065-01