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.: PACTR202205543939385 Date of Approval: 18/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Audio and written interventions to improve the perception of leprosy
Official scientific title Participatory development of audio-delivered interventions and written material and assessment of their impact on the perception and knowledge of and attitudes towards leprosy: A cluster randomised trial in Nigeria
Brief summary describing the background and objectives of the trial In Nigeria, like in many leprosy-endemic countries, leprosy is highly stigmatized. High levels of stigma among community members as well as internalized stigma among persons affected by leprosy often result in negative psychosocial consequences for persons affected and persons with disabilities. To break this vicious cycle, it is important that context-specific behavioural change activities are carried out. Although written material has been successful in improving knowledge and perception, written material is not suitable for populations with low educational levels. Audio-delivered interventions are likely to be more suitable for illiterate persons. The current project aims to assess the impact of an audio-delivered intervention on the perception (knowledge, attitudes, beliefs) of community members with regard to leprosy in Nigeria (by comparing an audio-delivered intervention with written health education and a control group). This project aims to answer the following research question: “What is the impact of an audio-delivered intervention compared to written information on the perception (knowledge, attitudes, beliefs) of community members with regard to leprosy in Nigeria?” The current study will use a mixed-methods cross-sectional study design for the intervention development, and a three-arm cluster randomised trial for the intervention implementation and evaluation, comprising: 1. Baseline assessments of knowledge, attitudes, perceptions and fears of community members in order to develop the audio-delivered content and written material. 2. Baseline assessment of self-esteem and internalized stigma of persons affected by leprosy. 3. Participatory development of the audio-delivered content and written material by persons affected by leprosy. 4. Pilot and implementation of the interventions in Nigeria. This will be done among different groups who will be compared (control group, audio-intervention group, written material group). Groups to be selected as CRT
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied Leprosy
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2023
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 385
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Audio Intervention 6 months An audio-delivered intervention for education on leprosy, awareness raising and stigma reduction. The content will be developed based on local beliefs, misconceptions and fears about leprosy identified in the baseline study. This will be done using participatory approaches. A group of persons affected by leprosy will be formed, who will be guided by a researcher to develop the messages and materials (participatory development). The key messages of the audio-delivered and written interventions will be the same. 114
Experimental Group Written Intervention 6 months A written-delivered intervention for education on leprosy, awareness raising and stigma reduction. The content will be developed based on local beliefs, misconceptions and fears about leprosy identified in the baseline study. This will be done using participatory approaches. A group of persons affected by leprosy will be formed, who will be guided by a researcher to develop the messages and materials (participatory development). The key messages of the audio-delivered and written interventions will be the same. 114
Control Group Control 6 months No intervention 157 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Only individuals of 18 years or older will be included Participants who do not speak Nigerian Pidgin or Hausa will be excluded. Persons unable or unwilling to give informed consent will be excluded. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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
No 25/05/2022 Health Research and Ethics Committee University of Nigeria Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu Enugu 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge, attitudes and practices using the KAP measure Baseline and follow-up
Primary Outcome Community stigma, using the EMIC Community Stigma Scale (EMIC-CSS) Baseline and follow-up
Primary Outcome Social distance towards persons affected by leprosy using the Social Distance Scale (SDS) Baseline and follow-up
Secondary Outcome Self-esteem and internalised stigma of persons affected by leprosy, using Rosenberg’s self-esteem scale Baseline and follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cross River State Calabar-South and Obubra Local Government Areas Calabar Nigeria
Taraba State Jalingo and Zing Local Government Areas Jalingo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Leprosy Research Initiative Wibautstraat 137k 1097 DN Amsterdam Amsterdam Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Leprosy Research Initiative Wibautstraat 137k 1097 DN Amsterdam Amsterdam Netherlands Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Anna van t Noordende Wibautstraat 137K 1097DN Amsterdam Amsterdam Netherlands
Carolin Gunesch Raiffeisenstrasse 3 97080 Wurzburg Wurzburg Germany
Dr. Tahir Dahiru No 30 Da Chibi Rwang Street Jos Jos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ngozi MurphyOkpala ngozi.murphyokpala@dahw.org 2348033705461 56 Nza Street Independence Layout
City Postal code Country Position/Affiliation
Enugu Nigeria Medical Adviser
Role Name Email Phone Street address
Public Enquiries Joseph Chukwu joseph.chukwu@dahw.org +2348036678024 56 Nza Street Independence Layout
City Postal code Country Position/Affiliation
Enugu Nigeria Ag. CEO and Medical Coordinator
Role Name Email Phone Street address
Scientific Enquiries Ngozi MurphyOkpala ngozi.murphyokpala@dahw.org +2348033705461 56 Nza Street Independence Layout
City Postal code Country Position/Affiliation
Enugu Nigeria Medical Adviser
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) will be shared. Informed Consent Form,Study Protocol Beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal may 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