Impact of Anti-HIV Treatment on Labor Productivity and Co... | NCT00270725

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

NCT00270725

Sponsor

Boston University

Status

Withdrawn

Last Update Posted

Feb 28, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

Not provided

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment never initiated, study withdrawn.

Expanded Access Info

Start Date

Jul 1, 2005Actual

Primary Completion Date

Jul 1, 2005Actual

Completion Date

Jul 1, 2005Actual

First Submitted Date

Dec 27, 2005

First Submission Date that Met QC Criteria

Dec 27, 2005

First Posted Date

Dec 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2017

Last Update Posted Date

Feb 28, 2017Actual

Name	Class
United States Agency for International Development (USAID)	FED

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

see elig

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sydney B. Rosen, MPA	Boston University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Economics Research Office, Helen Joseph Hospital		Johannesburg	Gauteng	2092	South Africa

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14996359	Background	Fox MP, Rosen S, MacLeod WB, Wasunna M, Bii M, Foglia G, Simon JL. The impact of HIV/AIDS on labour productivity in Kenya. Trop Med Int Health. 2004 Mar;9(3):318-24. doi: 10.1111/j.1365-3156.2004.01207.x.
15075551	Background	Rosen S, Vincent JR, MacLeod W, Fox M, Thea DM, Simon JL. The cost of HIV/AIDS to businesses in southern Africa. AIDS. 2004 Jan 23;18(2):317-24. doi: 10.1097/00002030-200401230-00023.

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral