NCT02127983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

December 1, 2012

Enrollment Period

2.9 years

First QC Date

April 29, 2014

Last Update Submit

April 30, 2014

Conditions

Keywords

TB, HIV, case finding, access, informal providers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • TB and HIV diagnostic uptake rates.

    2 years

Study Arms (2)

Early intervention

EXPERIMENTAL

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

Behavioral: Early intervention

Delayed intervention

ACTIVE COMPARATOR

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

Behavioral: Delayed intervention

Interventions

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

Also known as: Early intervention arm engaging informal providers, Received the intervention early in the first 12 months
Early intervention

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

Delayed intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • People accessing informal providers with possible TB or HIV

You may not qualify if:

  • children
  • people already with a diagnosis of TB or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REACH Trust

Lilongwe, Malawi

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tuberculosis

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Rachael Thomson, MSc

    LSTM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 1, 2014

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

May 1, 2014

Record last verified: 2012-12

Locations