The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan

Tuberculosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841541
• Other study ID #: 11.03RS
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: April 25, 2013
• Start date: January 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Liverpool School of Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sudan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Sudan	The Epidemiological Laboratory (EpiLab)	Khartoum

Sponsors (3)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	The Epidemiological Laboratory (EpiLab), Khartoum-Sudan., The Norwegian Heart and Lung Patients Association (LHL)

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No