STASH (STis and Sexual Health): a peer-led intervention to prevent and reduce STI transmission and improve sexual health in secondary schools in UK

ISRCTN	ISRCTN97369178
DOI	https://doi.org/10.1186/ISRCTN97369178
Protocol serial number	NIHR 14/182
Sponsor	University of Glasgow (UK)
Funder	National Institute for Health Research

Submission date: 25/02/2016
Registration date: 24/05/2016
Last edited: 10/07/2024

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Young people in the UK report higher levels of unsafe sex than any other age group. As a result, they are at highest risk of getting, and passing on, sexually transmitted infections. Young people often lack awareness of the risks or are unsure how to protect themselves. They are also vulnerable to social pressure from friends and peers who seem more sexually experienced, and to popular beliefs that safer sex behaviour is ‘uncool’. Youth peer-led interventions often involve peers 'teaching' friends or younger children. Peer educators often volunteer themselves for this role or are chosen by teachers; this type of selection tends to result in young people who are committed to school and who may find it difficult to relate to students who are disengaged and at highest risk. An alternative is to recruit young people from among those voted as most influential by their peers, and to train them not as peer educators but as peer supporters. These individuals then act as role models who change behavioural norms through social networks and other mechanisms of influence. This has been tried, with success, in a school-based anti-smoking intervention called ASSIST. Early research on the use of social media in promoting healthy behaviour is promising. Most UK teens are connected to online social networks; messages can spread rapidly; and social media provides an alternative to talking about sex directly, something many youth find embarrassing. We will build on components found to work well in ASSIST: recruiting influential peers, allowing knowledge and attitudes to spread via social networks, and using professionals to train peer supporters. However, this intervention focuses on sexual health, an older target group and utilises social media to spread messages. The main aim of this study is to find out whether this intervention is feasible, acceptable and implemented as intended. The study is not big enough to tell us whether the intervention works, but will let us to assess whether it is worth doing a larger trial, and if yes, how we should go about doing this.

Who can participate?
All S4 students (aged 14-16) at state-funded schools in the Lothian region of Scotland who have received or are currently receiving teacher-led sex RSHP (Relationships, Sexual Health and Parenting), regardless of their sexual experience or individual level of risk.

What does the study involve?
We identify and recruit the most influential students in fourth year (S4) of secondary school. These students attend a two-day training course run by specialist trainers. Over a defined period (between 4 and 10 weeks) they use social media and face-to-face interaction to influence sexual norms and behaviour among their peers. They are supported – through regular meetings and via social media – by the professionals who trained them. After a test in one school we implement the intervention in a further six schools, using the previous group of S4 students as controls; these students move to S5 before the intervention starts and are therefore not be exposed to it. We examine how the intervention was implemented by evaluating activities, and by talking to students, teachers and parents about their experience of being involved. We are interested in whether the intervention improves attitudes, knowledge, and risk-reduction skills, and whether these, in turn, delay first sex, increase condom use and improve the quality of sexual relationships. Peer supporters present the findings to their year group, teachers, and other professionals, and we write up the results for academic and policy audiences. If the intervention is successful, we will seek funds for a full-scale study.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Glasgow (UK)

When is the study starting and how long is it expected to run for?
January 2016 to December 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Kirstin Mitchell
kirstin.mitchell@glasgow.ac.uk

Contact information

Dr Kirstin Mitchell
Public

MRC/CSO Social and Public Health Sciences Unit
Institute of Health and Wellbeing, University of Glasgow
Top Floor, 200 Renfield Street
Glasgow
G2 3QB
United Kingdom

ORCID ID	0000-0002-4409-6601
Phone	+44 (0)141 353 7514
Email	kirstin.mitchell@glasgow.ac.uk

