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

Tracking Information
First Submitted Date	December 27, 2005
First Posted Date	December 28, 2005
Last Update Posted Date	February 28, 2017
Actual Study Start Date	July 1, 2005
Actual Primary Completion Date	July 1, 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00270725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Impact of Anti-HIV Treatment on Labor Productivity and Costs in South Africa
Official Title	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	Observational
Study Design	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	HIV Infections
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Withdrawn
Actual Enrollment; (submitted: February 26, 2017)	0
Original Enrollment; (submitted: December 27, 2005)	120
Actual Study Completion Date	July 1, 2005
Actual Primary Completion Date	July 1, 2005 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	South Africa
Removed Location Countries
Administrative Information
NCT Number	NCT00270725
Other Study ID Numbers	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	Boston University
Collaborators	United States Agency for International Development (USAID)
Investigators	Principal Investigator: Sydney B. Rosen, MPA Boston University
PRS Account	Boston University
Verification Date	February 2017