Participant Information Sheet 'Can text messages increase safer sex behaviours in young people': Pilot Study

We are inviting you to take part in a research study. Before you decide, it is important that you know why we are doing the study and what is involved. Please read the following information carefully.

What is the study?

This study is testing whether text messages providing information and tips to increase safer sex are acceptable to young people. We also want to find out if young people are willing to complete questionnaires and provide urine or vaginal swab samples after receiving the messages.

Why have I been chosen?

You are aged 16-24 and have taken part in the Chlamydia Screening Programme.

Do I have to take part?

No, it is up to you to decide whether to take part.

What will happen if I take part?

After you have had all your questions answered and have agreed to take part, we will ask you to provide consent. You can do this on our secure and confidential study website, by filling out a paper version, by text message or by email. We will then ask you to complete a short confidential questionnaire providing details about yourself.

After you have completed the questionnaire, an automated computer system will put you into one of two groups by chance (randomly). One group will receive safer sex text messages for 1-2 weeks, then about 5 messages a month for 11 months. The other group will receive text messages about taking part in the study, and are not about sexual health. This group will receive a few messages a month for 11 months.

We will ask you to complete the questionnaire again at 1 and 12 months after enrolling. This is to see how things have been for you joining the study. At 3 and 12 months we will ask you to provide a sample to test for Chlamydia. You can choose to have the testing kit sent to you by post or to pick it up at a local sexual health service. Participating in the study involves returning two urine samples or self taken vaginal swabs to test for Chlamydia. The clinic will also inform us of Chlamydia tests you have at the clinic during the study.

Will you compensate me for the time this takes?

We will offer you £5 as compensation for your time at each follow up: for the 1 month questionnaire, the 3 month sample, the 12 month questionnaire and the 12 month sample.

We do not charge for text messages we send to you.

What are the alternatives?

You do not have to take part.

What are the possible disadvantages in taking part?

Completing the questionnaires and providing a Chlamydia sample will take up some of your time. It is possible that the messages we send could be read by someone else. If you are concerned about this, you can password-lock your phone and delete the messages after you read them.

We cannot promise that your health will benefit from taking part.

What are the possible benefits of taking part?

Taking part in this study will help us find out if text messages about sexual health are acceptable to young people. You may find the messages helpful and you may learn about safer sex behaviours.

What happens when this study stops?

When the study stops, we will see how many people participated and how many completed their questionnaires and returned Chlamydia samples.

What will happen if I don't want to carry on with the study?

You can stop receiving text messages by texting STOP or pause the text messages by texting PAUSE or withdraw at any time by letting the Study Coordinator know (Ona McCarthy: 020 7927 2581; ona.mccarthy@lshtm.ac.uk). You do not have to give a reason for wanting to withdraw.

What if there is a problem?

You can contact the Study Coordinator if there is a problem. If you would like to make a formal complaint, contact Dr Caroline Free who will follow the complaints procedure.

Will my taking part in this study be kept confidential?

Yes. Your answers to the questionnaires will be stored anonymously and your contact details and Chlamydia test will be kept confidential. We will not inform your parents or your GP about your involvement in this research. With your permission, we may ask your sexual health service if you attended for testing during your involvement in the study. To keep the messages confidential, password-lock your phone and delete messages after you read them.

What will happen to the samples that I give?

You will post your sample to a laboratory to test for Chlamydia infection. Then the laboratory will destroy the samples. We will notify you if the test shows that there is Chlamydia infection.

What will happen to the results of the research study?

The results will be published in a scientific journal so that other people know about it. If you would like a copy of the results please text contact the Study Coordinator, Ona McCarthy (details below).

If you want to receive the safer sex messages after your participation in the study, please let us know and we will send them to you.

Depending on the results, this study may lead to another study that will see if the text messages help improve young people's sexual health.

Who is organising and funding the research?

The study is run by Dr Cari Free (Chief Investigator) from the London School of Hygiene and Tropical Medicine, at the University of London. The UK National Institute for Health Research is funding the trial.

Who has reviewed the trial?

Surrey NHS Medical Research Ethics Committee.

Thank you for taking the time to consider taking part.

If you would like further information please contact the Study Coordinator (details below)

The team contact details

Ona McCarthy (Study Coordinator)

Department of Population Health

London School of Hygiene and Tropical Medicine

Keppel St

London

WC1E 7HT

Tel: 020 7927 2581

ona.mccarthy@lshtm.ac.uk

Dr. Caroline Free (Chief Investigator)

Department of Population Health

London School of Hygiene and Tropical Medicine

Keppel St

London

WC1E 7HT

Tel: 020 7927 2581

caroline.free@lshtm.ac.uk