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Background/Aims: Recruiting to target in randomised controlled trials is crucial for providing reliable results, yet many trials struggle to achieve their target sample size. Many trials do not report sufficient, if any, details of their recruitment strategy for others to adapt for their own trials. Furthermore, much of the available evidence describes strategies to improve recruitment aimed at participants, as opposed to strategies aimed at engaging and motivating recruiting staff who are deemed essential for recruitment success. The safetxt trial aimed to recruit 6250 participants, aged 16–24 years, who had either tested positive, or received treatment, for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks, from across the United Kingdom into a randomised controlled trial investigating a text message intervention to improve sexual health outcomes. In this article, we describe in detail the recruitment strategies we employed that were primarily aimed at recruiters. Methods: Recruitment began in April 2016. We built on our recruitment methods established in the pilot trial and developed several strategies to increase recruitment as the trial progressed including optimising site set-up, monitoring recruitment progress and identifying issues, facilitating shared learning, tailored recruitment materials, sustaining motivation, and communication. We describe these strategies in detail and provide practical examples for each. Results: We combine our strategies for increasing recruitment into one cyclical approach whereby progress is continuously monitored, and interventions to improve recruitment are implemented. The site initiation visits were used to develop a clear recruitment plan and establish good relationships with local site staff. Screening logs were particularly helpful for monitoring recruitment challenges. We facilitated shared learning by organising meetings with recruiting sites and conducting site visits. Tailored recruitment materials helped to promote the trial in clinic environments, and rewards and goals helped sustain motivation among recruiting staff. Finally, at the centre of the approach is good communication which ensured we maintained good relationships with local site staff. Conclusion: We conducted a large, multi-centre trial and successfully recruited to target. Our dynamic collaborative approach to recruitment described in this paper builds upon previous research by combining suggested good practice into one cyclical approach to recruitment, and providing detailed examples of each strategy. It is not possible to attribute a causal link between our approach and recruitment success overall, or with specific sites or recruiting staff. Nonetheless we describe the processes we used to build a good relationship with recruiting staff and sites, and maintain recruitment of large numbers of participants over the 32 months of the trial. Other researchers can use our approach and adapt our examples for their own trials.

Background: Youth have poorer HIV-related outcomes when compared to other age-groups. We describe the protocol for a cluster randomised trial (CRT) to evaluate the effectiveness of community-based, integrated HIV and sexual and reproductive health services for youth on HIV outcomes. Protocol: The CHIEDZA trial is being conducted in three provinces in Zimbabwe, each with eight geographically demarcated areas (clusters) (total 24 clusters) randomised 1:1 to standard of care (existing health services) or to the intervention. The intervention comprises community-based delivery of HIV services including testing, antiretroviral therapy, treatment monitoring and adherence support as well as family planning, syndromic management of sexually transmitted infections (STIs), menstrual health management, condoms and HIV prevention and general health counselling. Youth aged 16-24 years living within intervention clusters are eligible to access CHIEDZA services. A CRT of STI testing (chlamydia, gonorrhoea and trichomoniasis) is nested in two provinces (16 of 24 clusters). The intervention is delivered over a 30-month period by a multidisciplinary team trained and configured to provide high-quality, youth friendly services. Outcomes will be ascertained through a population-based survey of 18–24-year-olds. The primary outcome is HIV viral load Ethics and Dissemination: The trial protocol was approved by the Medical Research Council of Zimbabwe, the Biomedical Research and Training Institute Institutional Review Board and the London School of Hygiene & Tropical Medicine Research Ethics Committee. Results will be submitted to open-access peer-reviewed journals, presented at academic meetings and shared with participating communities and with national and international policy-making bodies. Trial Registration https://clinicaltrials.gov/: NCT03719521

BackgroundThe 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.ObjectiveTo assess the effectiveness of mobile health interventions delivered to participants for preventing STIs and promoting preventive behaviour.MethodsWe 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.ResultsAfter 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.ConclusionsText 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.

IntroductionYoung people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK.Methods and analysisA single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners.Ethics and disseminationEthics approval was obtained from NHS Health Research Authority - London – Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals.Trial registration numberInternational Standard Randomised Controlled Trials Number:ISRCTN64390461. Registered on 17thMarch 2016.WHO trial registration data setavailable at:http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.Trial protocol version12, 19thJuly 2018.

Background Research has shown that mobile phone contraceptive behavioral interventions can increase knowledge and use of contraception, but other studies have failed to demonstrate a beneficial effect. The objective of this trial was to estimate the effect of a contraceptive behavioral intervention delivered by mobile phone text message on young Palestinian women’s attitudes towards effective contraception. Methods We conducted a randomized controlled trial among women aged 18–24 years living in the West Bank, who were not using an effective method of contraception. The intervention group received zero to three messages per day (113 messages for female-not married and 120 messages for female-married) for 120 days. The control group received 16 messages over 120 days about trial participation. The primary outcome was acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception at 4 months and any use during the study, acceptability of individual methods, service uptake, unintended pregnancy and abortion. Process outcomes included knowledge, perceived norms, personal agency and intention. All outcomes were self-reported. We analyzed the outcomes using logistic and linear regression. Results A total of 578 participants were enrolled and 464 (80%) completed follow up at 4 months. Intervention group participants were more likely to find at least one method of effective contraception acceptable (31% in the intervention group versus 17% in the control group, adjusted OR 2.34, 95% CI 1.48–3.68, p

