Copper IUD continuation, unwanted effects and cost consequences at 1 year in users aged under 30 - a secondary analysis of the EURAS-IUD study.

OBJECTIVE: To conduct a secondary analysis of continuation, unwanted effects and cost consequences at 1 year in copper intrauterine device (IUD) users aged under 30 in the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD study) based on IUD type. METHODS: Descriptive and comparative analyses of copper IUD continuation, unwanted effects and estimated cost consequences at 1 year were performed in users aged under 30 based on IUD copper surface area, shape or design, width and arms' flexibility. RESULTS: 5796 copper IUD users were identified to have been aged under 30 at EURAS-IUD study recruitment and data for 5762 users (99.4%) was analysed. Higher IUD continuation, fewer unwanted effects and lower costs were observed with IUDs of the lowest copper content (<300mm2), horse-shoe frame design, widths 18 mm to <30mm and flexible IUD arms. Discontinuation, unwanted effects and costs were greater with frameless IUDs and framed, ≥30mm width IUDs with 380mm2 of copper and copper bands on their rigid transverse IUD arms. CONCLUSIONS: Significant differences in continuation, reported unwanted effects and estimated costs at 1 year between IUD types were observed in users aged under 30. Although further research is needed, clinicians should consider these findings when counselling and choosing IUD types for younger women.

Test of cure study: a feasibility study to estimate the time to test of cure (TOC) for Neisseria gonorrhoeae and Chlamydia trachomatis infections.

OBJECTIVES: Test of cure (TOC) for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infection is an important tool in the public health management of STIs. However, there are limited data about the optimal time to perform TOC using nucleic acid amplification tests (NAATs) for NG and CT infections. A study was performed to assess the feasibility of a larger study to determine the optimal time to TOC using NAATS. METHODS: The Sexually Transmitted Bacteria Reference Unit at Public Health England undertook testing of gonococcal and chlamydial nucleic acids within neat urine stored in different conditions over 25 days to provide evidence of the stability of the nucleic acid prior to recruitment. Individuals diagnosed with uncomplicated NG or CT infection were recruited from three sexual health clinics. Individuals were asked to return nine self-taken samples from the site of infection over a course of 35 days. Survival analyses of time to first negative NAAT result for NG and CT infection and univariate regression analysis of factors that affect time to clearance were undertaken. RESULTS: At room temperature, chlamydial DNA in urine is stable for up to 3 weeks and gonococcal DNA for up to 11 days. We analysed data for 147 infections (81 NG and 66 CT). The median time to clearance of infection was 4 days (IQR 2-10 days) for NG infection and 10 days (IQR 7-14 days) for CT infection. Vaginal CT infections took longer to clear (p=0.031). NG infection in men who have sex with men took longer to clear (p=0.052). CONCLUSION: Chlamydial and gonococcal nucleic acids are stable in urine before addition of preservatives, longer than recommended by the manufacturer. The TOC results suggest that it may be possible to undertake TOC for NG and CT infections earlier than current guidelines suggest and that anatomical site of infection may affect time to clearance of infection.

Evaluation of the Krio Language Version of the London Measure of Unplanned Pregnancy in Western Area, Sierra Leone.

New ways of measuring pregnancy planning/intention such as the London Measure of Unplanned Pregnancy (LMUP), which recognise the complexity of the construct, are being adopted worldwide. The aim of this study was to evaluate the psychometric properties of the Krio version of the LMUP in Sierra Leone. An interviewer-administered version of the LMUP was translated into Krio and pre-tested with 12 pregnant women. Field testing involved 172 pregnant women aged 15-42, with 87 completing a re-test. Completion rates of LMUP items were 100%. LMUP scores 1-12 were captured. Reliability: the scale was internally consistent (Cronbach's alpha 0.84) and stable (weighted Kappa 0.93). Construct validity: all hypotheses were confirmed. Principal components analysis revealed five items (items 2-6) related to one construct. Mokken scaling procedure selected the same five items. Removal of item 1 (which had 97% endorsement of the _no contraception' response option) brought about only a very slight improvement in LMUP performance, therefore we recommend retaining all six items. The Krio LMUP is reliable, valid and suitable to use in Sierra Leone.

Prospective observational study to evaluate the performance of the BioSure HIV Self-Test in the hands of lay users.

OBJECTIVES: In order to assess whether the BioSure HIV Self-Test could be reliably performed by users at home and to determine whether they were able to perform and correctly interpret the test, we carried out an evaluation study among attendees at a sexual health service. METHODS: A prospective observational study of clinic attendees to determine their ability to follow the instructions, complete the test on themselves and correctly interpret the results. The evaluation included interpretation of three dummy (contrived) devices, chosen at random from a sample of 12 devices, to ensure that a sufficient number of all possible test outcomes were included. RESULTS: Two hundred participants were recruited. 97.0% (95% CI 93.5 to 98.9) conducted the test so as to achieve a valid result. 99.5% correctly identified the test result. Participants correctly interpreted the result of 94.0% (95% CI 91.4 to 95.9) of 586 contrived devices. CONCLUSIONS: The majority of participants were able to follow the instructions and perform the test in order to get a valid result. Interpretation of the test results was good and the majority of participants were able to correctly read the result of their own and contrived tests. The availability of HIV self-tests will provide another option to increase access to testing particularly for those who may not wish or are unable to access clinical services.

Randomized controlled trial of the tolerability and completion of maraviroc compared with Kaletra® in combination with Truvada® for HIV post-exposure prophylaxis (MiPEP Trial).

Objectives: Post-exposure prophylaxis (PEP) for HIV is often poorly tolerated and not completed. Alternative PEP regimens may improve adherence and completion, aiding HIV prevention. We conducted a randomized controlled trial of a maraviroc-based PEP regimen compared with a standard-of-care regimen using ritonavir-boosted lopinavir. Methods: Patients meeting criteria for PEP were randomized to tenofovir disoproxil/emtricitabine (200/245 mg) once daily plus ritonavir-boosted lopinavir (Kaletra ® 400/100 mg) or maraviroc 300 mg twice daily. The composite primary endpoint was completion of 28 days of the allocated PEP regimen without grade 3 or 4 clinical or laboratory adverse events (AEs) related to the PEP medication. Results: Two hundred and thirteen individuals were randomized (107 to maraviroc; 106 to Kaletra ® arm). Follow-up rates were high in both groups. There was no difference in the primary endpoint; 70 (71%) in the maraviroc and 64 (65%) in the Kaletra ® arm ( P = 0.36) completed PEP without grade 3 or 4 AEs. Discontinuation of PEP was the same (18%) in both groups. There were no grade 3 or 4 clinical AEs in either arm, but more grade 1 or 2 clinical AEs in the Kaletra ® arm (91% versus 70%; P < 0.001). Antidiarrhoeal medication use was higher in the Kaletra ® arm (67% versus 25%; P < 0.001). There were no HIV seroconversions in the study period. Conclusions: The completion rate in the absence of grade 3 or 4 AEs was similar with both regimens. Maraviroc-based PEP was better tolerated, supporting its use as an option for non-occupational PEP.

Patients' experiences and providers' observations on pain during intrauterine device insertion.

OBJECTIVE: To determine women's (patients') experiences of intrauterine device (IUD) insertion under our current practice and the extent to which these agreed with the observations of the health professionals (providers) who had performed the IUD insertion procedures. METHOD: Questionnaires were used to collect information on women's experiences of the IUD insertion procedure from both patients and providers in a sexual and reproductive health service. RESULTS: Overall response rates were high (77%, 284 responses in total). Seventy-three percent of patients were nulliparous and over half nulligravid. The providers predominantly used local anaesthesia for IUD insertions (93%). Most patients reported being anxious before their procedure (86%). Patients mainly described the overall experience of their IUD insertion procedure as being associated with 'minimal discomfort/nothing' (42%) or 'uncomfortable' (41%). 'Minimal discomfort/nothing' (56%) and 'uncomfortable' (33%) were the main observations of providers. When responses of patients and their providers were compared, agreement was slight for reported pain levels (k = 0.167 CI [0.13-0.24]). Patients' reported pain levels were significantly higher than those reported to have been observed by their providers (p < 0.001). CONCLUSION: Patients' and providers' responses suggested that the IUD insertion procedure under our current practice appeared acceptable to most patients. However, providers were not usually accurate in their observations and tended to underestimate the degree of pain experienced by their patients during IUD insertion procedures.

Determinants of long-acting reversible contraceptive (LARC) use by adolescent girls and young women.

OBJECTIVES: To identify factors relevant for adolescents and young women in their selection of a contraceptive method and reasons for acceptance or rejection of long-acting reversible contraceptives (LARCs). METHOD: Questionnaire survey among 194 women attending an integrated young people service. RESULTS: Compared to the number of those who had heard about all LARCs (71%), the number of respondents who had used a LARC was low (28%). Awareness of intrauterine methods was the lowest, compared to other LARCs. High efficacy, protection against sexually transmitted infections and non interference with sex were the three most important factors when choosing a contraceptive method, whereas the possibility of altering the menstrual pattern and reversibility were not considered important. Qualities of LARCs such as reliability and long duration of action would encourage young women to accept LARCs. Knowledge of peers' good experience with a LARC fosters, but fear of pain and needle (most obvious for intrauterine methods) restrains use of these methods. CONCLUSIONS: Despite reliability and long-term use being important advantages, fear of pain and needles make LARCs less appealing to young people. Current LARCs meet some, but not all expectations of adolescents and young women.

Improving quality of surgical and anaesthesia care in sub-Saharan Africa: a systematic review of hospital-based quality improvement interventions.

OBJECTIVES: To systematically review existing literature on hospital-based quality improvement studies in sub-Saharan Africa that aim to improve surgical and anaesthesia care, capturing clinical, process and implementation outcomes in order to evaluate the impact of the intervention and implementation learning. DESIGN: We conducted a systematic literature review and narrative synthesis. SETTING: Literature on hospital-based quality improvement studies in sub-Saharan Africa reviewed until 31 December 2021. PARTICIPANTS: MEDLINE, EMBASE, Global Health, CINAHL, Web of Science databases and grey literature were searched. INTERVENTION: We extracted data on intervention characteristics and how the intervention was delivered and evaluated. PRIMARY AND SECONDARY OUTCOME MEASURES: Importantly, we assessed whether clinical, process and implementation outcomes were collected and separately categorised the outcomes under the Institute of Medicine quality domains. Risk of bias was not assessed. RESULTS: Of 1573 articles identified, 49 were included from 17/48 sub-Saharan African countries, 16 of which were low-income or lower middle-income countries. Almost two-thirds of the studies took place in East Africa (31/49, 63.2%). The most common intervention focus was reduction of surgical site infection (12/49, 24.5%) and use of a surgical safety checklist (14/49, 28.6%). Use of implementation and quality improvement science methods were rare. Over half the studies measured clinical outcomes (29/49, 59.2%), with the most commonly reported ones being perioperative mortality (13/29, 44.8%) and surgical site infection rate (14/29, 48.3%). Process and implementation outcomes were reported in over two thirds of the studies (34/49, 69.4% and 35, 71.4%, respectively). The most studied quality domain was safety (44/49, 89.8%), with efficiency (4/49, 8.2%) and equitability (2/49, 4.1%) the least studied domains. CONCLUSIONS: There are few hospital-based studies that focus on improving the quality of surgical and anaesthesia care in sub-Saharan Africa. Use of implementation and quality improvement methodologies remain low, and some quality domains are neglected. PROSPERO REGISTRATION NUMBER: CRD42019125570.

HeAlth System StrEngThening in four sub-Saharan African countries (ASSET) to achieve high-quality, evidence-informed surgical, maternal and newborn, and primary care: protocol for pre-implementation phase studies.

To achieve universal health coverage, health system strengthening (HSS) is required to support the of delivery of high-quality care. The aim of the National Institute for Health Research Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme, with three healthcare platforms involving eight work-packages. Key to effective health system strengthening (HSS) is the pre-implementation phase of research where efforts focus on applying participatory methods to embed the research programme within the existing health system. To conceptualise the approach, we provide an overview of the key methods applied across work-package to address this important phase of research conducted between 2017 and 2021.Work-packages are being undertaken in publicly funded health systems in rural and urban areas in Ethiopia, Sierra Leone, South Africa, and Zimbabwe. Stakeholders including patients and their caregivers, community representatives, clinicians, managers, administrators, and policymakers are the main research participants.In each work-package, initial activities engage stakeholders and build relationships to ensure co-production and ownership of HSSIs. A mixed-methods approach is then applied to understand and address determinants of high-quality care delivery. Methods such as situation analysis, cross-sectional surveys, interviews and focus group discussions are adopted to each work-package aim and context. At the end of the pre-implementation phase, findings are disseminated using focus group discussions and participatory Theory of Change workshops where stakeholders from each work package use findings to select HSSIs and develop a programme theory.ASSET places a strong emphasis of the pre-implementation phase in order to provide an in-depth and systematic diagnosis of the existing heath system functioning, needs for strengthening and stakeholder engagement. This common approach will inform the design and evaluation of the HSSIs to increase effectiveness across work packages and contexts, to better understand what works, for whom, and how.

Improving nursing documentation for surgical patients in a referral hospital in Freetown, Sierra Leone: protocol for assessing feasibility of a pilot multifaceted quality improvement hybrid type project.

BACKGROUND: There is an urgent need to improve quality of care to reduce avoidable mortality and morbidity from surgical diseases in low- and middle-income countries. Currently, there is a lack of knowledge about how evidence-based health system strengthening interventions can be implemented effectively to improve quality of care in these settings. To address this gap, we have developed a multifaceted quality improvement intervention to improve nursing documentation in a low-income country hospital setting. The aim of this pilot project is to test the intervention within the surgical department of a national referral hospital in Freetown, Sierra Leone. METHODS: This project was co-developed and co-designed by in-country stakeholders and UK-based researchers, after a multiple-methodology assessment of needs (qualitative, quantitative), guided by a participatory 'Theory of Change' process. It has a mixed-method, quasi-experimental evaluation design underpinned by implementation and improvement science theoretical approaches. It consists of three distinct phases-(1) pre-implementation(project set up and review of hospital relevant policies and forms), (2) intervention implementation (awareness drive, training package, audit and feedback), and (3) evaluation of (a) the feasibility of delivering the intervention and capturing implementation and process outcomes, (b) the impact of implementation strategies on the adoption, integration, and uptake of the intervention using implementation outcomes, (c) the intervention's effectiveness For improving nursing in this pilot setting. DISCUSSION: We seek to test whether it is possible to deliver and assess a set of theory-driven interventions to improve the quality of nursing documentation using quality improvement and implementation science methods and frameworks in a single facility in Sierra Leone. The results of this study will inform the design of a large-scale effectiveness-implementation study for improving nursing documentation practices for patients throughout hospitals in Sierra Leone. TRIAL REGISTRATION: Protocol version number 6, date: 24.12.2020, recruitment is planned to begin: January 2021, recruitment will be completed: December 2021.

