NCT01841541

Brief Summary

Training and engaging of unpaid informal providers (such as tea-sellers, women's groups, youth clubs, small traders and religious groups) from poorer localities in TB disease recognition, referral and community awareness raising will increase the access of TB patients to formal health facilities and decrease their delay in initiating TB treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

3.2 years

First QC Date

April 24, 2013

Last Update Submit

April 25, 2013

Conditions

Keywords

TuberculosisInformal providersInformal carersBarriers to health system

Outcome Measures

Primary Outcomes (1)

  • Total number of TB patients registered and start receiving treatment in formal health care facilities

    This will be measured by comparing Data from routine patients registered in formal TB management units in the intervention arm and compare it with the same routine data from the control arm. similar data for the previous year will undergo the same comparison as time control for both arms

    12 months

Study Arms (2)

Ombda Locality: informal providers

EXPERIMENTAL

Ombda locality is located in Western Khartoum and populated with population size of 988,163. Intervention: 380 unpaid Informal providers trained to recognise TB symptoms and to refer presumptive TB cases to formal health care facilities within the area.

Behavioral: Referral of presumptive of TB cases by informal providers

Jabal Awlia Locality

NO INTERVENTION

The control arm: A locality in south eastern site of Khartoum state populated with 942,429. No intervention took place

Interventions

Training of informal providers to effectively refer TB suspects in the community to the primary health care system

Ombda Locality: informal providers

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Access point for health seeking by the poor and vulnerable
  • Active and well known in community
  • Intervention activities can be confined to intervention area
  • Based in community/locality
  • Longevity; long standing
  • Present in control and intervention areas
  • Able and willing to complete the training to be Triage-Plus providers (ie giving formal consent)

You may not qualify if:

  • Formal health providers, e.g. clinics, labs, hospitals (MOH, NGO or private)
  • Internationally funded organizations, e.g. international NGOs
  • Civil servants e.g. teachers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Epidemiological Laboratory (EpiLab)

Khartoum, Khartoum State, Sudan

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • S. Bertel ("Bertie") Squire, MB BChir, MD

    Liverpool School of Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 24, 2013

First Posted

April 26, 2013

Study Start

January 1, 2009

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations