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.: PACTR202305893513285 Date of Registration: 16/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of biomedical research literacy program in Lambaréné, Gabon
Official scientific title Contexts and social groups specific, multistage, adaptable by inductive studies- randomised controlled social experiment of a biomedical research literacy program for clinical trials' participants and their social network at CERMEL and other stakeholders in Gabon
Brief summary describing the background and objectives of the trial The recent pandemic of COVID-19 highlighted the need to promote public literacy about knowledge in biomedical research and medicine. To a large extent, sensitization is the method to provide evidence-based information to the public. Sociologically speaking, sensitization corresponds to the concept of secondary socialisation. However, secondary socialization builds on primary socialization, which is acquired through education. We hypothesize that education through several modules will provide stones to research participants and their relatives for an adequate understanding of evidence-based information. The intended objectives of the current study are: - To achieve the internalisation of the literacy program by engaging research participants and members of her/his network to recommend clinical research as a means for evidence-based public health decisions and rules - To update and optimise the corpus acquired during the primary socialisation about evidence generated by science for care seeking, medical decision and recognition of public health rules. Families willing to participate in a clinical study conducted at CERMEL, including adults or parents/ guardians of children, will be invited to enrol in this biomedical research literacy program. One to two members of their social network will also be invited to join the program. Volunteers will be randomly assigned to receive the biomedical literacy program or the study-specific information and consent as usual. Families in the intervention and the control group will be geographically and biologically distinct (at 2 Km away and no family or social relationships). Other social groups living in any place in the country may be invited for this study. The literacy program will be delivered as modules in a teaching class, followed by a group discussion based on multiple-choice questions. An individual examination based on a multiple-choice questionnaire and a short presentation of a randomly assigned topic or module in the
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ICE trials
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola,Fever in children ,Malaria
Purpose of the trial Education /Training
Anticipated trial start date 03/07/2023
Actual trial start date
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date 31/01/2024
Anticipated target sample size (number of participants) 195
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 a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group The biomedical research literacy program Seven modules Six months teaching program The literacy program contents teaching modules that will be delivered as courses followed by group discussions (practical aspects and challenges will be discussed). The modules are as follows :  Concepts and practices of scientific evidence for health care, medical decision, public health decision making  Biomedical research objectives, methods and procedures  Clinical trial objectives, methods and procedures  Ethics and regulation of biomedical research  Ethics and regulation of clinical trials  Make clinical trials a public norm in sub-Saharan Africa  Societal and economic impacts of biomedical research 98
Control Group The biomedical research literacy program None None Placebo, no intervention 97 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Willingness to participate and to invite one to two members of the social networks Signed informed consent None Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 64 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 31/10/2022 Instutional Ethic Committee
Ethics Committee Address
Street address City Postal code Country
Abongo Lambarene BP 242 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To measure the treatment effect of the literacy program on the types of recommendations of clinical research as evidence for public health and willingness to comply with evidence-based rules and recommend compliance to relatives and social network members. At one month post intervention
Secondary Outcome To measure the treatment effect of the literacy program on the understanding of the objectives, methods, procedures, ethics, regulation and expected soTo measure the treatment effect on spontaneous compliance to clinical study procedures. To measure the treatment effect of the literacy program on 1) the perceived impacts of biomedical research (for instance, incentives and/or compensation of short-term and long-term benefits, investments, business economic model), 2) participation of children and vulnerable people to biomedical research, 3) willingness, content and adherence to clinical trial law To measure the treatment effect of the literacy program on the internalisation of secondary socialisation in children At one month post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches Medicales de Lambarene Campus CERMEL Lambarene BP 242 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
CERMEL Campus CERMEL Lambarene BP 242 Gabon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CERMEL Campus CERMEL Lambarene BP 242 Gabon Investigator initiated study
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Selidji Todagbe Agnandji agnandjis@cermel.org +24177353114 Campus CERMEL
City Postal code Country Position/Affiliation
Lambarene BP 242 Gabon CERMEL
Role Name Email Phone Street address
Public Enquiries Anthony Mboumessieyi paul.mboumessieyi@cermel.org +24165443234 Campus CERMEL
City Postal code Country Position/Affiliation
Lambarene BP 242 Gabon CERMEL
Role Name Email Phone Street address
Scientific Enquiries Selidji Todagbe AGNANDJI agnandjis@cermel.org +24177353114 Campus CERMEL
City Postal code Country Position/Affiliation
Lambarene BP 242 Gabon CERMEL
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes "All of the individual participant data collected during the trial, after identification" Study Protocol The data will be available" beginning at 18 months and ending at 36 months following articles publication" "Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose." "Proposal may be submitted up to 36 months following article publication to admin@cermel.org. After 36 months, the data will be available in our research centre data warehouse without investigator support
URL Results Available Results Summary Result Posting Date First Journal Publication Date
cermel.org 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