Ona McCarthy

What Young People Want From a Sexual Health Website: Design and Development of Sexunzipped

Background Sexual 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. Objectives To 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. Methods We 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. Results Young 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. Conclusions While 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.

A randomised controlled trial of computer-assisted interviewing in sexual health clinics

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.

Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia

Abstract Objective To assess the effect of a mobile phone-based intervention (mHealth) on post-abortion contraception use by women in Cambodia. Methods 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. Findings 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. Conclusion 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.

The Sexunzipped Trial: Optimizing the Design of Online Randomized Controlled Trials

Background Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition. Objective This study addresses the feasibility of several dimensions of online trial design—recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up. Methods Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the “Sexunzipped” online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US

Integrating Psychological Theory Into the Design of an Online Intervention for Sexual Health: The Sexunzipped Website

16) or higher (£20/US

Young People's Views and Experiences of a Mobile Phone Texting Intervention to Promote Safer Sex Behavior

32) value shopping voucher compensation for 3-month outcome data. Results The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US

An Intervention Delivered by App Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Protocol of a Randomized Controlled Trial

32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of online self-reported sexual health outcomes and 47.4% (118/249) for return of chlamydia urine samples by post. Conclusions It was quick and efficient to recruit young people to this online trial. Our procedures for obtaining online consent, verifying participant identity, automated randomization, and concealment of allocation worked well. The optimal response rate for the online sexual health outcome measurement was comparable to face-to-face trials. Multiple methods of participant contact, requesting online data only, and higher value compensation increased trial retention at 3-month follow-up. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 55651027; http://www.controlled-trials.com/ISRCTN55651027 (Archived by WebCite at http://www.webcitation.org/6LbkxdPKf).

A randomised controlled trial of an intervention delivered by app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan: study protocol

Background The Internet can provide a confidential and convenient medium for sexual health promotion for young people. Objective This 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. Methods The 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. Results The 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. Conclusions Considerations 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.

Development of an intervention delivered by mobile phone aimed at decreasing unintended pregnancy among young people in three lower middle income countries

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.

Erratum to: Simple steps to develop trial follow-up procedures

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 Investigación, Educación 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 Tú 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)