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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) U.S. Agency for International Development |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00270764 |
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.
Condition |
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HIV Infections |
Study Type: | Observational |
Study Design: | Psychosocial, Longitudinal, Defined Population, Prospective Study |
Official Title: | Economic Outcomes of HIV/AIDS Care and Treatment in South Africa |
Estimated Enrollment: | 1069 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | June 2007 |
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 HIV/AIDS 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 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 participant's 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
South Africa, Gauteng | |
Health Economics Research Office, Helen Joseph Hospital | |
Johannesburg, Gauteng, South Africa, 2092 |
Principal Investigator: | Sydney B. Rosen, MPA | Boston University School of Public Health |
Study ID Numbers: | PEPFAR 13 |
Study First Received: | December 27, 2005 |
Last Updated: | August 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00270764 |
Health Authority: | United States: Federal Government; South Africa: National Health Research Ethics Council |
HIV/AIDS Antiretroviral therapy Quality of life South Africa Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Quality of Life Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |