Condition category
Respiratory
Date applied
27/03/2012
Date assigned
19/07/2012
Last edited
27/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tuberculosis (TB) is a bacterial infection that mainly affects the lungs. It is national and international policy to reduce the spread of TB by screening all household contacts of TB patients. This active case-finding is more effective than passive case-finding, but also more expensive. Contact screening identifies candidates for both TB treatment and preventive treatment with the antibiotic isoniazid. In Malawi, household contact screening involves health workers advising index patients (the first patient in the family to be diagnosed with TB) to bring their contacts for symptom screening and clinical investigations if needed. However, this service has been poorly carried out and often not used, possibly due to transport costs and the time required to complete the screening process. The aim of this study is to test the effectiveness of a home-based TB screening intervention in the households of TB patients in urban Blantyre, Malawi.

Who can participate?
Children and adults of all ages in Blantyre, Malawi who are household contacts of pulmonary TB patients.

What does the study involve?
Participants are randomly allocated to one of two groups. One group follows the standard routine of household screening provided at the health facility. In the other group screening is carried out by either the index patient or the parent in the household. They sort household members into contacts who need TB investigation, or are eligible for isoniazid preventive treatment (IPT), and those where no further action is required. They collect sputum (a thick fluid produced in the lungs and airways) for examination from household members who have symptoms but are otherwise well. The index patient can then bring all children eligible for IPT with them to their next routine appointment (TB drugs are collected weekly from primary care clinics), where IPT can be started. If the index patient is not the parent/guardian, then the children have to be accompanied by their parent/guardian. Thereafter the index patient, or parent of the children (if not the index patient) can collect isoniazid and carry out monthly symptom screening for isoniazid side-effects on behalf of all family members, thereby reducing the need for travel.

What are the possible benefits and risks of participating?
There are no risks associated with joining this study and treatment will be affected not in any way. If participants have any other illnesses other than TB, they will be referred for treatment.

Where is the study run from?
Queen Elizabeth Central Hospital, Blantyre, Malawi

When is the study starting and how long is it expected to run for?
June 2012 to December 2014

Who is funding the study?
Helsen Nord TB Initiative (HNTI) in collaboration with Malawi National TB Control Programme

Who is the main contact?
Kruger Kaswaswa
kkaswaswa@medcol.mw

Trial website

Contact information

Type

Scientific

Primary contact

Mr Kruger Kaswaswa

ORCID ID

Contact details

College of Medicine
Helse Nord Tuberculosis Initiative (HNTI)
Private Bag 360
Blantyre
-
Malawi
+265 (0)999 040929
kkaswaswa@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Providing sustainable household contact, tracing and screening for tuberculosis patients and families: a cluster randomised trial in Blanytre, Malawi (PACTS)

Acronym

PaCTS

Study hypothesis

1. Standard models of delivering contact screening, which are facility based, are ineffective because of the high burden of transport costs and time that are placed on tuberculosis (TB) patients and their families
2. That a Patient/parent-delivered contact screening model that aims to minimize the cost and inconvenience to the family will provide substantially higher uptake with TB symptom screening, higher yield of cases, and higher uptake and completion rates for IPT

Ethics approval

1. College of Medicine Reasearch Ethic Commitee, Malawi, 01/04/2012
2. London School Of Hygiene and Tropical Medicine, UK, 25/04/2012

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tuberculosis

Intervention

Parent/patient/household based contact based screening will be used to investigate a newly-developed approach of:
1. Initiating contact screening at home by the patient themselves, with the index patient then also responsible for:
1.1. Triaging household members into contacts who need TB investigation, or are eligible for IPT, and those where no further action is indicated
1.2. Collecting and bringing sputum for examination from symptomatic household members who are otherwise well
1.3. Initiating other actions as indicated, aided by “contact referral cards” that can be used to directly access paediatic services for under 5 year old family members with symptoms of TB
2. The index patient can then bring all children eligible for IPT with them to their next routine appointment (TB drugs are collected weekly from primary care clinics), where IPT can be initiated. If the index patient is not the parent/guardian, then the child(ren) will have to be accompanied by their parent/guardian
3. Thereafter the index patient, or parent of the children (if not the index patient) can assume responsibility for collecting isoniazid and carrying out monthly symptom screening for isoniazid side-effects on behalf of all family members, thereby minimizing the need for travel

The screening tool will include questions about cough, fever, weight loss, night sweats, and (for young children) failure to thrive.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The prevalence of bacteriologically confirmed TB in adult and child contacts diagnosed within three months of the diagnosis of the index case
2. The proportion of child contacts under 5 year who start IPT within three months of the diagnosis of the index case

Secondary outcome measures

The proportions of contacts under 5 years old who initiate and complete 6 months of IPT

Overall trial start date

01/06/2012

Overall trial end date

30/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pulmonary tuberculosis (PTB) patients registering at Queen Elizabeth Central Hospital (QECH), Malawi
2. Self-report of one or more under 5 year old household contact
3. Residence within Blantyre
4. Able and willing to provide written consent to participate in the study, including a 3 month household visit
5. If an inpatient: likely to be discharged within a two week period

Contacts will be defined as members of the same household (defined as sharing meals) or other residents of the same dwelling who share physical space such as sleeping or living rooms. Participation by contacts will be through oral consent, using a patient information leaflet.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

428 cluster

Participant exclusion criteria

1. Unable or unwilling to provide informed consent
2. Hospitalised patients who are unlikely to be discharged within a two week period (e.g due to retreatment requiring on TB treatment, and if transferred in and out of QECH)
3. Membership of a household that has already been recruited into the study

Recruitment start date

01/06/2012

Recruitment end date

30/12/2014

Locations

Countries of recruitment

Malawi

Trial participating centre

Helse Nord Tuberculosis Initiative (HNTI)
Blantyre
-
Malawi

Sponsor information

Organisation

Malawi National Tuberculosis Programme (Malawi)

Sponsor details

Ministry of Health
Community Health Sciences Unit
Private Bag 65
lilongwe
-
Malawi
+265 (0)1752 308
jmpunga@yahoo.com

Sponsor type

Government

Website

http://www.tbcta.org/Country/12/Malawi

Funders

Funder type

Research organisation

Funder name

Helse Nord TB Initiative Project (Malawi)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Malawi Liverpool Wellcome Trust (Malawi)

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

Publication citations

Additional files

Editorial Notes

27/07/2016: Plain English summary added.