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Trial registered on ANZCTR


Registration number
ACTRN12613000900718
Ethics application status
Approved
Date submitted
19/07/2013
Date registered
13/08/2013
Date last updated
13/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting sexual and reproductive health among adolescents in southern and eastern Africa – mobilizing schools, parents and communities
Scientific title
Will a manualised comprehensive sexual health and HIV prevention intervention facilitated by teachers, peer educators and health care providers compared to standard curriculum, reduce sex initiation, increase sexual health communication between learners with peers and significant adults (teachers and parents) and in adolescents self-reporting sexual activity increase safer sexual practices in Dar es Salaam, Tanzania?
Secondary ID [1] 282868 0
Grant agreement no. 241945 European Union
Universal Trial Number (UTN)
U1111-1145-5439
Trial acronym
PREPARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of HIV/AIDS risk behaviours 289682 0
adolescent sexuality 289683 0
HIV transmission risk prevention 289684 0
Condition category
Condition code
Public Health 290000 290000 0 0
Health promotion/education
Mental Health 290001 290001 0 0
Studies of normal psychology, cognitive function and behaviour
Reproductive Health and Childbirth 290068 290068 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Curriculum based intervention for targeting learners aged 12-14 in primary school years 5 and 6 aimed at: 1. Delaying sex initiation 2. Increasing sexual health communication peer-to-peer and peer to responsible adults 3. Increasing safer sex practices amongst sexually active young adolescents; is delivered as three components: two implemented in school by trained teachers and peer educators and one implemented by health care providers during class visits to youth friendly health service clinics.

The in-school components include 9 lessons, three of which are peer-led, taught over 19 hours (11 hours teacher led complemented by 8 hours peer-led sessions). Each class-room session lasting 40 or 80 minutes is taught over 8.5 weeks, as 16 two times a week interactive teaching and learning sessions suited for large classes with some didactic lessons and as part of the science curriculum; one hour duration peer-led sessions are taught once weekly over 8.5 weeks (9 sessions) as after school life skills. Lessons:1. Self awareness; 2. My sexuality; 3. Puberty*; 4. Relationships; 5. What influences my sexuality? 6. Risk taking sexual behaviours and consequences; 7. Decision making skills* 8. Self-protection; 9. Self-protection skills*. Lessons in asterisk are peer-led.

In class sessions build on a previous intervention developed using social cognitive theories, evaluation of which showed effects in delaying sex initiation. Peer-led sessions complement in-class sessions, are interactive held outdoors as part of after-school life skills training curriculum with trained teachers available to offer support when requested. These individual skills sessions utilize experiential learning approaches using scenarios derived from formative phase narratives, role-play and drama and are aimed to empower learners to work with adults in order to change the secrecy surrounding sexuality and sexual health communication.
Safe sex demonstrations and discussions occur during class visits to youth friendly services furthering the study aim to facilitate healthy sexuality messages and actions to peers and adults in young person’s lives.

Each intervention class made one visit to a youth friendly service for one hour after the class room session on my protection with the following objectives: 1. To know the location of the closest (YFHC); 2. Active learning of what is meant by youth friendly; 3. Type of services offered; 4. Discussion on safe sexual health; 5. Self-protection (Condoms demonstrations)

In monitoring the implementation of the intervention and adherence of students the following strategies were employed.
1. Lesson Plan: Each classroom teacher developed lesson plans for all 16 sessions. Each plan was later reviewed in relation to what was actually implemented
2. Student’s note book: At the end of each teacher led sessions students are asked to answer questions on their notebooks.
3. Activity records: Each activity conducted was documented
4. Peer leaders’ Diary
5. Observation: In each school one of teacher led sessions were observed and one of peer led.

Intervention code [1] 287567 0
Prevention
Intervention code [2] 287568 0
Behaviour
Comparator / control treatment
Standard Science National Curriculum for primary standards 5 and 6; Content in Science lessons includes HIV transmission and prevention on standard 5 and the reproductive health system and puberty in standard 6. Taught as didactic teacher facilitated sessions with no skills building components.

