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.: PACTR202311734380682 Date of Approval: 27/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of an association-led intervention on knowledge and compliance with regulatory practices on service provision among proprietary and patent medicine vendors in Oyo state, Nigeria.
Official scientific title Effect of an association-led intervention on knowledge and compliance with regulatory practices on service provision among proprietary and patent medicine vendors in Oyo state, Nigeria.
Brief summary describing the background and objectives of the trial The concept of Universal Health Coverage (UHC) which includes more access to care, dignified standard of treatments and improved health outcomes as well as its achievement in most of the countries in sub-Saharan Africa depends largely on the availability of well-trained healthcare personnel but in sub-Saharan Africa this need is often not met due to a shortage of workers in the healthcare sector. UHC cannot be achieved without the participation of private-sector partnership due to limited budgets from both governments and international donors, as well as implementation challenges. A sub-set of this sector comprises of healers, traditional birth attendants (TBA) midwives and patent and proprietary medicine vendors (PPMV) who provides care mainly to the poor and underserved in sub-Saharan Africa. There is however a dearth of intervention studies directly leveraging the role of local PPMV associations. These association could be a powerful tool in ensuring that members adhere to regulatory requirements and deliver high quality services aimed at improving PPMVs treatment practices (Liu et al., 2016, Durowade et al., 2018). These association could also be explored as a window for monitoring and strengthening the activities of the PPMVs which will come at a low cost (Durowade et al 2019). This research was developed to address these gap in knowledge. The broad objective of the study is to implement association-led intervention and evaluate the effect of an intervention on knowledge and compliance among PPMVs in Oyo State, Nigeria.The objectives of the trial are 1. To estimate the knowledge of PPMVs on existing guidelines regulating their practice 2. To determine the level of compliance of registered PPMVs to the guidelines regulating their practice 3. To identify influencing factors to compliance among registered PPMVs with the guidelines regulating their practices 4. To describe PPMV associations capacity and operation in monitoring compliance with existing guidelines
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) PPMV
Disease(s) or condition(s) being studied Compliance
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2024
Actual trial start date 30/01/2024
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date 30/09/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 100
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
Single Group Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training Bi-monthly Five months The intervention will involve the use of a training curriculum, result from the baseline (questionnaire, KII and IDI) will be used as guide to develop the curriculum to be used for the intervention group. The primary purpose of which is bringing the task force executive members to speed on knowledge and compliance with regulatory practices on service provision and indicators that will be used to monitor compliance among their members. The content of this curriculum will be developed with the assistance of PPMVs regulatory agency (PCN) with inputs from Public Health professionals. Qualitative Phase: Prior to each KII and IDI, a one-day training session will be conducted for all interviewers. The training session will adopt adult learning methodologies including return demonstrations, questions-answer session, presentation. It will focus on the study objectives; review and use of the KII and IDI tools (guides, demographic tools, recorders, and informed consent forms); expected behaviour to be modelled during the interview session and outcomes. To ensure optimum participation and contribution by all participants, the IDI guide will be translated to and administered in the local (Yoruba) dialect. Interviews will take place at individual offices for the KIIs, and a place agreed upon for the IDIs. Interviews will be conducted within 2 weeks with 4 interviews scheduled per week. Participants for each KII and IDI will be pre-informed [by telephone calls by research assistant] of the proposed study and other important details pertaining to the qualitative research clear and succinct enough to enable informed decision and participation. Based on participants’ feedback, an activity schedule will be drawn up which will include allocated dates for each participant per KII and IDI sessions. SMS which will serve as reminder containing venue, time for the discussion will be dispatched to participants prior to the actual KII and IDI sessions by research assistant. Each interview wil 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. All local PPMV association executives operating in the selected LGA. ii. All PPMVs who are willing to participate. iii. All PPMV that gives informed consent. iv. All PPMVs who are owners of the shops. i. All local PPMV Association executives and PPMVs at the selected LGAs who are not available as well as those not willing to participate in the study. ii. PPMVs who are undergoing apprenticeship. Adult: 19 Year-44 Year 18 Year(s) 60 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 13/10/2023 University of Ibadan and University College Hospital Ethical Review Board
Ethics Committee Address
Street address City Postal code Country
College of Medicine, Ibadan, Nigeria Ibadan 200113 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome It is anticipated that the design and implementation of this association-led intervention among PPMVs will significantly contribute to increase in knowledge of the regulatory practices on service provision as well as increase in compliance level with the regulatory practices which will in turn make the PPMVs safer contacts to the members of the communities which they serve. Four months after intervention
Secondary Outcome Intervention for local PPMV association that will result in improving standard of practice among PPMV and increased rate of compliance with guidelines regulating their practice. Four months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ibadan Oyo State Nigeria Egbeda and Akinyele LGA of Oyo State, Nigeria Ibadan Oyo State Nigeria 200113 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Comfort Avenue, Avenue, Jericho Ibadan 20013 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Temitope Ajayi INTECU, OAU IleIfe 230232 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olayinka ajayi Himmielove@gmail.com 2348032295330 Comfort Avenue
City Postal code Country Position/Affiliation
Ibadan 200113 Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries Olayinka Ajayi Himmielove@gmail.com +2348032295330 Comfort Avenue
City Postal code Country Position/Affiliation
Ibadan 200113 Nigeria Public Enquiry
Role Name Email Phone Street address
Scientific Enquiries Ademola Ajuwon ajajuwon@gmail.com +2348034892561 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200113 Nigeria Suoervisor
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 de-identification will be made available YES Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be made available YES Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Data will be made available to investigators who wishes to access
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