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

November 19, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

HIV Infections

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.

Study Type

Observational

Enrollment (Actual)

1065

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2092
    - Health Economics Research Office, Helen Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Full cohort Adult ART patients at 3 treatment facilities in South Africa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ability to perform normal activities in previous week Time Frame: Previous week	Previous week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

United States Agency for International Development (USAID)

Investigators

Principal Investigator: Sydney B. Rosen, MPA, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 27, 2005

First Submitted That Met QC Criteria