Background Although the most effective methods of contraception are available in Bolivia, unmet need for contraception among women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016). Mobile phones are a popular mode to deliver health behavior support. We developed a contraceptive behavioral intervention for young Bolivian women delivered by mobile phone and guided by behavioral science. The intervention consists of short instant messages sent through an app over 4 months. Objective This trial aimed to evaluate the effect of the intervention on young Bolivian women’s use of and attitudes toward the effective contraceptive methods available in Bolivia. Methods This was a parallel group, individually randomized superiority trial with a 1:1 allocation ratio. Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish. The target sample size was 1310 participants. Participants allocated to the intervention had access to an app with standard family planning information and intervention messages. Participants allocated to the control group had access to the same app and control messages. Coprimary outcomes were use of effective contraception and acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion. Process outcomes included knowledge, perceived norms, personal agency, and intention. Outcomes were analyzed using logistic and linear regression. We also asked participants about physical violence. Results A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception. There was no evidence that use differed between the groups (33% control vs 37% intervention; adjusted odds ratio [OR] 1.19, 95% CI 0.80 to 1.77; P=.40). There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06). There were no statistically significant differences in any of the secondary or process outcomes. The intervention dose received was low. In the control group, 2.8% (6/207) reported experiencing physical violence compared with 1.9% (4/202) in the intervention group (Fisher exact test P=.75). Conclusions This trial was unable to provide definitive conclusions regarding the effect of the intervention on use and acceptability of effective contraception because of under recruitment. Although we cannot strongly recommend implementation, the results suggest that it would be safe and may increase the acceptability of effective contraception if the intervention messages were offered alongside the download of the app. Trial Registration ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526

Background Unintended pregnancies can result in poorer health outcomes for women, children and families. Young people in low and middle income countries are at particular risk of unintended pregnancies and could benefit from innovative contraceptive interventions. There is growing evidence that interventions delivered by mobile phone can be effective in improving a range of health behaviours. This paper describes the development of a contraceptive behavioural intervention delivered by mobile phone for young people in Tajikistan, Bolivia and Palestine, where unmet need for contraception is high among this group. Methods Guided by Intervention Mapping, the following steps contributed to the development of the interventions: (1) needs assessment; (2) specifying behavioural change to result from the intervention; (3) selecting behaviour change methods to include in the intervention; (4) producing and refining the intervention content. Results The results of the needs assessment produced similar interventions across the countries. The interventions consist of short daily messages delivered over 4 months (delivered by text messaging in Palestine and mobile phone application instant messages in Bolivia and Tajikistan). The messages provide information about contraception, target attitudes that are barriers to contraceptive uptake and support young people in feeling that they can influence their reproductive health. The interventions each contain the same ten behaviour change methods, adapted for delivery by mobile phone. Conclusions The development resulted in a well-specified, theory-based intervention, tailored to each country. It is feasible to develop an intervention delivered by mobile phone for young people in resource-limited settings. Electronic supplementary material The online version of this article (10.1186/s12889-018-5477-7) contains supplementary material, which is available to authorized users.

Background Unintended pregnancy can negatively impact women’s lives and is associated with poorer health outcomes for women and children. Many women, particularly in low- and middle-income countries, continue to face obstacles in avoiding unintended pregnancy. In the State of Palestine, a survey conducted in 2006 estimated that 38% of pregnancies are unintended. In 2014, unmet need for contraception was highest among young women aged 20–24 years, at 15%. Mobile phones are increasingly being used to deliver health support. Once developed, interventions delivered by mobile phone are often cheaper to deliver than face-to-face support. The London School of Hygiene and Tropical Medicine and the Palestinian Family Planning and Protection Association have partnered to develop and evaluate a contraceptive behavioural intervention for young women in Palestine delivered by mobile phone. The intervention was developed guided by behavioural science and consists of short, mobile phone text messages that contain information about contraception and behaviour change methods delivered over 4 months. Methods We will evaluate the intervention by conducting a randomised controlled trial. Five hundred and seventy women aged 18–24 years, who do not report using an effective method of contraception, will be allocated with a 1:1 ratio to receive the intervention text messages or control text messages about trial participation. The primary outcome is self-reported acceptability of at least one method of effective contraception at 4 months. Secondary outcomes include the use of effective contraception, acceptability of individual methods, discontinuation, service uptake, unintended pregnancy and abortion. Process outcomes include knowledge, perceived norms, personal agency and intervention dose received. Outcomes at 4 months will be compared between arms using logistic regression. Discussion This trial will determine the effect of the intervention on young women’s attitudes towards the most effective methods of contraception. If the intervention is found to be effective, the intervention will be implemented widely across Palestine. The results could also be used to design a larger trial to establish its effect on unintended pregnancy. Trial registration ClinicalTrials.gov, ID: NCT02905461. Registered on 14 September 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2191-1) contains supplementary material, which is available to authorized users.

