Simple steps to develop trial follow-up procedures.

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

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

Unfortunately, the original version of this article [1] contained an error. There were errors in the reference numbers in Additional file 1. This has now been corrected and Additional file 1 is included here with the correct reference numbers

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.

INTRODUCTION: Women 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 ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: Clinicaltrial.gov NCT02905513. DATE OF REGISTRATION: 14 September 2016. WHO TRIAL REGISTRATION DATASET: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02905513

Texting Sexual Health Pilot - Interview Guide

A semi-structured topic guide used to discover participants’ views, experiences, and recommendations for improvements to behavioral intervention on sexual health. Questions cover tone and frequency of text messages, views regarding the message content, any concerns about others viewing texts, what (if anything) they had learned from text messages, sexual behavior since enrolment (such as condom use and partner notification), and suggested improvements to the intervention

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.

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)

A randomized controlled trial of an intervention delivered by mobile phone app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan.

BACKGROUND: Unintended pregnancy is associated with poorer health outcomes for women and their families. In Tajikistan, around 26% of married 15-24 year old women have an unmet need for contraception. There is some evidence that interventions delivered by mobile phone can affect contraceptive-related behaviour and knowledge. We developed an intervention delivered by mobile phone app instant messaging to improve acceptability of effective contraceptive methods among young people in Tajikistan. METHODS: This was a randomized controlled trial among Tajik people aged 16-24. Participants allocated to the intervention arm had access to an app plus intervention messages. Participants allocated to the control arm had access to the app plus control messages. 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 during the study, acceptability of individual methods, service uptake, unintended pregnancy and induced abortion. Process outcomes were knowledge, perceived norms, personal agency and intention. Outcomes were analysed using logistic and linear regression. We conducted a pre-specified subgroup analysis and a post-hoc analysis of change in acceptability from baseline to follow-up. RESULTS: Five hundred and seventy-three participants were enrolled. Intervention content was included on the app, causing contamination. Four hundred and seventy-two (82%) completed follow-up for the primary outcome. There was no evidence of a difference in acceptability of effective contraception between the groups (66% in the intervention arm vs 64% in the control arm, adjusted OR 1.21, 95% CI .80-1.83, p = 0.36). There were no differences in the secondary or process outcomes between groups. There was some evidence that the effect of the intervention was greater among women compared to men (interaction test p = 0.03). There was an increase in acceptability of effective contraception from baseline to follow-up (2% to 65%, p < 0.001). CONCLUSIONS: The whole intervention delivered by instant messaging provided no additional benefit over a portion of the intervention delivered by app pages. The important increase in contraceptive acceptability from baseline to follow-up suggests that the intervention content included on the app may influence attitudes. Further research is needed to establish the effect of the intervention on attitudes towards and use of effective contraception among married/sexually active young people. TRIAL REGISTRATION: Clinicaltrial.gov NCT02905513 . Date of registration: 14 September 2016

A dynamic and collaborative approach to trial recruitment in safetxt, a UK sexual health randomised controlled trial.

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

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

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

Safetxt: a pilot randomised controlled trial of an intervention delivered by mobile phone to increase safer sex behaviours in young people.

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

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

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