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

Not Applicable

Completed

• Conditions: Tuberculosis; HIV
• Interventions: Behavioral: Early intervention; Behavioral: Delayed intervention

• Registration Number: NCT02127983
• Lead Sponsor: Liverpool School of Tropical Medicine

Brief 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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-12
• Status Verified: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-30
• Last Update Submitted: 2014-04-30
• Study First Posted: 2014-05-01
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200000

Inclusion Criteria

• People accessing informal providers with possible TB or HIV

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Exclusion Criteria

• children
• people already with a diagnosis of TB or HIV

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early intervention	Early intervention	Early intervention arm engaging informal providers Received the intervention early in the first 12 months
Delayed intervention	Delayed intervention	Delayed intervention arm, engaging informal providers Received the intervention after one year

Primary Outcome Measures

Name	Time	Method
TB and HIV treatment initiation	2 years	the cumulative counts of patients initiating TB and HIV treatment per 10,000 adults aged 12 years and above each month over the intervention period

Secondary Outcome Measures

Name	Time	Method
TB and HIV diagnostic uptake rates.	2 years

Trial Locations

Locations (1)

REACH Trust; 🇲🇼 Lilongwe, Malawi