Study information

Primary study design	Interventional
Study design	Intervention development and exploratory study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	An exploratory study to test STASH (STis and Sexual Health), a peer-led intervention to prevent and reduce STI transmission and improve sexual health in secondary schools in UK
Study acronym	STASH
Study objectives	The hypothesis of this exploratory study is that the STASH intervention will be feasible, acceptable (both to target group and stakeholders), and not inferior to existing provision of sex education in schools. The hypotheses of the STASH intervention are: 1. That secondary students, nominated as influential by their peers and trained as peer supporters, can effect improvements in sexual attitudes and behaviour among their peers. 2. That social media provides an effective means through which peer supporters can disseminate positive sexual health messages
Ethics approval(s)	College of Medical Veterinary and Life Sciences (MVLS) Ethics committee, University of Glasgow, 23/08/2017, ref: 00160002
Health condition(s) or problem(s) studied	Prevention of sexually transmitted infections; sexual health and well-being
Intervention	Intervention development and exploratory study undertaken in two stages: Stage 1: Develop and formatively evaluate the intervention package, recruitment strategies and evaluation tools, pilot these in one school and make refinements Stage 2: Conduct an exploratory study in six schools in Scotland to include a feasibility trial and detailed process evaluation. This will be designed to assess whether progression criteria for a subsequent full trial are met The trial is multi-centre as the intervention will be delivered in 6 schools Building on learning from ASSIST (an effective peer-led anti-smoking intervention), we will identify and recruit the most influential students in fourth year (S4) of secondary schools (aged 14 to 16) in Scotland. These students will attend a two-day training run by specialist trainers. Over a defined period (between 4 and 10 weeks) they will use social media and face-to-face interaction to diffuse information, norm change and support for healthy sexual behaviour among their peers. They will be supported – through regular meetings and via social media – by the professionals who trained them.
Intervention type	Behavioural
Primary outcome measure(s)	The main outcome is attainment of progression criteria to a potential subsequent full trial. The primary intervention outcome is frequency of unprotected sex. We will also assess the feasibility and acceptability of linkage to NHS data on STI diagnosis as a longer-term outcome.
Key secondary outcome measure(s)	Secondary outcomes to be clarified during development stage but likely to include: 1. Self-reported STI diagnosis, testing and symptoms 2. Sexual behaviour 3. Relationship quality 4. Adherence to targeted behavioural norms 5. Perceptions about the behaviour of others 6. Knowledge of STI risk 7. Awareness and use of local sexual health services 8. STI prevention skills 9. Beliefs about capabilities Process measures include feasibility, fidelity, acceptability and reach of the intervention, for example the proportion of nominated peer supporters who agreed to participate. We will assess the perceived value of peer supporters among students, the level of exposure to the intervention, and acceptability to teachers. We will also record the key costs of intervention adaptation, implementation and maintenance and we will assess the feasibility of measuring sexual quality of life and information on sexual health related health care resource use.
Completion date	31/12/2018

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	14 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	1400
Total final enrolment	1376
Key inclusion criteria	State-funded schools in the Lothian region of Scotland. All S4 students (aged 14-16; male and female) at eligible schools who have received, or are currently in receipt of teacher-led sex RSHP (Relationships, Sexual Health and Parenting), regardless of their sexual experience or individual level of risk.
Key exclusion criteria	1. Faith schools in which STASH principles conflict with religious principles/teaching on sex education 2. Students in eligible schools who refuse their consent or whose parents/carers refuse consent
Date of first enrolment	15/01/2017
Date of final enrolment	15/01/2018

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

University of Glasgow

MRC/CSO Social and Public Health Sciences Unit
Top Floor
200 Renfield Street
Glasgow
G2 3QB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	opportunities and challenges	16/02/2021	10/07/2024	Yes	No
Protocol article	protocol	29/11/2018	30/11/2020	Yes	No
Dataset	Feasibility data	20/04/2021	12/04/2023	No	No
Interim results article	Feasibility results	01/11/2020	15/01/2021	Yes	No
Interim results article	Feasibility results	14/06/2021	17/06/2021	Yes	No
Interim results article	Intervention development and optimisation	11/04/2023	12/04/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v1.5	14/05/2018	06/06/2018	No	No

Additional files

ISRCTN97369178_protocol_v1.5_14May18.docx: Protocol uploaded 06/06/2018

Editorial Notes

10/07/2024: Publication reference added.
12/04/2023: The following changes have been made:
1. Publication reference added.
2. A dataset link has been added.
17/06/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
15/01/2021: Publication reference added.
30/11/2020: Publication reference added.
06/06/2018: Uploaded protocol version 1.5 14/05/2018 (not peer reviewed)
31/10/2017: Internal review.
30/08/2017: Ethics approval information has been added.