- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841541
The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan (Triage-Plus)
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 Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Khartoum, Sudan
- The Epidemiological Laboratory (EpiLab)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: S. Bertel ("Bertie") Squire, MB BChir, MD, Liverpool School of Tropical Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11.03RS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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