Condition category
Infections and Infestations
Date applied
26/06/2013
Date assigned
12/07/2013
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 teacher’s 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

Trial website

http://prepare.b.uib.no/prepare-brochure/

Contact information

Type

Scientific

Primary contact

Dr Handsome Onya

ORCID ID

Contact details

P/Bag x 1106
Sovenga
0727
Polokwne
0727
South Africa
+27 (0)15 263 6129
ho7@mweb.co.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

241945

Study information

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

Acronym

PREPARE

Study hypothesis

Culture-specific beliefs is a key driver to the spread of HIV/AIDS among young people in Limpopo, South Africa.

Ethics approval

MRE/HS/21/2011:CR

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2012

Overall trial end date

30/03/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

2400

Participant 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 child’s participation
3. Students who are not willing to participate

Recruitment start date

01/07/2012

Recruitment end date

30/03/2013

Locations

Countries of recruitment

South Africa

Trial participating centre

P/Bag x 1106
Polokwne
0727
South Africa

Sponsor information

Organisation

University of Limpopo (South Africa)

Sponsor details

P/Bag X 1106
Sovenga
Polokwane
0727
South Africa
+27 (0)15 263 6129
ho7@mweb.co.za

Sponsor type

University/education

Website

http://www.ul.ac.za/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24438582

Publication citations

  1. Protocol

    Aarø LE, Mathews C, Kaaya S, Katahoire AR, Onya H, Abraham C, Klepp KI, Wubs A, Eggers SM, de Vries H, Promoting sexual and reproductive health among adolescents in southern and eastern Africa (PREPARE): project design and conceptual framework., BMC Public Health, 2014, 14, 54, doi: 10.1186/1471-2458-14-54.

Additional files

Editorial Notes