Accessing sexual health care for people with severe mental illness
| ISRCTN | ISRCTN43081021 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43081021 |
| IRAS number | 335538 |
| Secondary identifying numbers | NIHR205310, IRAS 335538, CPMS 61699 |
- Submission date
- 07/03/2024
- Registration date
- 14/03/2024
- Last edited
- 25/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
People with severe mental illness (e.g., schizophrenia) experience more physical illnesses compared to those who do not have mental illness. As a result, mental health services are increasingly offering service users regular health checks and healthy living advice. However, sexual health often remains overlooked. People with severe mental illness are LESS likely to attend sexual health services. Improved engagement with, and access to, sexual health services is essential for the treatment and prevention of sexual ill health. However, very little is known about why people with severe mental illness are less likely to access sexual health services. Therefore, this study will seek to identify the barriers to effective support and offer recommendations around sexual and reproductive health care in this group. To do this, the research team will talk directly to people with severe mental illness and sexual and reproductive health staff.
Who can participate?
Adults aged 18 years old and over with a current diagnosis of severe mental illness. For this study, severe mental illness will be defined as including all psychosis, schizophrenia and schizophrenia-related disorders, bipolar disorder and psychotic major depression. People who work in the sexual and reproductive health services.
What does the study involve?
Participants will be asked about their views and experiences of sexual and reproductive healthcare in private 1 to 1 interview, either in person, on an online video call or using the telephone.
What are the possible benefits and risks of participating?
There will be no direct benefits from taking part in this research. However, participants might value speaking with the researcher in the interview and value having the opportunity to share their experiences. They will also receive a £20 voucher as a thank you.
Participants will be asked questions about their experiences, their opinions and, if applicable, their views on the care that they have received, which they may find personal. They can take time to answer and do not have to answer questions that they do not want to. They can also discuss any concerns at the end of the interview, and they will be asked if they would like their healthcare provider or case worker/support worker to be told so that they can provide further support.
Where is the study run from?
The study is run from the King’s College London and the South London and Maudsley NHS Trust.
When is the study starting and how long is it expected to run for?
January 2024 to May 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR)
Who is the main contact?
Dr Margaret Heslin, Margaret.heslin@kcl.ac.uk
Contact information
Public, Scientific, Principal Investigator
De Cresginy Park
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0002-3094-9255 |
|---|---|
| Phone | 02078485055 |
| margaret.heslin@kcl.ac.uk |
Study information
| Study design | National qualitative study using one-to-one semi-structured interviews and focus groups |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | Community, Home, Internet/virtual, Telephone |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Barriers and facilitators to accessing sexual health care for people with severe mental illness in England |
| Study hypothesis | Aim: To investigate the barriers and facilitators to accessing sexual and reproductive healthcare in people with severe mental illness from a service user and sexual and reproductive health providers’ perspective. Research Question: What are the barriers and facilitators to accessing sexual and reproductive healthcare in people with severe mental illness? Study Objectives There are two separate studies to answer two study objectives: * Study 1 - To explore the barriers and facilitators to accessing sexual and reproductive healthcare in people with severe mental illness from a service user perspective. * Study 2 - To explore the barriers and facilitators to accessing sexual and reproductive healthcare in people with severe mental illness from a sexual health providers’ perspective. |
| Ethics approval(s) |
Approved 09/04/2024, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8290; gmeast.rec@hra.nhs.uk), ref: 24/NW/0092 |
| Condition | Sexual health in people with severe mental illness (schizophrenia and related disorders, bipolar disorder and psychotic major depression) |
| Intervention | The two objectives will be met using slightly different methodologies and are described below separately. Study 1 - Service User Perspectives A qualitative research study will be used to explore the research question from the perspective of service users, informed by their experience of accessing sexual and reproductive health services. Individual semi-structured in-depth one-to-one interviews will be undertaken with participants. Interviews will be facilitated by a topic guide to ensure that the interviews have a clear focus on the study objectives while allowing research participants to develop their areas/topics for discussion. Stratified purposive sampling will be used to recruit a diverse range of people in terms of location, age, gender, gender identity, ethnicity, sexuality, disability and neurodiversity, with & without experience of sexual health services. The principal means of data collection will consist of recordings conducted in MS Teams interviews, transcribed verbatim. Transcripts will be analysed using reflexive thematic analysis. Study 2 - Sexual and Reproductive Health Providers’ Perspective Focus groups will be used to explore the research question from the perspective of sexual and reproductive health providers, informed by their experience of providing sexual health services to people with severe mental illness. Focus groups will be facilitated by a topic guide and analysed as above. |
| Intervention type | Other |
| Primary outcome measure | 1. Perspectives of service users, informed by their experience of accessing sexual and reproductive health services, measured using data collected from individual semi-structured in-depth one-to-one interviews conducted in MS Teams interviews, transcribed verbatim at one timepoint 2. Sexual and reproductive health providers’ perspectives measured using data collected from focus groups at one timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2024 |
| Overall study end date | 31/05/2025 |
Eligibility
| Participant type(s) | Health professional, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Service users: 30; Staff: 16 |
| Total final enrolment | 44 |
| Participant inclusion criteria | Service users: 1. Aged 18 years old and over 2. Have received a formal diagnosis of SMI described above from a mental health professional 3. Have the ability to give informed consent Staff: 1. Currently working in sexual or reproductive healthcare provision or have done so in the last 3 years 2. Have the ability to give informed consent |
| Participant exclusion criteria | Service users: 1. Not diagnosed with a severe mental illness 2. Aged under 18 years old 3. Are considered by the researcher(s) to be too unwell or distressed to participate in the study 4. Are unable to give informed consent to the study Staff: 1. Are not currently working in sexual and reproductive healthcare provision or have not done so in the last 3 years 2. Are unable to give informed consent to the study |
| Recruitment start date | 07/06/2024 |
| Recruitment end date | 22/04/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE5 8AF
United Kingdom
Denmark Hill
London
SE5 8AZ
United Kingdom
Sponsor information
University/education
Room 8.11, 8th Floor Melbourne House 44-46 Aldwych
London
WC2B 4LL
England
United Kingdom
| Phone | +44 (0)2078487306 |
|---|---|
| vpri@kcl.ac.uk | |
| Website | https://www.kcl.ac.uk/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from margaret.heslin@kcl.ac.uk. The type of data that will be shared are anonymised transcripts of interviews, which will be available after the journal paper's publication. informed consent from participants was required and obtained. There are no ethical or legal restrictions. |
Editorial Notes
25/04/2025: The following changes were made:
1. The recruitment end date was changed from 30/04/2025 to 22/04/2025.
2. The total final enrolment was added.
11/02/2025: The recruitment end date was changed from 28/02/2025 to 30/04/2025.
07/06/2024: The recruitment start date was changed from 01/05/2024 to 07/06/2024.
15/04/2024: Ethics approval details added.
05/04/2024: Internal review.
07/03/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
