How will accruals be allocated for safetxt?
All participants will be assigned to the clinic at which they were first identified, regardless of the method of consent and randomisation.
How are the messages sent out?
The messages are sent from a central system which is based at the CTU (Clinical Trials Unit). As this is an automated system, clinics do not have to worry about setting up any systems for sending texts.
How is follow up coordinated?
Follow up is all coordinated from the CTU at LSHTM. Participants will be sent questionnaires from the CTU at LSHTM and the replies will be sent back to them. However, we do ask all clinics to emphasise the importance of the follow up before recruiting participants into the trial.
How are the test kits coordinated?
The one year Chlamydia and gonorrhoea tests are sent directly to participants from the CTU at LSHTM. The samples are then forwarded to the laboratory by the participants using freepost boxes.
Will sites be told if a participant tests positive at 1 year?
Yes. CTU staff will pass on the details of these participants to the clinic where they were first identified.
Can letters and test kits be sent to other countries?
Yes, it is fine to include participants who live overseas providing they have a UK telephone number.
Can participants who have had a positive diagnosis of gonorrhoea from microscopy testing be included prior to confirmation of the diagnosis by PCR testing?
Yes, participants can be included if they have received a positive gonorrhoea result from a microscopy test.
Can participants take part in other randomised controlled trials alongside safetxt?
Participants can take part in randomised controlled trials investigating treatment for their STI. However, involvement in behavioural studies should be confirmed with LSHTM CTU prior to randomisation.
Can participants stop messages?
Yes, they can text ‘STOP’ as a reply to any of the text messages they receive and this will stop the messages. However, they will still be contacted to complete the follow up unless the participant requests otherwise.
Participants can also text ‘Pause’ and this will stop the messages on a temporary basis. They may want to do this if they are going on holiday. Staff from the CTU will contact participants after 2 weeks to see if they would like the messages to restart.
If a patient consents to their information being used to support other research, will any patient identifiable information be shared?
No, all data will be anonymised and so no identifiable information will be given to other researchers.
Why is Cervicitis not included in the eligibility criteria?
We considered the inclusion of cervicitis with a team of genitourinary leads. Their view was that the trial aims to reduce reinfection, but unless the cervicitis is caused by chlamydia or gonorrhoea then either there is a low chance of reinfection or, as in herpes cervicitis, recurrence can occur irrespective of whether safer sex behaviours are adopted (so our intervention couldn’t prevent recurrence). Furthermore cervicitis has multiple causes and unless a specific infection is identified the diagnosis can be somewhat subjective.
If a potential participant is unaware that their sexual partner is already taking part in the trial (but the nurse is aware), can he/she still be entered into the trial?
No, if you have a potential participant who is known to be a sexual partner of someone already recruited to the trial, then they are not eligible to take part.
Can Chlamydia contacts be approached to take part in the trial?
Yes, although you must be sure that the index person has not already agreed to take part in the trial.
If a Chlamydia contact attends the clinic for treatment, can they be approached to take part in the trial? – or do I need to wait for a positive diagnosis to come back?
Yes, the contact can be approached to sign up to the trial if they attend clinic and receive treatment. You must still ensure that the index person has not already agreed to take part in the trial.
I am trying to randomise a participant but I am unable to access safetxt.org?
Most of the time, problems with the website can be resolved by closing the page and restarting the questionnaire again. Sites can also fax the consent and baseline form to the secure fax in G37 or they can email them as a secure pdf for staff at LSHTM to randomise them.
I am trying to randomise a participant but they do not want to provide an address, can I use the clinic as their address?
We do not want to do this as it makes it difficult to be sure that the participant will receive their follow up questionnaires, cash incentive and test kit.
I am trying to randomise a participant but they missed out an answer to one of the questions in the questionnaire. How do I skip the question on the system so I can continue?
It isn’t possible to skip any questions. You will need to contact the participant to find out the answer in order to randomise them. Alternative phone/email and alternative contact details are optional. If the participant doesn’t have an email they can use email@example.com with a number after safetxt.
Can a participant be enrolled when they attend the clinic for retreatment?
Yes, they would meet the eligibility criteria for beginning treatment in the last 2 weeks, as long as they are not already enrolled in the study.
Can a participant be enrolled if they attend the clinic for retesting as part of their ongoing treatment?
The patient would not be eligible to enrol if they came back for retesting and this was after 2 weeks of beginning their treatment. However, if the patient receives a positive diagnosis from their retest they would then be eligible, or if retesting occurred within 2 weeks of starting their treatment.