IntroductionWomen in lower income countries experience unintended pregnancies at a higher rate compared with women in higher income countries. Unintended pregnancy is associated with numerous poorer health outcomes for both women and their children. In Tajikistan, an estimated 26% of married individuals aged 15–24 years have an unmet need for contraception. The strong cultural value placed on childbearing and oppositional attitudes towards contraception are major barriers to contraceptive uptake in the country.Mobile phone ownership is widespread in Tajikistan. The option of receiving reproductive health support on your personal phone may be an appealing alternative to attending a clinic, particularly for young people. The London School of Hygiene & Tropical Medicine and the Tajik Family Planning Association have partnered to develop and evaluate a contraceptive behavioural intervention delivered by mobile phone. The intervention was developed in 2015–2016 guided by behavioural science. It consists of short instant messages sent through an app over 4 months, contains information about contraception and behaviour change methods.Methods and analysisThis randomised controlled trial is designed to evaluate the effect of the intervention on self-reported acceptability of effective contraception at 4 months. 570 men and women aged 16–24 years will be allocated with a ratio of 1:1 to receive the intervention messages or the control messages about trial participation. The messages will be sent through the Tajik Family Planning Association’s ‘healthy lifestyles’ app, which contains basic information about contraception.Ethics and disseminationThe trial was granted ethical approval by the London School of Hygiene & Tropical Medicine Interventions Research Ethics Committee on 16 May 2016 and by the Tajik National Scientific and Research Centre on Paediatrics and Child Surgery on 15 April 2016. The results of the trial will be submitted for publication in peer-reviewed academic journals and disseminated to study stakeholders.Trial registration numberClinicaltrial.govNCT02905513.Date of registration14 September 2016.WHO trial registration datasethttp://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02905513

Objective To test the procedures proposed for a main trial of a safer sex intervention for young people delivered by mobile phone text message (‘safetxt’). Design and setting Pilot randomised controlled trial. Participants were recruited through sexual health services in the UK. An independent online randomisation system allocated participants to receive the safetxt intervention or to receive the control text messages (monthly messages about participation in the study). Texting software delivered the messages in accordance with a predetermined schedule. Participants Residents of England aged 16–24 who had received either a positive chlamydia test result or reported unsafe sex in the last year (defined as more than 1 partner and at least 1 occasion of sex without a condom). Intervention The safetxt intervention is designed to reduce sexually transmitted infection in young people by supporting them in using condoms, telling a partner about an infection and testing before unprotected sex with a new partner. Safetxt was developed drawing on: behavioural science; face-to-face interventions; the factors known to influence safer sex behaviours and the views of young people. Outcomes The coprimary outcomes of the pilot trial were the recruitment rate and completeness of follow-up. Results We recruited 200 participants within our target of 3 months and we achieved 81% (162/200) follow-up response for the proposed primary outcome of the main trial, cumulative incidence of chlamydia at 12 months. Conclusions Recruitment, randomisation, intervention delivery and follow-up were successful and a randomised controlled trial of the safetxt intervention is feasible. Trial registration number ISRCTN02304709; Results.

Background: The risk of poor sexual health, including unplanned pregnancy and sexually transmitted infections (STIs), is greatest amongst young people. Innovative and acceptable interventions to improve sexual health are required. Mobile phone text messaging (short message service, SMS) interventions have the potential to reach large numbers of people at relatively low cost, but greater understanding is needed on how these interventions should be developed and how they work. Objectives: The aim of this paper is to explore young people’s views of and experiences with a mobile phone text messaging intervention to promote safer sex behavior. Methods: We undertook qualitative interviews with young people aged 16 to 24 years as part of a pilot trial of a sexual health intervention delivered by text message in the United Kingdom. Study participants received sexual health promotion text messages based on behavior-change techniques. The message content, tailored by gender and STI status, included support for correct STI treatment and promotion of safer sex behaviors. Young people were eligible if they had received a positive chlamydia test or had more than one partner and at least one episode of unprotected sex in the last year. Telephone interviews were conducted 2 to 3 weeks after initiation of the intervention. A semi-structured topic guide was followed to explore participant experiences and a thematic analysis was conducted. Results: We conducted 16 telephone interviews with participants who had received the text intervention and an additional four interviews with those in the control group (13 women and 7 men). Intervention participants found text messages easy to understand and appearing to come from a friendly and trustworthy source. They considered the frequency and timing of messages to be appropriate, and delivery via mobile phones convenient. Receipt of support by text message allowed recipients to assimilate information at their own pace, and prompted reflection on and sharing of messages with friends, family members, and partners, thus providing opportunities for education and discussion. For some recipients, the messages had increased their knowledge of how to correctly use condoms. Some described how the messages had increased their confidence and reduced stigma, enabling them to disclose infection to a partner and/or to do so sooner and more calmly. Discussing the messages with a partner reportedly enabled some women to negotiate condom use. Conclusion: From the perspective of the recipients, the tone, frequency, and content of the text messaging-based sexual health intervention was acceptable and appropriate. Their accounts indicated that the intervention increased knowledge, confidence, and safer sex behaviors. A large-scale randomized controlled trial (RCT) is needed to assess effectiveness.

After publication of the original article [1], it came to the authors’ attention that there is a typo in the Results section.

