The Positive Choices trial of a social marketing intervention to promote sexual health and reduce health inequalities among English secondary school students
| ISRCTN | ISRCTN16723909 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16723909 |
| Secondary identifying numbers | NIHR131487 |
- Submission date
- 03/09/2021
- Registration date
- 03/09/2021
- Last edited
- 07/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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 January 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
Contact information
Scientific
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom
 ORCID ID |
0000-0002-6253-6498 |
|---|---|
| Phone | +44 (0)7532392862 |
| chris.bonell@lshtm.ac.uk |
Public
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom
| Phone | +44 (0)7532392862 |
|---|---|
| chris.bonell@lshtm.ac.uk |
Study information
| 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 |
| Participant information sheet | 40365_ConsentForm.doc |
| Scientific title | Phase III randomised controlled trial of Positive Choices: a whole-school social-marketing intervention to promote sexual health and reduce health inequalities |
| Study acronym | PositiveChoices |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/01/2025 |
Eligibility
| 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 |
| Total final enrolment | 6970 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 01/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
WC1H 9SH
United Kingdom
Sponsor information
University/education
Research Governance & Integrity Office
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 (0)20 7636 8636 |
|---|---|
| rgio@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Public Health Research Programme, PHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| 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. |
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 |
| Protocol file | version 6 | 30/05/2024 | 19/06/2024 | No | No |
| Participant information sheet | 04/07/2024 | 19/07/2024 | No | Yes | |
| Participant information sheet | 04/07/2024 | 19/07/2024 | No | Yes | |
| Participant information sheet | 04/07/2024 | 19/07/2024 | No | Yes | |
| Protocol file | version 7 | 30/07/2024 | 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
- ISRCTN16723909_PROTOCOL_V6_30May24.pdf
- ISRCTN16723909_PIS_ParentsFollowupSurvey_04Jul24.pdf
- ISRCTN16723909_PIS_StudentFollowupSurvey_04Jul24.pdf
- ISRCTN16723909_Follow-upSurveyConsentForm_04Jul24.pdf
- ISRCTN16723909_PROTOCOL_V7.pdf
Editorial Notes
07/03/2025: The following changes were made:
1. The overall study end date was changed from 31/03/2025 to 31/01/2025.
2. The intention to publish date was changed from 31/03/2025 to 31/09/2025.
30/07/2024: Protocol v7.0 re-uploaded.
19/07/2024: Protocol v7.0, consent form and participant information sheets uploaded.
19/06/2024: Uploaded protocol v6.0 (not peer-reviewed). Total final enrolment added.
06/11/2023: The following changes were made to the trial record:
1. Uploaded protocol v5.0 (not peer-reviewed).
2. The secondary outcome measures were changed.
21/10/2021: Internal review.
12/10/2021: Uploaded protocol (not peer reviewed).
03/09/2021: Trial's existence confirmed by the LSHTM research ethics committee.
