Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT
Background: The prevalence of genital chlamydia and gonorrhoea is higher in the 16–24 years age group than those in other age group. With users, we developed the theory-based safetxt intervention to reduce sexually transmitted infections. Objectives: To establish the effect of the safetxt interventi...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2023-01-01
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| Series: | Public Health Research |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/DANE8826 |
| _version_ | 1797942757339168768 |
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| author | Caroline Free Melissa J Palmer Kimberley Potter Ona L McCarthy Lauren Jerome Sima Berendes Anasztazia Gubijev Megan Knight Zahra Jamal Farandeep Dhaliwal James R Carpenter Tim P Morris Phil Edwards Rebecca French Louis Macgregor Katy ME Turner Paula Baraitser Ford CI Hickson Kaye Wellings Ian Roberts Julia V Bailey Graham Hart Susan Michie Tim Clayton Karen Devries |
| author_facet | Caroline Free Melissa J Palmer Kimberley Potter Ona L McCarthy Lauren Jerome Sima Berendes Anasztazia Gubijev Megan Knight Zahra Jamal Farandeep Dhaliwal James R Carpenter Tim P Morris Phil Edwards Rebecca French Louis Macgregor Katy ME Turner Paula Baraitser Ford CI Hickson Kaye Wellings Ian Roberts Julia V Bailey Graham Hart Susan Michie Tim Clayton Karen Devries |
| author_sort | Caroline Free |
| collection | DOAJ |
| description | Background: The prevalence of genital chlamydia and gonorrhoea is higher in the 16–24 years age group than those in other age group. With users, we developed the theory-based safetxt intervention to reduce sexually transmitted infections. Objectives: To establish the effect of the safetxt intervention on the incidence of chlamydia/gonorrhoea infection at 1 year. Design: A parallel-group, individual-level, randomised superiority trial in which care providers and outcome assessors were blinded to allocation. Setting: Recruitment was from 92 UK sexual health clinics. Participants: Inclusion criteria were a positive chlamydia or gonorrhoea test result, diagnosis of non-specific urethritis or treatment started for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks; owning a personal mobile phone; and being aged 16–24 years. Allocation: Remote computer-based randomisation with an automated link to the messaging system delivering intervention or control group messages. Intervention: The safetxt intervention was designed to reduce sexually transmitted infection by increasing partner notification, condom use and sexually transmitted infection testing before sex with new partners. It employed educational, enabling and incentivising content delivered by 42–79 text messages over 1 year, tailored according to type of infection, gender and sexuality. Comparator: A monthly message regarding trial participation. Main outcomes: The primary outcome was the incidence of chlamydia and gonorrhoea infection at 12 months, assessed using nucleic acid amplification tests. Secondary outcomes at 1 and 12 months included self-reported partner notification, condom use and sexually transmitted infection testing prior to sex with new partner(s). Results: Between 1 April 2016 and 23 November 2018, we assessed 20,476 people for eligibility and consented and randomised 6248 participants, allocating 3123 to the safetxt intervention and 3125 to the control. Primary outcome data were available for 4675 (74.8%) participants. The incidence of chlamydia/gonorrhoea infection was 22.2% (693/3123) in the intervention group and 20.3% (633/3125) in the control group (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). There was no evidence of heterogeneity in any of the prespecified subgroups. Partner notification was 85.6% in the intervention group and 84.0% in the control group (odds ratio 1.14, 95% confidence interval 0.99 to 1.33). At 12 months, condom use at last sex was 33.8% in the intervention group and 31.2% in the control group (odds ratio 1.14, 95% confidence interval 1.01 to 1.28) and condom use at first sex with most recent new partner was 54.4% in the intervention group and 48.7% in the control group (odds ratio 1.27, 95% confidence interval 1.11 to 1.45). Testing before sex with a new partner was 39.5% in the intervention group and 40.9% in the control group (odds ratio 0.95, 95% confidence interval 0.82 to 1.10). Having two or more partners since joining the trial was 56.9% in the intervention group and 54.8% in the control group (odds ratio 1.11, 95% confidence interval 1.00 to 1.24) and having sex with someone new since joining the trial was 69.7% in the intervention group and 67.4% in the control group (odds ratio 1.13, 95% confidence interval 1.00 to 1.28). There were no differences in safety outcomes. Additional sensitivity and per-protocol analyses showed similar results. Limitations: Our understanding of the mechanism of action for the unanticipated effects is limited. Conclusions: The safetxt intervention did not reduce chlamydia and gonorrhoea infections, with slightly more infections in the intervention group. The intervention increased condom use but also increased the number of partners and new partners. Randomised controlled trials are essential for evaluating health communication interventions, which can have unanticipated effects. Future work: Randomised controlled trials evaluating novel interventions in this complex area are needed. Trial registration: This trial is registered as ISRCTN64390461. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 1. See the NIHR Journals Library website for further project information. |
| first_indexed | 2024-04-10T20:13:26Z |
| format | Article |
| id | doaj.art-5cdff2c27d1f4ba1a27d85f852975839 |
| institution | Directory Open Access Journal |
| issn | 2050-4381 2050-439X |
| language | English |
| last_indexed | 2024-04-10T20:13:26Z |
| publishDate | 2023-01-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Public Health Research |
