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
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Economic Outcomes of HIV/AIDS Care and Treatment in South Africa

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Ability to perform normal activities in previous week [ Time Frame: Previous week ] [ Designated as safety issue: No ]

Enrollment: 1065
Study Start Date: July 2005
Study Completion Date: September 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Full cohort
Adult ART patients at 3 treatment facilities in South Africa

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270764

Locations
South Africa
Health Economics Research Office, Helen Joseph Hospital
Johannesburg, Gauteng, South Africa, 2092
Sponsors and Collaborators
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Sydney B. Rosen, MPA Boston University
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270764     History of Changes
Other Study ID Numbers: PEPFAR 13
Study First Received: December 27, 2005
Last Updated: November 19, 2013
Health Authority: United States: Federal Government
South Africa: National Health Research Ethics Council

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV/AIDS
Antiretroviral therapy
Quality of life
South Africa
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014