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

HIV Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127983
• Other study ID #: TriagePlus
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: April 30, 2014
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Liverpool School of Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200000
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• People accessing informal providers with possible TB or HIV

Exclusion Criteria:

• children

• people already with a diagnosis of TB or HIV

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Malawi	REACH Trust	Lilongwe

Sponsors (5)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	LHL International Tuberculosis Foundation, Ministry of Health and Population, Malawi, Research for Equity And Community Health REACH Trust, University of Warwick

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No
Secondary	TB and HIV diagnostic uptake rates.		2 years	No