Control group will be offered delayed intervention after 12 months
Control group
Active

Outcomes
Primary outcome [1] 290054 0
Sex initiation - self reported with a questionnaire using a previously developed and piloted items that explore for oral, anal and vaginal sex engagement in the child's' lifetime and the past 6 months.

Timepoint [1] 290054 0
At 6 months and 12 months after baseline survey
Secondary outcome [1] 303835 0
Incident self-reported sexual health communication between learners and peers (peer-to-peer), teachers, parents and health care workers. Uses items in questionnaire specifically developed for the study and informed by formative qualitative data. Uses Likert scales to determine the extent to which they communication with peers, parents, teachers and health care workers on delaying sex, using alcohol, drugs and condom use.
Timepoint [1] 303835 0
At 6 months and 12 months after baseline survey
Secondary outcome [2] 303836 0
Incident condom acquisition and use amongst learners that self-report sexual activity; questionnaire designed specifically for the study with items exploring past 6 months condom use and at last sexual encounter.
Timepoint [2] 303836 0
At 6 months and 12 months after baseline survey

Eligibility
Key inclusion criteria
All 12-14 year old male and female learner participants
1. Must be registered in one of randomly selected schools
2. Must be 12-14 years old
3. Are resident of Dar es Salaam
4. Must have assented to participate
5. Must have sent an information sheet to parents and parents have not returned rejection of their participation (passive parental consent) or parent agreed
6. Must demonstrate literacy in Swahili.
Minimum age
12 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Mentally ill or handicapped
2. Too sick to participate in the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster randomization occurred at school and grade level.
19 randomly selected public primary school pairs, implementing the mainstream National Science Curriculum were randomly allocated to control (delayed intervention) and intervention groups.
In each school two grade 5 and 6 classes were randomly selected using a computer based random number generator
Schools were paired by size (total number of registered learners) and locality (urban and peri-urban), and using simple random sampling schools were randomly allocated to the intervention and control condition
In all selected classes school learners aged 12-14 years were identified and invited to participate in the study and a sampling frame generated from assenters with passive parental consent
Random and proportionate sampling was used to select assenting 12-14 year olds with parental passive consent for participation in surveys from each class in intervention and control schools, targeting a total of 6000 learner participants.
All participants in selected classes in intervention schools were exposed to the intervention, while those in control schools will be exposed to the intervention after the second 12 month follow-up survey, but no evaluation data will be collected.
Allocation concealment: The study staff was blind to participant allocation to intervention or not during recruitment of participants and baseline data collection only. No one knew which schools will receive intervention or delayed intervention, because school randomization was done centrally by one investigator and was revealed to the rest of the team after completion of baseline data collection. Computer generated random allocation was utilized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sampling frame of all primary schools in the municipality (Initial sampling frame =138)
Selected all public primary schools in the municipality implementing mainstream National Science Curriculum, that had learners in grades 5 & 6 (23 ineligible including 8 special schools, 3 private schools, 6 newly registered schools without learners in required grades and 6 schools involved in piloting the interventions (final sampling frame =115 schools)
Paired schools by total number of learners and urban, peri-urban (26% of schools) locality
Schools pairs were clustered by location and a proportionate sample of 19 school pairs were selected using a computer based random number generator.
For each of the 19 randomly selected school pairs, simple random sampling using a dice roll was used to randomly allocate school pairs to control (delayed intervention) and intervention groups.
In each school a sampling frame of classes in grade 5 and 6 was developed and a computer based random number generator selected two classes in each grade to participate in the intervention and evaluation.

