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.: PACTR202109586981531 Date of Approval: 03/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 1. Assessment of effectiveness of peer –led education in improving contraceptive demand in Gedeo Zone, South Ethiopia. 2. Assessment of effectiveness of peer –led education in improving contraceptive utilization in Gedeo Zone, South Ethiopia. 3. Assessment of effectiveness of peer –led education in improving contraceptive intention in Gedeo Zone, South Ethiopia. 4. Assessment of effectiveness peer –led education in improving adolescent girls’ knowledge and attitude on modern contraceptive in Gedeo Zone, South Ethiopia. 5. Assessment of effectiveness of peer-led education in improving adolescent girls subjective norm & perceived behavioral control in Gedeo Zone, South Ethiopia.
Official scientific title Effectiveness of peer led education interventions in generating contraceptive demand and utilization behavior among adolescents in Gedeo Zone, South Ethiopia. A Cluster Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Intervention and control groups are matched in sociology-demographic and other coverts variables like both arms consider only government schools and assure that no intervention has been conducted in the last four Years in both arms. The comparator compares intervention and control arm based on specific intervention objective set up to resolve barriers to contraceptive demands of adolescent. The intervention approach in the current study will be peer to peer education techniques which has ample evidence on its effectiveness in influencing human behavior. In the current study the intervention take place within schools, often facilitated by peers, with the assistance of teachers or expert trainers. Through these intervention peer educator spread information among their peers about modern contraceptive and they may use exciting structure such as school clubs. Peer-to-peer educations intervention evaluate and compare primarily a short-term outcomes based on specific objective of the current study in relation to modern contraceptive knowledge, attitudes subjective norm, perceived behavioral control, intentions, current use of contraceptive, unmet need for contraceptive and demand to modern contraceptive among intervention and control arms. Peer educator who is recommended by teachers and selected by student will be selected for peer education. On peer educator will be assigned to 7-10 girls/peers (You may use classmates). In addition two females’ teachers per school will be assigned to facilitate the intervention. The interventions may include classroom education or school-wide activities. Peer education will be deliver once in weeks that stay at least to four to six months. 16 sessions of peer education will be delivered either Tuesday or Thursday for 30 minute to 1 hour, attendance sheet will be collected for every session in order to check a who will attend or not. As compliance parameter student should attend at least 80% of the sessions or above.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/09/2021
Actual trial start date
Anticipated date of last follow up 10/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 242
Actual target sample size (number of participants)
Recruitment status Active, not 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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Peer Education on generating contraceptive demand Once in a week For Six Month Intervention and control groups are matched in sociology-demographic and other coverts variables like both arms consider only government schools and assure that no intervention has been conducted in the last four Years in both arms. The comparator compares intervention and control arm based on specific intervention objective set up to resolve barriers to contraceptive demands of adolescent. The intervention approach in the current study will be peer to peer education techniques which has ample evidence on its effectiveness in influencing human behavior. In the current study the intervention take place within schools, often facilitated by peers, with the assistance of teachers or expert trainers. Through these intervention peer educator spread information among their peers about modern contraceptive and they may use exciting structure such as school clubs. Peer-to-peer educations intervention evaluate and compare primarily a short-term outcomes based on specific objective of the current study in relation to modern contraceptive knowledge, attitudes subjective norm, perceived behavioral control, intentions, current use of contraceptive, unmet need for contraceptive and demand to modern contraceptive among intervention and control arms. Peer educator who is recommended by teachers and selected by student will be selected for peer education. On peer educator will be assigned to 7-10 girls/peers (You may use classmates). In addition two females’ teachers per school will be assigned to facilitate the intervention. The interventions may include classroom education or school-wide activities. Peer education will be deliver once in weeks that stay at least to four to six months. 16 sessions of peer education will be delivered either Tuesday or Thursday for 30 minute to 1 hour, attendance sheet will be collected for every session in order to check a who will attend or not. As compliance parameter student should attend at least 80% of the sessions or above. 121 Active-Treatment of Control Group
Experimental Group Peer Education on generating contraceptive demand once in a week For six Month Intervention and control groups are matched in sociology-demographic and other coverts variables like both arms consider only government schools and assure that no intervention has been conducted in the last four Years in both arms. The comparator compares intervention and control arm based on specific intervention objective set up to resolve barriers to contraceptive demands of adolescent. The intervention approach in the current study will be peer to peer education techniques which has ample evidence on its effectiveness in influencing human behavior. In the current study the intervention take place within schools, often facilitated by peers, with the assistance of teachers or expert trainers. Through these intervention peer educator spread information among their peers about modern contraceptive and they may use exciting structure such as school clubs. Peer-to-peer educations intervention evaluate and compare primarily a short-term outcomes based on specific objective of the current study in relation to modern contraceptive knowledge, attitudes subjective norm, perceived behavioral control, intentions, current use of contraceptive, unmet need for contraceptive and demand to modern contraceptive among intervention and control arms. Peer educator who is recommended by teachers and selected by student will be selected for peer education. On peer educator will be assigned to 7-10 girls/peers (You may use classmates). In addition two females’ teachers per school will be assigned to facilitate the intervention. The interventions may include classroom education or school-wide activities. Peer education will be deliver once in weeks that stay at least to four to six months. 16 sessions of peer education will be delivered either Tuesday or Thursday for 30 minute to 1 hour, attendance sheet will be collected for every session in order to check a who will attend or not. As compliance parameter student should attend at least 80% of the sessions or above. 121
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sexually active adolescents from randomly selected senior public secondary school, who will not intend to transfer schools during the intervention period, will be included. Adolescents whose age below 15 Years (<15 Yrs) will be excluded from the study Schools received similar interventions in the Previous 4 years Adolescent: 13 Year-18 Year 15 Year(s) 19 Year(s) Female
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 05/11/2020 Institutional review board of Jimma University
Ethics Committee Address
Street address City Postal code Country
13 Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Contraceptive utilization Behavior 6 month
Secondary Outcome Knowledge, attitude, intention, Perceived behavioral control, Awareness, Subjective norm 4 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla Univesity 12 Dilla 419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
JImma University 12 Jimma 378 Ethiopia
Dilla University 13 Dilla 419 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University 12 Dilla 419 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Dr Zewedie Birhanu zbkoricha@yahoo.com +251917025852 12
City Postal code Country Position/Affiliation
Dilla Ethiopia Asistant Professor
Role Name Email Phone Street address
Principal Investigator Yohannes Addisu johnaddisu21@gmail.com +25911939416 12
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla University
Role Name Email Phone Street address
Public Enquiries Moges Tadesse moges125@yahoo.com +251911923244 13
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol Study Protocol After 5 month Not Access Yet.
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