Clinical trial NCT01841541: The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan
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
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis
Informal providers
Informal carers
Barriers to health system
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: The Epidemiological Laboratory (EpiLab), Khartoum-Sudan.
name: The Norwegian Heart and Lung Patients Association (LHL)
First posted: 2013-04-26
Enrollment: 380
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Total number of TB patients registered and start receiving treatment in formal health care facilities
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: The Epidemiological Laboratory (EpiLab)
Study officials:
affiliation: Liverpool School of Tropical Medicine
name: S. Bertel ("Bertie") Squire, MB BChir, MD
role: PRINCIPAL_INVESTIGATOR
References: