The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan (Triage-Plus)
Primary Purpose
Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Sudan
Study Type
Interventional
Intervention
Referral of presumptive of TB cases by informal providers
Sponsored by
About this trial
This is an interventional health services research trial for Tuberculosis focused on measuring Tuberculosis, Informal providers, Informal carers, Barriers to health system
Eligibility 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
Sites / Locations
- The Epidemiological Laboratory (EpiLab)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ombda Locality: informal providers
Jabal Awlia Locality
Arm Description
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.
The control arm: A locality in south eastern site of Khartoum state populated with 942,429. No intervention took place
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01841541
First Posted
April 24, 2013
Last Updated
April 25, 2013
Sponsor
Liverpool School of Tropical Medicine
Collaborators
The Epidemiological Laboratory (EpiLab), Khartoum-Sudan., The Norwegian Heart and Lung Patients Association (LHL)
1. Study Identification
Unique Protocol Identification Number
NCT01841541
Brief Title
The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan
Acronym
Triage-Plus
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool School of Tropical Medicine
Collaborators
The Epidemiological Laboratory (EpiLab), Khartoum-Sudan., The Norwegian Heart and Lung Patients Association (LHL)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis, Informal providers, Informal carers, Barriers to health system
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ombda Locality: informal providers
Arm Type
Experimental
Arm Description
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.
Arm Title
Jabal Awlia Locality
Arm Type
No Intervention
Arm Description
The control arm: A locality in south eastern site of Khartoum state populated with 942,429. No intervention took place
Intervention Type
Behavioral
Intervention Name(s)
Referral of presumptive of TB cases by informal providers
Intervention Description
Training of informal providers to effectively refer TB suspects in the community to the primary health care system
Primary Outcome Measure Information:
Title
Total number of TB patients registered and start receiving treatment in formal health care facilities
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Bertel ("Bertie") Squire, MB BChir, MD
Organizational Affiliation
Liverpool School of Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Epidemiological Laboratory (EpiLab)
City
Khartoum
Country
Sudan
12. IPD Sharing Statement
Learn more about this trial
The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan
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