Determining the Impact of Enhanced Case Finding on Tuberculosis Notification in The Gambia (ECF)

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

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Behavioral: Behavioral: community sensitization

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 Type: Interventional
• Enrollment (Actual): 650000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Gambia
  • Near Banjul
    • Fajara,, Near Banjul, Gambia
      • Medical Research Council Unit, The Gambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Other: Behavioral: community sensitization; 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	Behavioral: Behavioral: community sensitization; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 months

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Investigators: Principal Investigator: Ifedayo Adetifa, FWACP, MSc, Medical Research Council Unit, The Gambia

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Tuberculosis case finding
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: SCC 1205