Condition category
Mental and Behavioural Disorders
Date applied
08/01/2019
Date assigned
30/08/2019
Last edited
02/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Society has a duty to safeguard its citizens, and promote people’s rights to live free of violence. Sexual violence refers to any unwanted sexual act or activity. There are many different kinds of sexual violence, including but not restricted to: rape, sexual assault, child sexual abuse, sexual harassment, rape within marriage or relationships, forced marriage, so-called ‘honour’-based violence, female genital mutilation, trafficking, sexual exploitation, and ritual abuse. Each year there are 473,000 adult sexual offences in the UK, including 58,000 cases of rape. In 2014/15, there were 47,008 sexual offences against children. Sexual violence has devastating short- and long-term consequences for the wellbeing of victims and survivors. The negative effects can be seen across families and communities, affecting people’s abilities to work and participate in family and social life. Estimates suggest that child sexual abuse alone costs £182m in health spending annually. Hence, sexual violence is very costly to society, both in terms of the suffering and emotional pain it causes but also in terms of lost work, and health, policing and legal costs.
A victim of a sexual crime can find help from a Sexual Assault Referral Centre (SARC), either by making contact themselves or being offered a referral by another person or organisation like a doctor, nurse, school or member of the police. A SARC is intended as a place where individuals can receive medical care including a forensic medical examination if they consent to this, advice, counselling and support. There are over 40 SARCs across England, Wales and Scotland. SARCs are thought to bring benefits when a person who has experienced sexual assault or rape reaches out for help. However, the true impact of SARCs is largely unknown. The way things are done can vary from one centre to another, and it is not known what works best for different groups of people like men, members of the LGBT community, and people with particular vulnerabilities (e.g. those with disability, minority ethnicity, and children). This study takes an in-depth look at the work of SARCs and how they impact people’s recovery journeys.

Who can participate?
For the adult study, people who are aged 18 and above, have attended as a service user one of the participating sites (Sexual Assault Referral Centres) between 01/08/2019 and 30/06/2020 and can consent to participation. Please take a look at the MESARCH participant video: http://mesarch.coventry.ac.uk/getting-involved/
For the children and young people study, young people and children who are aged 13-17 and have attended participating sites (Sexual Assault Referral Centres) during a (yet to be) specified time period

What does the study involve?
This study is concerned with people’s recovery journeys over time following assault, abuse or rape and, in doing so, gathers information about the range of services (including SARC services) and interventions that service users are offered/receive over time and asks people about the impact of these on valued aspects of their lives (e.g. relationships; work and education; emotional, sexual and physical health; safety and security). Interviews are conducted over the phone mainly using a range of questionnaires and follow-up at 6 months, one and two years. A participant doesn’t have to complete each time point, everything remains voluntary and on the individual’s terms. This approach was co-created with survivors of sexual abuse and violence, and charities to ensure the study will be conducted respectfully and ethically and will lead to relevant changes in practice and policy.
Hear more about the study on the website http://mesarch.coventry.ac.uk/

What are the possible benefits and risks of participating?
The researchers' slogan is ‘join a thousand voices for change’. Some people find it helpful to join with others who have had similar experiences and be a part of something that is focused on turning injustice into positive action. It may also be helpful to share their story with people they don’t know and be signposted to different support agencies. Some people may perceive these as benefits. The research is also very important. Key stakeholders such as NHS England and Rape Crisis England and Wales are watching the research closely and will act on the findings. This is an opportunity for participants to have their say. One of the researchers' concerns is that participating in this research could be triggering for people who have experienced sexual abuse or violence. Thus, they have developed their processes to be empowering for individuals (e.g. they are guided by the participant each step of the way; there is no pressure to participate, they only want participants to respond to questions they are comfortable with, the researchers don’t ask about what happened or what brought them to the SARC). The researchers can’t always anticipate what might come up for a particular individual, but they are certainly ready to listen and offer support where possible, and in doing so, offer a safe space for research. They will protect participants' confidentiality and information in line with GDPR guidelines; they would explain this thoroughly for those interested in taking part. There is a small token of thanks for each survey, £10 for the baseline, 6 and 12 months and £20 for the final interview at 2 years.

