Plain English Summary
Background and study aims
Many young people experience poor sexual health. Most report a lack of ‘competence’ at first sex defining in terms of not using contraception, feeling pressure to have sex, partners not being equally willing to have sex and not feeling it is the right time to have sex. Relationships and sex education in school classrooms can contribute to promoting sexual competence and health, but in general its impact on students' sexual health is small, inconsistent and not sustained. Education in classrooms needs to be supplemented by ‘whole-school' work such as student campaigns or sexual health services. Such work can be informed by ‘social marketing’ techniques which harness commercial marketing to social ends. There is good evidence from other countries that such interventions work but not from the UK. This study evaluates Positive Choices, a school-based programme informed by the above evidence. The aim is to assess if the Positive Choices intervention is effective in ensuring young people are competent at first sex, alongside other benefits. Involvement from policy, practice and youth groups recommended this outcome because those who report lack of sexual competence at first sex are more likely to experience later problems such as sexually transmitted infections, unplanned pregnancy, forced sex and sexual dysfunction. Furthermore, sexual competence is relevant for young people regardless of gender and sexual orientation.
Who can participate?
Young people aged 12/13 years attending English secondary schools
What does the study involve?
Schools will be randomly allocated to either deliver the intervention or act as comparisons. The study will include involvement from the public and professionals. Positive Choices is a whole-school social marketing intervention for secondary schools aiming to promote sexual health and comprising: a school health promotion council which involves staff and students working together to coordinate intervention delivery; student surveys informing local decisions about how to deliver the intervention; classroom lessons; student-run campaigns; parent information; and review of sexual health services to inform improvements. The researchers will assess impacts by surveying students with questionnaires at the beginning of the study and then 33 months later. Surveys will ask students about sexual knowledge and experiences. They will also evaluate whether the intervention is worth the money and whether it is delivered well.
What are the possible benefits and risks of participating?
The intervention has the potential to improve participants’ sexual health and relationships. Neither the intervention nor the evaluation are likely to harm participants. The evaluation will assess any potential harms or adverse events that occur during the study.
Where is the study run from?
The London School of Hygiene and Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
August 2021 to March 2025
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof. Chris Bonell
Chris.Bonell@lshtm.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Prof Chris Bonell
ORCID ID
https://orcid.org/0000-0002-6253-6498
Contact details
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom
+44 (0)7532392862
chris.bonell@lshtm.ac.uk
Type
Public
Contact name
Prof Chris Bonell
ORCID ID
Contact details
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom
+44 (0)7532392862
chris.bonell@lshtm.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
NIHR131487
Study information
Scientific title
Phase III randomised controlled trial of Positive Choices: a whole-school social-marketing intervention to promote sexual health and reduce health inequalities
Acronym
PositiveChoices
Study hypothesis
The Positive Choices intervention reduces by 36% student-reported measures of non-competent first sex (primary outcome) in intention-to-treat analyses.
Ethics approval(s)
Approved 31/08/2021, LSHTM research ethics committee (London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK; +44 (0)20 7636 8636; ethics@lshtm.ac.uk), ref: 26411
Study design
Superiority Phase III cluster parallel-group randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
School
Study type
Prevention
Patient information sheet
See additional files
Condition
Sexual health
Intervention
Positive Choices is a whole-school intervention with the following components: school health promotion council comprising staff and students to plan, launch, coordinate and oversee delivery; a student needs survey of year-8 students which provides evidence to inform local tailoring; a classroom curriculum addressing social and emotional skills and relationships and sexual health knowledge and skills delivered by school staff; student-run social-marketing campaigns facilitated by trained teachers; parent information; and review of school and other local sexual and reproductive health services to inform improvements.
This trial will recruit 50 schools, half of whom will be randomly chosen to deliver the intervention with the others acting as
comparisons. Schools will be randomly allocated 1:1 to intervention/control as a single batch using a random number generator remotely by LSHTM clinical trials unit (CTU), stratified by school-level GCSE attainment and local index of deprivation, which are key predictors of sexual health. Schools will be given unique study numbers to preserve allocation concealment within the CTU.
The researchers will assess impacts by surveying students with questionnaires at the beginning of the trial and then 33 months later. Surveys will ask students about sexual knowledge and experiences. The researchers will also evaluate whether the intervention is worth the money and whether it is delivered well.
Intervention type
Behavioural
Primary outcome measure
Non-competent first sex assessed among trial participants having sex for the first time between baseline and follow-up (33 months), using the established Natsal self-report measure defined in terms of the absence at first sex of: autonomy of decision; equal willingness of partners; it being the ‘right time’; and, for those reporting heterosexual intercourse, use of effective contraception.
