HIV InfectionsNCT00270725
Impact of Anti-HIV Treatment on Labor Productivity and Costs in South Africa
An observational study of HIV Infections, run by Boston University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 0 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jul 2005to 1 Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: see elig
Who may be able to join
- Employed by participating company for at least 1 year prior to study entry
- Enrolled in the HIV/AIDS treatment program offered by the participating company
Who cannot join
- Enrolled in the HIV/AIDS treatment program prior to 01/01/04 or after 06/30/05
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Health Economics Research Office, Helen Joseph Hospital
Johannesburg, Gauteng, 2092
About this study
Official title: The Effectiveness of Antiretroviral Therapy in Reducing the Costs of HIV/AIDS
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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Labor productivity, Antiretroviral therapy, South Africa
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study start1 Jul 2005
- Primary completion1 Jul 2005
- Study completion1 Jul 2005
Why it stopped: Enrollment never initiated, study withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Investigators
- Sydney B. Rosen, MPA, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270725
- Sponsor's protocol ID
- RTC-BU-01
- Status last verified
- Feb 2017
- First submitted
- 27 Dec 2005
- Last updated
- 28 Feb 2017
- Results posted
- No
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. doi: 10.1111/j.1365-3156.2004.01207.x.
PubMed 14996359Rosen 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.
PubMed 15075551
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Antiretroviral Therapy in Reducing the Costs of HIV/AIDS
- ClinicalTrials.gov ID
- NCT00270725
- Acronym / sponsor ID
- RTC-BU-01
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Labor productivity, Antiretroviral therapy, South Africa
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Enrollment never initiated, study withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 1 Jul 2005 (actual)
- Primary completion
- 1 Jul 2005 (actual)
- Study completion
- 1 Jul 2005 (actual)
- First posted
- 28 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- see elig
Key inclusion criteria (2 listed)
- Employed by participating company for at least 1 year prior to study entry
- Enrolled in the HIV/AIDS treatment program offered by the participating company
Key exclusion criteria (1 listed)
- Enrolled in the HIV/AIDS treatment program prior to 01/01/04 or after 06/30/05
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Background: PubMed 14996359Fox 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.
- Background: PubMed 15075551Rosen 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.
- Click here for the Program on the Social and Economic Impacts of the AIDS Epidemic Web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney B. Rosen, MPA principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Boston University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00270725, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.