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.: PACTR202009656160779 Date of Registration: 02/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Addressing Teenage Pregnancies among Adolescents: Designing and Testing Effectiveness of Problem-based Learning Intervention in Tanzania
Official scientific title Integrated reproductive health content in a problem-based learning pedagogy for shaping safe sexual behavior among adolescents in Tanzania: A Randomized controlled trial
Brief summary describing the background and objectives of the trial The well-being of adolescents is crucial to the development of a country through its potential contribution to economic prosperity. However, Adolescents aged between 10 to 19 years old face problems ranging from their basic needs to economic needs. Unsafe sexual behaviors among adolescents remain substantial public health, as well as a growing concern worldwide. The Ministry of Health Community Development Gender Elderly and Children reported that 27% of adolescents in Tanzania for example, get underage pregnancies and an estimated 8,000 adolescent girls drop out of school every year. Moreover, the report noted that 57% and 48% of young women and men respectively, report having had sex by the age of 18 years. 35% of females and 33% of males aged between 10 to 14 years were reported to have HIV infection. The current study assumes that unsafe sexual behavior develops among adolescents aged between 10 to 19 years persists due to a lack of non-cognitive skills necessary for their early years of life. This study, therefore, aims at testing the effectiveness of a problem-based learning approach to shaping safe sexual behavior among 647 randomly selected school-going adolescents. As it has worked elsewhere, Problem-Based Learning intervention programs have improved later life outcomes when done in the early years of life because non-cognitive skills are malleable at that time. In conclusion, findings will help to improve educators/teachers/parents' and adolescent’s roles, and modalities in teaching and learning sexual and reproductive health respectively. They will initiate remedial strategies to improve adolescents’ reproductive health in Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PBL
Disease(s) or condition(s) being studied Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/09/2019
Actual trial start date 30/09/2019
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 870
Actual target sample size (number of participants) 660
Recruitment status Completed
Publication URL https://doi.org/10.1080/21642850.2022.2046474
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 by using procedures such as coin-tossing or dice-rolling 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 Pure Problem Based Learning Intervention Participants will learn by face-to-face delivery method for a maximum of 2 hrs per week (two sessions/week) to deliver 3 topics of sexual and reproductive health within 10 weeks An intervention will run for 10 weeks in the mid-semester 2018/2019 and the first semester of the academic year 2019/2020. A specified intervention will be school-based that intends to shape safe sexual behavior among a cohort of school-going adolescents. Three (3) intervention arms (A, B, and C) will be involved of which, the first arm (Institution A) will be taught sexual and reproductive health by Pure PBL (without lecture) and the second arm (Institution B) by hybrid PBL (with Lecture). The control (Institution C) arm will be taught the content by lecture (conventional) method. The study participants will learn the PBL content about SRH through ill-structured real-life problems. The developed problem will be paper-based in the form of scenarios that had approximately 500 words and pictures. The session of the first day will be used for problem presentation, exploration, and the identification of learning issues. The session of the second day will serve for experience and knowledge sharing, discussions, challenging information, and peer evaluation. Participants will learn by face-to-face delivery method for a maximum of 2 hrs per week (two sessions/week). The 10-minutes in a session will be devoted to mini-lecture to introduce problems and to fill the gaps within the scenario problems. Sessions will be scheduled to be conducted during morning times (half-day sessions) after a negotiation made with the headmaster/teacher of the respective schools. 2 to 5 Participants will randomly be selected for an informal interview after each try-outs to share their experiences post-intervention 142
