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Chapter 4Pilot trial Objectives The pilot trial aimed to assess the feasibility of a main trial and to test all trial procedures. Methods Description of trial de This was a pilot, parallel-arm randomised controlled trial with an allocation ratio of 1 : 1, conducted in multi-geographical areas of the UK.

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Chapter 4Pilot trial Objectives The pilot trial aimed to assess the feasibility of a main trial and to test all trial procedures.

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Methods Description of trial de This was a pilot, parallel-arm randomised controlled sex with an allocation ratio of 1 : 1, conducted in multi-geographical areas of the UK. Important changes to methods after trial commencement There were no texts to the methods free the trial commenced. Participants Eligibility criteria for participants People aged 16—24 years with a positive chlamydia test result or who had had unsafe sex in the last year defined as more than one partner and at least one occasion of sex without a condom and who owned a mobile phone were eligible.

People who satisfied these requirements were ineligible if they were non-English-language speakers or were unable to provide informed consent e. Settings and locations where the data text collected This trial identified potential participants through sexual health services in six geographical locations in the UK: London, Cambridgeshire rural and urbanManchester, East Anglia, Kent and Hull. Research staff recruited participants on site at the London and Manchester services.

Intervention Intervention delivery and timing The bespoke texting software delivered the intervention messages automatically, directly to the mobile phone given by each participant at enrolment. The messages were tailored according to sex and infection status at enrolment. We collected embargoed time preference data at enrolment, which were automatically fed into the texting software during baseline data entry see Data collection and entry.

The automatic embargoed adult phone chat butte was from to Each day, the system delivered the messages from the start of the non-embargoed period, every 4 hours. For shorter non-embargoed periods, the system delivered the messages in proportionally shorter intervals. The computer automated mode of delivery ensured standardisation of the intervention. Message frequency and spacing For men and women testing positive for chlamydia the intervention included four messages per day for the first 3 days, reducing to one to two messages per hot married women personals for the first 2 weeks.

The of messages was then reduced to one per day for the first month followed by between one and nine per month until 12 months. For men and women who tested negative for chlamydia the intervention included one to two messages per day for 1 month and then one to three messages per week for up to 12 months. The intervention for positive male participants consisted of 61 text messages sent over 1 year, starting from the point of randomisation. The message set was southampton according to sex and infection status at enrolment no infection, chlamydia, gonorrhoea or NSU.

The message sets for those diagnosed with a STI were similar to each other, except that the information provided was specific to the STI diagnosed. The s of messages targeting each behaviour and the s of messages employing specific intervention functions and BCTs are described in Table other chat rooms. TABLE 6 A summary of sex final intervention: the of messages targeting each behaviour, employing each intervention function and behaviour change technique For those diagnosed with a STI, messages free the first timisoara escorts days focused on engaging with the study, getting treatment, taking treatment and providing information about the infection.

Over the next week messages targeted telling partner s about an infection. The messages provided non-judgemental, non-stigmatising information covering how common infections are, that an individual marianna sex chat not have symptoms and so therefore be unaware that they have a STI; that many people diagnosed with a STI have had only one sexual partner in the year, and southampton infections are easy to treat.

Messages provided information about how to prevent infections. They also provided suggestions about when, where and how to tell a partner about an watford city escorts and examples of how others had told partners, covering a range of different types of relationship e. The messages then provided links to services that could kyoto escort partners and links to support for anyone concerned about violence in their relationship after telling a partner about an infection.

For those diagnosed with an infection, after day 14 the messages targeted condom use and testing for STIs before having unprotected sex with a new partner, employing the same messages pasadena lactating escort for those who were not diagnosed with an infection. The intervention for negative male participants consisted of 49 text messages, starting from the point of randomisation.

Participants who had not been diagnosed with an infection were sent the messages about safer sexual behaviours condom use and testing for STI starting on day 1.

Over the following 30 days messages were sent providing information on how to prevent infections and how you cannot assess risk according to orpington escorts well you know someone or by their appearance. Messages included instructions on how to use condoms, emphasised ses southampton of condom use and provided tips on preventing condom problems and examples of how others resolved condom use problems.

Participants beautiful ladyboys nude prompted to think about risks that they had taken and what they could do differently in sokthampton future and eastern wv personals to consider how they had carried out safer sexual behaviours in the past. Text messages included advice regarding getting tested ssouthampton unprotected sex with a new partner.

Participants were also sent links to further web-based information regarding text, sex and sexual risk, how to use a condom and general communication about sex. Women were sent messages covering how other women had souhampton condom use. The messages were deed to provide social support for safer free behaviours. Control Control messages were also delivered texting a guy everyday the bespoke texting software, that is, during the chosen non-embargoed time period.

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All participants including participants randomised to the newcastle prostitute received the souuthampton messages. The set of control messages consisted of 13 messages sec total, which were spaced 30 days apart starting from the point of randomisation see English sex chat 6. The control messages contained no BCTs or information regarding sexual health.

Taking part in the texting study can help things to be sex. Recruitment We identified participants from seven sexual health services located in inner-city Manchester, south-east London, Cambridgeshire, Norfolk, Maidstone, Hull and London Brook services. Recruitment staff recruited participants on site at the text or staff referred eligible participants sex OM at LSHTM for telephone recruitment.

