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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV, Tuberculosis

Intervention / Treatment
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* Behavioral: Early intervention
* Behavioral: Delayed intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People accessing informal providers with possible TB or HIV Exclusion Criteria: children people already with a diagnosis of TB or HIV

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early intervention<br>Early intervention arm engaging informal providers Received the intervention early in the first 12 months | Behavioral: Early intervention<br>* 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<br>* Other names: Received the intervention early in the first 12 months;|
| Active Comparator: Delayed intervention<br>Delayed intervention arm, engaging informal providers Received the intervention after one year | Behavioral: Delayed intervention<br>* Delayed intervention arm, engaging informal providers Received the intervention after one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TB and HIV diagnostic uptake rates. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TB, HIV, case finding, access, informal providers