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Completed

NCT Number: NCT02127983

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections HIV Infections Mycobacterium Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REACH Trust

Lilongwe, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People accessing informal providers with possible TB or HIV

Exclusion criteria

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

Treatment and study plan

Early Intervention

Behavioral

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

Other names: Early intervention arm engaging informal providers, Received the intervention early in the first 12 months

Delayed Intervention

Behavioral

Delayed intervention arm, engaging informal providers Received the intervention after one year

Primary outcomes

  1. TB and HIV treatment initiation

    Time frame: 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 outcomes

  1. TB and HIV diagnostic uptake rates.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Liverpool School of Tropical Medicine

Other

Collaborators

  • LHL International Tuberculosis Foundation
  • Ministry of Health, Malawi
  • Research for Equity And Community Health REACH Trust
  • University of Warwick

Registry information

Official study title

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

Acronym: Triage

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 1, 2014
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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