A qualitative study exploring experiences of the safetxt digital health intervention to reduce sexually transmitted infections in young people in the UK.

OBJECTIVES: People aged 16-24 are more likely than other age groups to acquire sexually transmitted infections (STI). Safetxt was a randomised controlled trial of a theory-based digital health intervention to reduce STIs among 16-24 year-old people in the UK. We report results of qualitative research regarding participants' perceptions and experiences of the intervention and trial participation. DESIGN: Qualitative thematic analysis following a critical realist paradigm of written open feedback comments provided in the 12-month follow-up questionnaire and semistructured interviews. SETTING: Safetxt trial participants were recruited from UK sexual health clinics. PARTICIPANTS: Trial inclusion criteria: people aged 16-24 diagnosed with or treated for chlamydia, gonorrhoea or non-specific urethritis. Optional open feedback provided by 3526 of 6248 safetxt participants at 12 months and interviews with a purposive sample of 18 participants after the trial. RESULTS: We summarise and report results in seven broad themes. According to recipients, the safetxt intervention increased awareness of the importance of avoiding STIs and ways to prevent them. Participants reported improved confidence, agency, sexual well-being and communication about sexual health with partners, friends and family. Recipients attributed increased condom use, increased STI testing after (rather than before) sex with new partners, and more confident partner notification to the intervention. Recipients described a reduced sense of isolation and stigma in having an STI. Control group participants reported that having had an STI and receiving control texts asking them to report any changes in contact details acted as reminders to use condoms and get tested. We also summarise participant recommendations for future interventions and studies. CONCLUSIONS: While control group participants reported precautionary behaviours were 'triggered' by trial participation, intervention recipients reported additional benefits of the intervention in increasing precautionary behaviours and in broader aspects of sexual health such as confidence, communication, emotional well-being and agency. TRIAL REGISTRATION: ISRCTN registry ISRCTN64390461.

Effectiveness of a behavioural intervention delivered by text messages (safetxt) on sexually transmitted reinfections in people aged 16-24 years: randomised controlled trial.

OBJECTIVE: To quantify the effects of a series of text messages (safetxt) delivered in the community on incidence of chlamydia and gonorrhoea reinfection at one year in people aged 16-24 years. DESIGN: Parallel group randomised controlled trial. SETTING: 92 sexual health clinics in the United Kingdom. PARTICIPANTS: People aged 16-24 years with a diagnosis of, or treatment for, chlamydia, gonorrhoea, or non-specific urethritis in the past two weeks who owned a mobile phone. INTERVENTIONS: 3123 participants assigned to the safetxt intervention received a series of text messages to improve sex behaviours: four texts daily for days 1-3, one or two daily for days 4-28, two or three weekly for month 2, and 2-5 monthly for months 3-12. 3125 control participants received a monthly text message for one year asking for any change to postal or email address. It was hypothesised that safetxt would reduce the risk of chlamydia and gonorrhoea reinfection at one year by improving three key safer sex behaviours: partner notification at one month, condom use, and sexually transmitted infection testing before unprotected sex with a new partner. Care providers and outcome assessors were blind to allocation. MAIN OUTCOME MEASURES: The primary outcome was the cumulative incidence of chlamydia or gonorrhoea reinfection at one year, assessed by nucleic acid amplification tests. Safety outcomes were self-reported road traffic incidents and partner violence. All analyses were by intention to treat. RESULTS: 6248 of 20 476 people assessed for eligibility between 1 April 2016 and 23 November 2018 were randomised. Primary outcome data were available for 4675/6248 (74.8%). At one year, the cumulative incidence of chlamydia or gonorrhoea reinfection was 22.2% (693/3123) in the safetxt arm versus 20.3% (633/3125) in the control arm (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). The number needed to harm was 64 (95% confidence interval number needed to benefit 334 to ∞ to number needed to harm 24) The risk of road traffic incidents and partner violence was similar between the groups. CONCLUSIONS: The safetxt intervention did not reduce chlamydia and gonorrhoea reinfections at one year in people aged 16-24 years. More reinfections occurred in the safetxt group. The results highlight the need for rigorous evaluation of health communication interventions. TRIAL REGISTRATION: ISRCTN registry ISRCTN64390461.

