My name is Janet Wilson and I'm the Chief Investigator of the DEVA study. I am a Consultant in Sexual Health at Leeds Teaching Hopsitals NHS Trust. I have always had an interest in BV and I have been involved with, and led, BV studies since the mid-1990s. I will be on hand to support the Research Nurses and Nottingham team with any medical support and guidance during the DEVA study.
I'm Mickey and I'm one of the team who will manage the study follow-up on hand to help with questionnaires, sample kit issues and general queries. My team at the Nottingham Clinical Trials Unit will manage the study with the majority of study activity run by the doctors and nurses and Leeds Sexual Health
My name is Michelle and I have worked as a Research Nurse for 7 years at Leeds Sexual Health. I have had a lot of experience working on a variety of studies, including a study for Bacterial Vaginosis in the past. I am really excited and looking forward to supporting you throughout your participation in the DEVA study. I will be here to answer any of your questions about the study, your kits and your treatment.
My name is Rudy, and I am a midwife by background, having worked both in the NHS and in the charity sector. I'm part of the sexual health research team delivering the DEVA trial at the Leeds site, so you may speak to me on the phone or get an email from me if you take part in the study. I'm passionate about health justice and improving health outcomes for marginalised groups, and look forward to helping improve our knowledge around BV.
I’m Caroline and I am a Senior Clinical Trials Assistant at Leeds Sexual Health. I have worked in the health service in various departments all of my career and thoroughly enjoy working in research. I work closely with the research nurses and deal with all the admin relating to your involvement in the trial including posting out kits, receiving mail and inputting and collating data for the Nottingham Clinical Trials Unit.
My study data
What will happen to the information collected about me?
We will need to use information from you for this research project. In doing this we will follow all clinical and research ethical and legal practice. All information about you will be kept strictly confidential and we will keep all information about you safe and secure.
This information will include your name, date of birth (DOB) and contact details. Some of the data collected for the study may be looked at by authorised persons from the Nottingham Clinical Trials Unit (NCTU) at the University of Nottingham who are coordinating the research. They may also be looked at by authorised people from regulatory authorities and Leeds Teaching Hospitals NHS Trust to check that the study is carried out correctly. All will have a duty of confidentiality to you as a research participant.
People who do not need to know who you are will not be able to see your name or contact details. A copy of your consent form will be sent to the NCTU but any other information about you which leaves the clinic will have your name and address removed (anonymised). Your data will be anonymised with only your initials and DOB and will be identified by a code number instead. No one will be able to identify your involvement when the findings are published at the end of the study. The anonymised information collected about you may be used to support other research in the future and may be shared with other researchers.
Your personal contact details will be available to the Nottingham Clinical Trials Unit (NCTU) so they can contact you during the study and send the questionnaires. Once the study is finished, some of the data will be kept so we can check the results. Your name and email address will be kept after the end of the study so that we can contact you about the findings of the study. If you do not wish to be contacted with the results of the study all your contact details will be disposed of securely (deleted) at the end of the study. All other data (research data) will be kept securely for 25 years. After this time, your data will be disposed of securely.
As an optional addition to the study, you may also agree to have your name and telephone number will be shared with Esendex, our text messaging provider and their subprocessors, and will be used to send you text message reminders about the study and study questionnaires whilst you are participating in the study. Once your participation has ended you will no longer be contacted but Esendex will retain the data for two years or until the end of the study (whichever occurs first).
What are your choices about how your information is used?
- You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
- If you are pregnant, we will let your GP know that you are taking part in this study and ask them to provide us with information on the outcome of your pregnancy. With your permission, we may use NHS Digital and other central UK NHS bodies to help us obtain your pregnancy outcome.
- If you agree to take part in this study, you may have the option to take part in future research using your data saved from this study.
Where can you find out more about how your information is used?
You can find out more about how we use your information
Phone: 0115 8231613
Tik Tok: @deva_study