Improving quality of surgical and anaesthesia care at hospital level in sub-Saharan Africa: a systematic review protocol of health system strengthening interventions.

INTRODUCTION: Over 5 billion people in the world do not have access to safe, affordable surgical and anaesthesia care when needed. In order to improve health outcomes in patients with surgical conditions, both access to care and the quality of care need to be improved. A recent commission on high-quality health systems highlighted that poor-quality care is now a bigger barrier than non-utilisation of the health system for reducing mortality. AIM: To carry out a systematic review to provide an evidence-based summary of hospital-based interventions associated with improved quality of surgical and anaesthesia care in sub-Saharan African countries (SSACs). METHODS AND ANALYSIS: Three search strings (1) surgery and anaesthesia, (2) quality improvement hospital-based interventions and (3) SSACs will be combined. The following databases EMBASE, Global Health, MEDLINE, CINAHL, Web of Science and Scopus will be searched. Further relevant studies will be identified from national and international health organisations and publications and reference lists of all selected full-text articles. The review will include all type of original articles in English published between 2008 and 2019. Article screening, data extraction and assessment of methodological quality will be done by two reviewers independently and any disputes will be resolved by a third reviewer or team consensus. Three types of outcomes will be collected including clinical, process and implementation outcomes. The primary outcome will be mortality. Secondary outcomes will include other clinical outcomes (major and minor complications), as well as process and implementation outcomes. Descriptive statistics and outcomes will be summarised and discussed. For the primary outcome, the methodological rigour will be assessed. ETHICS AND DISSEMINATION: The results will be published in a peer reviewed open access journal and presented at national and international conferences. As this is a review of secondary data no formal ethical approval is required. PROSPERO REGISTRATION NUMBER: CRD42019125570.

An interactive website for informed contraception choice: randomised evaluation of Contraception Choices.

OBJECTIVE: Improving use of effective contraception to prevent unintended pregnancy is a global priority, but misperceptions and concerns about contraception are common. Our objective was to evaluate an interactive website to aid informed choice of contraception. METHODS: The Contraception Choices website is an interactive digital intervention which offers tailored advice to aid contraception decision-making (www.contraceptionchoices.org). In a parallel single-blind trial, we randomised 927 women aged 15-30 years from six clinic settings to access the intervention website (n = 464) or to a waiting-list control group (n = 463). The study was initially a feasibility trial, evolving into an evaluation of efficacy, with two primary outcomes at six months: long-acting reversible contraception (LARC) use, and satisfaction with contraceptive method. Secondary outcomes included self-reported pregnancy and sexually transmitted infection diagnoses. Free-text comments on the 3 and 6 month outcome surveys were analysed thematically. FINDINGS: There was no significant difference between intervention and control groups in the proportion of women using LARC [30.4% intervention versus 31.0% control; adjusted odds ratio 0.87 (95% confidence interval 0.60 to 1.28)]; satisfaction with contraceptive method [82.6% versus 82.1%; adjusted ordinal odds ratio 0.93 (95% CI 0.69 to 1.25)]; self-reported pregnancy [3.3% versus 4.1%; adjusted odds ratio 0.90 (95% CI 0.45 to 1.79)] nor sexually transmitted infection [5.3% versus 4.7%; adjusted odds ratio 0.72 (95% CI 0.55 to 2.36)]. Highly positive free-text comments from intervention participants indicated that the website facilitates contraception choice and can help women feel better prepared before consultation with healthcare providers. INTERPRETATION: The Contraception Choices website was popular for its design, trustworthy information and decision aids but it was not associated with significant differences in use of LARC or satisfaction with contraceptive method. An interactive website can aid contraception choice, but interventions that address factors beyond women's control, such as access to services, and partner, family or community influences are needed to complement this approach. RESEARCH IN CONTEXT: Preventing unintended pregnancy through effective use of contraception is essential for women's health, but choosing between different contraceptive methods can be challenging, and the opportunity for adequate discussion during routine consultations is often constrained. EVIDENCE BEFORE THIS STUDY: We conducted two systematic literature reviews: 1) Factors influencing contraception choice, uptake and use: a meta-synthesis of systematic reviews; and 2) Effectiveness of interactive digital interventions (IDI) for contraception choice, uptake and use. For the first review we searched PubMed, CDSR, Epistemonikos, DoPHER, DARE, NHS Economic Evaluation Database, Campbell Library, NIHR Health Technology Assessment, and Health Evidence Canada databases for systematic reviews which addressed contraceptive choice, uptake or use, from 2000 to 2017. PROSPERO registration number: CRD42017081521 https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81521. We synthesised the findings of 18 systematic reviews of mostly moderate or high quality. They highlighted the importance of women's knowledge, beliefs, perceptions of side effects and health risks, as well as relationship status, social network, economic and healthcare factors on contraception choice and use. For the second review, we searched 23 electronic databases, trials registers and reference lists for randomised controlled trials of IDI for contraception, including CENTRAL, MEDLINE, EMBASE, CINAHL, ERIC, ASSIA and PsycINFO, from start date to June 2017. PROSPERO registration number: CRD42017081636. We found only five randomised trials of IDI, all from the USA. Risk of bias prevented synthesis of results. www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81636. ADDED VALUE OF THIS STUDY: Women's common concerns about contraception - fear of hormones, weight gain, cancer, infertility, mood changes, breaks from contraception and changes in bleeding patterns - underpinned development of a new interactive website (www.contraceptionchoices.org). Contraception Choices addresses women's concerns through succinct text; Q and A format (Frequently Asked Questions, Did you Know?; videos of women and health professionals); an effectiveness infographic, and an interactive decision aid (What's right for me?).In an online randomised trial with 927 women attending clinics, we found no association of the Contraception Choices intervention with the primary outcomes - satisfaction with contraceptive method and uptake of long-acting reversible methods at 6 months. Nor did we find an association with secondary adverse outcomes - sexually transmitted infections or pregnancy. Comments from women indicated that the website can meet young women's need for information on the benefits and drawbacks of contraception, help them to make informed decisions, and feel better prepared before healthcare consultations. Contraception Choices is now available on the NHS website: www.nhs.uk/conditions/contraception/which-method-suits-me. IMPLICATIONS OF ALL THE AVAILABLE EVIDENCE: Interactive digital interventions (websites) can aid contraception choice, but other intervention research is needed to address wider influences on unintended pregnancy, including partner views, friends, family, the media, wider society and experiences with healthcare professionals. Future research could examine the impact of the website in different settings, e.g. schools or different countries. We hypothesise that use of the website during contraceptive consultations might improve the efficiency or quality of consultation, for both patients and healthcare providers. Appropriate methodology and time-scale for evaluating digital health interventions remains a key question.

An interactive website to aid young women's choice of contraception: feasibility and efficacy RCT.

BACKGROUND: Effective use of contraception can reduce numbers of unintended pregnancies, but misunderstandings and concerns about contraception abound. Increasingly, women seek health-care information online. OBJECTIVES: To develop an interactive website to aid informed choice of contraceptive method, including long-acting reversible contraception (Phase I), and test its effectiveness in a parallel, single-blind randomised trial (Phase II). Approval came from London - Camden & King's Cross Research Ethics Committee (reference 17/LO/0112). SETTING AND PARTICIPANTS: For both phases, women aged 15-30 years were recruited from general practice, sexual health services, maternity services, community pharmacies and an abortion service. DESIGN: In Phase I, we conducted three systematic literature reviews, a review of YouTube (YouTube, LLC, San Bruno, CA, USA) videos about contraception, and focus groups and interviews with young women to explore barriers to and concerns and misperceptions about contraception. We then iteratively co-designed an interactive website, Contraception Choices [URL: www.contraceptionchoices.org (accessed June 2020)], with young women and a software company. In Phase II, we evaluated the website through a randomised trial that began as a feasibility trial. Early demand for Contraception Choices stimulated a design change from a feasibility to an efficacy trial, with follow-up for clinical outcomes at 3 and 6 months. A randomisation list was incorporated into the trial software program to allocate participants to the intervention (website) or control group (standard care). INTERVENTION: Contraception Choices is a co-designed, evidence-based, interactive website to aid informed choice of contraception. It provides information about different methods, addresses common concerns and offers tailored contraceptive options in response to individual preferences. MAIN OUTCOME MEASURES: Qualitative - participant views and experience of the intervention, assessed through qualitative interviews. Quantitative primary outcomes - follow-up rate at 6 months in the initial feasibility trial, using a long-acting reversible contraception method, and satisfaction with contraceptive method at 6 months in the efficacy trial. RESULTS: A total of 927 women were randomised online to the website (n = 464) or control group (n = 463), of whom 739 (80%) provided follow-up data at 6 months [786 women (85%) provided data at 3 and/or 6 months that were included in the analysis of primary outcomes]. There was little difference between groups in the proportion using long-acting reversible contraception at 6 months [30.4% intervention vs. 31.0% control, adjusted odds ratio after imputation 0.87 (95% confidence interval 0.60 to 1.27)] or in satisfaction with contraceptive method [proportion being 'satisfied' or 'very satisfied', 82.6% intervention vs. 82.1% control, adjusted odds ratio 0.93 (95% confidence interval 0.69 to 1.25)]. Qualitative evaluation indicated highly positive views about the website and increased knowledge of contraceptive methods that could dispel misperceptions. Women appreciated having information tailored to their specific needs and felt better prepared before consultations. LIMITATIONS: We did not include intermediate measures, such as knowledge of contraceptive methods, intention to change method or confidence in discussing contraception with a health-care professional, which may have indicated other benefits of using the website. In future, the website should be studied in different settings (e.g. schools and in routine practice) to see whether or not it improves the quality or efficiency of contraceptive consultations. CONCLUSIONS: Our systematic review indicated wide-ranging influences on women's use of contraception globally. The website, Contraception Choices, was very popular with young women and contraception service providers. It was not associated with statistically significant differences in use of long-acting reversible contraception or satisfaction with contraceptive method at 6 months. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13247829. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 56. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Choosing between types of contraception can be challenging, so can a website help women make the right choice for them? WHAT DID WE DO?: We asked women what they think about contraception. We looked at other studies and YouTube (YouTube, LLC, San Bruno, CA, USA) videos. We then designed the Contraception Choices website with young women [URL: www.contraceptionchoices.org (accessed January 2020)]. The website describes each type of contraception and compares them side by side. When users answer questions about what matters to them, the website suggests three types of contraception they might like. A total of 927 women helped us test the website in an online trial. We asked everyone what contraception they were using and how satisfied they were with it 6 months later. WHAT DID WE FIND?: Women really liked the website. Ninety-seven per cent of participants found it helpful or very helpful for 'getting useful information about contraception' and 87% responded that it was helpful or very helpful for 'finding a method of contraception that is right for you'. Comments included: However, seeing the website did not mean that women used a more reliable type of contraception. Women were just as satisfied with their contraception whether or not they had seen the website. We think that this is because many other factors are involved; for example, some women found it difficult to access long-acting contraception methods from health services. WHAT DOES THIS MEAN?: Young women liked the Contraception Choices website and found it useful. Women can be put off by contraception side effects and the views of partners, friends, family and others. On its own, the Contraception Choices website was not enough to help more women use the most reliable contraception methods.