School randomization to arms of the RCT was done by the investigators, and results only released to schools and the study field team after completion of baseline data collection. Hence schools and research assistants were blind to random allocation as intervention or control during the baseline survey
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: Power calculations used the Hayes and Bennett (1991) formula. Power calculation was based on expected effects of the intervention on sexual debut. According to earlier findings in Dar es Salaam 4.8% of 12-14 year old school based adolescents were sexually active at baseline. Our pilot results indicated a non-response proportion of 7%. We assumed that the baseline rate of sexual debut will be about the same in this study and that the PREPARE intervention would reduce the proportion of adolescents becoming sexually active by 2.0 percentage point (from 5.0% to 3.0%), corresponding to a 40.0% reduction. The intra-class correlation was set to .01. To achieve 80% power with a significance level of 0.05 in a two-sided test to detect that change, we would need 38 schools (19 schools in each arm) with 153 learners per school, totalling to 5814.
Analysis plan: In the analyses of quantitative data we will test measurement models for latent variables, use structural equation modelling, item-response analyses for knowledge-scales, growth curve models, multilevel statistical analyses, and procedures for testing of model equivalence across groups and across measurement occasions. All the analyses will take in to account the repeated nature of the measurements and cluster effects.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5233 0
Tanzania, United Republic Of
State/province [1] 5233 0
Dar es Salaam

Funding & Sponsors
Funding source category [1] 287649 0
Other Collaborative groups
Name [1] 287649 0
European Commission
Address [1] 287649 0
1049 Bruxelles/Brussel,
BELGIQUE/BELGIE
Country [1] 287649 0
Belgium
Primary sponsor type
University
Name
University of Bergen
Address
Museplassen 1, Bergen, 5007
Country
Norway
Secondary sponsor category [1] 286392 0
University
Name [1] 286392 0
Muhimbili University of Health and Allied Sciences
Address [1] 286392 0
P.O. Box 65001 Dar es Salaam
Country [1] 286392 0
Tanzania, United Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289618 0
Muhimbili University of Health and Allied Sciences Senate Research and Publications Committee
Ethics committee address [1] 289618 0
P.O. Box 65001, Dar es Salaam
Ethics committee country [1] 289618 0
Tanzania, United Republic Of
Date submitted for ethics approval [1] 289618 0
Approval date [1] 289618 0
15/02/2012
Ethics approval number [1] 289618 0
MU/RP/AEC/Vol. XIII/

Summary
Brief summary
The purpose of the intervention was to deliver 9 lessons implemented by trained teachers, peer-educators and health care providers with the purpose of enhancing sexual health knowledge and building skills for avoiding the initiation of sex, increasing peer-peer and peer to responsible adults (parents, teachers and health care workers) communications on sexuality and sexual health and increasing safer sexual practices in 12-14 year old school based male and female adolescents in Dar es Salaam, Tanzania.

The study hypothesizes that the interventions will increase levels of correct information on sexuality and HIV transmission risk behaviors, decrease reported secrecy in communications between peer to peer and peer to adults about sexuality and sexual practices, increase reports of delayed sex initiation and safer sexual practices in sexually active young adolescents -- in 12-14 year old adolescents that are exposed compared to those not exposed to the intervention
Trial website
http://prepare.b.uib.no
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41582 0
A/Prof Sylvia F. Kaaya
Address 41582 0
Department of Psychiatry and Mental Health,
Muhimbili University of Health and Allied Sciences
P.O. Box 65293,
Dar es Salaam
Country 41582 0
Tanzania, United Republic Of
Phone 41582 0
+255 713 262756
Fax 41582 0
Email 41582 0
skaaya@gmail.com
Contact person for public queries
Name 41583 0
Prof Mainen Moshi
Address 41583 0
Director of Research and Publications,
Muhimbili University of Health and Allied Sciences
P.O. Box 65001,
Dar es Salaam
Country 41583 0
Tanzania, United Republic Of
Phone 41583 0
+255 22 2152489
Fax 41583 0
Email 41583 0
nmoshi@muhas.ac.tz
Contact person for scientific queries
Name 41584 0
A/Prof Sylvia F. Kaaya
Address 41584 0
Department of Psychiatry and Mental Health,
Muhimbili University of Health and Allied Sciences
P.O. Box 65293,
Dar es Salaam
Country 41584 0
Tanzania, United Republic Of
Phone 41584 0
+255 713 262756
Fax 41584 0
Email 41584 0
skaaya@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary