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.: PACTR202404852537141 Date of Approval: 30/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title LIVEX PROJECT
Official scientific title Improving physical and mental well-being of persons affected by NTDs: a 4-arm cluster-randomized trial.
Brief summary describing the background and objectives of the trial The World Health Organization (WHO) estimates that mental disorders (especially depression and anxiety disorders) will be the highest cause of disease burden by 2030. WHO declares that, “The world is accepting the concept of universal health coverage (UHC). Mental health must be an integral part of UHC. Nobody should be denied access to mental health care because she or he is poor or lives in a remote place.” WHO estimates that by 2023, universal health coverage (UHC) will ensure access to quality and affordable care for mental health conditions in 12 priority countries to 100 million more people. In Nigeria, neglected tropical diseases (NTDs) including leprosy, lymphatic filariasis (LF) and Buruli ulcer (BU) co-exist in many states and are often associated with high levels of stigma and discrimination owing to their tendency to cause visible deformities. Over time, stigma and discrimination negatively impact the well-being and mental health of persons with these diseases resulting especially in depression, anxiety disorders or even suicidal ideation. The Country NTD Master Plan 2021-2025 and the Neglected Tropical Diseases (NTD), Nigeria multi-year Master Plan both described the need to focus on reducing morbidity, disability and mortality due to NTDs using integrated and cost-effective approaches. Mental health services in Nigeria are deficient in quantity and quality. It is estimated that there is currently one psychiatrist to one million inhabitants and 40:1,000,000 for psychiatric nurses. Furthermore, distribution of the available professionals is grossly skewed in favour of urban areas. This study is designed to ascertain the effectiveness, acceptability and feasibility of providing both mental health and self-care interventions in an integrated approach to improve quality of life and social inclusion as well as reduce disability and cost of healthcare by families affected by leprosy, Buruli ulcer (BU) and lymphatic filariasis (LF).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied Leprosy, Buruli Ulcer and Lymphatic Filariasis
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2022
Actual trial start date 01/10/2022
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 238
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ARM A The groups in this arm met once every month where they practice self care and got basic mental health services(Screening for depression then counselling/referral if needed) from the NTD-Champions. 8 months July 2023 to February 2024 This intervention arm was provided with mental health and self-care interventions. 5 integrated Self Help Groups (SHG) were established in this arm with an average of 10 persons affected per SHG. Local SHG Facilitators who are community members not affected by NTDs were recruited and trained to directly support the respective SHGs operations, under the overall supervision of NTD-Champions (Persons affected by NTDs who are done with treatment and willing to serve others) in-charge of the cluster. During the meeting they practiced self care and got basic mental health services(Screening for depression then counselling/referral if needed) from the NTD-Champions. 72
Experimental Group ARM B The groups in this arm met once every month where they practiced self care and get basic mental health services(Screening for depression then counselling/referral if needed) from the Healthcare workers 8 months July 2023 to February 2024 This intervention arm was provided with mental health and self-care interventions. 5 integrated Self Help Groups (SHG) were established in this arm with an average of 10 persons affected per SHG. Local SHG Facilitators who are community members not affected by NTDs were recruited and trained to directly support the respective SHGs operations, under the overall supervision of Healthcare workers in-charge of the cluster. During the meeting they practiced self care and get basic mental health services(Screening for depression then counselling/referral if needed) from the Trained Healthcare workers. the difference between this ARM and ARM A is that this ARM is coordinated by Healthcare workers. 57
Experimental Group ARM C The groups in this arm met once every month where they practiced self care and get basic mental health services(Screening for depression then counselling/referral if needed) from the Healthcare workers. 8 months July 2023 to February 2024 This intervention arm was provided with self-care interventions only without mental health intervention. 5 integrated Self Help Groups (SHG) were established in this arm with an average of 10 persons affected per SHG. Local SHG Facilitators who are community members not affected by NTDs will be recruited and trained to directly support the respective SHGs operations, under the overall supervision of Healthcare workers in-charge of the cluster. During the meeting they practiced self care ALONE without mental health intervention. and this is coordinated by healthcare workers. The absence of mental health is the basic difference between this ARM and ARMS A&B. 53
Control Group ARM D No interventions was carried out in this arm. No interventions was carried out in this arm. No interventions was carried out in this arm. 51 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Persons affected by leprosy, Buruli ulcer or Lymphatic filariasis including children with G2D, Category III BU lesions, BU complications such as contractures and other conditions (who need self-care) Family members of persons affected by NTDs who give consent to participate Persons affected by NTDs who are willing to learn and practice self-care Consent to participate in SHG meetings of persons affected by leprosy, BU and LF Persons who are unable to participate due to severe illness 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 6 Year(s) 90 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 17/02/2023 University of Nigeria teaching Hospital ethics committee Enugu.
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla Enugu-Porthrcourt Expressway Enugu 400102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved well-being (physical, mental and socioeconomic) and quality of life of persons affected by NTDs in Nigeria Post-intervention
Secondary Outcome Reduced stigma and discrimination related to NTDs Post-intervention
Secondary Outcome Improved morbidity management practices (physical and mental) for persons affected by NTDs Post-intervention
Secondary Outcome Strengthened health system through sustainable community participation in control of NTDs Post-intervention
Secondary Outcome Increased action by NTBLCP and NTD Units of the Federal Ministry of Health toward best practices in morbidity management of people affected by NTDs. Post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bende Local Government Headquarters Abia State Bende Abia State 440001 Nigeria
Aninri Local Government Area Aninri Community Enugu State 402142 Nigeria
Oji River Local Government Area Oji River Leprosy settlement Enugu State 401145 Nigeria
Ago ireti leprosy settlement Akure Ago ireti leprosy settlement Akure LGA Ondo state 340106 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
EFFECT HOPE CANADA Effect Hope 101-20 Valleywood Dr Markham, ON L3R 6G1 Canada Ontario K0A 0A1 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EFFECT HOPE CANADA 20 Valleywood Dr Unit 101, Markham, ON L3R 6G1, Canada Ontario K0A 0A1 Canada Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ngozi Ekeke ngozi.ekeke@redaid-nigeria.org 08035076274 56 Nza street independence layout Enugu
City Postal code Country Position/Affiliation
Enugu 400102 Nigeria Senior Programe Manager
Role Name Email Phone Street address
Public Enquiries Francis Iyama francis.iyama@redaid-nigeria.org 08147652510 56 Nza Street Street Independence layout
City Postal code Country Position/Affiliation
Enugu 400102 Nigeria Monitoring and Evaluation Officer
Role Name Email Phone Street address
Scientific Enquiries Ngozi Ekeke ngozi.ekeke@redaid-nigeria.org 08035076274 56 Nza Street Independence layout
City Postal code Country Position/Affiliation
Enugu 400102 Nigeria Senior Program Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial, after identification will not be available to the public. Study Protocol, and Clinical Study Report, will be published. Only the result or the finding of the study will be made available following publication to anyone who wishes to get it. Clinical Study Report,Study Protocol immediately after publication Researchers who provide a methodologically sound proposal to achieve the aims in the proposal
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