Higher discontinuation rate with a standard-sized compared to a small-sized 'gold standard' copper intrauterine device: a case-control review.

BACKGROUND: T-shaped intrauterine devices (IUDs) with a copper surface area of 380 mm2 and copper bands on the transverse arms are the most effective types of copper-containing IUDs. A small-sized 'gold standard' IUD is available but there has been little research to compare the effects of this small-sized IUD to its standard-sized counterpart. AIM: To determine discontinuation rates and reasons for discontinuation at 1 year of the small-sized Mini TT380 Slimline IUD compared with the standard-sized TT380 Slimline. METHODS: The clinical records of women fitted with Mini TT380 Slimline ('mini') IUDs were compared with those of women fitted with standard-sized TT380 Slimline ('standard') IUDs over a 3-year period (2013-2016). RESULTS: Clinical records were available for 67 women fitted with a mini IUD (mean age 23 years, 64% nulliparous) and 63 women fitted with a standard IUD (mean age 25 years, 39% nulliparous). At 1 year, twice as many standard IUD users (32%, n=20) had discontinued their IUD use compared with mini IUD users (15%, n=10). Complaints of pain and bleeding were more than double (70%, n=14) in those women who discontinued standard IUD use compared with those who discontinued using the mini IUD (30%, n=3). These differences were statistically significant and were unrelated to parity. CONCLUSIONS: More women using a standard-sized 'gold standard' IUD rather than its smaller counterpart complained of pain and bleeding, leading to higher discontinuation at 1 year. More research on the association between size and discontinuation of these IUDs is needed.

Alcohol, smoking, folic acid and multivitamin use among women attending maternity care in London: A cross-sectional study.

OBJECTIVES: This study describes the patterns of change in health behaviours that pregnant women adopt before and during pregnancy. STUDY DESIGN: A cross-sectional survey of pregnant women asked questions about pregnancy planning, health knowledge, and health behaviour. Analysis was descriptive with associations examined using logistic regression models. MAIN OUTCOME MEASURES: Health behaviours before and during pregnancy (smoking, alcohol consumption, and folic acid and multivitamin (supplement) intake), and recall of healthcare professional advice. RESULTS: 1173 women completed the survey (mean age 32 ±â€¯5 years, 68% white) of whom 73% indicated that their pregnancy was highly planned. 38% of women reported having never smoked, 45% quit smoking before becoming pregnant, and fewer (5%, 95% CI 3-6%) reported currently smoking. Current smokers reported reduced cigarette consumption compared to pre-pregnancy, and higher recall of health professional information. Nine percent (95% CI 5-8%) reported currently drinking, reducing the number of units consumed from 6 units weekly before pregnancy (IQR 2-10) to 1 unit weekly during pregnancy (IQR 1-2, p < 0.001). Most (62%) women were currently taking supplements, of whom 81% reported daily use. Women with more planned pregnancies had higher odds of adopting healthier behaviours of stopping smoking or drinking before pregnancy compared to those who stopped during pregnancy or continued the behaviour. CONCLUSIONS: Most women adopted one or more healthy behaviours during pregnancy, with a small minority continuing to smoke or drink alcohol. For women who continued smoking in pregnancy and recalled information from health professionals, additional tailored approaches need to be explored.