BackgroundYounger people bear the heaviest burden of sexually transmitted infections (STIs). Partner notification, condom use and STI testing can reduce infection but many young people lack the knowledge, skills and confidence needed to carry out these behaviours. Text messages can provide effective behavioural support. The acceptability and feasibility of a randomised controlled trial of safer sex support delivered by text message are not known.ObjectivesTo assess the acceptability and feasibility of a randomised controlled trial of a safer sex intervention delivered by text message for young people aged 16–24 years.Design(1) Intervention development; (2) follow-up procedure development; (3) a pilot, parallel-arm randomised controlled trial with allocation via remote automated randomisation (ratio of 1 : 1) (participants were unmasked, whereas researchers analysing samples and data were masked); and (4) qualitative interviews.SettingParticipants were recruited from sexual health services in the UK.ParticipantsYoung people aged 16–24 years diagnosed with chlamydia or reporting unprotected sex with more than one partner in the last year.InterventionsA theory- and evidence-based safer sex intervention designed, with young people’s input, to reduce the incidence of STIs by increasing the correct treatment of STIs, partner notification, condom use and STI testing before unprotected sex with a new partner. The intervention was delivered via automated mobile phone messaging over 12 months. The comparator was a monthly text message checking contact details.Main outcome measures(1) Development of the intervention based on theory, evidence and expert and user views; (2) follow-up procedures; (3) pilot trial primary outcomes: full recruitment within 3 months and follow-up rate for the proposed primary outcomes for the main trial; and (4) participants’ views and experiences regarding the acceptability of the intervention.ResultsIn total, 200 participants were randomised in the pilot trial, of whom 99 were allocated to the intervention and 101 were allocated to the control. We fully recruited early and achieved an 81% follow-up rate for our proposed primary outcome of the cumulative incidence of chlamydia at 12 months. There was no differential follow-up between groups. In total, 97% of messages sent were successfully delivered to participants’ mobile phones. Recipients reported that the tone, language, content and frequency of messages were appropriate. Messages reportedly increased knowledge of and confidence in how to use condoms and negotiate condom use and reduced stigma about STIs, enabling participants to tell a partner about a STI.ConclusionsOur research shows that the intervention is acceptable and feasible to deliver. Our pilot trial demonstrated that a main trial is feasible. It remains unclear which behaviour change techniques and elements of the intervention or follow-up procedures are associated with effectiveness. A further limitation is that in the trial one person entering data and the participants were unmasked. A randomised controlled trial to establish the effects of the intervention on STIs at 12 months is needed.Trial registrationCurrent Controlled Trials ISRCTN02304709.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 57. See the NIHR Journals Library website for further project information.

Background: Unintended pregnancy is associated with numerous poorer health outcomes for both women and their children. Fulfilling unmet need for contraception is essential in avoiding unintended pregnancies, yet millions of women in low- and middle-income countries continue to face obstacles in realizing their fertility desires. In Bolivia, family planning progress has improved in recent decades but lags behind other countries in the region. Unmet need for contraception among women aged 15 to 19 years is estimated to be 38%, with the adolescent fertility rate at 70 per 1000 women. Mobile phones are an established and popular mode in which to deliver health behavior support. The London School of Hygiene & Tropical Medicine and the Centro de Investigacion, Educacion y Servicios in Bolivia have partnered to develop and evaluate a contraceptive behavioral intervention for Bolivian young women delivered by mobile phone. The intervention was developed guided by behavioral science and consists of short instant messages sent through an app over 4 months. Objective: The objective of this study is to evaluate the effect of the intervention on young women’s use of and attitudes toward the most effective contraceptive methods. Methods: We will allocate 1310 women aged 16 to 24 years with an unmet need for contraception in a 1:1 ratio to receive the intervention messages or the control messages about trial participation. The messages are sent through the Tu decides app, which contains standard family planning information. Coprimary outcomes are use and acceptability of at least one effective contraceptive method, both measured at 4 months. Results: Recruitment commenced on March 1, 2017 and was completed on July 29, 2017. We estimate that the follow-up period will end in January 2018. Conclusions: This trial will evaluate the effect of the intervention on young women’s use of and attitudes toward the (nonpermanent) effective contraception methods available in Bolivia. Trial Registration: ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526 (Archived by WebCite at http://www.webcitation.org/6vT0yIFfN) [JMIR Res Protoc 2017;6(12):e252]

Background/introduction Younger people bear the heaviest burden of sexually transmitted infections (STIs). The acceptability and feasibility of conducting a randomised controlled trial of safer sex support delivered by text message are not known. Aim(s)/objectives To develop a safer sex intervention delivered by text messages for people aged 16–24. To assess the acceptability and feasibility of a randomised controlled trial. Methods The intervention was developed based on evidence, behavioural theory, and user views. It was designed to reduce STIs by increasing correct treatment of STI, partner notification, condom use and STI testing. We conducted a pilot, randomised controlled trial with people aged 16–24 diagnosed with chlamydia or reporting unprotected sex with more than one partner in the last year. We conducted qualitative interviews. Results Two hundred participants were randomised. We fully recruited early and achieved 81% follow up for our proposed primary outcome cumulative incidence of chlamydia at 12 months. Ninety-seven percent of messages sent were successfully delivered to participants’ phones. Recipients reported that the tone, language, content, and frequency of messages was appropriate. Messages reportedly increased knowledge and confidence in how to use and negotiate condom use, and reduced stigma enabling participants to tell a partner about a STI. Discussion/conclusion T he intervention is acceptable and a main trial is feasible. The NIHR have funded a randomised controlled trial to establish the effects of the intervention on sexually transmitted infections at 12 months.

