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 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
Trial website
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 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 trial start date
01/07/2012
Overall trial end date
30/03/2013
Reason abandoned (if study stopped)
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 childs 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
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
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24438582
Publication citations
-
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.