Achieving proportional representation in a reproductive health survey through social media: process and recommendations.

BACKGROUND: The narrative surrounding women's reproductive health has shifted from a medical model to an emphasis on reproductive well-being over different life-stages. We developed and piloted a tracker survey for monitoring women's reproductive health and well-being in England, recruiting respondents online. This paper reports on the success of the online recruitment strategies in achieving a sample proportionally representative of the England general population. METHODS: Recruitment was through Facebook and Instagram advertisements and dissemination through Twitter and a blog. At the end week one, the sample was reviewed and compared to the 2011 Census England population. From week two, recruitment targeted under-represented groups. Key data were compared with prevalence estimates from the Third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). RESULTS: Between 1 July-17 August 2021, 13,962 people initiated the online survey, with 11,578 completing it. Numbers were low initially, but peaked at 1700 survey initiations per day after increasing the daily advertisement budget on day seven. At the end of week one, minority ethnic groups and people without a degree or equivalent were under-represented. From week two, we altered the advertisement settings to show to people whose profile indicated they were a 'high school leaver' had 'up to some high school', worked in industries that do not typically require a degree or lived in local authorities with a high proportion of ethnic minority residents. This had a modest effect, with the final sample short of proportional representation in terms of ethnicity and education but close in terms of region and age. Compared to Natsal-3, we found consistency in the proportion of respondents reporting an abortion and a live birth in the last year, however, the proportion of our sample reporting ever having experienced infertility was significantly higher than in Natsal-3, as was the proportion of 'planned' pregnancies in the last year. CONCLUSIONS: It is possible to recruit large numbers of respondents online, relatively quickly, to complete a reproductive health survey. This will be valuable to track reproductive health and well-being at a national level over time. More work is needed to understand reasons for non-response among under-represented groups.

Participant views and experiences of sexual health research: The Contraception Choices online trial.

BACKGROUND: Online sexual health research can be convenient, efficient and low cost, but there are debates about the adequacy of online informed consent, privacy, and the acceptability of different methods of follow-up. OBJECTIVES: To explore women's views and experiences of the Contraception Choices feasibility trial procedures and the place of digital interventions for contraception decision making. METHODS: We analysed data from two sources: (1) Qualitative interviews. Eighteen interviews were conducted with women who had taken part in the Contraception Choices pre-trial feasibility study, to evaluate recruitment and online trial procedures. (2) Free-text comments. Women in the main Contraception Choices randomised controlled trial were followed up at 3 and 6 months, and asked 'Please tell us what you liked or disliked about the website' and 'Has being in the study had any good or bad effects on your life?' A total of 387 and 414 comments were made at 3 and 6 months respectively. Data were analysed thematically. RESULTS: Participants liked being involved in a study about contraception, although recruitment from an abortion clinic was less acceptable than in other sexual health settings. Women found the trial procedures straightforward, and expressed no major concerns about online self-registration, informed consent or online data collection. Online survey questions about contraception and fertility were acceptable, and participants liked the convenience of being followed up by email or text. CONCLUSIONS: Participants appreciated the advantages of the online research design and did not express concerns about consent or privacy. Women would welcome digital interventions for contraception in a variety of settings.

Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.

