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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010691865364 Date of Approval: 14/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Active Case Finding for Tuberculosis Among Community Health Workers in Nigeria
Official scientific title Improving TB Case Finding Using Community Involvement to Increase Uptake of Services in Akwa Ibom State, Nigeria
Brief summary describing the background and objectives of the trial In many Nigerian communities, patent medicine vendors (PMVs) and community pharmacists (CPs) are the first-point-of-care providers for many ailments including cough. Already existing structures of PMVs and CPs can be harnessed as part of a community involvement intervention to improve case detection. Data review was conducted with the State TB and Leprosy Control Program (STBLCP) to identify high TB burden communities in Akwa-Ibom State, Nigeria with persistently low case detection of all forms of TB. This study carried out a rapid assessment of knowledge, attitudes and practices (KAP) of TB and available services among households and community health workers (CHWs) in the target communit(ies). After the survey, Healthcare workers (HCWs) in selected public PHCs, PMVs and CPs were trained in order to close their knowledge gap and increase the uptake of TB services using community involvement. The HCWs, PMVs and CPs were trained to improve their knowledge on systematic detection of active TB cases as well as increase their index of suspicion to identify and link more presumptive TB cases to diagnosis. They were then requested to saturate the community with outreaches and health education campaigns in order to improve the knowledge of TB among the population and increase their uptake of available TB services.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Early detection /Screening
Anticipated trial start date 13/03/2019
Actual trial start date 15/05/2019
Anticipated date of last follow up 30/03/2021
Actual Last follow-up date 30/11/2020
Anticipated target sample size (number of participants) 356
Actual target sample size (number of participants) 221
Recruitment status Closed to recruitment,follow-up continuing
Publication URL N/A
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
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training Once, at baseline One day, followed by quarterly supportive supervisory visits Training on causes, risk factors, signs and symptoms, identification of a presumptive TB case, sputum collection was carried out. This was followed by quarterly supportive supervisory visits 58
Experimental Group Cash Incentives Quarterly One year Cash incentives(200 naira) are given to the Patent medicine vendors for referral of presumptive cases. 3000 is given as cash incentive to the Community Health Workers based in the facility for outreaches to carry out health education campaign on TB 53
Control Group Control None One year Neither training nor cash incentives were given to CHWs in the control arm. 72 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All Community Health workers identified in the catchment clusters, including Patent Medicine Vendors and Community Health Extension Workers(CHEWs) Adults in the Households in the catchment cluster All non consenting Community Health Workers 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 20/12/2018 University of Uyo Teaching Hospital Institutional Health Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Olusegun Obasanjo way End Uyo PMB 1136 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of presumptive cases of TB referred to health facilities and Case detection rate for TB Quarterly and at Endline
Secondary Outcome 1. Proportion of community members with improved knowledge of Tuberculosis 2. Proportion of Community Health Workers with improved knowledge of TB post intervention 3. Proportion of Community Health Workers with sustained increased referral of Presumptive cases post intervention 6months and one year Baseline, Endline, 6months post endline and one year post endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health Systems and Policy Research Center University of Uyo Olusegun Obasanjo Way End, Ekom Iman Uyo 1167 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tropical Disease Research Cite du Djoue, Congo Brazaville POBox 06 Congo
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor WHO Cite du Djoue, Congo Brazzaville POBox06 Congo Funding Agency
COLLABORATORS
Name Street address City Postal code Country
State Tuberculosis and Leprosy Control Program State Ministry of Health Idongesit Nkanga Secretariat Uyo PMB1030 Nigeria
KNCV TB State housing Uyo Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christie Akwaowo christieakwaowo@uniuyo.edu.ng +2348121007387 Health Systems and Policy Research Center, University of Uyo
City Postal code Country Position/Affiliation
Uyo PMB1167 Nigeria Senior Lecturer Community Medicine
Role Name Email Phone Street address
Public Enquiries Idongesit Umoh idongesitumoh@uniuyo.edu.ng +23480660060577 Department of Internal Medicine, University of Uyo
City Postal code Country Position/Affiliation
Uyo PMB1167 Nigeria Senior Lecturer and Consultant Cardiologist
Role Name Email Phone Street address
Scientific Enquiries Victor Umoh victorumoh@uniuyo.edu.ng +2348055026582 Department of Internal Medicine, University of Uyo
City Postal code Country Position/Affiliation
Uyo PMB1167 Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Study Protocol From 3-12 months of completion of study Anybody who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information