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

NCT ID: NCT01841541

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-04-30

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.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Referral of presumptive of TB cases by informal providers

Intervention Type: BEHAVIORAL

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

Jabal Awlia Locality

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Epidemiological Laboratory (EpiLab), Khartoum-Sudan.

UNKNOWN

Sponsor Role: collaborator

The Norwegian Heart and Lung Patients Association (LHL)

UNKNOWN

Sponsor Role: collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Tropical Medicine

Locations

The Epidemiological Laboratory (EpiLab)

Khartoum, Khartoum State, Sudan

Countries

Sudan

Other Identifiers

11.03RS

Identifier Type: -

Identifier Source: org_study_id