Clinical trial NCT00270764: Social and Economic Outcomes of HIV/AIDS Care and Treatment in HIV Infected South African Adults
Official title: Economic Outcomes of HIV/AIDS Care and Treatment in South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV/AIDS
Antiretroviral therapy
Quality of life
South Africa
Treatment Naive
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2005-12-28
Enrollment: 1065
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult ART patients receiving treatment at 3 treatment facilities in South Africa

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* HIV infected
* Willing to accept ART if medically eligible according to South Africa's national treatment guidelines

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ability to perform normal activities in previous week
timeFrame: Previous week
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Health Economics Research Office, Helen Joseph Hospital
state: Gauteng
Study officials:
affiliation: Boston University
name: Sydney B. Rosen, MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rosen 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.
citation: Rosen 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.
citation: Rosen 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.
citation: Rosen 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.
citation: Rosen 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.