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.: PACTR202309818377202 Date of Approval: 01/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assess the Effect of Sexual and Reproductive Health Training Package using problem based learning (SRHpbl) on Knowledge, Attitude and Self reported Sexual behavior among secondary adolescent: A Cluster Randomized Trial in Mwanza
Official scientific title Assess the Effect of Sexual and Reproductive Health Training Package using problem based learning (SRHpbl) on Knowledge, Attitude and Self reported Sexual behavior among secondary adolescent: A Cluster Randomized Trial in Mwanza
Brief summary describing the background and objectives of the trial Background: Teenage pregnancy, school dropout and sexually transmitted infection including human immunodeficiency virus continue to be a great concern in Tanzania. According to different studies showed that the problems are increasing despite of interventions which are exists. The sexual and reproductive health training package could be a potential intervention to address the identified issue. Objective of the study The broad objective is to assess the effect of sexual and reproductive health training package using problem based learning approach on knowledge, attitude and self-reported sexual behaviour among secondary adolescents: a cluster randomized control trial in Mwanza region, Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SRHpbl
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 10/05/2023
Actual trial start date 16/05/2023
Anticipated date of last follow up 22/05/2023
Actual Last follow-up date 07/07/2023
Anticipated target sample size (number of participants) 560
Actual target sample size (number of participants) 555
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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SEXUAL AND REPRODUCTIVE HEALTH TRAINING ONCE 2 WEEKS SRH training package was a package prepared by the principal investigator whereby its contents were extracted from the training packaged developed by Ministry of health with the collaboration of other stake holders titled “Mwongozo wa mafunzo ya afya ya uzazi, jinsia na stadi za kazi. The intervention was conducted in a parallel 10 secondary schools in Ilemela municipal-Mwanza region whereby this group were subjected to SRH training and the rest 10 schools were continued with their business as usual (control one). The intervention aimed to impact study participant’s with SRH information’s towards improving knowledge, attitude and formulation of new sexual behavior. The interventions were delivered by trained RAs, two per cluster. The package consists of five sessions that were conducted for total of two weeks in all the 10 clusters under intervention. The package used three main methods for facilitation of learning including role plays, lecture discussion and problem-based learning methods as active ingredients of the intervention. Problem based learning dominated the study because this method asked the study participants to solve a case that was similar to the problems they face in their daily life. The study participants assumed ownership of their learning while trainer played part more in facilitation process. The study participants engaged in inquest and self-directed learning as they builded their knowledge in the course of numerous problem solving procedures. Moreover, the study participants worked with their peers and resolve their differing ideas come upon inquest. Therefore this teaching strategy was efficient in preparing the study participants for all types of difficulties encountered in the aspect of behavior/practice (Tawfik et al., 2021). As opposed to pure lecture methods use for the school health promotion program, these teaching and learning methods helped the student to participate actively in teaching and learning activities, thus understood the contents, used critical thinking and learned how to solve the problems (Fran, 2021;Einstein 2022).These processes lead to increase of knowledge, change the adolescent’s attitude and sexual behaviors (Davis,2006 ). 280
Control Group usual care once 2weeks The control group continue with the usual care which provided with their teachers 280 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility of school will involve government school allocated in more periphery adolescent’s girls and boys aged 12 to 19 years, current student in secondary school under study in Ilemela district. Adolescents who have conditions such as epilepsy . A student enrolled in an SRH training as determined during screening excluded to prevent bias. Adolescents who was absent at school during the time when the study conducted. Adolescent: 13 Year-18 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 25/04/2023 UDOM INSTITUTIONAL RESEARCH REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
BENJAMIN MKAPA STREET,P.O BOX 259 DODOMA 41107 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge T0,T1,and T2
Secondary Outcome knowledge, Attitude and self reported sexual behavior T2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ilemela Mwanza Ilemela municipal Mwanza 33200 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF DODOMA DODOMA 41101 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NAOMI LAWRENCE MZEE DODOMA DODOMA 41101 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
GOLDEN MASIKA MWAKIBO DODOMA DODOMA 41101 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NAOMI MZEE azitamzee78@gmail.com +255745646599 DODOMA
City Postal code Country Position/Affiliation
DODOMA 41101 United Republic of Tanzania STUDENT
Role Name Email Phone Street address
Scientific Enquiries GOLDEN MASIKA gmwakibo@gmail.com +255717813222 DODOMA
City Postal code Country Position/Affiliation
DODOMA 41101 United Republic of Tanzania SUPERVISOR
Role Name Email Phone Street address
Public Enquiries ANGELINA JOHO johoangeljoho@yahoo.co.uk +255784788302 DODOMA
City Postal code Country Position/Affiliation
DODOMA 41101 United Republic of Tanzania SUPERVISOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available and the results reported in these article after the deidentification will be shared, also the study protocol will be available. The data will be available immediately following publication with no end date and it will be shared with the researchers who will provide a methodological sound proposal to achieve aims in the approved proposal. Data will be available indefinitely at a link to be provided after publication. Study Protocol The results will be available after 1 month because are still in the process The information will be shared through emails ,and any information request will be shared by scientific inquiries, public inquires and principle investigator
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