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

NCT ID: NCT02127983

Last Updated: 2014-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Tuberculosis; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Early intervention

Early intervention arm engaging informal providers Received the intervention early in the first 12 months

Group Type: EXPERIMENTAL

Early intervention

Intervention Type: BEHAVIORAL

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

Group Type: ACTIVE_COMPARATOR

Delayed intervention

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Delayed intervention

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Early intervention arm engaging informal providers; Received the intervention early in the first 12 months

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research for Equity And Community Health REACH Trust

UNKNOWN

Sponsor Role: collaborator

Ministry of Health and Population, Malawi

OTHER_GOV

Sponsor Role: collaborator

LHL International Tuberculosis Foundation

UNKNOWN

Sponsor Role: collaborator

University of Warwick

OTHER

Sponsor Role: collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachael Thomson, MSc

Role: PRINCIPAL_INVESTIGATOR

LSTM

Locations

REACH Trust

Lilongwe, , Malawi

Countries

Malawi

References

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.

Reference Type: DERIVED

PMID: 28877245 (View on PubMed)

Other Identifiers

TriagePlus

Identifier Type: -

Identifier Source: org_study_id