BACKGROUND: Cardiovascular disease (CVD) is a major cause of disability and mortality globally. Premature fatal and non-fatal CVD is considered to be largely preventable through the control of risk factors by lifestyle modifications and preventive medication. Lipid-lowering and antihypertensive drug therapies for primary prevention are cost-effective in reducing CVD morbidity and mortality among high-risk people and are recommended by international guidelines. However, adherence to medication prescribed for the prevention of CVD can be poor. Approximately 9% of CVD cases in the EU are attributed to poor adherence to vascular medications. Low-cost, scalable interventions to improve adherence to medications for the primary prevention of CVD have potential to reduce morbidity, mortality and healthcare costs associated with CVD. OBJECTIVES: To establish the effectiveness of interventions delivered by mobile phone to improve adherence to medication prescribed for the primary prevention of CVD in adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two other databases on 7 January 2020. We also searched two clinical trials registers on 5 February 2020. We searched reference lists of relevant papers. We applied no language or date restrictions. SELECTION CRITERIA: We included randomised controlled trials investigating interventions delivered wholly or partly by mobile phones to improve adherence to cardiovascular medications prescribed for the primary prevention of CVD. We only included trials with a minimum of one-year follow-up in order that the outcome measures related to longer-term, sustained medication adherence behaviours and outcomes. Eligible comparators were usual care or control groups receiving no mobile phone-delivered component of the intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The main outcomes of interest were objective measures of medication adherence (blood pressure (BP) and cholesterol), CVD events, and adverse events. We contacted study authors for further information when this was not reported. MAIN RESULTS: We included 14 trials with 25,633 randomised participants. Participants were recruited from community-based primary and tertiary care or outpatient clinics. The interventions varied widely from those delivered solely through short messaging service (SMS) to those involving a combination of modes of delivery, such as SMS in addition to healthcare worker training, face-to-face counselling, electronic pillboxes, written materials, and home blood pressure monitors. Some interventions only targeted medication adherence, while others additionally targeted lifestyle changes such as diet and exercise. Due to heterogeneity in the nature and delivery of the interventions and study populations, we reported most results narratively, with the exception of two trials which were similar enough to meaningfully pool in meta-analyses. The body of evidence for the effect of mobile phone-based interventions on objective outcomes of adherence (BP and cholesterol) was of low certainty, due to most trials being at high risk of bias, and inconsistency in outcome effects. Two trials were at low risk of bias. Among five trials (total study enrolment: 5441 participants) recording low-density lipoprotein cholesterol (LDL-C), two studies found evidence for a small beneficial intervention effect on reducing LDL-C (-5.30 mg/dL, 95% confidence interval (CI) -8.30 to -2.30; and -9.20 mg/dL, 95% CI -17.70 to -0.70). The other three studies found results varying from a small reduction (-7.7 mg/dL) to a small increase in LDL-C (0.77 mg/dL). All of which had wide confidence intervals that included no effect. Across 13 studies (25,166 participants) measuring systolic blood pressure, effect estimates ranged from a large reduction (MD -12.45 mmHg, 95% CI -15.02 to -9.88) to a small increase (MD 2.80 mmHg, 95% CI 0.30 to 5.30). We found a similar range of effect estimates for diastolic BP, ranging from -12.23 mmHg (95% CI 14.03 to -10.43) to 1.64 mmHg (95% CI -0.55 to 3.83) (11 trials, 19,716 participants). Four trials showed intervention benefits for systolic and diastolic BP with confidence intervals excluding no effect, and among these were all three of the trials evaluating self-monitoring of blood pressure with mobile phone-based telemedicine. The fourth trial included SMS and provider support (with additional varied features). Seven studies (19,185 participants) reported 'controlled' BP as an outcome, and intervention effect estimates varied from negligible effects (odds ratio (OR) 1.01, 95% CI 0.76 to 1.34) to large improvements in BP control (OR 2.41, 95% CI: 1.57 to 3.68). The three trials of clinician training or decision support combined with SMS (with additional varied features) had confidence intervals encompassing benefits and harms, with point estimates close to zero. Pooled analyses of the two trials of interventions solely delivered through SMS were indicative of little or no beneficial intervention effect on systolic BP (MD -1.55 mmHg, 95% CI -3.36 to 0.25; I2 = 0%) and small increases in controlled BP (OR 1.32, 95% CI 1.06 to 1.65; I2 = 0%). Based on four studies (12,439 participants), there was very low-certainty evidence (downgraded twice for imprecision and once for risk of bias) relating to the intervention effect on combined (fatal and non-fatal) CVD events. Two studies (2535 participants) provided low-certainty evidence for the effect of the intervention on cognitive outcomes, with little or no difference between trial arms for perceived quality of care and satisfaction with treatment. There was moderate-certainty evidence (downgraded due to risk of bias) that the interventions did not cause harm, based on six studies (8285 participants). Three studies reported no adverse events attributable to the intervention. One study reported no difference between groups in experience of adverse effects of statins, and that no participants reported intervention-related adverse events. One study stated that potential side effects were similar between groups. One study reported a similar number of deaths in each arm, but did not provide further information relating to potential adverse events. AUTHORS' CONCLUSIONS: There is low-certainty evidence on the effects of mobile phone-delivered interventions to increase adherence to medication prescribed for the primary prevention of CVD. Trials of BP self-monitoring with mobile-phone telemedicine support reported modest benefits. One trial at low risk of bias reported modest reductions in LDL cholesterol but no benefits for BP. There is moderate-certainty evidence that these interventions do not result in harm. Further trials of these interventions are warranted.

