Condition category
Infections and Infestations
Date applied
07/04/2006
Date assigned
05/05/2006
Last edited
13/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Godfrey-Faussett

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19790.03

Study information

Scientific title

Acronym

ZAMSTAR

Study hypothesis

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

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

Study design

Community randomised, factorial design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/07/2006

Overall trial end date

01/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Population served by tuberculosis diagnostic centre in each of 24 communities

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,500,000

Participant exclusion criteria

Individuals who do not consent to trial procedures

Recruitment start date

01/07/2006

Recruitment end date

01/07/2010

Locations

Countries of recruitment

South Africa, Zambia

Trial participating centre

London School of Hygiene and Tropical Medicine (LSHTM)
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)

Sponsor details

Johns Hopkins Center for Tuberculosis Research
1820 Lancaster Street/Suite 300
Baltimore
Maryland
21231
United States of America

Sponsor type

Charity

Website

http://www.tbhiv-create.org

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation - CREATE (Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23915882

Publication citations

  1. Results

    Ayles H, Muyoyeta M, Du Toit E, Schaap A, Floyd S, Simwinga M, Shanaube K, Chishinga N, Bond V, Dunbar R, De Haas P, James A, Gey van Pittius NC, Claassens M, Fielding K, Fenty J, Sismanidis C, Hayes RJ, Beyers N, Godfrey-Faussett P, , Effect of household and community interventions on the burden of tuberculosis in southern Africa: the ZAMSTAR community-randomised trial., Lancet, 2013, 382, 9899, 1183-1194, doi: 10.1016/S0140-6736(13)61131-9.

Additional files

Editorial Notes