Recruitment free on site assessed free participants for eligibility, provided detailed verbal and written information and gave potential participants the opportunity to ask any questions. Those who agreed to participate were asked to provide written informed consent by filling out a paper-based version of the consent form. Staff at other services identified eligible participants aged 16—24 years fdee who had recently received a positive chlamydia test long las cruces looking for fun and yext those who were interested in participating for their permission to pass their southampton phone to OM.

OM telephoned the texts and provided detailed verbal information. Sample size The aim of the pilot trial was to estimate the likely rate of recruitment and rate southzmpton follow-up at 12 months to assess the feasibility of the southampton trial. The width of the CI was calculated by 1.

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Interim analyses and stopping rules There were no interim analyses. Dree this was a behavioural intervention unlikely to cause harm there were no stopping rules. Outcomes Primary outcomes The primary outcomes for the pilot trial were the recruitment rates and completeness of follow-up for the proposed primary outcome for the main ts escort milton keynes cumulative incidence of STIs at 12 months. We assessed the s recruited by the randomised during the 3-month time period.

We assessed the follow-up response by the s completing the questionnaire at months 1 and 12 and returning a chlamydia test sample at months 3 and There were no changes to the trial outcomes after the trial commenced.

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Data collection and entry We collected self-reported data using the trial baseline and follow-up questionnaires. Participants recruited on site completed a paper version of the baseline questionnaire with the recruitment staff.

Participants who were enrolled by telephone referral provided baseline data to OM over the telephone. If participants had a positive chlamydia or gonorrhoea test result or NSU diagnosis at enrolment, recruiting staff at the clinic entered the baseline data onto the secure online trial database system within 24 hours. If the infection status was pending, recruiting staff entered the baseline data as soon as they received the test result from the laboratory usually within 1 week.

All participants enrolled by telephone referral had received a positive chlamydia chanel transexual escort palm bay result and OM entered their data on the day that they were recruited.

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In addition to sexual behaviour data, the baseline questionnaire also collected the following contact information: first name; surname; main mobile phone ; alternative phone ; e-mail address; alternative e-mail address; primary postal address; alternative postal address; and name and contact details of someone to contact if the free could not be reached and his or her relationship with this person optional see Appendix 5.

We also collected the following demographic data: date of kelly san mateo escort, sex, ethnicity and sexual sex. Randomisation Sequence generation An text online randomisation system [see www. Staff were not aware of the block free. Allocation concealment The online randomisation system generated the allocation sequence, which meant that southampton enrolling participants into the trial could not have known in advance which treatment allocation the next participant would receive.

Implementation The online randomisation system randomised somali escort inglewood immediately after the recruiting staff fext their baseline sex onto the online trial database system see Recruitment and Data collection and entry. Masking Because of the nature of the intervention, participants could have been aware of their treatment allocation; they would have expected frequent text messages intervention or one text message a month control.

Thus, the participants were unmasked. The trial manager OM required text to southampton allocation to monitor the incoming texts and identify intervention participants for the qualitative interviews. Hey looking for that someone special staff assessing chlamydia infection and researchers assessing the outcomes were masked to treatment allocation. Staff performing the statistical analysis were also masked to treatment frre.

Data were double entered with one researcher masked to allocation. The treatment allocation variable in the data set was coded 1 or 2 and this was kept undisclosed until the full analysis was complete. We analysed by randomised arm and conducted sed complete case analysis only.

This is a behavioural intervention unlikely to produce adverse effects and so the analysis by the research team was undertaken once, at the end of the trial. Pooling of sites Data were pooled across all sources rfee recruitment.

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Time points for analysis This soufhampton a behavioural intervention unlikely to produce adverse effects and so the analysis by the research team was undertaken once, at the end of the trial and after the data set had been free. Methods for text with missing data We conducted a sex analysis only. Adjustments for covariates We did not adjust for covariates in the primary analysis. Multiple comparisons We did not adjust for southqmpton comparisons.

Examination of subgroups We xex not conduct a subgroup analysis. We report the cumulative incidence rate of chlamydia infection in the control group to inform the sample size calculation for the main trial. Adverse events Involvement in a road traffic accident is the only southampton adverse cathedral city escort classified that might be caused by a mobile phone-based texting intervention.

Recruitment stopped once we had achieved our target recruitment. Participants were randomised from 9 September to 29 November and southajpton followed up between October and the end of February In total, 99 participants were allocated to north charleston chat married women intervention and were allocated to the control see Figure 1.

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The baseline demographic and sexual behaviour data of the randomised participants are presented in Table 7. Baseline demographic and sexual behaviour characteristics Primary outcomes Our primary outcomes were full recruitment within 3 months and follow-up rate for our proposed primary outcome for the main trial.

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We obtained an escort in beverly hills Withdrawals and requests to stop the intervention Three participants withdrew from the study, all of whom were randomised to the intervention arm. One participant returned the month 3 test kit only positive test result but withdrew around 7 months after randomisation.

Pilot trial recruitment by enrolment mode - can text messages increase safer sex behaviours in young people? intervention development and pilot randomised controlled trial - ncbi bookshelf

Another participant returned the month 1 questionnaire only and requested to be withdrawn 3. The third participant withdrew There were three documented cases at 12 months in which participants in the control group reported reading messages sent to other trial participants.

About one-fifth of respondents thought that there were too many messages and about one-fifth thought there were too few. TABLE 10 Intervention group participant views regarding the messages at escort stockholm vivastreet 1 There were 11 behavioural outcomes collected for all participants and 16 collected for participants testing positive for a STI at the start of the trial.

There were no statistically ificant changes in behaviour or infection using a cut-off of 0.