Social and Economic Outcomes of HIV/AIDS Care and Treatment in HIV Infected South African Adults

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00270764
First received: December 27, 2005
Last updated: November 19, 2013
Last verified: November 2013

December 27, 2005
November 19, 2013
July 2005
June 2011   (final data collection date for primary outcome measure)
Ability to perform normal activities in previous week [ Time Frame: Previous week ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00270764 on ClinicalTrials.gov Archive Site
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Social and Economic Outcomes of HIV/AIDS Care and Treatment in HIV Infected South African Adults
Economic Outcomes of HIV/AIDS Care and Treatment in South Africa

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.

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 degree of functional impairment among patients seeking care for HIV/AIDS,
  • 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 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Adult ART patients receiving treatment at 3 treatment facilities in South Africa

HIV Infections
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Full cohort
Adult ART patients at 3 treatment facilities in South Africa

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1065
September 2013
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected
  • Willing to accept ART if medically eligible according to South Africa's national treatment guidelines

Exclusion Criteria:

  • Inability to answer questions due to disability
  • On ART for more than 6 months at the time of study entry
  • Refuse to accept ART despite medical eligibility
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00270764
PEPFAR 13
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
United States Agency for International Development (USAID)
Principal Investigator: Sydney B. Rosen, MPA Boston University
National Institute of Allergy and Infectious Diseases (NIAID)
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP