Exploring human papillomavirus and microbial environment in transgender and non-binary individuals with neovaginas

Understanding the human papillomavirus and microbial environment in transgender and non-binary people with neovaginas; a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN83943170

Enrollment

Registered

2024-05-16

Start date

2024-06-03

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of microbial disease in transgender women with neovaginas Infections and Infestations

Interventions

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 complet

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Scotland, United Kingdom

Contacts

Public ContactKate Cuscheiri

Kate.Cuschieri@nhslothian.scot.nhs.uk+44 (0)1312426039

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026