BackgroundSexual health education in the United Kingdom is of variable quality, typically focusing on the biological aspects of sex rather than on communication, relationships, and sexual pleasure. The Internet offers a unique opportunity to provide sexual health education to young people, since they can be difficult to engage but frequently use the Internet as a health information resource. ObjectivesTo explore through qualitative research young people’s views on what elements of a sexual health website would be appealing and engaging, and their views on the content, design, and interactive features of the Sexunzipped intervention website. MethodsWe recruited 67 young people aged 16–22 years in London, UK. We held 21 focus groups and 6 one-to-one interviews to establish sexual health priorities, views on website look and feel, and what features of a sexual heath website would attract and engage them. Two researchers facilitated the focus groups, using a semistructured topic guide to lead the discussions and asking open questions to elicit a range of views. The discussions and interviews were audio recorded and detailed notes were made on key topics from the audio recording. Young people’s views influenced design templates for the content and interactive features of Sexunzipped. ResultsYoung people particularly wanted straightforward information on sexual pleasure, sexually transmitted infections and pregnancy, how to communicate with partners, how to develop skills in giving pleasure, and emotions involved in sex and relationships. Focus group participants wanted social interaction with other young people online and wanted to see themselves reflected in some way such as through images or videos. ConclusionsWhile it is challenging to meet all of young people’s technological and design requirements, consultation with the target audience is valuable and necessary in developing an online sexual health intervention. Young people are willing to talk about sensitive issues, enjoy the discussions, and can offer key insights that influence intervention development.

Objectives To assess the impact of computer-assisted interview compared with pen and paper on disclosure of sexual behaviour, diagnostic testing by clinicians, infections diagnosed and referral for counselling. Methods Two-centre parallel three-arm randomised controlled open trial. Computer-generated randomisation with allocation concealment using sealed envelopes. Setting Two London teaching hospital sexual health clinics. Participants 2351 clinic attenders over the age of 16 years. Interventions Computer-assisted self-interview (CASI). Computer-assisted personal interview (CAPI). Pen and paper interview (PAPI). Main Outcome Measures Diagnostic tests ordered, sexually transmitted infections (STI). Secondary Outcomes Disclosure of sexual risk, referral for counselling. Results 801, 763 and 787 patients randomly allocated to receive CASI, CAPI and PAPI. 795, 744 and 779 were available for intention-to-treat analysis. Significantly more diagnostic testing for hepatitis B and C and rectal samples in the CAPI arm (odds for more testing relative to PAPI 1.32; 95% CI 1.09 to 1.59). This pattern was not seen among CASI patients. HIV testing was significantly lower among CASI patients (odds for less testing relative to PAPI 0.73; 95% CI 0.59 to 0.90). STI diagnoses were not significantly different by trial arm. A summary measure of seven prespecified sensitive behaviours found greater reporting with CASI (OR 1.4; 95% CI 1.2 to 1.6) and CAPI (OR 1.4; 95% CI 1.2 to 1.7) compared with PAPI. Conclusion CASI and CAPI can generate greater recording of risky behaviour than traditional PAPI. Increased disclosure did not increase STI diagnoses. Safeguards may be needed to ensure that clinicians are prompted to act upon disclosures made during self-interview. Trial registration ISRCTN: 97674664.

High experienced continuity of care in patients with cancer is associated with lower needs for care, better quality of life and better psychological outcomes. We developed and evaluated an intervention to improve experienced continuity. The intervention, consisted of (1) a 17-item patient-completed continuity assessment; (2) feedback to clinical nurse specialists and action to address the needs identified. Multidisciplinary team meetings and oncology outpatient clinics were observed, and patients and staff were interviewed. After qualitative work and reliability testing, the intervention was evaluated in a feasibility trial. Sixty-one patients provided data for analysis. No statistically significant differences were found in patients' experienced continuity between the trial arms, but important trends were seen in measures of needs for care in favour of those receiving the intervention. Feeding back findings from the continuity assessment to clinicians reduced patients' needs for care. Our results indicate that an intervention to target patients' experiences of continuity can reduce their subsequent needs for care. However, overcoming barriers to organisational change and addressing some patients' hesitation to report their continuity difficulties must be considered when implementing such an intervention. A phase III trial targeting patients with inadequate experienced continuity of care is recommended.

To assess the effect of a mobile phone-based intervention (mHealth) on post-abortion contraception use by women in Cambodia.The Mobile Technology for Improved Family Planning (MOTIF) study involved women who sought safe abortion services at four Marie Stopes International clinics in Cambodia. We randomly allocated 249 women to a mobile phone-based intervention, which comprised six automated, interactive voice messages with counsellor phone support, as required, whereas 251 women were allocated to a control group receiving standard care. The primary outcome was the self-reported use of an effective contraceptive method, 4 and 12 months after an abortion.Data on effective contraceptive use were available for 431 (86%) participants at 4 months and 328 (66%) at 12 months. Significantly more women in the intervention than the control group reported effective contraception use at 4 months (64% versus 46%, respectively; relative risk, RR: 1.39; 95% confidence interval, CI: 1.17-1.66) but not at 12 months (50% versus 43%, respectively; RR: 1.16; 95% CI: 0.92-1.47). However, significantly more women in the intervention group reported using a long-acting contraceptive method at both follow-up times. There was no significant difference between the groups in repeat pregnancies or abortions at 4 or 12 months.Adding a mobile phone-based intervention to abortion care services in Cambodia had a short-term effect on the overall use of any effective contraception, while the use of long-acting contraceptive methods lasted throughout the study period.Évaluer l'effet d'une intervention par téléphone portable (santé sur mobile) sur l’utilisation de méthodes contraceptives après un avortement par les femmes au Cambodge.L'étude MOTIF (Mobile Technology for Improved Family Planning – Technologie mobile pour une meilleure planification familiale) a mobilisé des femmes ayant eu recours à des services d'avortement médicalisé dans quatre cliniques Marie Stopes International du Cambodge. Nous avons aléatoirement affecté 249 femmes au groupe bénéficiant d'une intervention par téléphone portable, laquelle comprenait six messages vocaux automatisés et interactifs et, au besoin, l'assistance téléphonique d'un conseiller, et 251 femmes au groupe de contrôle recevant une prise en charge standard. Le critère d'évaluation principal était l'utilisation autodéclarée d'une méthode contraceptive efficace, 4 et 12 mois après un avortement.Les données relatives à l'utilisation de contraceptifs efficaces étaient disponibles pour 431 (86%) participantes à 4 mois et pour 328 (66%) à 12 mois. Les femmes appartenant au groupe ayant bénéficié de l’intervention sont beaucoup plus nombreuses que les femmes du groupe de contrôle à avoir mentionné l'utilisation de contraceptifs efficaces à 4 mois (64% pour les premières contre 46% pour les secondes; risque relatif, RR: 1,39; intervalle de confiance, IC, à 95%: 1,17-1,66), ce qui n’est pas le cas à 12 mois (50% contre 43%; RR: 1,16; IC à 95%: 0,92-1,47). Cependant, un nombre beaucoup plus élevé de femmes ayant bénéficié de l’intervention a indiqué avoir utilisé une méthode contraceptive à long terme sur ces deux périodes de suivi. Aucune différence notable n'a été constatée entre les deux groupes concernant des grossesses ou des avortements répétés à 4 ou 12 mois.L'adjonction d'une intervention par téléphone portable aux services de soins après avortement au Cambodge a produit un effet à court terme sur l'utilisation générale de contraceptifs efficaces, tandis que l'utilisation de méthodes contraceptives à long terme s'est poursuivie tout au long de la période d'étude.Evaluar el efecto de una intervención basada en la telefonía móvil (mHealth) en el uso de métodos anticonceptivos postaborto entre las mujeres de Camboya.El estudio Mobile Technology for Improved Family Planning (MOTIF) involucró a mujeres que recurrieron a servicios de aborto seguros en cuatro clínicas Marie Stopes International de Camboya. Se asignaron de forma aleatoria 249 mujeres a una intervención basada en la telefonía móvil que consistía en seis mensajes de voz interactivos y automatizados y el apoyo de un asesor a través del teléfono, cuando fuera necesario, y 251 mujeres a un grupo de control que recibía atención estándar. El resultado principal fue el uso autodeclarado de un método anticonceptivo efectivo 4 y 12 meses después de sufrir un aborto.Los datos sobre el uso efectivo de los métodos anticonceptivos estuvieron disponibles al cabo de 4 meses en el caso de 431 (86%) de las participantes y al cabo de 12 meses en el caso de 328 (66%). Significativamente más mujeres del grupo de la intervención que del grupo de control informaron de un uso efectivo de los métodos anticonceptivos al cabo de 4 meses (64% frente a 46% respectivamente; riesgo relativo, RR: 1,39; intervalo de confianza (IC) del 95%: 1,17–1,66) pero no al cabo de 12 meses (50% frente a 43% respectivamente; RR: 1,16 (IC del 95%: 0,92–1,47). Sin embargo, más mujeres del grupo de la intervención informaron sobre el uso de métodos anticonceptivos de larga duración en los dos momentos del seguimiento. No hubo una diferencia importante entre los grupos en cuanto a embarazos futuros o abortos al cabo de 4 o 12 meses.Añadir una intervención basada en la telefonía móvil a los servicios de atención al aborto en Camboya tuvo un efecto a corto plazo en el uso general de cualquier método anticonceptivo efectivo, mientras que el uso de métodos anticonceptivos a largo plazo perduró a lo largo de todo el periodo de estudio.تقييم تأثير التدخل القائم على الهاتف الجوّال (mHealth) على استخدام النساء لموانع الحمل بعد الإجهاض في كمبوديا.تضمنت دراسة استخدام تكنولوجيا الهاتف الجوّال لتحسين تنظيم الأسرة (‏MOTIF‏) النساء اللاتي سعين إلى الحصول على خدمات الإجهاض الآمن في أربع من عيادات "ماري ستوبس الدولية" في كمبوديا. ولقد قمنا بتخصيص 249 امرأة على نحو عشوائي لإجراء التدخل القائم على الهاتف الجوّال، الذي يتألف من ست رسائل صوتية آلية وتفاعلية مع خدمة الدعم الهاتفي للمرشد العلاجي، عند الضرورة، في حين تم تخصيص 251 امرأة إلى مجموعة شاهدة تتلقى مستوى معياريًا من الرعاية. وكانت المحصلة الأساسية هي الإبلاغ الذاتي عن استخدام وسيلة فعالة لمنع الحمل بعد مرور 4 شهور و12 شهرًا من الإجهاض.توفرت البيانات عن استخدام موانع الحمل الفعالة لعدد 431 من المشاركات (بنسبة 86%) بعد مرور 4 شهور و328 من المشاركات (بنسبة 66%) بعد مرور 12 شهرًا. وبشكل ملحوظ، قامت الكثير من النساء المشاركات في مجموعات التدخل عن النساء المشاركات في المجموعة الشاهدة بالإبلاغ عن استخدام موانع حمل فعالة بعد مرور 4 شهور (بنسبة 64% مقابل 46%، على التوالي؛ الاختطار النسبي: 1.39؛ بنسبة أرجحية مقدارها 95%: 1.17–1.66) ولكن ليس بعد مرور 12 شهرًا (بنسبة 50% مقابل 43%، على التوالي؛ الاختطار النسبي: 1.16؛ بنسبة أرجحية مقدارها 95%: 0.92–1.47). ومع ذلك، أبلغت الكثير من النساء المشاركات في مجموعة التدخل عن استخدام وسيلة لمنع الحمل طويلة المفعول في كلٍ من المرتين اللتين تمت فيهما المتابعة. لم يكن هناك فرق كبير بين المجموعتين في حالات الحمل أو الإجهاض المتكررة بعد مرور 4 شهور أو 12 شهرًا.أدت إضافة التدخل القائم على الهاتف الجوّال إلى خدمات الرعاية بعد الإجهاض في كمبوديا إلى تحقيق تأثير قصير الأجل على الاستخدام العام لأي موانع حمل فعالة، في حين استمر استخدام وسائل منع الحمل طويلة المفعول طوال فترة الدراسة.旨在评估基于手机的干预（移动医疗）对柬埔寨女性流产后避孕的影响。.面向在柬埔寨的四家玛丽斯特普国际组织 (Marie Stopes International) 下属诊所中寻求安全流产服务的女性，展开改善计划生育的移动技术 (MOTIF) 研究。我们随机分配 249 位女性进行基于手机的干预，其包括带有顾问电话支持的 6 个自动化、交互式语音信息，而另外 251 位女性被分配至对照组，接受标准治疗。主要结果为，流产后 4 和 12 个月时自报有效避孕方法的使用情况。.4 个月时，431 位参与者 (86%) 获得有效避孕的使用数据，12 个月时为 328 位 (66%)。4 个月时，报告有效避孕的女性中，参与干预的女性明显超出对照组（64% 比 46%；相对风险率 RR： 1.39；95% 置信区间 CI：1.17-1.66），但 12 个月时却有所不同（分别为 50% 比 43%，相对风险率 RR：1.16；95% 置信区间 CI：0.92–1.47). 然而，在后续两个时间点，干预组中报告使用长效避孕方法的女性明显更多。4 个月或 12 个月时，两组中再次怀孕或流产的人数没有显著差异。.为柬埔寨为流产护理服务添加基于手机的干预，可在短期内对任何有效避孕的总体使用情况产生一定的效果，而整个研究期间则继续使用长效避孕方法。.Оценить влияние мероприятий здравоохранения, проводимых с помощью мобильной связи (mHealth), на применение способов постабортной контрацепции женщинами, проживающими в Камбодже.В исследовании «Применение мобильных технологий для усовершенствованного планирования семьи» (MOTIF) приняли участие женщины, желающие пройти процедуру безопасного аборта в четырех клиниках Marie Stopes International, Камбоджа. 249 женщин были случайным образом распределены в группу, в которой медицинское обслуживание проводилось посредством мобильной связи и включало возможность отправки шести автоматизированных интерактивных голосовых сообщений с поддержкой телефонной связи с консультантом при необходимости, а 251 женщина была распределена в контрольную группу, в которой участники получали медицинское обслуживание стандартным способом. Первичным результатом являлось применение эффективного способа контрацепции через 4 и 12 месяцев после аборта, о чем участницы сообщали самостоятельно.Данные о применении эффективного способа контрацепции были получены для 431 (86%) участницы через 4 месяца и для 328 (66%) участниц через 12 месяцев. Число женщин, сообщивших о применении эффективного способа контрацепции через 4 месяца, было больше в группе, в которой проводилось обслуживание посредством мобильной связи, чем в контрольной группе (64 против 46% соответственно, относительный риск, ОР: 1,39; 95% доверительный интервал, ДИ: 1,17–1,66), но через 12 месяцев был получен другой результат (50 против 43% соответственно, ОР: 1,16; 95% ДИ: 0,92–1,47). Тем не менее в каждый из двух контрольных моментов времени послеоперационного наблюдения число женщин в группе проведения исследуемого мероприятия, сообщивших о применении способа контрацепции длительного действия, преобладало. Что касается числа повторных беременностей или абортов через 4 или 12 месяцев, значимой разницы между двумя группами выявлено не было.Добавление медицинского обслуживания посредством мобильной связи в рамки медицинской помощи при аборте в Камбодже оказало краткосрочное влияние на общее применение какого-либо эффективного способа контрацепции, в то время как способы контрацепции длительного действия применялись в течение всего исследования.

