What does taking part in the study involve?

 Find out if you're eligible to take part                                                                                                      

 

View the DEVA Patient Information Sheet (Version 1.0_11March2021) (opens a PDF)

 

You can participate in the DEVA study without the need to visit your local sexual health clinic or GP. Our team of doctors and nurses can check your suitability to take part all from the comfort of your own home over the phone and by checking results of self-taken swabs which we send directly to you.

This page summarises the participant journey for those women who choose to take part in the DEVA study. Please remember you do not need to take part in the study, you choose whether to take part or not. If you do participate, you can stop being involved at any point, you just need to let us know so we can record this and prevent further contact from any members of our team.

Phone or video call with the doctor/nurse from your local sexual health clinic.

Initially you will have a phone/video call with a doctor or a nurse (approx. 15 minutes) to learn about the study, during this call you have the opportunity to ask questions. If you are interested in taking part you will be sent a link, via email or text that includes the Patient Information Sheet  and a copy of the study consent form. It is important that you read all the information in this information sheet before consenting to join the study. If you would like to take part in the DEVA study you will be asked to give written informed consent. This consent form will be completed remotely, using a computer or a mobile device. Once you have completed the consent form it will be sent to the DEVA research team, who will then countersign the consent form. If there are any problems with your consent form it will be sent back to you.

Home vaginal swab kit

Once your consent form is signed (by you and your doctor/nurse) a vaginal swab kit will be sent to your home address. The kit will contain everything you need to take and return your swabs including instructions and a pre-paid envelope. The kit will contain two swabs; one to confirm your BV diagnosis and the other to screen for sexually transmitted infections (STIs), These are the same as the tests you would have if you visited the sexual health clinic with these symptoms outside of the study. You will be informed of the results of your BV test. If your BV test and final checks show you are suitable, and if you choose to participate, your STI screen will be tested and those results reported back to you at a later date by your sexual health clinic. If you do not participate you will be advised to speak to your GP or local sexual health team regarding your symptoms and your STI screening swab will be discarded without testing.

Randomisation

If you have a positive BV test result and your doctor agrees you should take part in the DEVA study, your treatment will be decided by a process called ‘randomisation’.

 

Randomisation: means that participants are equally likely to be given one of the two treatments. It is a little like tossing a coin but is done by a computer. Neither you, nor anyone else will able to choose whether you get usual care antibiotics or dequalinium chloride. This is to make sure that this study is doing a ‘fair comparison’ of dequalinium chloride versus antibiotics.

So, before you agree to join the study you need to be sure that you are willing to use either of the treatment options.

Taking your treatment

You will be sent your treatment in the post and it is best to start your treatment the day you receive it. You will be asked to take all your treatment as instructed. We will text you 14 days after you join the study, to ask if you have taken all your treatment, and if you have not, we will ask you how much you took.

Week 4 vaginal swab kit

You will be sent a further vaginal swab kit containing one swab to test whether your BV has cleared following your treatment. You will be asked to take this swab four weeks after joining the trial, at the same time as completing your first study questionnaire. Like the samples you take to check your suitability to join the study, you will be sent the kit and instructions on how to take the swab at home and you will need to post them back to the central laboratory at Leeds Sexual Health in the package provided to you.

Answering some questions

We will send you two short questionnaires; one will be 4 weeks after joining the study and the other 2 months later. This can either be posted to you or can be done on-line using a link we will send by text or e-mail. You can choose how you would prefer to receive this. The questionnaires will ask about your BV symptoms and any additional BV treatment you have used, any changes in your sexual partners and if you have used any NHS services related to your BV or study treatment.

We understand that sometimes you can forget to take treatment or give up before you finish all your treatment. It is valuable for us to know this, and for you to complete your questionnaires as planned even if you did not take your treatment.

There is an extra part of the study that you may be asked to consider taking part in. Taking part in this is completely optional and will not affect your participation in the main study.

This extra part of the study would require you to take 2 additional swabs, one to take at the same time as your study entry checks and the other to be taken at the same time as your week 4 swab. These additional samples will be posted as part of the study sample kits. These swabs will be stored for future research.

 

All the samples you take for the study will be anonymised and are for research purposes only.