Where is the study run from?
The study is hosted at Coventry University and the lead NHS partner is University Hospitals Birmingham NHS Foundation Trust. The study has grown to include police-led, charity- and privately-run and NHS-led SARCs, along with third sector and rape crisis organisations from all over the country. The study website is http://mesarch.coventry.ac.uk/

When is the study starting and how long is it expected to run for?
September 2018 to May 2022

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

Who is the main contact?
Dr Grace Carter
mesarch@coventry.ac.uk

Trial website

http://mesarch.coventry.ac.uk/

Contact information

Type

Scientific

Primary contact

Dr Lorna O'Doherty

ORCID ID

http://orcid.org/0000-0003-0816-9321

Contact details

Richard Crossman Building
Priory Street
Coventry
CV1 5FB
United Kingdom
+44 (0)2477659130
lorna.odoherty@coventry.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

37956, 16/117/04

Study information

Scientific title

Multi-disciplinary Evaluation of Sexual Assault Referral Centres for better Health (MESARCH)

Acronym

MESARCH

Study hypothesis

Sexual violence is any unwanted sexual act or activity, including though not limited to: rape, sexual assault, child sexual abuse, sexual harassment, rape within relationships, forced marriage, female genital mutilation, and sexual exploitation. Sexual violence affects people of all ages, backgrounds and genders, with recent figures suggesting that 1 in 5 women and 1 in 25 men have experienced sexual assault since the age of 16. Sexual violence has serious impacts on a person’s health and well-being. A Sexual Assault Referral Centre (or SARC) offers 24/7 medical care and psychological support, and a first point of contact for victims of sexual violence, whether the police are involved or not. SARCs are set up to support the wide range of needs and wishes of individuals, which is vital in the aftermath of such a devastating experience. There are now 47 SARCs in England. However, the true impact of SARCs is largely unknown, with a lack of evidence at a national level about the extent to which SARCs bring benefit to survivors/service users.

The MESARCH project aims to evaluate whether the services provided through SARCs are effective in supporting them. It will pursue this aim using mixed approaches including service mapping, in-depth cases studies at 10 SARC sites, a longitudinal study of health and wellbeing in around 1,000 survivors attending 15 sites and an embedded qualitative study of 55 service user and survivor experiences. This research will be critical to shaping future SARC service provision in England. The MESARCH project will also strengthen the international evidence base on interventions for sexual assault and abuse.

There are 4 planned workstreams. The current application refers to a pilot of the longitudinal study to be undertaken in workstream 3.

Ethics approval

Approved 30/07/2019, East Midlands Derby REC (Riverside Centre, Derwent Room, Pride Park, Derby, Riverside Court, Pride Park, Derby, DE24 8HY; Tel: +44 (0)207 1048109; Email: NRESCommittee.eastmidlands-derby@nhs.net), ref: 19/EM/0198

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post-traumatic stress disorder (PTSD) and other conditions in victims of sexual violence

Intervention

Steps through the study:
1. Service user is seen by SARC staff in person
2. SARC staff member screens service user for eligibility. All eligibility information is anonymous and conveyed to the project team using secure sharing platform
3. At an appropriate time, eligible service users are approached by a SARC staff member or Independent Sexual Violence Advisor (ISVA) and officially invited to consider being involved in the study. Consent is requested to pass contact details to the project team (‘Level 1’ consent completed)
5. Additional approaches for enabling recruitment include (i) placing a trained member of the project team at the SARC to respond to opportunities to invite service users as they visit the SARC for after care; (ii) having members of the project team ready to speak by phone or video link to a service user if the SARC worker believes this is an appropriate approach for a particular service user; (iii) showing a short video message of invitation co-produced with our Lived Experiences Group which could be used by SARC staff to explain about the project (available on the project website)
6. Once the contact information has been passed on, there is no more involvement of the SARC or ISVA except in circumstances such as the participant requires support and has agreed for us to notify the SARC
7. A trained project team member makes contact within 1 week of receiving the research referral consent form from the SARC or third sector worker, and contact is made in line with service user preferences for example by email, text or phone call
8. Once contact is made by the project team at baseline, the project team will follow recruitment and safety protocols, explain study purpose and gain full consent ('Level 2' consent)
9. When consent to take part in the study is established (using email or text or signed consent form), baseline data are collected using a range of options. These include offering a structured telephone interview, a weblink to complete the data collection online, an interview in person or via Skype (or alternative). Those submitting baseline data will be considered ‘enrolled’ in MESARCH
10. Follow-up is undertaken according to the service users’ preferences at 6, 12 and 24 months

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Presence and severity of PTSD symptoms in the last month assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline, 6, 12 and 24 months

Secondary outcome measures

1. Depression symptoms measured using the Centre for Epidemiologic Studies-Depression Scale (CESD-R-10) at baseline, 6, 12 and 24 months
2. Quality of life measured using WHOQoL-Bref at baseline, 6, 12 and 24 months
3. Sexual health measured using bespoke measure for sexual health at baseline, 6, 12 and 24 months
4. Sexual abuse and violence re-victimisation measured using bespoke measure for sexual violence at 6, 12 and 24 months
5. Alcohol use measured using AUDIT-C at baseline, 6, 12 and 24 months
6. Drug use measured using DUDIT at baseline, 6, 12 and 24 months
7. Eating behaviours measured using SCOFF measure and TFEQ-R21 (select items) at baseline, 6, 12 and 24 months
8. Resource use measured using bespoke measure at baseline, 6, 12 and 24 months
9. Health-related QoL measured using EQ5D-5L at baseline, 6, 12 and 24 months
10. Capability measured using ICECAP-A at baseline, 6, 12 and 24 months
11. Adverse Childhood Experiences measured using WHO ACE International Questionnaire at baseline only
12. Intimate partner violence measured using ACTS screen (baseline only) and Composite Abuse Scale at 6, 12 and 24 months

Overall trial start date

01/09/2018

Overall trial end date

31/05/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Individuals aged ≥16 years who have accessed services at a SARC
2. A small, non-representative sample of children (13-15 years) who have accessed services at one paediatric SARC

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 25; UK Sample Size: 25

Participant exclusion criteria

1. Whilst every effort will be made to ensure inclusivity, service users may be excluded if in exercising judgement the responsible member of SARC staff anticipates that the potential participant would likely encounter difficulties in providing informed consent or responding to or understanding the content of surveys or interviews used in data collection due to significant mental health issues (psychosis or high risk of suicide), cognitive impairment, or intellectual disability
2. People who access information or support from the SARC by telephone or email only
3. People who view information on the SARC website only

Recruitment start date

01/08/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Blue Sky Centre (G4S)
-
United Kingdom

Trial participating centre

Horizon (G4S)
-
United Kingdom

Trial participating centre

Hope House (Gloucestershire Care Services NHS Trust)
-
United Kingdom

Trial participating centre

Avon and Somerset SARC (University Hospitals Bristol NHS Trust)
-
United Kingdom

Trial participating centre

Oakwood Place (Mountain Healthcare)
-
United Kingdom

Trial participating centre

The Herts SARC (Mountain Healthcare)
-
United Kingdom

Trial participating centre

Saturn Centre (Mountain Healthcare)
-
United Kingdom

Trial participating centre

The Elms (Mountain Healthcare)
-
United Kingdom

Trial participating centre

Swindon and Wiltshire SARC (First Light)
-
United Kingdom

Trial participating centre

The Harbour Centre (Norfolk Constabulary)
-
United Kingdom

Trial participating centre

The Reach (Northumbria Constabulary)
-
United Kingdom

Trial participating centre

Safe Link
-
United Kingdom

Trial participating centre

Safeline
-
United Kingdom

Trial participating centre

Rosa
-
United Kingdom

Trial participating centre

Coventry Rape and Sexual Abuse Centre (CRASAC)
-
United Kingdom

Trial participating centre

Gloucestershire Rape and Sexual Abuse Centre (GRASAC)
-
United Kingdom

Trial participating centre

Essex Partnership of Rape Crisis Centres (Synergy)
-
United Kingdom

Trial participating centre

RSVP
-
United Kingdom

Trial participating centre

Crisis Point
-
United Kingdom

Trial participating centre

Black Country Women's Aid
-
United Kingdom

Trial participating centre

Splitz
-
United Kingdom

Trial participating centre

Cambridge Rape Crisis Centre
-
United Kingdom

Trial participating centre

Peterborough Rape Crisis Centre
-
United Kingdom

Sponsor information

Organisation

Coventry University

Sponsor details

Vice Chancellor's Office
Priory Street
Coventry
CV1 5FB
United Kingdom
+44 (0)2477684031
csx300@coventry.ac.uk

Sponsor type

University/education

Website

https://www.coventry.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The findings will be shared online (through the study website), as part of a host of events for a range of people, in academic journals and at conferences.

Effectiveness and cost-effectiveness of SARC provision of care for survivors of sexual violence:
Publications and evidence briefings
From cohort study:
Publication of quantitative and qualitative findings on trajectories and outcomes
Brief version of the evidence released following publications Journal publication baseline/6m data
Journal publication 12m
Journal publication 24m
Journal publication of qualitative findings
Journal publication of economic evaluation Journal publication on children and young people study outcomes
Evidence briefings, available in electronic format from website and leaflets after publication
Confidential evidence briefings for commissioners, prior to publication
Conference

Participant cohort
A ‘live’ cohort of participants for future research
Database of participant contact details for those who consented to follow up after project

Resource for survivors, families, friends, public
'How do I find support for an experience of sexual assault for myself or someone I know?’
Leaflets distributed to NHS settings and community
Info available on project website

Best practice guidance
Best practice guidance and transferable recommendations to improve service provision, with focus on hard to reach groups
5 interactive knowledge transfer workshops on implementation of good practice A5 laminated poster, leaflets
Infographic hosted on website
and distributed via newsletter
MS PowerPoint slides

Summary reports
5x progress reports

End of project report
A report integrating findings
Full, executive and plain English summary available on website
International conference
MESARCH final conference

Planned publication in a high-impact peer-reviewed journal by 2023

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/05/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/08/2019: Uploaded protocol Version 2.2, 21 June 2019 (not peer reviewed). 23/08/2019: Trial's existence confirmed by the NIHR.