A cluster randomized controlled trial of an electronic decision-support system to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India: trial protocol.

BACKGROUND: India contributes 15% of the total global maternal mortality burden. An increasing proportion of these deaths are due to Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anaemia. This study aims to evaluate the effectiveness of a tablet-based electronic decision-support system (EDSS) to enhance routine antenatal care (ANC) and improve the screening and management of PIH, GDM, and anaemia in pregnancy in primary healthcare facilities of Telangana, India. The EDSS will work at two levels of primary health facilities and is customized for three cadres of healthcare providers - Auxiliary Nurse Midwifes (ANMs), staff nurses, and physicians (Medical Officers). METHODS: This will be a cluster randomized controlled trial involving 66 clusters with a total of 1320 women in both the intervention and control arms. Each cluster will include three health facilities-one Primary Health Centre (PHC) and two linked sub-centers (SC). In the facilities under the intervention arm, ANMs, staff nurses, and Medical Officers will use the EDSS while providing ANC for all pregnant women. Facilities in the control arm will continue to provide ANC services using the existing standard of care in Telangana. The primary outcome is ANC quality, measured as provision of a composite of four selected ANC components (measurement of blood pressure, blood glucose, hemoglobin levels, and conducting a urinary dipstick test) by the healthcare providers per visit, observed over two visits. Trained field research staff will collect outcome data via an observation checklist. DISCUSSION: To our knowledge, this is the first trial in India to evaluate an EDSS, targeted to enhance the quality of ANC and improve the screening and management of PIH, GDM, and anaemia, for multiple levels of health facilities and several cadres of healthcare providers. If effective, insights from the trial on the feasibility and cost of implementing the EDSS can inform potential national scale-up. Lessons learned from this trial will also inform recommendations for designing and upscaling similar mHealth interventions in other low and middle-income countries. CLINICALTRIALS: gov, NCT03700034, registered 9 Oct 2018, https://www. CLINICALTRIALS: gov/ct2/show/NCT03700034 CTRI, CTRI/2019/01/016857, registered on 3 Mar 2019, http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=28627&EncHid=&modid=&compid=%27,%2728627det%27.

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.

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

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

Adapting an evidence-based contraceptive behavioural intervention delivered by mobile phone for young people in Zimbabwe.

BACKGROUND: Despite the availability of a range of contraceptive methods, young people around the world still face barriers in accessing and using them. The use of digital technology for the delivery of health interventions has expanded rapidly. Intervention delivery by mobile phone can be a useful way to address young people's needs with regard to sexual and reproductive health, because the information can be digested at a time of the recipients' choosing. This study reports the adaptation of an evidence-based contraceptive behavioural intervention for young people in Zimbabwe. METHODS: Focus group discussions and in depth interviews were used to evaluate the 'fit' of the existing intervention among young people in Harare, Zimbabwe. This involved determining how aligned the content of the existing intervention was to the knowledge and beliefs of young Zimbabweans plus identifying the most appropriate intervention deliver mode. The verbatim transcripts were analysed using a thematic analysis. The existing intervention was then adapted, tested and refined in subsequent focus group discussions and interviews with young people in Harare and Bulawayo. RESULTS: Eleven key themes resulted from the discussions evaluating the fit of the intervention. While there were many similarities to the original study population, key differences were that young people in Zimbabwe had lower levels of personal and smart mobile phone ownership and lower literacy levels. Young people were enthusiastic about receiving information about side effects/side benefits of the methods. The iterative testing and refinement resulted in adapted intervention consisting of 97 messages for female recipients (94 for male), delivered over three months and offered in English, Shona and Ndebele. CONCLUSIONS: Young people in Zimbabwe provided essential information for adapting the existing intervention. There was great support for the adapted intervention among the young people who took part in this study. The adapted intervention is now being implemented within an integrated community-based sexual and reproductive health service in Zimbabwe.

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

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

An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial.

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.

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

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.

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.

Correction to: 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.

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

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.

mHealth interventions for postpartum family planning in LMICs: A realist review.

The unmet need for family planning is a pervasive public health concern in many low- and middle-income countries (LMICs). Mobile health (mHealth) interventions have been designed and implemented in LMIC settings to address this issue through health information dissemination via voice calls, apps, and short message services (SMS). Although the impact of mHealth programmes on postpartum family planning outcomes have been systematically reviewed, the contexts, conditions, and mechanisms underpinning programme engagement and their impact on outcomes remain unclear. This study aims to formulate hypotheses in the form of context-mechanism-outcome configurations (CMOCs) of whether, how, why, for whom, and in what contexts mHealth interventions implemented in LMICs influence postpartum family planning (PPFP) outcomes. We conducted a realist review of peer-reviewed and grey literature. Peer-reviewed literature was identified through MEDLINE, Embase, Global Health, Web of Science, and Google Scholar. Grey Literature was identified through The National Grey Literature Conference, FHI 360, Guttmacher Institute, Population Council, and MSI Reproductive Choices. Inclusion criteria were updated as the review progressed. Narrative data were analysed using dimensional analysis to build CMOCs. Two overarching concepts (underpinned by 12 CMOCs) emerged from the 37 included records: mobile phone access, use, and ownership as well as women's motivation. Women's confidence to independently own, access, and operate a mobile phone was a central mechanism leading to mHealth programme engagement and subsequent change in PPFP knowledge, awareness, and outcomes. Receiving family and social support positively interacted with this while low digital literacy and harmful gender norms pertaining to prescribed domestic duties and women's household influence were barriers to programme engagement. Intrinsic motivation for health improvement functioned at times both as a context and potential mechanism influencing mHealth programme engagement and PPFP outcomes. However, these contexts rarely occur in isolation and need to be evaluated as co-occurring phenomena. (Review registration: PROSPERO CRD42023386841).

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$16) or higher (£20/US$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$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).

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.

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

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

The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial.

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 screening (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 <1000 copies/ml in those living with HIV and proportion who test positive for STIs (for the nested trial). A detailed process and cost evaluation of the trial will be conducted. 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.

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.

Safetxt: a safer sex intervention delivered by mobile phone messaging on sexually transmitted infections (STI) among young people in the UK - protocol for a randomised controlled trial.

INTRODUCTION: Young 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 ANALYSIS: A 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 DISSEMINATION: Ethics 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 NUMBER: International Standard Randomised Controlled Trials Number: ISRCTN64390461. Registered on 17th March 2016. WHO trial registration data set available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461. TRIAL PROTOCOL VERSION: 12, 19th July 2018.

A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine.

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 < 0.001). They had a higher mean knowledge score, were more likely to find the intrauterine device, injection, implant and patch acceptable, to agree that their friends would use an effective method and to intend to use an effective method, compared to participants in the control group. While in the direction of intervention benefit, there were no differences between the groups in the use of effective contraception at 4 months and any use during the study, pill acceptability, service uptake, unintended pregnancy and induced abortion. CONCLUSIONS: The intervention can improve attitudes, knowledge-perceived norms and intention to use effective contraception among young women in Palestine. Research is needed to evaluate the efficacy of the intervention for contraceptive behavioral outcomes in Palestine. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02905461 . Registered on 14 September 2016. World Health Organization Trial Registration Data Set: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02905461.

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.

An intervention delivered by text message to increase the acceptability of effective contraception among young women in Palestine: study protocol for a randomised controlled trial.

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.