Social and Economic Outcomes of HIV/AIDS Care and Treatment in HIV Infected South African Adults
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00270764 |
Recruitment Status
:
Completed
First Posted
: December 28, 2005
Last Update Posted
: November 20, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
HIV Infections |
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.
Study Type : | Observational |
Actual Enrollment : | 1065 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Economic Outcomes of HIV/AIDS Care and Treatment in South Africa |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | September 2013 |

Group/Cohort |
---|
Full cohort
Adult ART patients at 3 treatment facilities in South Africa
|
- Ability to perform normal activities in previous week [ Time Frame: Previous week ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270764
South Africa | |
Health Economics Research Office, Helen Joseph Hospital | |
Johannesburg, Gauteng, South Africa, 2092 |
Principal Investigator: | Sydney B. Rosen, MPA | Boston University |
Publications of Results:
Other Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00270764 History of Changes |
Other Study ID Numbers: |
PEPFAR 13 |
First Posted: | December 28, 2005 Key Record Dates |
Last Update Posted: | November 20, 2013 |
Last Verified: | November 2013 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |