Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201501000963213 Date of Registration: 07/12/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ebola Contact Tracing Study
Official scientific title Reducing Ebola virus transmission: Improving contact identification and tracing in Sierra Leone
Brief summary describing the background and objectives of the trial In the current Ebola outbreak in West Africa, there have been problems with identification of contacts, and inefficiencies in the current paper-based reporting system. The trial seeks to improve key elements of the contact tracing strategy: complete identification and listing of contacts; timely and correct communication of contact details to the community-based tracers; and timely reporting of contacts who develop symptoms so they can be screened and, if necessary, isolated and treated. We will evaluate the effectiveness of smartphone-based interventions to improve contact tracing. The study will include a 3-arm cluster-randomised trial in which Arm A) contact tracing supervisors, or Arm B) supervisors and their contact tracing teams, will be trained and provided with smartphones to evaluate the effectiveness of a smartphone-based electronic data capture and management system relative to Arm C) the current paper-based system used in Sierra Leone. In all three trial arms an expanded case interview will be used that attempts to improve identification of high-risk contacts of Ebola cases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ebola,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention
Anticipated trial start date 29/12/2014
Actual trial start date
Anticipated date of last follow up 27/03/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 750
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Randomised Clusters (each cluster based on contact tracing supervisor) assigned randomly using a computer programme Allocation determined by thrid party situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arm A: Electronic data capture and management by contact tracing supervisors only Not applicable 3 months initially 25 Contact tracing supervisors are given smart phones with a data management app 250
Experimental Group Arm B: Electronic data capture and management by contact tracing supervisors and contact tracers Not applicable 3 months initially Contact tracing supervisors and their contact tracers are given smart phones with a data management app 250
Control Group Control Group Not applicable 3 months initially Standard care 250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Contact of Probable or Confirmed Ebola case Contact of Suspected Ebola case who turns out not to be a Probable or Confirmed Ebola case 0 Day(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2014 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Connaught Hospital Freetown Not applicable Sierra Leone
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/12/2014 LSHTM Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel St London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Completeness, quality and timeliness of each step on the contact tracing cascade Continuous
Secondary Outcome Case fatality ratio among secondary cases Within 30 days of last exposure to the index case
Secondary Outcome The number and proportion of contacts followed by a contact tracer daily to 21 days (or until symptom onset) Up to 21 days after contact first traced
Primary Outcome Time from symptom onset to isolation in a contact who develops symptoms and is subsequently determined to be either a confirmed or probable Ebola case Continous
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
International Medical Corps Ebola Treatment Centre, near Lunsar, Port Loko District, Sierra Leone Not known Near Lunsar Not applicable Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
GiZ Friedrich-Ebert-Allee 40 Bonn 53113 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel St London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene & Tropical Medicine Keppel St London WC1E 7HT United Kingdom
Innovations for Poverty Action 101 Whitney Ave New Haven CT 06510 United States of America
International Medical Corps 12400 Wilshire Blvd Los Angeles CA 90025 United States of America
Ministry of Health and Sanitation, Sierra Leone Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Ross david.ross@lshtm.ac.uk +44.20.7927.2668 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor
Role Name Email Phone Street address
Public Enquiries Rachel Miles rachel.miles@lshtm.ac.uk +44.20 7927 2579 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Administrator (Ebola Contact Tracing Study)
Role Name Email Phone Street address
Scientific Enquiries David Ross david.ross@lshtm.ac.uk +44.20.7927.2668 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information