TuberculosisTriage-PlusNCT01841541
The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan
A study testing Referral of presumptive of TB cases by informal providers in people with Tuberculosis, run by Liverpool School of Tropical Medicine at 1 site in Sudan.
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Referral of presumptive of TB cases by informal providers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteSudan
- Study dates
- Jan 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Formal health providers, e.g. clinics, labs, hospitals (MOH, NGO or private)
- Internationally funded organizations, e.g. international NGOs
- Civil servants e.g. teachers
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Referral of presumptive of TB cases by informal providers
- Keywords
- Tuberculosis, Informal providers, Informal carers, Barriers to health system
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral of presumptive of TB cases by informal providersBehavioural
Training of informal providers to effectively refer TB suspects in the community to the primary health care system
| Study group | Role | What they receive |
|---|---|---|
| Ombda Locality: informal providers | Experimental | 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. Receives: Behavioral: Referral of presumptive of TB cases by informal providers |
| Jabal Awlia Locality | No intervention | The control arm: A locality in south eastern site of Khartoum state populated with 942,429. No intervention took place |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startJan 2009
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Epidemiological Laboratory (EpiLab), Khartoum-Sudan., The Norwegian Heart and Lung Patients Association (LHL)
- Responsible party
- Sponsor
- Investigators
- S. Bertel ("Bertie") Squire, MB BChir, MD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841541
- Sponsor's protocol ID
- 11.03RS
- Acronym
- Triage-Plus
- Status last verified
- Apr 2013
- First submitted
- 24 Apr 2013
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01841541
- Acronym / sponsor ID
- Triage-Plus / 11.03RS
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Informal providers, Informal carers, Barriers to health system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- The Epidemiological Laboratory (EpiLab), Khartoum-Sudan., The Norwegian Heart and Lung Patients Association (LHL)
- Study start
- Jan 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ombda Locality: informal providers | Experimental | Behavioral: Referral of presumptive of TB cases by informal providersOmbda 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. |
| Jabal Awlia Locality | No intervention | –The control arm: A locality in south eastern site of Khartoum state populated with 942,429. No intervention took place |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Formal health providers, e.g. clinics, labs, hospitals (MOH, NGO or private)
- Internationally funded organizations, e.g. international NGOs
- Civil servants e.g. teachers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral of presumptive of TB cases by informal providersTraining of informal providers to effectively refer TB suspects in the community to the primary health care system | Behavioural | Ombda Locality: informal providers |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Bertel ("Bertie") Squire, MB BChir, MD principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral of presumptive of TB cases by informal providers in people with Tuberculosis, run by Liverpool School of Tropical Medicine at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of TB patients registered and start receiving treatment in formal health care facilities (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.