Control Group Lecture Based Learning LBL The face-to-face delivery method for 2 hrs per week (two sessions/week) to deliver 4 topics of sexual and reproductive health content within 10 weeks An intervention will run for 10 weeks in the mid-semester 2018/2019 and the first semester of the academic year 2019/2020. The conventional teaching method will be used to conduct tutorials in all sessions per day/week among participants in the control group. The face-to-face delivery method for 2 hrs per week (two sessions/week). Teaching-learning processes will be retained according to the existing conventional approach. No self-directed learning time will be given to the participants as they will learn the content through lecture-discussion whereas instructors will typically deliver information and facts, explaining terms, pictures, concepts, and procedures. Sessions will be scheduled to be conducted during morning times (half-day sessions) after a negotiation made with the headmaster/teacher. There will be no informal interviews after classroom sessions. 317 Active-Treatment of Control Group
Experimental Group Hybrid Problem Based Learning HPBL Intervention Participants will learn by face-to-face delivery method for a maximum of 2 hrs per week (two sessions/week) to deliver 3 topics of sexual and reproductive health within 10 weeks An intervention will run for 10 weeks in the mid-semester 2018/2019 and the first semester of the academic year 2019/2020 A specified intervention will be school-based that intends to shape safe sexual behavior among a cohort of school-going adolescents. Three (3) intervention arms (A, B, and C) will be involved of which, the first arm (Institution A) will be taught sexual and reproductive health by Pure PBL (without lecture) and the second arm (Institution B) by hybrid PBL (with Lecture). The control (Institution C) arm will be taught the content by lecture (conventional) method. The study participants will learn the PBL content about SRH through ill-structured real-life problems. The developed problem will be paper-based in the form of scenarios that had approximately 500 words and pictures. The session of the first day will be used for problem presentation, exploration, and the identification of learning issues. The session of the second day will serve for experience and knowledge sharing, discussions, challenging information, and peer evaluation. Participants will learn by face-to-face delivery method for a maximum of 2 hrs per week (two sessions/week). The 10-minutes in a session will be devoted to mini-lecture to introduce problems and to fill the gaps within the scenario problems. Sessions will be scheduled to be conducted during morning times (half-day sessions) after a negotiation made with the headmaster/teacher of the respective schools. 2 to 5 Participants will randomly be selected for an informal interview after each try-outs to share their experiences post-intervention 188
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Informed Consent Age Exposed to sexual and reproductive health contents Enrolled in ordinary level secondary schools Consented to participate in the study Participating in other projects Health problems Severe cognitive impairment Inability to talk and understand Swahili language as there were no funds for translation services in this study Form four students (they were in their final examination preparations) Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year 12 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 21/08/2019 DIRRC
Ethics Committee Address
Street address City Postal code Country
UDOM Dodoma Box 259 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sexual and Reproductive health Knowledge, and soft skills for safe sexual behavior among adolescents At baseline, immediate, three months and six months post-intervention
Secondary Outcome Sexual behavior - Abstinence, Condom use At 6-months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Secondary schools Kondoa district council, Dodoma municipal council, Lindi municipal council and Kilwa district council Dodoma and Lindi regions Box 914 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Education Science and Technology Dodoma Dodoma Box 10 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MoEST Dodoma Dodoma Box 10 United Republic of Tanzania Governmental Body
COLLABORATORS
Name Street address City Postal code Country
Dr. Stephen M. Kibusi The University of Dodoma Dodoma Box 259 United Republic of Tanzania
Prof. Kalafunja M. Osaki St. Augustine University of Tanzania Dar es Salaam Box 72359 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walter Millanzi wcleo87@outlook.com +255768969530 College of Health Sciences
City Postal code Country Position/Affiliation
Dodoma Box 395 United Republic of Tanzania Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Kalafunja Osaki kalafunja@gmail.com +255754296381 St. Augustine University
City Postal code Country Position/Affiliation
Dar es Salaam Box 395 United Republic of Tanzania Professor
Role Name Email Phone Street address
Scientific Enquiries Stephen Kibusi skibusi@gmail.com +255712600966 College of Health Sciences
City Postal code Country Position/Affiliation
Dodoma Box 395 United Republic of Tanzania Deputy Principal
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I would like to share the baseline and end-line documents of the trial Study Protocol At baseline, intervention, immediate (one month after intervention), 3-months and 6-month post-intervention as follow-ups Principal Investigator The University of Dodoma Dr. Stephen M. Kibusi Prof. Kalafunja M. Osaki
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