Counselling to include tailored use of combined oral contraception in clinical practice: an evaluation.

BACKGROUND: Combined oral contraception (COC, 'the pill') remains the most prescribed method of contraception in the UK. Although a variety of regimens for taking monophasic COC are held to be clinically safe, women are not routinely counselled about these choices and there is a lack of evidence on how to provide this information to women. AIM: To assess the usefulness and feasibility of including tailored use of monophasic COC within routine COC counselling in a sexual and reproductive health (SRH) service using a structured format. METHOD: Using a structured format, healthcare professionals (HCPs) counselled new and established COC users attending an SRH service about standard and tailored ways of taking the pill. Questionnaires were used to survey both the HCPs and patients immediately after the initial consultation, and then the patients again 8 weeks later. RESULTS: Nearly all patients (98%, n=95) felt it was helpful to be informed of the different ways of using monophasic COC by the HCP, without giving too much information at one time (96%, n=108). The HCPs were confident of their COC counselling (99%, n=110) and did not think the consultations took significantly longer (88%, n=98). CONCLUSION: This study demonstrates that information on different pill taking regimens is useful and acceptable to patients, and can improve contraceptive pill user choice. It is also feasible for HCPs to perform COC counselling to include tailored pill use during routine consultations in a clinical setting.

Early virological response to HIV treatment: can we predict who is likely to experience subsequent treatment failure? Results from an observational cohort study, London, UK.

INTRODUCTION: For people living with HIV, the first antiretroviral treatment (ART) regimen offers the best chance for a good virological response. Early identification of those unlikely to respond to first-line ART could enable timely intervention and increase chances of a good initial treatment response. In this study we assess the extent to which the HIV RNA viral load (VL) at 1 and 3 months is predictive of first-line treatment outcome at 6 months. Methods All previously ART-naive individuals starting ART at two London centres since 2000 with baseline (-180 to 3 days) VL >500 c/mL had a VL measurement between 6 and 12 months after starting ART, and at least one at month 1 (4-60 days) or month 3 (61-120 days) were included. Lack of treatment response was defined as (i) VL >200 copies/mL at 6 months or (ii) VL >200 copies/mL at 6 months or simultaneous switch in drugs from at least two different drug classes before 6 months. The association with VL measurements at 1 and 3 months post-ART; change from pre-ART in these values; and CD4 count measurements at 1 and 3 months were assessed using logistic regression models. The relative fit of the models was compared using the Akaike information criterion (AIC). RESULTS: A total of 198 out of 3258 individuals (6%) experienced lack of treatment response at 6 months (definition i), increasing to 511 (16%) for definition (ii). Those with a 1-month (day 4-60 window) VL of <1000, 1000-9999, 10,000-99,999 and >100,000 copies/ml had a 4%, 8%, 23% and 24% chance, respectively, of subsequently experiencing treatment non-response at 6 months (definition (i)). When considering the 3-month (day 61-120 window) VL, the chances of subsequently experiencing treatment non-response were, respectively, 3%, 25%, 67% and 75%. Results were similar for definition (ii). CONCLUSIONS: Whilst 3-month VL provides good discrimination between low and high risk of treatment failure, 1-month VL does not. Presence of a VL >10,000 copies/ml after 3 months of ART is a cutoff above which individuals are at a sufficiently higher risk of non-response that they may be considered for intervention.

Real-world persistence with antiretroviral therapy for HIV in the United Kingdom: A multicentre retrospective cohort study.

OBJECTIVES: Persistence with an antiretroviral therapy (ART) regimen for HIV can be defined as the length of time a patient remains on therapy before stopping or switching. We aimed to describe ART persistence in treatment naïve patients starting therapy in the United Kingdom, and to describe differential persistence by treatment regimen. METHODS: We performed a retrospective cohort study at eight UK centres of ART-naïve adults commencing ART between 2012 and 2015. Aggregate data were extracted from local treatment databases. Time to discontinuation was compared for different third agents and NRTI backbones using incidence rates. RESULTS: 1949 patients contributed data to the analysis. Rate of third agent change was 28 per 100 person-years of follow up [95% CI 26-31] and NRTI backbone change of 15 per 100 person-years of follow up [95% CI 14-17]). Rilpivirine, as co-formulated rilpivirine/tenofovir/emtricitabine had a significantly lower discontinuation rate than all other third agents and, excluding single tablet regimens, co-formulated tenofovir/emtricitabine had a significantly lower discontinuation rate than co-formulated abacavir/lamivudine. The reasons for discontinuation were not well recorded. CONCLUSIONS: Treatment discontinuation is not an uncommon event. Rilpivirine had a significantly lower discontinuation rate than other third agents and tenofovir/emtricitabine a lower rate than co-formulated abacavir/lamivudine.

