The Zambia, South Africa, Tuberculosis and Acquired Immune Deficiency Syndrome-reduction Trial
| ISRCTN | ISRCTN36729271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36729271 |
| Protocol serial number | 19790.03 |
| Sponsor | Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA) |
| Funder | Bill and Melinda Gates Foundation - CREATE (Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic) |
- Submission date
- 07/04/2006
- Registration date
- 05/05/2006
- Last edited
- 16/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Godfrey-Faussett
Scientific
Scientific
London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Community randomised, factorial design |
| Secondary study design | Randomised controlled trial |
| Scientific title | The Zambia, South Africa, Tuberculosis and Acquired Immune Deficiency Syndrome-reduction Trial |
| Study acronym | ZAMSTAR |
| Study objectives | Two new approaches to improving case detection of tuberculosis in communities with a high burden of tuberculosis and human immunodeficiency virus (HIV) are able to reduce the prevalence of tuberculosis (TB) at a community level over a three year period |
| Ethics approval(s) | Approved by the London School of Hygiene and Tropical Medicine on 14/03/05, reference number: 3008; approved by the University of Zambia on 15/12/04 and also approved by the University of Stellenbosch on 18/01/05 reference number: N04/10/173 |
| Health condition(s) or problem(s) studied | Tuberculosis |
| Intervention | The two interventions are: 1. Improved case finding: by allowing individuals direct access to diagnostic services and empowering communities to seek care, we will bypass the health system barriers and greatly reduce the number of people who are spreading infection 2. Integrated TB/HIV care delivered through the household: by harnessing the capacity of households and the community we will reduce the burden on the health system, increase the coverage and efficiency of preventive and curative tuberculosis services and break down the barriers of stigma and denial The two interventions described are divided equally among the 24 randomised communities: six will receive both, another six will receive improved case finding only, another six will receive integrated TB/HIV care delivered through the household and another six will receive neither. All communities benefit from support to the general health service to improve routine TB/HIV activities that are not part of either interventions. |
| Intervention type | Other |
| Primary outcome measure(s) | The primary outcome will be the prevalence of culture-positive tuberculosis among a randomly selected population of adults in each arm of the trial, measured after 3 years of the interventions |
| Key secondary outcome measure(s) | Secondary outcomes measured at the community level include: 1. Cumulative incidence of tuberculosis infection in school children 2. Indicators of tuberculosis and HIV programme performance At the household level, they include: 1. Cumulative incidence of tuberculosis 2. Changes in HIV incidence and stigma |
| Completion date | 01/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1500000 |
| Key inclusion criteria | Population served by tuberculosis diagnostic centre in each of 24 communities |
| Key exclusion criteria | Individuals who do not consent to trial procedures |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
- South Africa
- Zambia
Study participating centre
London School of Hygiene and Tropical Medicine (LSHTM)
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/10/2013 | Yes | No | |
| Other publications | secondary analysis | 14/12/2021 | 16/12/2021 | Yes | No |
Editorial Notes
16/12/2021: Internal review. Publication reference added.