Sexual health interventions delivered to participants by mobile technology: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: The use of mobile technologies to prevent STIs is recognised as a promising approach worldwide; however, evidence has been inconclusive, and the field has developed rapidly. With about 1 million new STIs a day globally, up-to-date evidence is urgently needed. OBJECTIVE: To assess the effectiveness of mobile health interventions delivered to participants for preventing STIs and promoting preventive behaviour. METHODS: We searched seven databases and reference lists of 49 related reviews (January 1990-February 2020) and contacted experts in the field. We included randomised controlled trials of mobile interventions delivered to adolescents and adults to prevent sexual transmission of STIs. We conducted meta-analyses and assessed risk of bias and certainty of evidence following Cochrane guidance. RESULTS: After double screening 6683 records, we included 22 trials into the systematic review and 20 into meta-analyses; 18 trials used text messages, 3 used smartphone applications and 1 used Facebook messages as delivery modes. The certainty of evidence regarding intervention effects on STI/HIV occurrence and adverse events was low or very low. There was moderate certainty of evidence that in the short/medium-term text messaging interventions had little or no effect on condom use (standardised mean differences (SMD) 0.02, 95% CI -0.09 to 0.14, nine trials), but increased STI/HIV testing (OR 1.83, 95% CI 1.41 to 2.36, seven trials), although not if the standard-of-care control already contained an active text messaging component (OR 1.00, 95% CI 0.68 to 1.47, two trials). Smartphone application messages also increased STI/HIV testing (risk ratio 1.40, 95% CI 1.22 to 1.60, subgroup analysis, two trials). The effects on other outcomes or of social media or blended interventions is uncertain due to low or very low certainty evidence. CONCLUSIONS: Text messaging interventions probably increase STI/HIV testing but not condom use in the short/medium term. Ongoing trials will report the effects on biological and other outcomes.

An interactive website to aid young women's choice of contraception: feasibility and efficacy RCT.

