Clinical Trials Directory

Trials / Completed

CompletedNCT02127983

Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)

Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus): a Cluster Randomised Health System Intervention Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200,000 (actual)
Sponsor
Liverpool School of Tropical Medicine · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Accepted

Summary

The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.

Detailed description

A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEarly interventionTraining non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention
BEHAVIORALDelayed interventionDelayed intervention arm, engaging informal providers Received the intervention after one year

Timeline

Start date
2009-01-01
Primary completion
2011-12-01
Completion
2012-12-01
First posted
2014-05-01
Last updated
2014-05-01

Locations

1 site across 1 country: Malawi

Source: ClinicalTrials.gov record NCT02127983. Inclusion in this directory is not an endorsement.