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.: PACTR201508001215416 Date of Approval: 23/07/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of a Malaria treatment and prevention training program on Patent Medicine Vendor's knowledge, attitudes and practices
Official scientific title Effectiveness of a Malaria treatment and prevention training program on Patent Medicine Vendor's knowledge, attitudes and practices in Yobe-south district, Nigeria.
Brief summary describing the background and objectives of the trial The world Malaria Report (2013) estimated 3.4 billion people at risk of malaria and an estimated 207 million cases that had led to about 627,000 deaths in 2012 alone. 81% of all cases and 91% of the deaths are from sub-Saharan Africa, of which Nigeria alone bears up to 25 percent of malarial disease burden in Africa. Malaria is thus holo-endemic and constitutes a major public health problem in Nigeria, despite the fact that the disease is preventable and treatable. So also, the WHO and the Nigerian government acknowledge that Patent Medicine Vendors (PMVs) represent a valuable human resource for malaria case management in Nigeria and as such play a potential role as partners for malaria control in Nigeria. This huge potential cannot be effectively exploited due to the poor knowledge, attitudes and practices of PMVs, despite the huge mortality / morbidity rates within the country. The general objective of this study is to develop, implement and determine the effectiveness of a malaria treatment and prevention training program on knowledge, attitudes and practices to selected Patent Medicine Vendors in an attempt to improving their activities.
Type of trial RCT
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 Malaria
Purpose of the trial Education /Training
Anticipated trial start date 03/08/2015
Actual trial start date 24/08/2016
Anticipated date of last follow up 10/03/2016
Actual Last follow-up date 10/03/2016
Anticipated target sample size (number of participants) 292
Actual target sample size (number of participants) 292
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Allocation was done with wrapped pieces of paper wrapped to conceal allocation Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training group or Intervention group Training of participants one week period A training program will be conducted on participants of the intervention group 146
Control Group Wait list no training No training will be conducted in this group 139 Placebo
Experimental Group Intervention group Training conducted on group members 140
Control Group Wait list group No training given No intervention given to this group 140
Control Group Control group - One week period No training conducted on group members 146 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Registered PMV's with the national / local associations. - PMV's resident within the study area - PMV's not practicing during study period - PMV's that do not give their consents 16 Year(s) 65 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 13/03/2015 Ethics Committee for Research Involving Human Subjects, University Putra Malaysia
Ethics Committee Address
Street address City Postal code Country
Office of the Deputy Vice Chancellor (Research & Innovation), University Putra Malaysia, 43400 UPM Serdang Selangor - Malaysia Serdang 43400 Malaysia
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 13/03/2015 Ethics Committee for Research Involving Human Subjects, University Putra Malaysia
Ethics Committee Address
Street address City Postal code Country
Office of the Deputy Vice Chancellor (Research & Innovation), University Putra Malaysia, 43400 UPM Serdang Selangor - Malaysia Serdang 43400 Malaysia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome An improvement in KAP of sampled participants Pre-intervention Immediately after intervention At 3 months post-intervention At 6 months post-intervenion
Primary Outcome It will improve treatment and prevention practices among PMVs thereby addressing deficits and gaps ther-in Pre-Intervention Immediately after intervention At 3 months post intervention
Primary Outcome The study will contribute to Health planning and policy formulation activities by providing baseline information on the level of Malaria awareness, treatment and prevention standards Pre-intervention Immediately after intervention At 3 months post-intervention
Secondary Outcome The study will have significance to the scientific community and research activities by having the findings of the study being published in an academic journal to be cited with other research studies in relevant fields Pre-intervention Immediately after intervention At 3 months post-intervention At 6 months post intervention
Primary Outcome It will improve treatment and prevention practices among PMVs thereby addressing deficits and gaps ther-in Pre-Intervention Immediately after intervention At 3 months post intervention At 6 months post-intervention
Primary Outcome The study will contribute to Health planning and policy formulation activities by providing baseline information on the level of Malaria awareness, treatment and prevention standards Pre-intervention Immediately after intervention At 3 months post-intervention
Secondary Outcome The study will have significance to the scientific community and research activities by having the findings of the study being published in an academic journal to be cited with other research studies in relevant fields Pre-intervention Immediately after intervention At 3 months post-intervention At 6 months post-intervention
Primary Outcome It will improve treatment and prevention practices among PMVs thereby addressing deficits and gaps ther-in Pre-Intervention Immediately after intervention At 3 months post intervention
Primary Outcome The study will contribute to Health planning and policy formulation activities by providing baseline information on the level of Malaria awareness, treatment and prevention standards Pre-intervention Immediately after intervention At 3 months post-intervention At 6 months post intervention
Secondary Outcome The study will have significance to the scientific community and research activities by having the findings of the study being published in an academic journal to be cited with other research studies in relevant fields Pre-intervention Immediately after intervention At 3 months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAPPMED Potiskum Bakin Kasuwa Potiskum Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor NAFDAC Federal Secretariat Complex Damaturu Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Kabiru Sabitu Faculty of Medicine, Ahmadu Bello University Zaria Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yahaya Mohammed Katagum mkyahaya07@gmail.com (+234) 803 606 4563 No 9 old Kano Road
City Postal code Country Position/Affiliation
Azare Nigeria
Role Name Email Phone Street address
Public Enquiries Yahaya Mohammed Katagum mkyahaya07@gmail.com (+234) 803 606 4563 No 9 old Kano Road
City Postal code Country Position/Affiliation
Azare Nigeria
Role Name Email Phone Street address
Scientific Enquiries Faisal Bin Ibrahim faisalupm@upm.edu.my (+60) 038947 2416 University Putra Malaysia
City Postal code Country Position/Affiliation
Serdang 43400 Malaysia
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information