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

NCT01660646 | Completed

• 1 other identifier: SCC 1205
• Study Type: interventional
• Target: 650,000
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis

Keywords

Tuberculosis case finding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The total cost of making diagnosis and receiving treatment will be compared between ECF and passive case finding

  30 months

Study Arms (2)

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

Behavioral: Behavioral: community sensitization

control

NO INTERVENTION

Interventions

Behavioral: community sensitization BEHAVIORAL

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: community sensitization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Medical Research Council Unit, The Gambia

Fajara, Near Banjul, The Gambia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Ifedayo Adetifa, FWACP, MSc

  Medical Research Council Unit, The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 9, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

TH (1)