TuberculosisECFNCT01660646
Determining the Impact of Enhanced Case Finding on Tuberculosis Notification in The Gambia
A study testing Behavioral: community sensitization in people with Tuberculosis, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF) strategy will be compared to passive TB case reporting in The Gambia. And that the impact of ECF on community and household transmission of TB will also be assessed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Behavioral: community sensitization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650,000 participants
- Where
- 1 siteThe Gambia
- Study dates
- Jun 2012to Oct 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any newly diagnosed case initiating TB therapy at any of the Gambia Government TB diagnostic and treatment centres in the Greater Banjul Area.
- All TB patients are eligible regardless of age, residency, HIV status, or type of TB
- All settlements randomised to the intervention arm
Who cannot join
- Inability to understand the implications of study participation, whether through cognitive impairment or insurmountable language barrier.
- Communities that refuse to accept intervention through decision conveyed by the alkalo and other recognised community leaders
Trial locations and contacts
1 site in 1 country.
The Gambia1 site
Medical Research Council Unit, The Gambia
Fajara, Near Banjul
About this study
Official title: A Cluster Randomised Trial to Assess the Impact of an Enhanced Case Finding Strategy on Tuberculosis Notification in The Gambia
This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF) strategy will be compared to passive TB case reporting in The Gambia. And that the impact of ECF on community and household transmission of TB will also be assessed.
The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost effective manner. The impact of ECF on community and household transmission of TB will also be assessed. The investigators hope this trial will contribute to this evidence base. The timing alongside a nationwide TB prevalence survey is particularly of benefit as that would provide a baseline for disease burden against which the investigators may be able to compare case notification or case detection in selected clusters
Read the detailed description
TB is a chronic, transmissible disease, albeit with effective and curative combination therapeutic regimens available. However insufficient case detection, delayed diagnosis of TB , which prolong the duration of potential transmission, and co prevalent HIV/AIDS are the major factors responsible for increasing TB incidence. The DOTs strategy, which relies on a process of passive TB case finding, has helped to control TB in many parts of the world. Currently, the World Health Organisation's Stop TB DOTS policy is being questioned as countries that have reached and maintained targets of 70% case detection and 85% cure rates are unable to demonstrate a decline in number of cases notified.
Studies in Southern Africa suggest that if the investigators want to prevent TB in HIV-infected and uninfected people a major focus should be on decreasing transmission from people who are HIV-negative that may transmit TB for a long time on account of delayed diagnosis 5, 6. Data from studies in Ethiopia, Peru, Brazil, and Zimbabwe show different strategies of intensified or active case finding (ICF or ACF) yield significantly more TB cases than the standard of care-passive case finding.7-10 In the Zimbabwe study, point prevalence of TB declined significantly over 2 time points and was attributed to the ICF intervention. Since effective treatment for TB renders patients non-infectious within 2-4 weeks, it is likely that earlier diagnosis and initiation of treatment will ultimately reduce the incidence of TB by interrupting TB transmission. However the quantitative effect of enhanced case finding (ECF) on TB case notification rates, TB transmission, prevalence and incidence remains largely unproven.
Although there is now data from Zimbabwe regarding the impact of untargeted active case finding strategies, it is unclear how each case finding strategy compares to the standard passive case finding and the investigators are currently unable to address the cost effectiveness or otherwise of active case finding strategies in high TB burden settings with low HIV prevalence which is the scenario in most West African countries including The Gambia. Consequently, there is insufficient data to support a policy change and an urgent need for evidence to drive the necessary review of policy.
The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost effective manner. The impact of ECF on community and household transmission of TB will also be assessed. The investigators hope this trial will contribute to this evidence base. The timing alongside a nationwide TB prevalence survey is particularly of benefit as that would provide a baseline for disease burden against which the investigators may be able to compare case notification or case detection in selected clusters.
- Conditions
- Tuberculosis
- Being tested
- Behavioral: community sensitization
- Keywords
- Tuberculosis case finding
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: community sensitizationBehavioural
Behavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: community sensitization | Other | Behavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB Receives: Behavioral: Behavioral: community sensitization |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of successive TB cases notified in the intervention area compared to the total number of successive TB cases notified in the control areas
Measured: 30 months
Secondary outcomes (1)
The total cost of making diagnosis and receiving treatment will be compared between ECF and passive case finding
Residual burden of TB after intervention Proportion of TB detected through ECF vs. passive case finding in intervention areas.
Evaluation of diagnostic delay and treatment outcome in cases detected through ECF versus passive case finding
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionOct 2015
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ifedayo Adetifa, FWACP, MSc, Principal investigator, Medical Research Council Unit, The Gambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660646
- Sponsor's protocol ID
- SCC 1205
- Acronym
- ECF
- Status last verified
- Mar 2018
- First submitted
- 26 Jul 2012
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Trial to Assess the Impact of an Enhanced Case Finding Strategy on Tuberculosis Notification in The Gambia
- ClinicalTrials.gov ID
- NCT01660646
- Acronym / sponsor ID
- ECF / SCC 1205
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis case finding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650,000 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Aug 2012 (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.
This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF) strategy will be compared to passive TB case reporting in The Gambia. And that the impact of ECF on community and household transmission of TB will also be assessed.
The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost effective manner. The impact of ECF on community and household transmission of TB will also be assessed. The investigators hope this trial will contribute to this evidence base. The timing alongside a nationwide TB prevalence survey is particularly of benefit as that would provide a baseline for disease burden against which the investigators may be able to compare case notification or case detection in selected clusters
Detailed description
TB is a chronic, transmissible disease, albeit with effective and curative combination therapeutic regimens available. However insufficient case detection, delayed diagnosis of TB , which prolong the duration of potential transmission, and co prevalent HIV/AIDS are the major factors responsible for increasing TB incidence. The DOTs strategy, which relies on a process of passive TB case finding, has helped to control TB in many parts of the world. Currently, the World Health Organisation's Stop TB DOTS policy is being questioned as countries that have reached and maintained targets of 70% case detection and 85% cure rates are unable to demonstrate a decline in number of cases notified.
Studies in Southern Africa suggest that if the investigators want to prevent TB in HIV-infected and uninfected people a major focus should be on decreasing transmission from people who are HIV-negative that may transmit TB for a long time on account of delayed diagnosis 5, 6. Data from studies in Ethiopia, Peru, Brazil, and Zimbabwe show different strategies of intensified or active case finding (ICF or ACF) yield significantly more TB cases than the standard of care-passive case finding.7-10 In the Zimbabwe study, point prevalence of TB declined significantly over 2 time points and was attributed to the ICF intervention. Since effective treatment for TB renders patients non-infectious within 2-4 weeks, it is likely that earlier diagnosis and initiation of treatment will ultimately reduce the incidence of TB by interrupting TB transmission. However the quantitative effect of enhanced case finding (ECF) on TB case notification rates, TB transmission, prevalence and incidence remains largely unproven.
Although there is now data from Zimbabwe regarding the impact of untargeted active case finding strategies, it is unclear how each case finding strategy compares to the standard passive case finding and the investigators are currently unable to address the cost effectiveness or otherwise of active case finding strategies in high TB burden settings with low HIV prevalence which is the scenario in most West African countries including The Gambia. Consequently, there is insufficient data to support a policy change and an urgent need for evidence to drive the necessary review of policy.
The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost effective manner. The impact of ECF on community and household transmission of TB will also be assessed. The investigators hope this trial will contribute to this evidence base. The timing alongside a nationwide TB prevalence survey is particularly of benefit as that would provide a baseline for disease burden against which the investigators may be able to compare case notification or case detection in selected clusters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: community sensitization | Other | Behavioral: Behavioral: community sensitizationBehavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB |
| control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Any newly diagnosed case initiating TB therapy at any of the Gambia Government TB diagnostic and treatment centres in the Greater Banjul Area.
- All TB patients are eligible regardless of age, residency, HIV status, or type of TB
- All settlements randomised to the intervention arm
Key exclusion criteria (2 listed)
- Inability to understand the implications of study participation, whether through cognitive impairment or insurmountable language barrier.
- Communities that refuse to accept intervention through decision conveyed by the alkalo and other recognised community leaders
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 |
|---|---|---|
| Behavioral: community sensitizationBehavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB | Behavioural | Behavioral: community sensitization |
Primary outcome
The total number of successive TB cases notified in the intervention area compared to the total number of successive TB cases notified in the control areas
Time frame: 30 months
1 secondary outcome
The total cost of making diagnosis and receiving treatment will be compared between ECF and passive case finding
Time frame: 30 months
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 22 Mar 2018.
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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.
Ifedayo Adetifa, FWACP, MSc principal investigator
Medical Research Council Unit, The Gambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: community sensitization in people with Tuberculosis, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 3 inclusion and 2 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 22 Mar 2018. 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 The Gambia. 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?
The total number of successive TB cases notified in the intervention area compared to the total number of successive TB cases notified in the control areas (time frame: 30 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 22 Mar 2018.