Secondary outcome measures
Current secondary outcome measures as of 06/11/2023:
1. Age at sexual debut measured using an adapted version of the RIPPLE measure of sexual debut at baseline and 33 months
2. Non-use of contraception at first and last sex among those reporting heterosexual intercourse measured using an adapted version of the RIPPLE measure of contraception use at 33 months
3. Number of sexual partners measured using an adapted RIPPLE measure of partner numbers at 33 months
4. Dating and relationship violence victimisation measured using an adapted version of the short Conflicts in Adolescent Dating Relationships Inventory at baseline and 33 months
5. Self-reported diagnoses of sexually transmitted infections measured using an adapted version of the RIPPLE measure of sexually transmitted infections at 33 months
6. Pregnancy and unintended pregnancy among girls measured using adapted versions of the RIPPLE measures of pregnancy at 33 months
7. Initiation of pregnancy among boys measured using an adapted version of the RIPPLE measures of pregnancy initiation at 33 months
8. Health-related quality of life measured using the Child Health Utility 9D measure at baseline and 33 months
_____
Previous secondary outcome measures:
1. Non-competent last sex measured using the Natsal measure of sexual competence at 33 months
2. Age at sexual debut measured using an adapted version of the RIPPLE measure of sexual debut at baseline and 33 months
3. Non-use of contraception at first and last sex among those reporting heterosexual intercourse measured using an adapted version of the RIPPLE measure of contraception use at 33 months
4. Number of sexual partners measured using an adapted RIPPLE measure of partner numbers at 33 months
5. Dating and relationship violence victimisation measured using an adapted version of the short Conflicts in Adolescent Dating Relationships Inventory at baseline and 33 months
6. Self-reported diagnoses of sexually transmitted infections measured using an adapted version of the RIPPLE measure of sexually transmitted infections at 33 months
7. Pregnancy and unintended pregnancy among girls measured using adapted versions of the RIPPLE measures of pregnancy at 33 months
8. Initiation of pregnancy among boys measured using an adapted version of the RIPPLE measures of pregnancy initiation at 33 months
9. Health-related quality of life measured using the Child Health Utility 9D measure at baseline and 33 months
Overall study start date
01/08/2021
Overall study end date
31/03/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Students aged 12-16 years
2. Deemed competent to consent by schools
3. Moving from year 8 into year 11 during the trial
4. In English secondary schools (including faith schools, free schools, academies and private schools) excluding pupil referral units, schools for those with special educational needs and disabilities, and schools with poor Ofsted (government school inspectorate) inspections
Participant type(s)
Other
Age group
Child
Lower age limit
12 Years
Upper age limit
16 Years
Sex
Both
Target number of participants
50 schools; minimum 6440, maximum 8500 students
Participant exclusion criteria
1. Students not deemed competent to consent by schools or students in pupil referral units
2. Schools for those with special educational needs and disabilities
3. Schools with poor Ofsted inspections
Recruitment start date
01/09/2021
Recruitment end date
01/03/2022
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
London School of Hygiene and Tropical Medicine
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom
Sponsor information
Organisation
London School of Hygiene & Tropical Medicine
Sponsor details
Research Governance & Integrity Office
Keppel Street
London
WC1E 7HT
England
United Kingdom
+44 (0)20 7636 8636
rgio@lshtm.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Public Health Research Programme
Alternative name(s)
NIHR Public Health Research Programme, PHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Our knowledge exchange will be informed by consultation at the end of the study with the ALPHA (Advice Leading to Public Health Action) young researchers’ group as well as with our group of policy/practitioner stakeholders. As well as reporting in the National Institute for Health Research Public Health Research journal, we will submit two open-access papers to top journals. We will present our findings at two international conferences (Society of Prevention Research; International Association for Adolescent Health), plus national academic and policy conferences. We will disseminate the results to participating schools, the ALPHA group and the policy/practice stakeholder group. We will draft an article for the Times Education Supplement about the research. The research team will also use blog posts and Twitter to increase public awareness of the study. A policy and practice dissemination event will be held at the Sex Education Forum targeting the central and local government, education, public health and voluntary sectors. The most important scientific outputs generated by this project will be evidence about the effectiveness, costs and potential scalability and transferability of a whole-school social-marketing intervention to promote sexual health. If this trial finds that Positive Choices is effective in reducing non-competent first sex, this would be scaled up by SEF working collaboratively with the investigators, marketing the intervention to secondary schools, local authorities, school networks and academy chains who would be charged by SEF to be trained to deliver the intervention. Background intellectual property for the intervention lies with LSHTM.
Intention to publish date
31/03/2025
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Chris Bonell (chris.bonell@lshtm.ac.uk). Anonymised baseline and follow-up quantitative data will be available from January 2026 for 5 years for academic researchers with a peer-reviewed protocol and ethics committee approval who contact the trial team contact to analyse the data to assess intervention effects subject to the development of a data-sharing agreement between the researchers and the trial team. Consent was obtained from participants for this.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Consent form | 03/09/2021 | No | Yes | |
| Participant information sheet | Parents/carers | 03/09/2021 | No | Yes | |
| Participant information sheet | Students | 03/09/2021 | No | Yes | |
| Protocol file | version 1.0 | 09/07/2021 | 03/09/2021 | No | No |
| Protocol file | version 2.0 | 15/10/2021 | 12/10/2021 | No | No |
| Protocol file | Flowchart for v2 | 21/10/2021 | No | No | |
| Protocol file | Logic model for v2 | 21/10/2021 | No | No | |
| Protocol file | version 5 | 03/11/2023 | 06/11/2023 | No | No |
Additional files
- 40365_PIS_parentscarers.doc Parents/carers
- 40365_PIS_student.doc Students
- 40365_PROTOCOL_V2.0_09Jul21.docx
- 40365_ConsentForm.doc Consent form
- 40365_PROTOCOL_V2.0_15Oct21.pdf
- 40365 Flowchart 2.docx Flowchart for v2
- 40365 Logic model 2.docx Logic model for v2
- ISRCTN16723909 Protocol v5 03Nov23.pdf