TuberculosisNCT02533089
Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi
A study testing KT intervention in people with Tuberculosis, run by Dignitas International at 1 site in Malawi.
Trial summary
Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- What is being tested?
- KT intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,153 participants
- Where
- 1 siteMalawi
- Study dates
- May 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all health centers in participating districts that routinely provide TB care will be included.
- LHWs who have received the intervention and patients receiving care at participating health centers will be eligible to participate in interviews
Who cannot join
- health centers that do not routinely provide TB care
- LHWs unwilling or unable to give informed consent.
- TB patients less than 18 years of age unaccompanied by a parent or guardian, patients/guardians or LHWs unwilling or unable to give informed consent, patients presenting to a health center they are not routinely followed at.
Trial locations and contacts
1 site in 1 country.
Malawi1 site
4 Districts, SE zone of Malawi (Balaka, Machinga, Mangochi, Mulanje)
Malawi, Malawi
About this study
Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In response to the combined high TB burden and severe healthcare worker shortages in these settings, outpatient TB care is among the tasks commonly shifted to LHWs.
LHWs are community members who have received some training but are not healthcare professionals. Randomised trials show LHWs improve access to basic health services and TB treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness.
The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of evidence into LHW practice. The investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.
- Conditions
- Tuberculosis
- Being tested
- KT intervention
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT interventionOther
Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
| Study group | Role | What they receive |
|---|---|---|
| KT intervention | Experimental | Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. Receives: Other: KT intervention |
| Control | No intervention | Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.
primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.
Measured: 1 year
Secondary outcomes (2)
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)
secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months)
Measured: 1 year
Proportion of Successes Among HIV Co-infected Cases
secondary outcome = proportion of successes among HIV co-infected cases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startMay 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 1,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dignitas International
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Lisa M Puchalski Ritchie, Unity Health Toronto
- Investigators
- Lisa M Puchalski Ritchie, MD,PhD, Principal investigator, Li Ka Shing Knowledge Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533089
- Sponsor's protocol ID
- TB KT intervention
- Status last verified
- Mar 2020
- First submitted
- 20 Aug 2015
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Puchalski Ritchie LM, Kip EC, Mundeva H, van Lettow M, Makwakwa A, Straus SE, Hamid JS, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. Process evaluation of an implementation strategy to support uptake of a tuberculosis treatment adherence intervention to improve TB care and outcomes in Malawi. BMJ Open. 2021 Jul 2;11(7):e048499. doi: 10.1136/bmjopen-2020-048499.
PubMed 34215610Puchalski Ritchie LM, van Lettow M, Makwakwa A, Kip EC, Straus SE, Kawonga H, Hamid JS, Lebovic G, Thorpe KE, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial. Implement Sci. 2020 Dec 11;15(1):107. doi: 10.1186/s13012-020-01067-y.
PubMed 33308257Puchalski Ritchie LM, van Lettow M, Makwakwa A, Chan AK, Hamid JS, Kawonga H, Martiniuk AL, Schull MJ, van Schoor V, Zwarenstein M, Barnsley J, Straus SE. The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial. Trials. 2016 Sep 7;17(1):439. doi: 10.1186/s13063-016-1563-2.
PubMed 27604571
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi
- ClinicalTrials.gov ID
- NCT02533089
- Acronym / sponsor ID
- TB KT intervention
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,153 participants (actual)
- Lead sponsor
- Dignitas InternationalUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- May 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In response to the combined high TB burden and severe healthcare worker shortages in these settings, outpatient TB care is among the tasks commonly shifted to LHWs.
LHWs are community members who have received some training but are not healthcare professionals. Randomised trials show LHWs improve access to basic health services and TB treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness.
The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of evidence into LHW practice. The investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KT intervention | Experimental | Other: KT interventionMultifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. |
| Control | No intervention | –Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- all health centers in participating districts that routinely provide TB care will be included.
- LHWs who have received the intervention and patients receiving care at participating health centers will be eligible to participate in interviews
Key exclusion criteria (3 listed)
- health centers that do not routinely provide TB care
- LHWs unwilling or unable to give informed consent.
- TB patients less than 18 years of age unaccompanied by a parent or guardian, patients/guardians or LHWs unwilling or unable to give informed consent, patients presenting to a health center they are not routinely followed at.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KT interventionMultifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. | Other | KT intervention |
Primary outcome
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.
Time frame: 1 year
primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.
2 secondary outcomes
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)
Time frame: 1 year
Proportion of Successes Among HIV Co-infected Cases
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34215610Puchalski Ritchie LM, Kip EC, Mundeva H, van Lettow M, Makwakwa A, Straus SE, Hamid JS, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. Process evaluation of an implementation strategy to support uptake of a tuberculosis treatment adherence intervention to improve TB care and outcomes in Malawi. BMJ Open. 2021 Jul 2;11(7):e048499. doi: 10.1136/bmjopen-2020-048499.
- Derived from this study: PubMed 33308257Puchalski Ritchie LM, van Lettow M, Makwakwa A, Kip EC, Straus SE, Kawonga H, Hamid JS, Lebovic G, Thorpe KE, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial. Implement Sci. 2020 Dec 11;15(1):107. doi: 10.1186/s13012-020-01067-y.
- Derived from this study: PubMed 27604571Puchalski Ritchie LM, van Lettow M, Makwakwa A, Chan AK, Hamid JS, Kawonga H, Martiniuk AL, Schull MJ, van Schoor V, Zwarenstein M, Barnsley J, Straus SE. The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial. Trials. 2016 Sep 7;17(1):439. doi: 10.1186/s13063-016-1563-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Puchalski Ritchie, MD,PhD principal investigator
Li Ka Shing Knowledge Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KT intervention in people with Tuberculosis, run by Dignitas International at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533089, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.