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

April 30, 2014 updated by: Liverpool School of Tropical Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Lilongwe, Malawi
        • REACH Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People accessing informal providers with possible TB or HIV

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early intervention
Early intervention arm engaging informal providers Received the intervention early in the first 12 months
Behavioral: Early intervention

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
Active Comparator: Delayed intervention
Delayed intervention arm, engaging informal providers Received the intervention after one year
Behavioral: Delayed intervention
Delayed intervention arm, engaging informal providers Received the intervention after one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
TB and HIV diagnostic uptake rates.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool School of Tropical Medicine

Collaborators

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

Investigators

  • Principal Investigator: Rachael Thomson, MSc, LSTM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TriagePlus

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV

Clinical Trials on Early intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe