Clinical trial NCT01660646: Determining the Impact of Enhanced Case Finding on Tuberculosis Notification in The Gambia
Official title: A Cluster Randomised Trial to Assess the Impact of an Enhanced Case Finding Strategy on Tuberculosis Notification in The Gambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis case finding
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 650000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: 30 months
Secondary outcomes:
measure: The total cost of making diagnosis and receiving treatment will be compared between ECF and passive case finding
timeFrame: 30 months
Other outcomes:
Locations:
city: Fajara,
country: Gambia
facility: Medical Research Council Unit, The Gambia
state: Near Banjul
Study officials:
affiliation: Medical Research Council Unit, The Gambia
name: Ifedayo Adetifa, FWACP, MSc
role: PRINCIPAL_INVESTIGATOR
References: