Promoting sexual and reproductive health among high school adolescents in Limpopo province, South Africa (PREPARE): culture-specific norms, attitudes and beliefs

ISRCTN	ISRCTN10386599
DOI	https://doi.org/10.1186/ISRCTN10386599
Secondary identifying numbers	241945

Submission date: 26/06/2013
Registration date: 12/07/2013
Last edited: 30/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The main aim of this study is to develop new and innovative programmes for the promotion of healthy sexual practices among adolescents in their early adolescence (in school grades corresponding to the age groups 12-14 years) using schools as a medium to deliver these programmes.

Who can participate?
Boys and girls in Grade 8 attending public high schools in Limpopo Province. 2400 adolescents were recruited. The students were from 24 high schools in Limpopo Province. No specific exclusion criteria were used.

What does the study involve?
Half of the schools were randomly allocated to receive the intervention (programmes for the promotion of healthy sexual practices) in 2013, and the other half served as control schools. Participants completed a questionnaire in August 2013 before the intervention. The school-based intervention took place for five weeks and questionnaires were completed again at the completion of the intervention, October 2013.
Intervention- Key Health Promotion Behaviours:
Delay onset of sexual intercourse for those that have not had sex
Carry condoms when planning to have sex.
Consistent correct condom use for those already sexually active.
Teachers were provided with the teachers manual to assist with preparation Learners were also provided with a workbook for self-assessment and group assessment.

What are the possible benefits and risks of participating?
There will be no immediate or direct benefits to participants. We hope that the results will influence policy makers, leading to benefits on a larger scale.
There is little potential risk associated with participation. It is possible that some questions in the questionnaire may make students feel uncomfortable or emotional. Research staff will be trained to manage these students or refer them for professional help.

Where is the study run from?
The University of Limpopo, South Africa.

When is the study starting and how long is it expected to run for?
The study started in July 2012 and completed in March 2013.

Who is funding the study?
European Commission (EC) Health research program (under the 7th Framework Program).

Who is the main contact?
Dr Hans Onya
ho7@mweb.co.za

Study website

Contact information

Dr Handsome Onya
Scientific

P/Bag x 1106
Sovenga
0727
Polokwne
0727
South Africa

Phone	+27 (0)15 263 6129
Email	ho7@mweb.co.za

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Promoting sexual and reproductive health among high school adolescents in Limpopo province, South Africa (PREPARE): culture-specific norms, attitudes and beliefs: a randomised controlled trial
Study acronym	PREPARE
Study objectives	Culture-specific beliefs is a key driver to the spread of HIV/AIDS among young people in Limpopo, South Africa.
Ethics approval(s)	MRE/HS/21/2011:CR
Health condition(s) or problem(s) studied	HIV and culture-specific norms, attitudes and beliefs
Intervention	Half of the schools have been randomly allocated to receive the intervention in 2013, and the other half will serve as control schools. Twelve schools were selected to participate in the teachers training. Fifteen teachers attended the training workshop. The workshop duration was three days. The Proximal programme objectives of this intervention are: Key Health Promotion Behaviours: 1. Delay onset of sexual intercourse for those who have not had sex 2. Carry condoms when planning to have sex 3. Consistent correct condom use for those already sexually active Teachers were provided with the teachers manual to assist with preparation. Learners were also provided with a workbook for self-assessment and group assessment.
Intervention type	Other
Primary outcome measure	To measure changes in culture-specific beliefs amongst adoloscence. 1. Baseline questionnaire: 01-16 August 2012: Fieldworkers were involved in data collection, and the coordinator supervised the data collection procedures. 24 schools around Mankweng circuit were involved in data collection,12 intervention, 12 control. The Mankweng main road was used to divide the intervention and the control schools. Grade 8 students, between the age of 12 and 15, were involved in data collection. The learners selected were as follows, intervention 1877 and control 1298. 2. Classroom- based intervention: 20 August - 21September 2012 3. Follow-up questionnaire:10-20 October 2012 Data collection took place in 24 schools, 12 intervention and 12 control.
Secondary outcome measures	Reduction in HIV/AIDS prevalence amongst adolescents
Overall study start date	01/07/2012
Completion date	30/03/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	2400
Key inclusion criteria	1. Grade 8 high school students between 12 and 19 years 2. Having parental consent for participation 3. Willing to participate in the study
Key exclusion criteria	1. Students who are not attending school at the time of recruitment or who are not in Grade 8 at one of the selected high schools 2. Students of whom parents decline to consent to their childs participation 3. Students who are not willing to participate
Date of first enrolment	01/07/2012
Date of final enrolment	30/03/2013

Locations

Countries of recruitment

South Africa

Study participating centre

P/Bag x 1106

Polokwne
0727
South Africa

Sponsor information

University of Limpopo (South Africa)
University/education

P/Bag X 1106
Sovenga
Polokwane
0727
South Africa

Phone	+27 (0)15 263 6129
Email	ho7@mweb.co.za
Website	http://www.ul.ac.za/
"ROR"	https://ror.org/017p87168

Funders

Funder type

Government

European Commission (EC) Health research program (under the 7th Framework Program) (Grant Agreement number: 241945)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/01/2014		Yes	No