Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus) (Triage)
Primary Purpose
Tuberculosis, HIV
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Early intervention
Delayed intervention
Sponsored by
About this trial
This is an interventional health services research trial for Tuberculosis focused on measuring TB, HIV, case finding, access, informal providers
Eligibility Criteria
Inclusion Criteria:
- People accessing informal providers with possible TB or HIV
Exclusion Criteria:
- children
- people already with a diagnosis of TB or HIV
Sites / Locations
- REACH Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early intervention
Delayed intervention
Arm Description
Early intervention arm engaging informal providers Received the intervention early in the first 12 months
Delayed intervention arm, engaging informal providers Received the intervention after one year
Outcomes
Primary Outcome Measures
TB and HIV treatment initiation
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.
Full Information
NCT ID
NCT02127983
First Posted
April 29, 2014
Last Updated
April 30, 2014
Sponsor
Liverpool School of Tropical Medicine
Collaborators
Research for Equity And Community Health REACH Trust, Ministry of Health and Population, Malawi, LHL International Tuberculosis Foundation, University of Warwick
1. Study Identification
Unique Protocol Identification Number
NCT02127983
Brief Title
Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)
Acronym
Triage
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool School of Tropical Medicine
Collaborators
Research for Equity And Community Health REACH Trust, Ministry of Health and Population, Malawi, LHL International Tuberculosis Foundation, University of Warwick
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV
Keywords
TB, HIV, case finding, access, informal providers
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early intervention
Arm Type
Experimental
Arm Description
Early intervention arm engaging informal providers Received the intervention early in the first 12 months
Arm Title
Delayed intervention
Arm Type
Active Comparator
Arm Description
Delayed intervention arm, engaging informal providers Received the intervention after one year
Intervention Type
Behavioral
Intervention Name(s)
Early intervention
Other Intervention Name(s)
Early intervention arm engaging informal providers, Received the intervention early in the first 12 months
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Delayed intervention
Intervention Description
Delayed intervention arm, engaging informal providers Received the intervention after one year
Primary Outcome Measure Information:
Title
TB and HIV treatment initiation
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
TB and HIV diagnostic uptake rates.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
People accessing informal providers with possible TB or HIV
Exclusion Criteria:
children
people already with a diagnosis of TB or HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachael Thomson, MSc
Organizational Affiliation
LSTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
REACH Trust
City
Lilongwe
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
28877245
Citation
Bello G, Faragher B, Sanudi L, Namakhoma I, Banda H, Malmborg R, Thomson R, Squire SB. The effect of engaging unpaid informal providers on case detection and treatment initiation rates for TB and HIV in rural Malawi (Triage Plus): A cluster randomised health system intervention trial. PLoS One. 2017 Sep 6;12(9):e0183312. doi: 10.1371/journal.pone.0183312. eCollection 2017.
Results Reference
derived
Learn more about this trial
Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)
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