BackgroundThe Internet can provide a confidential and convenient medium for sexual health promotion for young people. ObjectiveThis paper describes the development of an interactive, theory-based website (Sexunzipped) aimed at increasing safe sexual behavior of young people, as well as an outline of the evaluation protocol. MethodsThe website focuses on safer sex, relationships, and sexual pleasure. An overview of the site is provided, including a description of the theoretical constructs which form the basis of the site development. An integrated behavioral model was chosen as the guiding theory for the Sexunzipped intervention. A randomized trial design will be used to evaluate the site quantitatively. ResultsThe content of the site is described in detail with examples of the main content types: information pages, quizzes, and decision-making activities. We describe the protocol for quantitative evaluation of the website using a randomized trial design and discuss the principal challenges involved in developing the site, including the challenge of balancing the requirements of theory with young people’s views on website content and design. ConclusionsConsiderations for future interventions are discussed. Developing an online behavior-change intervention is costly and time consuming. Given the large public health potential, the cost involved in developing online interventions, and the need for attractive design, future interventions may benefit from collaborating with established sites that already have a user base, a brand, and a strong Internet presence. It is vital to involve users in decisions about intervention content, design, and features, paying attention to aspects that will attract and retain users’ interest. A central challenge in developing effective Internet-based interventions for young people is to find effective ways to operationalize theory in ways that address the views and perspectives of young people.