Differences in pre-conception and pregnancy healthy lifestyle advice by maternal BMI: Findings from a cross sectional survey.

OBJECTIVE: Being underweight at pregnancy commencement is associated with a range of adverse maternal and infant outcomes, as is being overweight or obese, yet it is an aspect of maternal health which has been relatively neglected by healthcare professionals and researchers. We aimed to investigate differences in pre-pregnancy and pregnancy healthy lifestyle advice routinely offered by relevant healthcare professionals, including midwives and GPs, to women across three different BMI categories - underweight, normal, and overweight or obese. DESIGN: A cross-sectional study nested in an antenatal survey of pregnant women. SETTING: Antenatal clinics of three National Health Service (NHS) hospitals in London, UK. PARTICIPANTS: Pregnant women at any gestation of pregnancy were invited to participate in the study whilst attending a routine antenatal scan appointment. MEASUREMENTS: Main outcomes of interest were whether women had sought and/or had been offered healthy lifestyle advice by relevant healthcare professionals before or during the index pregnancy and whether the advice offered had included weight management, tobacco smoking cessation and alcohol intake. Other outcomes included alcohol consumption and tobacco smoking before and during the index pregnancy. FINDINGS: A total of 1173 women completed the survey, with pre-pregnancy BMI data available for 918 (78.3%) women, 632 (69%) of whom were of normal weight, 232 (25%) were overweight or obese, and 54 (6%) were underweight. Overall, 253 (28%) of these women reported they had sought pre-conception advice. Women with a low BMI were offered pre-pregnancy and pregnancy healthy lifestyle advice of a similar content to women with a normal BMI, whereas women with a high BMI were more likely to be offered specific pre-conception and pregnancy advice on healthy BMI (respectively OR 2.55; 95% CI 1.64-3.96: OR 1.79; 95% CI 1.26-2.54), pre-conception healthy diet (OR 1.58; 95% CI 1.06-2.37), reducing alcohol consumption (OR 1.63; 95% CI 1.06-2.51) and smoking cessation (OR 1.62; 95% CI 1.05-2.50). For all women, reported alcohol consumption during pregnancy was lower than pre-conception, but within each BMI group around half of the women reported consuming alcohol at some time during their pregnancy. KEY CONCLUSIONS: Women with a low BMI are no more likely than women with a normal BMI to be advised by health professionals about a healthy lifestyle or a healthy weight for their height before or during pregnancy. In contrast women with a high BMI are more likely to receive such advice. Provision of pre-conception care could provide opportunity to advise women across the weight spectrum of the importance of adopting a healthy lifestyle for optimal pregnancy outcomes, as well as consider management of any pre-existing medical conditions. IMPLICATIONS FOR PRACTICE: Healthy lifestyle advice, including alcohol consumption and smoking cessation, should be offered to women who are underweight before and during pregnancy as well as to women who are overweight or obese, to improve adherence to recommendations to optimise maternal and infant outcomes. Advice should also be tailored to reflect women's ethnic background, which could be an important influence on lifestyle behaviour and weight management. The potential clinical benefit of routine provision of pre-conception care, particularly for women who have a high risk of a poorer pregnancy outcome due to weight status or other medical complications, needs to be explored.

A comparison of the expected and actual pain experienced by women during insertion of an intrauterine contraceptive device.

OBJECTIVE: To compare the expected and actual pain experienced with the insertion of intrauterine contraception in women, and to determine whether either of these are related to their personal circumstances, or affected their satisfaction with the procedure. DESIGN: A convenience sample of 89 women aged 15-50 years attending a sexual health clinic for same day intrauterine contraception insertion were given a questionnaire that they completed following the procedure. The women were asked to rate their expectation of pain prior to insertion and to rate the actual pain they experienced immediately after insertion, on a scale of 1-10, with 10 being severe pain. Information on the women's circumstances and their level of satisfaction with the procedure was also obtained. RESULTS: Overall, the median actual pain experienced by women during insertion (4) was significantly lower than the expected pain median (6) (P<0.001). For those women who had not had a previous vaginal delivery, actual pain was significantly higher compared with women who had had a previous vaginal delivery (median [interquartile range]: 6 [3.5-7.5] and 3 [1-5], P<0.001, respectively), but there was no significant difference between expected and actual pain experiences. In women who had a previous vaginal delivery, actual pain was much lower than expected (P<0.001). Neither actual nor expected pain experiences were linked to any other sociodemographic reproductive health or service use factors. CONCLUSION: All women had a high expectation of pain prior to IUD insertion, but for those who had had a previous vaginal delivery, this was significantly greater than that actually experienced. Satisfaction levels overall were high. Counseling of women should take into account their expected pain prior to IUD insertion and consideration should be given to alternative and additional methods of pain relief in women who have not had a previous vaginal delivery.