The Scottish ePrEP Clinic Feasibility Study: Assessing the feasibility of providing HIV prevention medication online
| ISRCTN | ISRCTN57061725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57061725 |
| IRAS number | 342338 |
| Secondary identifying numbers | HLS/NCH/23/030, CPMS 65655 |
- Submission date
- 10/10/2024
- Registration date
- 01/11/2024
- Last edited
- 19/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
PrEP (oral HIV pre-exposure prophylaxis) is a HIV prevention medication taken by people who do not have HIV, before and after sex. It is an important part of Scotland's HIV transmission elimination strategy, moving towards zero new HIV transmissions. To get PrEP, people typically have to attend a sexual health clinic to test for HIV and sexually transmitted infections (STIs), discuss continuing PrEP with a healthcare professional, and receive more PrEP. This can be challenging for people and difficult for sexual health services to keep up with demand because these appointments can be up to four times per year. In order to address some of these challenges, we have developed an alternative way for people to get their PrEP online: the ePrEP Clinic.
The ePrEP Clinic is a way of getting PrEP that people can do without having to come into the clinic every time they need PrEP. It consists of postal self-sampling for HIV and STIs, an "asynchronous online consultation" (essentially an online medical questionnaire), and, if appropriate, provision of PrEP by post or in-clinic collection, depending on the user's preference. We developed the service over a series of research studies and are now at the stage where we are ready to test it out on a small scale.
Who can participate?
This is a relatively small study in which we are trying out the ePrEP Clinic by offering it to a group of PrEP service users. Therefore, we are only recruiting from a specific clinic in Glasgow, Scotland. The ePrEP Clinic is also limited in the complexity of care it can deliver. For example, it is not able to offer kidney function testing, which some people need at every PrEP appointment. Therefore, in this study, we are focusing on people who do not need frequent kidney function testing or any other care that falls outside of the ePrEP Clinic's capabilities. People's eligibility will be assessed by the study clinician on an individual basis, using our specific eligibility criteria.
What does the study involve?
1. Potential participants will be identified by the study clinician and introduced to the study by text message or a flyer in clinic. They then have the option to speak to the study clinician to discuss participation, after which they can enrol.
2. As their next PrEP appointment approaches, the study clinician will order a self-sampling kit on the participant's behalf and send them a link to the online medical questionnaire by text message. The self-sampling kit is a specially designed kit that participants have delivered to their house. The participant then collects their own swabs, finger-prick blood sample, and urine sample, as needed. The samples are then posted to the laboratory by the participant, where they are analysed and the results are sent to the study clinician. These kits are already commonplace in many parts of the UK.
3. Once the study clinician has received the results of the HIV test and questionnaire, they will decide if more PrEP is appropriate and if any other clinical input is required (e.g. treatment for an STI). All clinical input will be delivered in line with standard clinical protocols.
4. If more PrEP is appropriate, the study clinician will post it to the participant or let them know it is ready to collect at the clinic, whichever the participant prefers.
5. The study clinician will then send the participant a link to an evaluation questionnaire.
What are the possible benefits and risks of participating?
There are no immediate benefits to taking part in this study; however, it is a necessary step in deciding if the ePrEP Clinic becomes a permanent option for PrEP appointments, which participants may go on to use in the future. Our previous research suggests that the ePrEP Clinic might be more convenient for people and reduce the number of times they need to go to a physical clinic per year.
Where is the study starting and how long is it expected to run for?
September 2024 to September 2025
Who is funding the study?
The study is part of The Scottish ePrEP Clinic research programme funded by the Scottish Government.
Who is the main contact?
Study queries can be directed to Dr Ross Kincaid (Ross.Kincaid@gcu.ac.uk). It is important to note that you cannot request to take part by emailing the study team.
