Sustainable household contact tracing and screening for tuberculosis patients and families in Blantyre, Malawi
| ISRCTN | ISRCTN81659509 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81659509 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/03/2012
- Registration date
- 19/07/2012
- Last edited
- 09/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
College of Medicine
Helse Nord Tuberculosis Initiative (HNTI)
Private Bag 360
Blantyre
-
Malawi
| Phone | +265 (0)999 040929 |
|---|---|
| kkaswaswa@yahoo.com |
Study information
| Study design | Cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Providing sustainable household contact tracing and screening for tuberculosis patients and families: a cluster randomised trial in Blantyre, Malawi (PACTS) |
| Study acronym | PaCTS |
| Study objectives | 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(s) | 1. College of Medicine Reasearch Ethic Commitee, Malawi, 01/04/2012 2. London School Of Hygiene and Tropical Medicine, UK, 25/04/2012 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2012 |
| Completion date | 30/12/2014 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 428 cluster |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 30/12/2014 |
Locations
Countries of recruitment
- Malawi
Study participating centre
-
Malawi
Sponsor information
Government
Ministry of Health
Community Health Sciences Unit
Private Bag 65
lilongwe
-
Malawi
| Phone | +265 (0)1752 308 |
|---|---|
| jmpunga@yahoo.com | |
| Website | http://www.tbcta.org/Country/12/Malawi |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 08/09/2022 | 09/09/2022 | Yes | No |
Editorial Notes
09/09/2022: Publication reference added.
27/07/2016: Plain English summary added.
