A randomised controlled trial of a safer sex intervention delivered through mobile phone messaging

ISRCTN	ISRCTN64390461
DOI	https://doi.org/10.1186/ISRCTN64390461
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CPMS 20710
Sponsor	London School of Hygiene and Tropical Medicine
Funder	National Institute for Health Research

Submission date: 17/03/2016
Registration date: 17/03/2016
Last edited: 20/11/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Sexually transmitted infections (STIs) are common in young people. Easy-to-treat conditions such as chlamydia or gonorrhea are particularly common, and can lead to major health problems if left untreated. Practicing safe sex by using condoms and getting tested for STIs before they stop using condoms with a new partner, lowers the risk of getting an infection. Likewise, people with an infection are less likely to get another infection if they tell their partner. These practices can be very difficult for young people however. The use of text messages offering support has been shown to be very effective in other areas, such as quitting smoking, as so it is possible that it could also help encourage safe sex, getting tested for STIs and helping people to tell their partner if they are infected. The aim of this study is to find out whether delivering support using text messages over the course of one year is an effective way of reducing STIs by promoting safe sex and regular STI testing.

Who can participate?
Young adults aged between 16 and 24 who have had a positive chlamydia or gonorrhoea test in the last two weeks and own a mobile phone.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive regular text messages for one year (one-two per day for one month, two-three per week for the second month and then two-five per month for the rest of the study). These messages are tailored to individual participants based on gender, sexual orientation and which STI they have been diagnosed with. The messages contain information about treatment for their STI as well as promoting condom use to encourage safe sex. The messages also offer support on how to tell their partner so that they can be tested and treated. Participants in the second group receive a monthly text message for a year, asking them to provide information about any changes in the contact details. These participants receive usual care and are free to seek treatment and support as needed. After one year, participants are re-tested in order to find out how many have an STI. The number of participant’s partners who also came for treatment is also recorded.

What are the possible benefits and risks of participating?
Participants may benefit from the trial as they may find the messages helpful and may learn about safer sex behaviours. There are very few risks in taking part. Completing the questionnaires and providing a sample will take up some time. It is possible that the messages could be read by someone other than the participant. Participants are advised to password-lock their phones and delete messages after they read them. Data will be collected regarding whether other people viewed messages and whether the participant was happy/unhappy about this. Data will be collected about involvement in road traffic accidents as they are the only demonstrated harm resulting from text messaging.

Where is the study run from?
London School of Hygiene and Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
April 2016 to May 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Caroline Free
Caroline.Free@lshtm.ac.uk

