Impact of Anti-HIV Treatment on Labor Productivity and Costs in South Africa

This study has been withdrawn prior to enrollment.

(Enrollment never initiated, study withdrawn.)

Sponsor:

Collaborator:

United States Agency for International Development (USAID)

Information provided by:

Boston University

ClinicalTrials.gov Identifier:

NCT00270725

First received: December 27, 2005

Last updated: February 26, 2017

Last verified: February 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

December 27, 2005

Last Updated Date

February 26, 2017

Actual Start Date ^ICMJE

July 1, 2005

Primary Completion Date

July 1, 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00270725 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Anti-HIV Treatment on Labor Productivity and Costs in South Africa

Official Title ^ICMJE

The Effectiveness of Antiretroviral Therapy in Reducing the Costs of HIV/AIDS

Brief Summary

The purpose of this study is to determine the impact of anti-HIV treatment on the work attendance of employed people in South Africa. The study will enroll participants from a large manufacturing and distribution firm in South Africa.

Detailed Description

Little is known about the economic benefits of providing antiretroviral therapy (ART) for HIV infected patients in sub-Saharan Africa and other resource-limited areas. In South Africa, an increasing number of private sector firms are providing access to ART for their employees. One of the barriers to such action, however, is the lack of available information on the success of ART in restoring workers to full productivity, retaining skilled employees in the workforce, and reducing the costs of medical care and death and disability benefits. HIV infected employees on ART may be absent from work less often than untreated HIV infected employees, but more often than HIV uninfected employees. This study will collect data from an independent HIV/AIDS disease treatment program and a large private sector employer in Johannesburg, South Africa to estimate the benefits and costs for businesses to provide ART to eligible employees.

The study will combine individual-level medical outcome and treatment cost data from the treatment program with data on employee work attendance and retention in the workforce from the participating employer. The work attendance of HIV infected employees enrolled in the HIV/AIDS treatment program (index participants) who are either taking ART or receiving pre-ART care will be compared with each other and with that of HIV uninfected employees. There are no study visits associated with this study; all data will be collected from medical records maintained by the HIV/AIDS treatment program and the participants' employer. The financial costs and benefits of the treatment program for the participating company will also be estimated.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

see elig

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

July 1, 2005

Primary Completion Date

July 1, 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria for All Participants:

Employed by participating company for at least 1 year prior to study entry

Inclusion Criteria for Index Participants:

Enrolled in the HIV/AIDS treatment program offered by the participating company

Exclusion Criteria for Index Participants:

Enrolled in the HIV/AIDS treatment program prior to 01/01/04 or after 06/30/05

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

South Africa

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00270725

Other Study ID Numbers ^ICMJE

RTC-BU-01

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Sydney Rosen, Boston University

Study Sponsor ^ICMJE

Boston University

Collaborators ^ICMJE

United States Agency for International Development (USAID)

Investigators ^ICMJE

Principal Investigator:

Sydney B. Rosen, MPA

Boston University

PRS Account

Boston University

Verification Date

February 2017

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

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