Trial Outcomes & Findings for Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi (NCT NCT02533089)

Results Overview

primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1153 participants

Primary outcome timeframe

1 year

Results posted on

2020-03-24

Participant Flow

103 health centers enrolled, a total of 1153 patients

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

Unit of analysis: health centers

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	605 51	548 52
Overall Study COMPLETED	364 36	434 38
Overall Study NOT COMPLETED	241 15	114 14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KT Intervention n=605 Participants 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.	Control n=548 Participants 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.	Total n=1153 Participants Total of all reporting groups
Age, Continuous	35.4 years n=605 Participants	36.3 years n=548 Participants	35.9 years n=1153 Participants
Sex: Female, Male Female	273 Participants n=605 Participants	227 Participants n=548 Participants	500 Participants n=1153 Participants
Sex: Female, Male Male	332 Participants n=605 Participants	321 Participants n=548 Participants	653 Participants n=1153 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
TB type = pulmonary TB	457 Participants n=605 Participants	455 Participants n=548 Participants	912 Participants n=1153 Participants

PRIMARY outcome

Timeframe: 1 year

primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.

Outcome measures

Outcome measures
Measure	KT Intervention n=605 Participants 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.	Control n=548 Participants 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.
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.	297 Participants	348 Participants

SECONDARY outcome

Timeframe: 1 year

Population: analysis not conducted due to small proportion of default cases

secondary outcome =proportion of default cases (treatment interrupted \>= 2 consecutive months)

Outcome measures

Outcome measures
Measure	KT Intervention n=605 Participants 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.	Control n=548 Participants 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.
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 1 year

Population: analysis not conducted due to large proportion of missing data

secondary outcome = proportion of successes among HIV co-infected cases

Outcome measures

Outcome measures
Measure	KT Intervention n=605 Participants 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.	Control n=548 Participants 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.
Proportion of Successes Among HIV Co-infected Cases	0 Participants	0 Participants

Adverse Events

KT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 49 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 61 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. L M Puchalski Ritchie

Li Ka Shing knowledge institute

Phone: 416 864 6060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place