Exploring human papillomavirus and microbial environment in transgender and non-binary individuals with neovaginas
| ISRCTN | ISRCTN83943170 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83943170 |
| IRAS number | 341484 |
| Secondary identifying numbers | IRAS 341484, UMON ED-001 |
- Submission date
- 13/05/2024
- Registration date
- 16/05/2024
- Last edited
- 17/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
There is a good understanding of the viruses and bacteria (microbes) that reside in the vaginas of cisgender women. However, there is less understanding of the microbial environment within the constructed vaginas of transgender women post-gender affirmation surgery. Human papillomavirus (HPV), a common genital infection in cis individuals, is notably less understood in trans women. This study aims to find out if transgender women are willing to participate in research to help us understand more about the microbes that can reside in neovaginas and assess what kind of swab can be used in neovaginas to provide a good sample for testing in the laboratory. This work will serve to understand and improve neovaginal health in this population.
Who can participate?
Transgender or non-binary people aged 18 years and older (no upper age limit) who have had a vaginal construction procedure
What does the study involve?
This is a single centre, observational feasibility pilot study of 1-year duration that is targeting the recruitment of 20 participants. Participants will be asked to complete a questionnaire and provide two swabs from their neovagina.
What are the possible benefits and risks of participating?
There are no direct benefits that the participants will receive however they will be adding to the scientific knowledge of this area and, in turn, helping transgender individuals in the future. In terms of risks – there is a risk that some participants may find the sampling procedure uncomfortable however, the swabs are soft-tipped and have been used to support microbiological testing in the past so this risk is low.
Where is the study run from?
Royal Infirmary of Edinburgh, Scottish HPV Reference Laboratory
When is the study starting and how long is it expected to run for?
October 2023 to December 2025
Who is funding the study?
1. The Chief Scientist Office
2. The University of Glasgow
Who is the main contact?
Dr Kate Cuschieri, kate.cuschieri@nhslothian.scot.nhs.uk
Contact information
Public, Scientific, Principal Investigator
Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, 51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
 ORCID ID |
0000-0002-2604-3928 |
|---|---|
| Phone | +44 (0)1312426039 |
| Kate.Cuschieri@nhslothian.scot.nhs.uk |
Study information
| Study design | Single-centre feasibility pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | GP practice, Laboratory, Medical and other records |
| Study type | Other, Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Understanding the human papillomavirus and microbial environment in transgender and non-binary people with neovaginas; a feasibility study |
| Study acronym | UMON |
| Study objectives | This is a feasibility/pilot study so not powered. The main hypothesis is whether it is feasible to recruit transgender women into a study designed to assess HPV and microbial diversity in neovaginas through a gender identity clinic. |
| Ethics approval(s) |
Approved 12/06/2024, West Midlands - Solihull Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8191; solihull.rec@hra.nhs.uk), ref: 24/WM/0114 |
| Ethics approval additional information | Submission pending |
| Health condition(s) or problem(s) studied | Prevention of microbial disease in transgender women with neovaginas |
| Intervention | This is a single centre, observational feasibility pilot study of 1-year duration that is targeting the recruitment of 20 participants. There is no randomisation, participants will be asked to complete a questionnaire and provide two swabs from their neovagina. Participants will be asked to provide two vaginal swabs, one self-taken and one taken by the clinician. They will also be asked to complete a brief questionnaire on vaginal hygiene procedures. Vaginal swabs will be sent to a central laboratory for testing using a human papillomavirus (HPV) genotyping assay which detects up to 28 types and includes a cellularity control. In addition to the HPV assay swabs will be tested using a 16S Ribosomal RNA PCR. Results will be experimental only and not influence the standard of care treatment provision. |
| Intervention type | Other |
| Primary outcome measure | The number of eligible individuals approached versus the number who consented measured using data collected in study records at the end of the recruitment period. |
| Secondary outcome measures | The following secondary outcome measures will be assessed at the end of the recruitment period: 1. The quality of self-taken and clinician-taken vaginal swabs to support HPV and microbial molecular testing measured using qualitative and quantitative assay (laboratory) outputs for microbial and housekeeping targets (PCR yes/no and Ct values) 2. Feasibility to collate information on vaginal hygiene procedures and acceptability of vaginal sampling in transgender and non-binary people with neovaginas (TGNBP) measured using the level of completion of the questionnaire 3. The proportion of TGNBP willing in principle to engage in a longitudinal study to assess the microbial environment of neovaginas (i.e. involving the collection of sequential samples) measured using the response in the questionnaire to the theoretical willingness to take part in a longer-term study |
| Overall study start date | 20/10/2023 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Transgender or non-binary person who has had a vaginal construction procedure 2. Ability to provide informed consent 3. Aged 18 years and older (no upper age limit) |
| Key exclusion criteria | 1. Inability to provide informed consent 2. Vaginal construction in the last 3 months 3. Participation in other interventional research project in the last 30 days |
| Date of first enrolment | 03/06/2024 |
| Date of final enrolment | 03/06/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Edinburgh
Lothian
EH3 9ES
United Kingdom
Sponsor information
University/education
The Queens Medical Research Institute, 47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3330 |
|---|---|
| resgov@accord.scot | |
| Website | https://www.accord.ed.ac.uk/ |
"ROR" |
https://ror.org/01nrxwf90 |
Hospital/treatment centre
The Queens Medical Research Institute, 47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3330 |
|---|---|
| accord@nhslothian.scot.nhs.uk | |
| Website | https://www.accord.ed.ac.uk/ |
|
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 03/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication of a short report in a peer-reviewed journal as a feasibility study 2. Presentation at Scottish HPV Investigators Network Meeting |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Kate Cuschieri, Kate.Cuschieri@nhslothian.scot.nhs.uk. No data containing any personally identifiable information will be made available to external researchers. Anonymised lab data will be made available as will aggregate data from the questionnaire. |
Editorial Notes
17/06/2025: Ethics approval was added, and the overall study end date was changed from 01/05/2025 to 31/12/2025.
14/05/2024: Study's existence confirmed by the University of Glasgow.