Contact information
Public
Sandyford Sexual Health Services
2-6 Sandyford Pl
Glasgow
G3 7NB
United Kingdom
 ORCID ID |
0009-0004-0023-7806 |
|---|---|
| Phone | +44 1412218130 |
| beth.bateson2@nhs.scot |
Scientific
M436 George Moore Building
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
| ORCID ID |
0000-0002-3489-8897 |
|---|---|
| Phone | +44 1413318419 |
| Ross.Kincaid@gcu.ac.uk |
Principal Investigator
M421 George Moore Building
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
| ORCID ID |
0000-0001-5523-5630 |
|---|---|
| Phone | +44 1413313099 |
| Claudia.Estcourt@gcu.ac.uk |
Study information
| Study design | Single-centre feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Internet/virtual, Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The Scottish ePrEP Clinic Feasibility Study |
| Study acronym | ePrEP Feasibility |
| Study objectives | The aim of this study is to assess the feasibility and acceptability of providing PrEP through the ePrEP Clinic by offering NHS PrEP service users the option to complete one of their PrEP appointments through the ePrEP Clinic pathway. |
| Ethics approval(s) |
1. Approved 09/09/2024, Glasgow Caledonian University Nursing and Community Health Research Ethics Committee (Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, United Kingdom; +44 1413313114; HLSEthicsNursing@gcu.ac.uk), ref: HLS/NCH/23/030 2. Submitted 24/09/2024, NHS Research Ethics Committee (TBC, TBC, TBC, United Kingdom; TBC; approvals@hra.nhs.uk), ref: TBC |
| Health condition(s) or problem(s) studied | HIV transmission prevention |
| Intervention | Participants will complete the 'ePrEP Clinic' pathway instead of their usual in-clinic interim PrEP review. The ePrEP Clinic consists of postal self-sampling for HIV and STIs, an asynchronous online consultation (questionnaire-based), and provision of PrEP by post or collection from a sexual health service. Additional clinical care will be delivered as needed following standard clinical protocols. |
| Intervention type | Other |
| Primary outcome measure | Uptake and completion rate measured by tracking participants' completion of each of the pathway stages over the course of the study. |
| Secondary outcome measures | 1. Clinical input required by participants measured by logging clinical input received throughout participation 2. Acceptability measured using a self-report questionnaire at the end of the study 3. Costs associated with the ePrEP Clinic pathway measured by conducting a costing analysis using study data (primarily, mapping participants' journeys through the intervention and the resources used) 4. Details of any challenges or lessons learned when implementing the study measured by maintaining a log throughout the study period |
| Overall study start date | 09/09/2024 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 39 Years |
| Sex | Both |
| Target number of participants | Up to 200 service users |
| Key inclusion criteria | 1. Reside in the Greater Glasgow and Clyde health board 2. Existing Sandyford PrEP service user 3. Currently use tenofovir disoproxil and emtricitabine for PrEP (‘standard’ oral PrEP) 4. Willing and able to receive the postal self-sampling kit 5. Does not require enhanced kidney (renal) monitoring at that visit 5.1. Is aged 18-39 years 5.2. No known medical conditions that increase kidney risks 5.3. No known medications that interact with kidney function or are associated with kidney impairment 5.4. Does not have >1 + protein on previous urinalysis 6. No scheduled testing that cannot be delivered within the ePrEP Clinic (e.g. urinalysis, hepatitis B/C testing) 7. Not prescribed interacting medications 8. Not known to have viral hepatitis 9. Not known to have osteoporosis or be at significant risk of osteoporosis 10. Not pregnant or a cis woman not on contraception 11. No known ‘social complexities’ as determined by a clinician using local criteria 12. No significant PrEP adherence issues 13. Able to read English well enough to understand the study materials (including self-sampling instructions and asynchronous consultation), and provide informed consent |
| Key exclusion criteria | Anyone who does not fulfil all inclusion criteria. |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 15/08/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow
G3 7NB
United Kingdom
Sponsor information
University/education
Cowcaddens Road
Glasgow
G4 0BA
Scotland
United Kingdom
| Phone | +44 141 331 3000 |
|---|---|
| Sharron.Dolan@gcu.ac.uk | |
| Website | http://www.gcu.ac.uk/ |
"ROR" |
https://ror.org/03dvm1235 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- The Scottish Government, Scottish Executive, Riaghaltas na h-Alba
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer reviewed journal and conference presentations. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the sensitive and potentially identifiable nature of the data. |
Editorial Notes
19/08/2025: The contact confirmed the record is up to date.
16/01/2025: Internal review.
10/10/2024: Trial's existence confirmed by Glasgow Caledonian University Nursing and Community Health Research Ethics Committee.