BACKGROUND: Effective use of contraception can reduce numbers of unintended pregnancies, but misunderstandings and concerns about contraception abound. Increasingly, women seek health-care information online. OBJECTIVES: To develop an interactive website to aid informed choice of contraceptive method, including long-acting reversible contraception (Phase I), and test its effectiveness in a parallel, single-blind randomised trial (Phase II). Approval came from London - Camden & King's Cross Research Ethics Committee (reference 17/LO/0112). SETTING AND PARTICIPANTS: For both phases, women aged 15-30 years were recruited from general practice, sexual health services, maternity services, community pharmacies and an abortion service. DESIGN: In Phase I, we conducted three systematic literature reviews, a review of YouTube (YouTube, LLC, San Bruno, CA, USA) videos about contraception, and focus groups and interviews with young women to explore barriers to and concerns and misperceptions about contraception. We then iteratively co-designed an interactive website, Contraception Choices [URL: www.contraceptionchoices.org (accessed June 2020)], with young women and a software company. In Phase II, we evaluated the website through a randomised trial that began as a feasibility trial. Early demand for Contraception Choices stimulated a design change from a feasibility to an efficacy trial, with follow-up for clinical outcomes at 3 and 6 months. A randomisation list was incorporated into the trial software program to allocate participants to the intervention (website) or control group (standard care). INTERVENTION: Contraception Choices is a co-designed, evidence-based, interactive website to aid informed choice of contraception. It provides information about different methods, addresses common concerns and offers tailored contraceptive options in response to individual preferences. MAIN OUTCOME MEASURES: Qualitative - participant views and experience of the intervention, assessed through qualitative interviews. Quantitative primary outcomes - follow-up rate at 6 months in the initial feasibility trial, using a long-acting reversible contraception method, and satisfaction with contraceptive method at 6 months in the efficacy trial. RESULTS: A total of 927 women were randomised online to the website (n = 464) or control group (n = 463), of whom 739 (80%) provided follow-up data at 6 months [786 women (85%) provided data at 3 and/or 6 months that were included in the analysis of primary outcomes]. There was little difference between groups in the proportion using long-acting reversible contraception at 6 months [30.4% intervention vs. 31.0% control, adjusted odds ratio after imputation 0.87 (95% confidence interval 0.60 to 1.27)] or in satisfaction with contraceptive method [proportion being 'satisfied' or 'very satisfied', 82.6% intervention vs. 82.1% control, adjusted odds ratio 0.93 (95% confidence interval 0.69 to 1.25)]. Qualitative evaluation indicated highly positive views about the website and increased knowledge of contraceptive methods that could dispel misperceptions. Women appreciated having information tailored to their specific needs and felt better prepared before consultations. LIMITATIONS: We did not include intermediate measures, such as knowledge of contraceptive methods, intention to change method or confidence in discussing contraception with a health-care professional, which may have indicated other benefits of using the website. In future, the website should be studied in different settings (e.g. schools and in routine practice) to see whether or not it improves the quality or efficiency of contraceptive consultations. CONCLUSIONS: Our systematic review indicated wide-ranging influences on women's use of contraception globally. The website, Contraception Choices, was very popular with young women and contraception service providers. It was not associated with statistically significant differences in use of long-acting reversible contraception or satisfaction with contraceptive method at 6 months. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13247829. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 56. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Choosing between types of contraception can be challenging, so can a website help women make the right choice for them? WHAT DID WE DO?: We asked women what they think about contraception. We looked at other studies and YouTube (YouTube, LLC, San Bruno, CA, USA) videos. We then designed the Contraception Choices website with young women [URL: www.contraceptionchoices.org (accessed January 2020)]. The website describes each type of contraception and compares them side by side. When users answer questions about what matters to them, the website suggests three types of contraception they might like. A total of 927 women helped us test the website in an online trial. We asked everyone what contraception they were using and how satisfied they were with it 6 months later. WHAT DID WE FIND?: Women really liked the website. Ninety-seven per cent of participants found it helpful or very helpful for 'getting useful information about contraception' and 87% responded that it was helpful or very helpful for 'finding a method of contraception that is right for you'. Comments included: However, seeing the website did not mean that women used a more reliable type of contraception. Women were just as satisfied with their contraception whether or not they had seen the website. We think that this is because many other factors are involved; for example, some women found it difficult to access long-acting contraception methods from health services. WHAT DOES THIS MEAN?: Young women liked the Contraception Choices website and found it useful. Women can be put off by contraception side effects and the views of partners, friends, family and others. On its own, the Contraception Choices website was not enough to help more women use the most reliable contraception methods.