| spelling | doaj.art-5cdff2c27d1f4ba1a27d85f8529758392023-01-26T08:13:50ZengNIHR Journals LibraryPublic Health Research2050-43812050-439X2023-01-0111110.3310/DANE882614/182/07Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCTCaroline Free0Melissa J Palmer1Kimberley Potter2Ona L McCarthy3Lauren Jerome4Sima Berendes5Anasztazia Gubijev6Megan Knight7Zahra Jamal8Farandeep Dhaliwal9James R Carpenter10Tim P Morris11Phil Edwards12Rebecca French13Louis Macgregor14Katy ME Turner15Paula Baraitser16Ford CI Hickson17Kaye Wellings18Ian Roberts19Julia V Bailey20Graham Hart21Susan Michie22Tim Clayton23Karen Devries24Clinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKMedical Research Council Clinical Trials Unit, London, UKClinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, UKDepartment of Social and Environmental Health Research, London School of Hygiene & Tropical Medicine, London, UKBristol Veterinary School, University of Bristol, Bristol, UKBristol Veterinary School, University of Bristol, Bristol, UKCentre for Global Health, King’s College London, London, UKSigma Research, London School of Hygiene & Tropical Medicine, London, UKDepartment of Social and Environmental Health Research, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, UKeHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UKDepartment of Infection and Population Health, University College London, London, UKCentre for Outcomes Research and Effectiveness, University College London, London, UKDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKBackground: The prevalence of genital chlamydia and gonorrhoea is higher in the 16–24 years age group than those in other age group. With users, we developed the theory-based safetxt intervention to reduce sexually transmitted infections. Objectives: To establish the effect of the safetxt intervention on the incidence of chlamydia/gonorrhoea infection at 1 year. Design: A parallel-group, individual-level, randomised superiority trial in which care providers and outcome assessors were blinded to allocation. Setting: Recruitment was from 92 UK sexual health clinics. Participants: Inclusion criteria were a positive chlamydia or gonorrhoea test result, diagnosis of non-specific urethritis or treatment started for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks; owning a personal mobile phone; and being aged 16–24 years. Allocation: Remote computer-based randomisation with an automated link to the messaging system delivering intervention or control group messages. Intervention: The safetxt intervention was designed to reduce sexually transmitted infection by increasing partner notification, condom use and sexually transmitted infection testing before sex with new partners. It employed educational, enabling and incentivising content delivered by 42–79 text messages over 1 year, tailored according to type of infection, gender and sexuality. Comparator: A monthly message regarding trial participation. Main outcomes: The primary outcome was the incidence of chlamydia and gonorrhoea infection at 12 months, assessed using nucleic acid amplification tests. Secondary outcomes at 1 and 12 months included self-reported partner notification, condom use and sexually transmitted infection testing prior to sex with new partner(s). Results: Between 1 April 2016 and 23 November 2018, we assessed 20,476 people for eligibility and consented and randomised 6248 participants, allocating 3123 to the safetxt intervention and 3125 to the control. Primary outcome data were available for 4675 (74.8%) participants. The incidence of chlamydia/gonorrhoea infection was 22.2% (693/3123) in the intervention group and 20.3% (633/3125) in the control group (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). There was no evidence of heterogeneity in any of the prespecified subgroups. Partner notification was 85.6% in the intervention group and 84.0% in the control group (odds ratio 1.14, 95% confidence interval 0.99 to 1.33). At 12 months, condom use at last sex was 33.8% in the intervention group and 31.2% in the control group (odds ratio 1.14, 95% confidence interval 1.01 to 1.28) and condom use at first sex with most recent new partner was 54.4% in the intervention group and 48.7% in the control group (odds ratio 1.27, 95% confidence interval 1.11 to 1.45). Testing before sex with a new partner was 39.5% in the intervention group and 40.9% in the control group (odds ratio 0.95, 95% confidence interval 0.82 to 1.10). Having two or more partners since joining the trial was 56.9% in the intervention group and 54.8% in the control group (odds ratio 1.11, 95% confidence interval 1.00 to 1.24) and having sex with someone new since joining the trial was 69.7% in the intervention group and 67.4% in the control group (odds ratio 1.13, 95% confidence interval 1.00 to 1.28). There were no differences in safety outcomes. Additional sensitivity and per-protocol analyses showed similar results. Limitations: Our understanding of the mechanism of action for the unanticipated effects is limited. Conclusions: The safetxt intervention did not reduce chlamydia and gonorrhoea infections, with slightly more infections in the intervention group. The intervention increased condom use but also increased the number of partners and new partners. Randomised controlled trials are essential for evaluating health communication interventions, which can have unanticipated effects. Future work: Randomised controlled trials evaluating novel interventions in this complex area are needed. Trial registration: This trial is registered as ISRCTN64390461. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 1. See the NIHR Journals Library website for further project information.https://doi.org/10.3310/DANE8826sexually transmitted infectionsexually transmitted diseasessexual health, sexual behaviourhealth behaviourcondomsyoung peopleadolescentmhealthtelemedicinetext messagingpublic healthhealth educationrandomised controlled trial |
| spellingShingle | Caroline Free Melissa J Palmer Kimberley Potter Ona L McCarthy Lauren Jerome Sima Berendes Anasztazia Gubijev Megan Knight Zahra Jamal Farandeep Dhaliwal James R Carpenter Tim P Morris Phil Edwards Rebecca French Louis Macgregor Katy ME Turner Paula Baraitser Ford CI Hickson Kaye Wellings Ian Roberts Julia V Bailey Graham Hart Susan Michie Tim Clayton Karen Devries Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT Public Health Research sexually transmitted infection sexually transmitted diseases sexual health, sexual behaviour health behaviour condoms young people adolescent mhealth telemedicine text messaging public health health education randomised controlled trial |
| title | Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT |
| title_full | Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT |
| title_fullStr | Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT |
| title_full_unstemmed | Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT |
| title_short | Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT |
| title_sort | behavioural intervention to reduce sexually transmitted infections in people aged 16 24 years in the uk the safetxt rct |
| topic | sexually transmitted infection sexually transmitted diseases sexual health, sexual behaviour health behaviour condoms young people adolescent mhealth telemedicine text messaging public health health education randomised controlled trial |
| url | https://doi.org/10.3310/DANE8826 |
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