An interventional study of KT intervention in Tuberculosis, sponsored by Dignitas International. Completed at 1 site in Malawi. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by Dignitas International · Not applicable, Interventional, and Health services research
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 1,153 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Dignitas International is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
Other: KT 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.
Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
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
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)
secondary outcome =proportion of default cases (treatment interrupted \>= 2 consecutive months)
Time frame: 1 year
Proportion of Successes Among HIV Co-infected Cases
secondary outcome = proportion of successes among HIV co-infected cases
Time frame: 1 year
103 health centers enrolled, a total of 1153 patients
| Milestone | KT Intervention | Control |
|---|---|---|
| Started | 605 | 548 |
| Completed | 364 | 434 |
| Not completed | 241 | 114 |
primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.
| Participants | KT Intervention | Control |
|---|---|---|
| Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment. | 297 | 348 |
secondary outcome =proportion of default cases (treatment interrupted \>= 2 consecutive months)
| Participants | KT Intervention | Control |
|---|---|---|
| Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months) | 4 | 6 |
secondary outcome = proportion of successes among HIV co-infected cases
| Participants | KT Intervention | Control |
|---|---|---|
| Proportion of Successes Among HIV Co-infected Cases | 0 | 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KT Intervention | 49/605 (8.1%) | 0/605 (0%) | 0/605 (0%) |
| Control | 61/548 (11.1%) | 0/548 (0%) | 0/548 (0%) |
| Age, Continuous(years) | KT Intervention | Control | Total |
|---|---|---|---|
| Mean | 35.4 (0 to 94) | 36.3 (0 to 94) | 35.9 (0 to 94) |
| Sex: Female, Male(Participants) | KT Intervention | Control | Total |
|---|---|---|---|
| Female | 273 | 227 | 500 |
| Male | 332 | 321 | 653 |
| Race and Ethnicity Not Collected(Participants) | KT Intervention | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| TB type = pulmonary TB(Participants) | KT Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 457 | 455 | 912 |
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Dignitas International