Tuberculosis
Conditions
Brief 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 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.
Interventions
OTHERKT intervention
Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
Sponsors
Unity Health Toronto
Dignitas International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment. | 1 year | primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months) | 1 year | secondary outcome =proportion of default cases (treatment interrupted \>= 2 consecutive months) |
| Proportion of Successes Among HIV Co-infected Cases | 1 year | secondary outcome = proportion of successes among HIV co-infected cases |
Countries
Malawi
Participant flow
Recruitment details
103 health centers enrolled, a total of 1153 patients
Pre-assignment details
109 health centers assessed for eligability, 6 health centers excluded as TB care not provided at the health center: all patients registered for TB care with treatment start and end dates within the study period included
Participants by arm
| Arm | Count |
|---|---|
| KT Intervention Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. | 605 |
| Control 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. | 548 |
| Total | 1,153 |
Baseline characteristics
| Characteristic | Total | KT Intervention | Control |
|---|---|---|---|
| Age, Continuous | 35.9 years | 35.4 years | 36.3 years |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 500 Participants | 273 Participants | 227 Participants |
| Sex: Female, Male Male | 653 Participants | 332 Participants | 321 Participants |
| TB type = pulmonary TB | 912 Participants | 457 Participants | 455 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 49 / 605 | 61 / 548 |
| other Total, other adverse events | 0 / 605 | 0 / 548 |
| serious Total, serious adverse events | 0 / 605 | 0 / 548 |
Outcome results
Primary
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KT Intervention | Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment. | 297 Participants |
| Control | Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment. | 348 Participants |
Secondary
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)
secondary outcome =proportion of default cases (treatment interrupted \>= 2 consecutive months)
Time frame: 1 year
Population: analysis not conducted due to small proportion of default cases
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KT Intervention | Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months) | 4 Participants |
| Control | Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months) | 6 Participants |
Secondary
Proportion of Successes Among HIV Co-infected Cases
secondary outcome = proportion of successes among HIV co-infected cases
Time frame: 1 year
Population: analysis not conducted due to large proportion of missing data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KT Intervention | Proportion of Successes Among HIV Co-infected Cases | 0 Participants |
| Control | Proportion of Successes Among HIV Co-infected Cases | 0 Participants |