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The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan (Triage-Plus)

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ClinicalTrials.gov Identifier: NCT01841541
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Collaborators:
The Epidemiological Laboratory (EpiLab), Khartoum-Sudan.
The Norwegian Heart and Lung Patients Association (LHL)
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Behavioral: Referral of presumptive of TB cases by informal providers Not Applicable

Detailed Description:

Barriers to accessing health services faced by poor and vulnerable populations are numerous in developing countries. These include; geography, income poverty, lack of trust in the quality of public health services, and lack of empowerment of women and adolescent girls (as patients and carers) to mobilize adequate and timely resources to access these services.

The project aims to test if TB case detection can be increased by engaging informal health care providers in active case finding. In one urban district of Khartoum, these providers will be trained to work as first point of entry to the health system using a comprehensive package that includes disease recognition, health communication, and patient referral. In a comparator urban district of Khartoum, no attempts will be made to engage informal providers.

By comparing data of TB patients and Lab registers between the intervention and comparator districts in Khartoum, this project aims to test if, and to what extent, these expected effects can be realized.

Overall this is a trial of a health policy so individual patients will not be recruited or randomized to one intervention or the other. Rather the policy is being applied in one district while the other district is being used as a comparator.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Triage Plus for TB: Improving Community‐Based Provision for TB in Africa. The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan
Study Start Date : January 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Ombda Locality: informal providers

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

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



Primary Outcome Measures :
  1. Total number of TB patients registered and start receiving treatment in formal health care facilities [ Time Frame: 12 months ]
    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



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841541


Locations
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Sudan
The Epidemiological Laboratory (EpiLab)
Khartoum, Sudan
Sponsors and Collaborators
Liverpool School of Tropical Medicine
The Epidemiological Laboratory (EpiLab), Khartoum-Sudan.
The Norwegian Heart and Lung Patients Association (LHL)
Investigators
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Principal Investigator: S. Bertel ("Bertie") Squire, MB BChir, MD Liverpool School of Tropical Medicine

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Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT01841541     History of Changes
Other Study ID Numbers: 11.03RS
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013
Keywords provided by Liverpool School of Tropical Medicine:
Tuberculosis
Informal providers
Informal carers
Barriers to health system
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections