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

This study has been completed.
Sponsor:
Collaborators:
Research for Equity And Community Health REACH Trust
Ministry of Health and Population, Malawi
LHL International Tuberculosis Foundation
University of Warwick
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT02127983
First received: April 29, 2014
Last updated: April 30, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention
Tuberculosis
HIV
Behavioral: Early intervention
Behavioral: Delayed intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official 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

Resource links provided by NLM:


Further study details as provided by Liverpool School of Tropical Medicine:

Primary Outcome Measures:
  • TB and HIV treatment initiation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • TB and HIV diagnostic uptake rates. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 200000
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People accessing informal providers with possible TB or HIV

Exclusion Criteria:

  • children
  • people already with a diagnosis of TB or HIV
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02127983

Locations
Malawi
REACH Trust
Lilongwe, Malawi
Sponsors and Collaborators
Liverpool School of Tropical Medicine
Research for Equity And Community Health REACH Trust
Ministry of Health and Population, Malawi
LHL International Tuberculosis Foundation
University of Warwick
Investigators
Principal Investigator: Rachael Thomson, MSc LSTM
  More Information

No publications provided

Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT02127983     History of Changes
Other Study ID Numbers: TriagePlus
Study First Received: April 29, 2014
Last Updated: April 30, 2014
Health Authority: Malawi: National Health Sciences Research Committee

Keywords provided by Liverpool School of Tropical Medicine:
TB, HIV, case finding, access, informal providers

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 20, 2014