HIV InfectionsNCT00270764
Social and Economic Outcomes of HIV/AIDS Care and Treatment in HIV Infected South African Adults
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 1,065 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2005to Sep 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult ART patients receiving treatment at 3 treatment facilities in South Africa
Who may be able to join
- HIV infected
- Willing to accept ART if medically eligible according to South Africa's national treatment guidelines
Who cannot join
- 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
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: 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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Antiretroviral therapy, Quality of life, South Africa, Treatment Naive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Full cohort | Adult ART patients at 3 treatment facilities in South Africa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to perform normal activities in previous week
Measured: Previous week
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 startJul 2005
- Primary completionJun 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Prospective
- Enrolment
- 1,065 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Sydney B. Rosen, MPA, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270764
- Sponsor's protocol ID
- PEPFAR 13
- Status last verified
- Nov 2013
- First submitted
- 27 Dec 2005
- Last updated
- 20 Nov 2013
- Results posted
- No
Publications
Beard J, Feeley F, Rosen S. Economic and quality of life outcomes of antiretroviral therapy for HIV/AIDS in developing countries: a systematic literature review. AIDS Care. 2009 Nov;21(11):1343-56. doi: 10.1080/09540120902889926.
PubMed 20024710Rosen S, Ketlhapile M, Sanne I, Desilva MB. Differences in normal activities, job performance and symptom prevalence between patients not yet on antiretroviral therapy and patients initiating therapy in South Africa. AIDS. 2008 Jul;22 Suppl 1:S131-9. doi: 10.1097/01.aids.0000327634.92844.91.
PubMed 18664945Rosen S, Ketlhapile M, Sanne I, DeSilva MB. Characteristics of patients accessing care and treatment for HIV/AIDS at public and nongovernmental sites in South Africa. J Int Assoc Physicians AIDS Care (Chic). 2008 Jul-Aug;7(4):200-7. doi: 10.1177/1545109708320684. Epub 2008 Jul 14.
PubMed 18626120Rosen S, Ketlhapile M, Sanne I, DeSilva MB. Cost to patients of obtaining treatment for HIV/AIDS in South Africa. S Afr Med J. 2007 Jul;97(7):524-9.
PubMed 17805455Rosen S, Larson B, Brennan A, Long L, Fox M, Mongwenyana C, Ketlhapile M, Sanne I. Economic outcomes of patients receiving antiretroviral therapy for HIV/AIDS in South Africa are sustained through three years on treatment. PLoS One. 2010 Sep 14;5(9):e12731. doi: 10.1371/journal.pone.0012731.
PubMed 20856821Rosen S, Larson B, Rohr J, Sanne I, Mongwenyana C, Brennan AT, Galarraga O. Effect of antiretroviral therapy on patients' economic well being: five-year follow-up. AIDS. 2014 Jan 28;28(3):417-24. doi: 10.1097/QAD.0000000000000053.
PubMed 24076660
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Outcomes of HIV/AIDS Care and Treatment in South Africa
- ClinicalTrials.gov ID
- NCT00270764
- Acronym / sponsor ID
- PEPFAR 13
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Antiretroviral therapy, Quality of life, South Africa, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,065 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Jul 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2013 (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 social and economic outcomes of anti-HIV treatment in South African adults, with data collected from interviews, detailed questionnaires, and patients' medical records.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full cohort | – | –Adult ART patients at 3 treatment facilities in South Africa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ART patients receiving treatment at 3 treatment facilities in South Africa
Key inclusion criteria (2 listed)
- HIV infected
- Willing to accept ART if medically eligible according to South Africa's national treatment guidelines
Key exclusion criteria (3 listed)
- 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
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
Ability to perform normal activities in previous week
Time frame: Previous week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Background: PubMed 20024710Beard J, Feeley F, Rosen S. Economic and quality of life outcomes of antiretroviral therapy for HIV/AIDS in developing countries: a systematic literature review. AIDS Care. 2009 Nov;21(11):1343-56. doi: 10.1080/09540120902889926.
- Results publication: PubMed 18664945Rosen S, Ketlhapile M, Sanne I, Desilva MB. Differences in normal activities, job performance and symptom prevalence between patients not yet on antiretroviral therapy and patients initiating therapy in South Africa. AIDS. 2008 Jul;22 Suppl 1:S131-9. doi: 10.1097/01.aids.0000327634.92844.91.
- Results publication: PubMed 18626120Rosen S, Ketlhapile M, Sanne I, DeSilva MB. Characteristics of patients accessing care and treatment for HIV/AIDS at public and nongovernmental sites in South Africa. J Int Assoc Physicians AIDS Care (Chic). 2008 Jul-Aug;7(4):200-7. doi: 10.1177/1545109708320684. Epub 2008 Jul 14.
- Results publication: PubMed 17805455Rosen S, Ketlhapile M, Sanne I, DeSilva MB. Cost to patients of obtaining treatment for HIV/AIDS in South Africa. S Afr Med J. 2007 Jul;97(7):524-9.
- Results publication: PubMed 20856821Rosen S, Larson B, Brennan A, Long L, Fox M, Mongwenyana C, Ketlhapile M, Sanne I. Economic outcomes of patients receiving antiretroviral therapy for HIV/AIDS in South Africa are sustained through three years on treatment. PLoS One. 2010 Sep 14;5(9):e12731. doi: 10.1371/journal.pone.0012731.
- Results publication: PubMed 24076660Rosen S, Larson B, Rohr J, Sanne I, Mongwenyana C, Brennan AT, Galarraga O. Effect of antiretroviral therapy on patients' economic well being: five-year follow-up. AIDS. 2014 Jan 28;28(3):417-24. doi: 10.1097/QAD.0000000000000053.
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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 National Institute of Allergy and Infectious Diseases (NIAID) 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 3 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: finished, as of the sponsor's last update on 20 Nov 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Ability to perform normal activities in previous week (time frame: Previous week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00270764, which also lists 6 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 20 Nov 2013.