Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270764
Status:
COMPLETED
Last Update Posted:
2013-11-20
First Post:
2005-12-27
Brief Title:
Social and Economic Outcomes of HIVAIDS Care and Treatment in HIV Infected South African Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Economic Outcomes of HIVAIDS Care and Treatment in South Africa
Status:
COMPLETED
Status Verified Date:
2013-11
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 this study is to determine the social and economic outcomes of anti-HIV treatment in South African adults with data collected from interviews detailed questionnaires and patients medical records
Detailed Description:
The Government of the Republic of South Africa is implementing a national program to provide antiretroviral therapy ART to all eligible HIV infected South African adults While the medical effectiveness of ART in suppressing viral replication is well established little is known about the economic effectiveness of treatment In particular it is not known if treatment will offset the impact of HIVAIDS on labor productivity household stability quality of life and other aspects of social and economic development The purpose of this study is to estimate the impact of ART on the productivity economic welfare and quality of life of adult HIV infected patients in South Africa The study will investigate
the degree of functional impairment among patients seeking care for HIVAIDS
the impact of treatment on the ability of patients to perform normal daily activities and attend work
the full economic costs to patients of obtaining treatment
the impact of treatment on sources of household income
social and economic correlates of adherence to therapy and
the cost of delivering ART to different types of patients in diverse settings
The study will last 4 years and will comprise a one-year cross-sectional analysis and a three-year longitudinal analysis Data will be collected from questionnaires administered during patients routine visits to public and non-governmental organization-based HIV clinics in South Africa In accordance with current South African national treatment guidelines patients who have started ART will visit a clinic every 3 months during the longitudinal analysis for a total of 12 visits patients not yet on ART will visit a clinic every 6 months for a total of 6 visits
Questionnaire responses will be matched to indicators of disease progression and treatment history drawn from patients medical records The initial one-year analysis will compare outcomes for groups of patients stratified by disease stage and treatment duration Longitudinal analysis will compare outcomes before and after the initiation of ART each participants responses and medical outcomes will be compared with his or her own previous results and with those of other participants at a similar stage of disease progression or treatment duration This study will generate information needed to sustain large-scale treatment interventions improve the focus and management of treatment delivery programs and provide a better understanding of barriers to treatment adherence among HIV infected South African patients
the degree of functional impairment among patients seeking care for HIVAIDS
the impact of treatment on the ability of patients to perform normal daily activities and attend work
the full economic costs to patients of obtaining treatment
the impact of treatment on sources of household income
social and economic correlates of adherence to therapy and
the cost of delivering ART to different types of patients in diverse settings
The study will last 4 years and will comprise a one-year cross-sectional analysis and a three-year longitudinal analysis Data will be collected from questionnaires administered during patients routine visits to public and non-governmental organization-based HIV clinics in South Africa In accordance with current South African national treatment guidelines patients who have started ART will visit a clinic every 3 months during the longitudinal analysis for a total of 12 visits patients not yet on ART will visit a clinic every 6 months for a total of 6 visits
Questionnaire responses will be matched to indicators of disease progression and treatment history drawn from patients medical records The initial one-year analysis will compare outcomes for groups of patients stratified by disease stage and treatment duration Longitudinal analysis will compare outcomes before and after the initiation of ART each participants responses and medical outcomes will be compared with his or her own previous results and with those of other participants at a similar stage of disease progression or treatment duration This study will generate information needed to sustain large-scale treatment interventions improve the focus and management of treatment delivery programs and provide a better understanding of barriers to treatment adherence among HIV infected South African patients
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