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.: PACTR202107905622610 Date of Approval: 16/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of School Linked Adolescent Friendly Sexual and Reproductive Health Interventions on Knowledge and Services Utilization Among Adolescents in Pastoral Districts of Guji Zone South Ethiopia
Official scientific title Effect of School Linked Adolescent Friendly Sexual and Reproductive Health Interventions on Knowledge, Life Skills, Services Quality and Utilization Among Adolescents in Pastoral Districts of Guji Zone South Ethiopia
Brief summary describing the background and objectives of the trial Although the governments have been launched youth and adolescent friendly Sexual and reproductive Health services, Adolescent Sexual and Reproductive Health are less studied and remains as problem in Developing countries. AFSRH services play important roles in improving ASRH. However, although there is increasing demand for service among adolescent population they are not properly utilized SRHS in public facilities. Although much has done about ASRH, still we know little about School-Linked AFSRH intervention in pastoral district of South Ethiopia. The overall objective of this study is to determine the Effect of School-Linked Adolescent friendly sexual and reproductive health intervention on knowledge, Life Skill, Services Quality and Utilization among pastoral Districts of Guji Zone, South Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AFSRH
Disease(s) or condition(s) being studied Adolescent Sexual and Reproductive Health problem
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 20/07/2021
Actual trial start date 23/07/2021
Anticipated date of last follow up 20/01/2022
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 788
Actual target sample size (number of participants) 788
Recruitment status Active, not recruiting
Publication URL No Identified
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group School Linked Reproductive Health Education training and intervention on Adolescent health CSRH Education and Life skill training 40 minutes every meek for 24 times RHC 2 hour every month for 6 times duration Provision of Selected SRH Issues 1 hours every other week for 6 times For six month The intervention packages have mainly categorized in to three. Includes (Providing Age relevant CSRH education, life skills development training and provision of selected AFSRH services) 1. Provide Comprehensive Sexual and Reproductive Health education and life skill development training at intervention schools for 40 minutes every week for six month  It is a rights-based and gender-focused approach to sexuality and reproductive Health education 2. Provide counseling and selected Adolescent Friendly Sexual and Reproductive Health services at intervention schools 40 minutes every week for six month  It is proposed services for a trial intervention includes (Information and counseling Promotion of healthy sexual behaviors FP information, STI/HIV Prevention and treatment and appropriate referral 3. Establish orient and lead school Reproductive health club at intervention schools for 2 hours every month for six month  RH Club is the members of organized adolescent for the purpose of promotion of healthy sexual behaviors through sharing right RH Information using Mimi media, peer education, conversations on selected topics, HIV counseling and testing, STIs symptoms and treatment, discourage unsafe sexual practices and unsafe abortion encourage Utilizing of AFRH Services. 394
Control Group No specific intervention control No any intervention dose six month Just observation but their status survey will have conducted on the beginning and at end line of the study 394 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria were being middle and late adolescents with age interval of 14-16 and 17-19 years who has been enrolled in randomly selected schools for quantitative study and in case of qualitative study age 15+ adolescent who ever utilized AFSRH Services. The exclusion criteria in case of qualitative data collection were adolescent age group 15+ who never utilized AFSRH Services. Adolescent: 13 Year-18 Year 14 Year(s) 19 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 18/04/2020 Jimma University Health Institute IRB
Ethics Committee Address
Street address City Postal code Country
Ferenji Arada street Jimma Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sexual and Reproductive Health Knowledge within one month just after baseline survey and at end line of the intervention
Primary Outcome Participant Life skill within one month just after baseline survey and at the end line of the intervention
Secondary Outcome Adolescent Friendly Sexual and Reproductive Health Service utilization within one month just after baseline survey and at the end line of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gorodola District Bitata Harekello Street Harekello Not avail Ethiopia
Wadara Kontoma Wadara Street Wadara Not avail Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
PhD Research Grant Ferenji Arada street Jimma Jimma 378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Federal Ministry of Health Ethiopia Uganda Street Addis Ababa 1000 Ethiopia Ministry Of Health salary during study periods
COLLABORATORS
Name Street address City Postal code Country
Oromia Regional Health Bureau Adems Pavlion Street Addis Ababa 1000 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gobena Boku godana.t@yahoo.com +251911545441 Sebeta Alemgana Street
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Members of Ethiopian Public Health Association
Role Name Email Phone Street address
Public Enquiries Kasu Tola kasu.tola@yahoo.com +251913261518 Sebeta Alemgana Street
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Senior Member of Public Health
Role Name Email Phone Street address
Scientific Enquiries Silesh PhD Garama garamaabe@gmail.com +251911076012 Jamo street
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia University Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD Reports will have prepared for all baseline and end line study. we plan each of the survey outcome will have published on reputative or impact factor journals Informed Consent Form,Statistical Analysis Plan,Study Protocol just within two week of baseline survey data collection and after six month or End line survey period being student at study sites, being adolescent and Sexually active,
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not Identified 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