Plain English Summary
Background and study aims
Approximately 10% of patients being treated for tuberculosis (TB) each year in Malawi have already received one course of TB treatment. A first episode of TB is treated with a standard course of tablets for six months. For patients who require treatment for a second episode of TB, the World Health Organisation recommends that they should receive tablets for eight months, and also have daily injections of the antibiotic streptomycin for the first two months of the treatment course (this treatment is called re-treatment regimen). Currently, the only way for patients to receive these injections is to be admitted to the hospital for two months. There are many potential disadvantages to these long period of hospital admissions, including financial and social costs to patients and their households, economic costs to health systems, and risks of patients acquiring infections from being in the hospital. The aim of this study is to test whether these patients can be managed in the community rather than in the hospital.
Who can participate?
Any adult, aged 16 years or older, who is being registered to start TB re-treatment regimen at the participating hospitals, can be enrolled into the study.
What does the study involve?
Patients recruited to the study will identify a guardian who, if they are willing, will be trained how to give the injections. During the period when the guardian is being trained, the patient will stay in the hospital. Of the patients whose guardian successfully learns how to give the injections, half will stay in the hospital for 2 months in order to receive the injections, and the other half will go home where their guardian will give them the injections every day. The study team will visit the patients at home every 1 to 2 weeks, and more often if there are any problems. The outcome will be compared. Social and economic factors associated with hospital and community management will also be assessed.
What are the possible benefits and risks of participating?
The possible benefit of participating in the study is that patients and guardians will be able to return home rather than staying in hospital for 2 months. The risks of participating in the study are mainly those related to unsafe injection of streptomycin by guardians in the home. The main concerns are that the injections could introduce infections if not done in a sterile, germ-free way, or cause damage to nerves supplying the leg if they are given at the wrong position. In order to reduce these risks, thorough training and strict assessments of guardians will be made prior to discharging the patients, so that, only those patients who have a guardian able to safely give injections are sent home.
Where is the study run from?
The study will be run from two central hospitals in Malawi Queen Elizabeth Central Hospital in Blantyre, and Bwaila Hospital in Lilongwe.
When is the study starting and how long is it expected to run for?
The study is starting in June 2013, and it is expected to run for up to 2 years.
Who is funding the study?
The Wellcome Trust (UK)
Who is the main contact?
Dr Danielle Cohen
Danielle.Cohen@liverpool.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Danielle Cohen
ORCID ID
Contact details
Malawi Liverpool Wellcome Clinical Research Programme
Box 30096
Chichiri
Blantyre
BT3
Malawi
Danielle.Cohen@liverpool.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13.11
Study information
Scientific title
The TB Re-treatment Regimen: Outcomes and Care Study (TB-RROC): A trial of hospital versus community management during the intensive phase of the TB re-treatment regimen
Acronym
TB-RROC
Study hypothesis
Community-based management provides a safe and feasible alternative to hospital-based management during the intensive phase of the TB retreatment regimen.
Ethics approval
1. Malawi College of Medicine Research Ethics Committee, Reference number: P.02/13/1340, Date: 17.05.2013
2. Liverpool School of Tropical Medicine Research Ethics Committee, Reference number: 13.11, Date: 22.05.2013
Study design
Pragmatic, individually randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Community management of patients requiring injectable therapy as part of the TB re-treatment regimen
Intervention
There will be a 2-stage enrolment and recruitment process. In the first stage, all patients starting retreatment regimen will be approached to identify a treatment supporter (guardian) who will be trained in the technique of intramuscular injection. In the second stage, those who are deemed clinically fit for discharge and whose guardian becomes competent at injection technique will be randomised to receive standard of care (i.e. remain in hospital for the duration of the intensive phase of TB treatment) or to the intervention arm (i.e. to complete the intensive phase of treatment in the community).
Group 1: 134 patients, randomised to receive the intervention. These participants will be discharged home where they will receive daily oral treatment and intramuscular streptomycin injections administered by their trained guardian, until the 2 month course of injections is completed.
Group 2: 134 patients, randomised to receive standard of care. These participants will remain in hospital where they will receive daily oral treatment and intramuscular streptomycin injections administered by nursing staff, until the 2 month course of injections is completed.
Participants will all be reviewed at home or in hospital by the study team at 1, 3, 5 and 7 weeks post randomisation, and more frequently if required. At the end of the 2 month intervention period, all patients will continue to receive TB treatment under routine care and complete the 8 month course of oral TB treatment as per national guidelines.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Patient still alive and on TB treatment at the end of the two-month intervention period
Secondary outcome measures
1. 2-month culture conversion in those culture positive at baseline
2. 8-month programmatic TB outcome
3. Serious adverse events during the intensive phase of treatment
4. Karnofsky score 1, 3, 5, and 7 weeks post randomisation
5. Mental health status at 2 months using a Chichewa validated self-reporting questionnaire (SRQ)
Overall trial start date
10/06/2013
Overall trial end date
10/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults ≥ 16 years of age starting TB re-treatment regimen
2. Patients who are able to give informed consent
3. Patients who are able to identify a suitable treatment supporter
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
268
Participant exclusion criteria
1. Patients identified as having Multi-drug-resistant tuberculosis (MDR-TB) on GXP or drug sensitivity testing using culture (these patients will be referred to the NTP MDR programme)
2. Pregnant women
3. Patients not planning to stay in Blantyre/Lilongwe for the 2-month duration of the intervention
4. Patients unable to give informed consent
5. Patients unable to identify a suitable treatment supporter
Recruitment start date
10/06/2013
Recruitment end date
10/06/2015
Locations
Countries of recruitment
Malawi
Trial participating centre
Malawi Liverpool Wellcome Clinical Research Programme
Blantyre
BT3
Malawi
Sponsor information
Organisation
Liverpool School of Tropical Medicine (UK)
Sponsor details
Pembroke Place
Liverpool
L3 5QA
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) Reference no: 097466/B/11/Z
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
Basic results (scientific)
Publication list