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.: PACTR201510001290321 Date of Approval: 02/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Peer-led Education Intervention Program in Improving Knowledge, attitude, and practice on Hepatitis B among Non-medical and Non-veter
Official scientific title Effectiveness of Peer-led Education Intervention Program in Improving Knowledge, attitude, and practice on Hepatitis B among Non-medical and Non-veterinary Undergraduate University Students in Nigeria, a Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Introduction: Hepatitis B infection is a life-threatening liver infection caused by hepatitis B virus. It causes chronic liver diseases and chronic infection and put people at higher risk of death from cirrhosis of the liver and liver. Hepatitis B infection is the number eight leading cause of death globally. Globally, there are 2 billion people infected and 360 million with chronic infection. More than 500,000 people die every year from liver cirrhosis resulting from chronic hepatitis B infection. Policies on hepatitis B are not in place and there is no implementation of any kind to fight the high burden in Nigeria. Awareness is very key to the reduction of any infectious disease in the world. In Nigeria, awareness is very low, which has helped to fuel the spread of the virus. General Objective: ¿ To develop, implement and evaluate the effectiveness of student peer- led educational intervention program on Knowledge, Attitude and Practice regarding HBV among Non-medical and veterinary Undergraduate Students of Usman Danfodiyo University, Sokoto Nigeria. Specific objectives: ¿ To determine the socio-demographic characteristics of the respondents (such as age, gender, marital status etc). ¿ To develop an educational intervention module on knowledge, attitude and practice regarding hepatitis B infection. ¿ To implement the educational intervention module among non-medical and non-veterinary undergraduate students of Usman Danfodio University, Sokoto, Nigeria. ¿ To determine at baseline, immediately post-intervention, 3 months, and 6 months post-intervention, the knowledge, attitude and practice regarding hepatitis B infection among the respondents. ¿ To evaluate the effectiveness of the intervention on knowledge, attitude, and practice regarding hepatitis B virus among the respondents.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) No
Disease(s) or condition(s) being studied Hepatitis B Virus Infection
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/06/2015
Actual trial start date 06/06/2015
Anticipated date of last follow up 07/11/2015
Actual Last follow-up date 17/10/2015
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 380
Recruitment status Closed to recruitment,follow-up continuing
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 (spss). Allocation was determined by the holder of the sequence who is situated off site (an independent statistician). Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Educate the participants regarding hepatitis B using the education intervention module Two times for two days 12 HOURS Lectures, video show, pictures, drama play. 95
Experimental Group Experimental group Educate the participants regarding hepatitis B using education intervention module Two times for two days for twelve hours Lectures, video show, pictures, drama play. 95
Control Group Educate the participant with importance of physical activities by a expert in the field Two times for two days 12 hours Lectures and pictures demostration 95 Placebo
Control Group Educate the participant with importance of physical activities by a expert in the field Two times for two days 12 hours Lectures and pictures demostration 95 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Non-medical and Non-veterinary undergraduate students aged 17 to 24 years. Postgraduate students, Foreign students, Final year undergraduate students. 17 Year(s) 24 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 31/03/2015 JKEUPM
Ethics Committee Address
Street address City Postal code Country
University Putra 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 03/06/2015 UDUEC
Ethics Committee Address
Street address City Postal code Country
Usman Danfodiyo University Sokoto New Site Sokoto 840001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Increased HBV Knowledge 1. Immediately 2. One month after 3. Three month after 4. Six month after
Primary Outcome 2. Improved attitude related to HBV 1. Immediately 2. One month after 3. Three month after 4. Six month after
Secondary Outcome Acquiring preventive skills 1. Immediately three months after intervention 2. Immediately six months after inntervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Usman Danfodiyo University Sokoto New Site Usman Danfodiyo University sokoto Sokoto 840001 Nigeria
Old site Usman Danfodiyo University Sokoto Usman Danfodiyo University old site road Sokoto 840001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
TETFUND Abdu Gusau Polytechnic Talata Mafara +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TETFUND Abdu Gusau Polytechnic Talata Mafara 892001 Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
University Putra Malaysia Selengor serdang 43400 Malaysia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lekhraj Rampal dr_rampal1@hotmail.com +60122964308 Faculty of Medicine and Health Science University Putra Malaysia
City Postal code Country Position/Affiliation
Serdang, Selangor 43400 Malaysia Senior Consultant Epidemiologist
Role Name Email Phone Street address
Public Enquiries Hussaini Yakubu Anka yakubuhussaini@ymail.com +2348037853038 Abdu Gusau Polytechnic
City Postal code Country Position/Affiliation
Talata Mafara 892001 Nigeria Principal Lecturer
Role Name Email Phone Street address
Scientific Enquiries Iliyasu Zubairu ziliyasu@gmail.com +2348035868293 Aminu Kano university Teaching Hospital
City Postal code Country Position/Affiliation
Kano 700001 Nigeria Head of Department
REPORTING
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Result URL Hyperlinks
Changes to trial information