Contact information

Prof Caroline Free
Public

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)207958 8109
Email	Caroline.Free@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Safetxt: A randomised controlled trial of an intervention delivered by mobile phone messaging to reduce sexually transmitted infections (STI) by increasing sexual health precaution behaviours in young people
Study objectives	The aim of this study is to establish the effectiveness of a safer sex intervention delivered by mobile phone messaging on STI infection at 1 year; partner notification and condom use at 4 weeks; and partner notification, condom use and STI testing at 1 year.
Ethics approval(s)	London - Riverside Research Ethics Committee, 16/10/2015, ref: 15/LO/1665
Health condition(s) or problem(s) studied	Topic: Infectious Diseases; Subtopic: Infectious Diseases; Disease: Infectious Diseases and Microbiology
Intervention	Participants will be randomly allocated, using a remote computer based randomised system, to a safer sex intervention delivered by text messaging or to a control group. The allocation will be by simple randomisation. Control group: Participants receive a monthly text message asking the participant to provide information about changes in postal or email addresses Intervention group: Participants receive regular messages delivered by text message to influence safer sex behaviours. The intervention employs education, enabling and incentivising behaviour change functions and twelve behaviour change techniques identified in effective face to face safer sex interventions. The information on safer sexual practices is in accordance with existing guidelines. The intervention text message content has been developed in collaboration with young people and has been shown to be acceptable, comprehensible and relevant. Participants will be sent messages at the following frequencies: 1. 4 messages per day for days 1-3 2. 1-2 messages per day for days 4-28 3. 2-3 messages per week for month 2 4. 2-5 messages per month for months 3-12
Intervention type	Other
Primary outcome measure(s)	Cumulative incidence of Chlamydia and gonorrhoea infection at one year assessed by NAAT (nucleic acid amplification test) tests: urine for men with pharyngeal and anal swabs for MSM (men who have sex with men) and self-taken vulvo-vaginal swab for women.
Key secondary outcome measure(s)	Current secondary outcome measures as of 30/10/2019: Measured at 4 weeks: Behaviours: 1. Whether participants took the (prescribed antibiotic) treatment and avoided sex for 7 days after treatment, self-reported on 4-week questionnaire 2. Whether they told the last person they had sex with before testing positive, that they needed to get treatment, self-reported on 4-week questionnaire 3. Clinic attendance by partner for treatment, identified from clinic records 4. Condom use at last sex, self-reported on 4-week questionnaire Process outcomes – scores of the theoretical constructs underlying the components of the intervention (behaviour change mediators): 1. Attitudes towards partner notification, self-reported on 4-week questionnaire 2. Self–efficacy in telling a partner about an infection, self-reported on 4-week questionnaire 3. Self–efficacy in negotiating condom use, self-reported on 4-week questionnaire 4. Correct condom use self-efficacy, self-reported on 4-week questionnaire 5. Knowledge related to STIs, self-reported on 4-week questionnaire Measured at 1 year: STIs: 1. Diagnosed with any STI after joining the trial according to self-report confirmed by postal test results and clinic records, self-reported on 1-year questionnaire Behaviours: 1. Condom use at last sex, self-reported on one year questionnaire 2. Number of sexual partners since joining the trial, self-reported on one year questionnaire 3. Sex with someone new since joining the trial, self-reported on one year questionnaire 4. Condom use at first sex with most recent new partner, self-reported on one year questionnaire 5. Self-reported sexually transmitted infection testing for self - prior to first sex with most recent new partner, self-reported on 1-year questionnaire 6. Sexually transmitted infection testing for self - prior to first sex with most recent new partner, confirmed according to clinic record that testing occurred 7. Participant’s report as to whether their most recent new partner was tested for sexually transmitted infection prior to sex with them, self-reported on 1-year questionnaire 8. Number of sexual partners since joining the trial, self-reported on 1-year questionnaire 9. Reading and sharing of intervention content, self-reported on 1-year questionnaire 10. Number of text messages read, self-reported on one year questionnaire 11. Whether anyone else read the messages, if yes how did the participant feel about them reading the messages? Self-reported on 1-year questionnaire 12. Reading someone else’s messages in the trial (to be reported for control group participants), self-reported on 1-year questionnaire 13. Someone else in the trial reading participants’ messages (to be reported for intervention group participants), self-reported on 1-year questionnaire Potential harms: 1. Car accident where the participant was the driver in the past year, self-reported on one year questionnaire 2. Experience of partner violence in the past year, self-reported on one year questionnaire Previous secondary outcome measures: 1. Clinic attendance by partner for treatment is determined at 4 weeks 2. Whether participants took the treatment and avoided sex for 7 days after treatment is determined at 4 weeks
Completion date	06/05/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Upper age limit	24 Years
Sex	All
Target sample size at registration	6250
Total final enrolment	6248
Key inclusion criteria	1. Aged 16 to 24 inclusive 2. Received a positive chlamydia or gonorrhoea test result or have been diagnosed with NSU in the last 2 weeks 3. Own a personal mobile phone 4. Able to provide informed consent
Key exclusion criteria	Known to be a sexual partner of someone already recruited to the trial.
Date of first enrolment	01/04/2016
Date of final enrolment	27/11/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

London School of Hygiene and Tropical Medicine

Keppel Street
London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		28/09/2022	29/09/2022	Yes	No
Results article	Qualitative results	24/10/2023	26/10/2023	Yes	No
Protocol article	protocol	08/03/2020	11/03/2020	Yes	No
HRA research summary			20/09/2023	No	No
Other publications	Secondary data analysis	07/11/2024	20/11/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	version v6	10/06/2020	19/06/2020	No	No

Additional files

ISRCTN64390461_SAP_v6_10June2020.pdf: Uploaded 19/06/2020

Editorial Notes

20/11/2024: Publication reference added.
26/10/2023: Publication reference added.
20/09/2023: A link to the HRA research summary was added.
29/09/2022: Publication reference added.
12/08/2021: The following changes have been made:
1. The study contact has been updated and the plain English summary has been updated accordingly.
2. The total final enrolment number has been added.
19/06/2020: The following changes have been made:
1. The overall trial end date has been changed from 30/04/2020 to 06/05/2020 and the plain English summary has been updated accordingly.
2. The intention to publish date has been changed from 01/10/2020 to 31/10/2020.
3. The statistical analysis plan has been uploaded as an additional file.
11/03/2020: Publication reference added.
01/11/2019: The secondary outcome measures were updated.
18/12/2018: The following changes were made:
1. The planned sample size was changed from 5000 to 6250.
2. The recruitment end date was changed from 30/03/2018 to 27/11/2018.
3. The overall trial end date was changed from 31/07/2019 to 30/04/2020.
4. The intention to publish date was changed from 31/07/2020 to 01/10/2020.
5. The plain English summary was updated.
10/08/2016: The study contact has been changed from Rebecca Matthews to Rosemary Knight.
05/08/2016: Study status verified with principal investigator.