Loss to follow-up in randomised controlled trials reduces statistical power and increases the potential for bias. Almost half of all trials fail to achieve their follow-up target. Statistical methods have been described for handling losses to follow-up and systematic reviews have identified interventions that increase follow-up. However, there is little guidance on how to develop practical follow-up procedures. This paper describes the development of follow-up procedures in a pilot randomised controlled trial of a sexual health intervention that required participants to provide and return questionnaires and chlamydia test samples in the post. We identified effective methods to increase follow-up from systematic reviews. We developed and tested prototype procedures to identify barriers to follow-up completion. We asked trial participants about their views on our follow-up procedures and revised the methods accordingly.We identified 17 strategies to increase follow-up and employed all but five. We found that some postal test kits do not fit through letterboxes and that that the test instructions were complicated. After identifying the appropriate sized test kit and simplifying the instructions, we obtained user opinions. Users wanted kits to be sent in coloured envelopes (so that they could identify them easily), with simple instructions and questionnaires and wanted to be notified before we sent the kits. We achieved 92 % (183/200) overall follow-up for the postal questionnaire at 1 month and 82 % (163/200) at 12 months. We achieved 86 % (171/200) overall follow-up for the postal chlamydia test at 3 months and 80 % (160/200) at 12 months.By using established methods to increase follow-up, testing prototype procedures and seeking user opinions, we achieved higher follow-up than previous sexual health trials. However, it is not possible to determine if the increase in response was due to our follow-up procedures.Current Controlled Trials ISRCTN02304709 Date of registration: 27 March 2013.

Background Loss to follow-up in randomised controlled trials reduces statistical power and increases the potential for bias. Almost half of all trials fail to achieve their follow-up target. Statistical methods have been described for handling losses to follow-up and systematic reviews have identified interventions that increase follow-up. However, there is little guidance on how to develop practical follow-up procedures. This paper describes the development of follow-up procedures in a pilot randomised controlled trial of a sexual health intervention that required participants to provide and return questionnaires and chlamydia test samples in the post. We identified effective methods to increase follow-up from systematic reviews. We developed and tested prototype procedures to identify barriers to follow-up completion. We asked trial participants about their views on our follow-up procedures and revised the methods accordingly. Results We identified 17 strategies to increase follow-up and employed all but five. We found that some postal test kits do not fit through letterboxes and that that the test instructions were complicated. After identifying the appropriate sized test kit and simplifying the instructions, we obtained user opinions. Users wanted kits to be sent in coloured envelopes (so that they could identify them easily), with simple instructions and questionnaires and wanted to be notified before we sent the kits. We achieved 92 % (183/200) overall follow-up for the postal questionnaire at 1 month and 82 % (163/200) at 12 months. We achieved 86 % (171/200) overall follow-up for the postal chlamydia test at 3 months and 80 % (160/200) at 12 months. Conclusions By using established methods to increase follow-up, testing prototype procedures and seeking user opinions, we achieved higher follow-up than previous sexual health trials. However, it is not possible to determine if the increase in response was due to our follow-up procedures. Trial registration Current Controlled Trials ISRCTN02304709 Date of registration: 27 March 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1155-1) contains supplementary material, which is available to authorized users.