Provision of the progestogen-only pill by community pharmacies as bridging contraception for women receiving emergency contraception: the Bridge-it RCT.

INTRODUCTION: Unless women start effective contraception after using emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies that are unable to provide ongoing contraception (apart from barrier methods which have high failure rates). This means that women need an appointment with a general practitioner or at a sexual and reproductive health clinic. We conducted a pragmatic cluster randomised cohort crossover trial to determine whether or not pharmacist provision of a bridging supply of a progestogen-only pill plus the invitation to attend a sexual and reproductive health clinic resulted in increased subsequent use of effective contraception (hormonal or intrauterine). METHODS: Twenty-nine pharmacies in three UK cities recruited women receiving emergency contraception (levonorgestrel). In the intervention, women received a 3-month supply of the progestogen-only pill (75 µg of desogestrel) plus a card that provided rapid access to a local sexual and reproductive health clinic. In the control arm, pharmacists advised women to attend their usual contraceptive provider. The primary outcome was reported use of an effective contraception (hormonal and intrauterine methods) at 4 months. Process evaluation was also conducted to inform any future implementation. RESULTS: The study took place December 2017 and June 2019 and recruited 636 women to the intervention (n = 316) and control groups (n = 320). There were no statistically significant differences in demographic characteristics between the groups. Four-month follow-up data were available for 406 participants: 63% (198/315) of the control group and 65% (208/318) of the intervention group. The proportion of participants reporting use of effective contraception was 20.1% greater (95% confidence interval 5.2% to 35.0%) in the intervention group (58.4%, 95% confidence interval 48.6% to 68.2%) than in the control group (40.5%, 95% confidence interval 29.7% to 51.3%) (adjusted for recruitment period, treatment arm and centre; p = 0.011). The proportion of women using effective contraception remained statistically significantly larger, when adjusted for age, current sexual relationship and history of past use of effective contraception, and was robust to the missing data. There were no serious adverse events. CONCLUSION: Provision of a bridging supply of the progestogen-only pill with emergency contraception from a pharmacist and the invitation to a sexual and reproductive health clinic resulted in a significant increase in self-reported subsequent use of effective contraception. This simple intervention has the potential to prevent more unintended pregnancies for women after emergency contraception. TRIAL REGISTRATION: Current Controlled Trials ISRCTN70616901. 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. 25, No. 27. See the NIHR Journals Library website for further project information.

The emergency contraceptive pill can prevent pregnancy following unprotected sex or a burst condom; however, unless women start a regular method of contraception they remain at risk of pregnancy. Most women obtain emergency contraception from a community pharmacy (chemist), but then require an appointment with a general practitioner or at a sexual and reproductive health clinic for ongoing contraception. Getting an appointment can take time and unintended pregnancies can occur during this time. If a pharmacist could give women a small supply of a progestogen-only pill or 'mini-pill' with their emergency contraception, together with help to get an appointment at a clinic, then this might help more women to start effective contraception. We undertook a study in 29 pharmacies in Lothian, Tayside and London among women receiving emergency contraception. Pharmacists provided either their standard advice about contraception (control group) or the intervention. The intervention was a 3-month supply of the progestogen-only pill plus a rapid-access card, which, if presented at a sexual and reproductive health clinic, would help women get an appointment for contraception. The order in which the pharmacy provided either control or intervention was randomised. We conducted telephone interviews with the women 4 months later to find out what contraception they were using. A total of 636 women took part in the study, 316 in the intervention group and 320 in the control group. The proportion who said that they were using an effective method of contraception was around 20% larger in the intervention group. In addition, fewer women in this group said that they had used emergency contraception again. This study shows that community pharmacy provision of a small supply of progestogen-only pills and the invitation to attend a sexual and reproductive health clinic results in a large increase in the use of effective contraception after emergency contraception. If this became routine practice then it could help prevent unintended pregnancies.

Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.

BACKGROUND: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception. METHODS: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 µg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete). FINDINGS: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred. INTERPRETATION: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception. FUNDING: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).

A cohort study of the service-users of online contraception.

BACKGROUND: In January 2017, the first free service providing oral contraceptive pills (OCPs) ordered online and posted home became available in the London boroughs of Lambeth and Southwark - ethnically and socioeconomically diverse areas with high rates of unplanned pregnancy. There are concerns that online services can increase health inequalities; therefore, we aimed to describe service-users according to age, ethnicity and Index of Multiple Deprivation (IMD) quintile of area of residence and to examine the association of these with repeated use. METHODS: We analysed routinely collected data from January 2017 to April 2018 and described service-users using available sociodemographic factors and information on patterns of use. Logistic regression analysis examined factors associated with repeat ordering of OCPs. RESULTS: The service was accessed by 726 individuals; most aged between 20 and 29 years (72.5%); self-identified as being of white ethnic group (58.8%); and residents of the first and second most deprived IMD quintiles (79.2%). Compared with those of white ethnic group, those of black ethnic group were significantly less likely to make repeat orders (adjusted OR 0.53, 95% CI 0.31 to 0.89; p=0.001), as were those of Asian and mixed ethnic groups. CONCLUSIONS: These are the first empirical findings on free, online contraception and suggest that early adopters broadly reflect the population of the local area in terms of ethnic diversity and deprivation as measured by IMD. Ongoing service development should prioritise the identification and removal of barriers which may inhibit repeat use for black and minority ethnic groups.

Online testing for sexually transmitted infections: A whole systems approach to predicting value.

BACKGROUND: Online testing for sexually transmitted infections has a lower unit cost than testing in clinical services and economic analysis has focused on the cost per test and cost per diagnosis in clinics and online. However, online services generate new demand for testing and shift activity between services, requiring system-level analysis to effectively predict cost-effectiveness. METHODS AND FINDINGS: Routinely collected, anonymised, retrospective data on sexual health service activity from all specialist services (clinic and online) within an inner London sexual health economy were collated and harmonised to generate a complete dataset of individual level clinic attendances. Clinic activity and diagnoses were coded using nationally standardised codes assigned by clinicians. Costs were taken from locally or regionally agreed sexual health tariffs. The introduction of online services changed patterns of testing. In an inner London sexual health economy, online STI testing increased total number of tests, the total cost of testing and total diagnoses while slightly reducing the average cost per diagnosis. Two years after the introduction of online services 37% of tests in the were provided online and total diagnoses increased. The positivity of online services is generally lower than that in clinics but varies between contexts. Where the positivity ratio between clinic and online is less than the cost ratio, online services will reduce cost per diagnosis. In this analysis, areas with different classifications as urban and rural had different clinic/online positivity ratios changing the cost effectiveness between areas. Even after the introduction of online services, simple STI testing activity continues in clinics and providers should consider online-first options where clinically appropriate. CONCLUSIONS: Online services for STI testing are not 'stand alone'. They change STI testing behaviour with impacts on all elements of the sexual health economy. Planning, development and monitoring of such services should reference the dynamic nature of these systems and the role of online services within them.

Web-Based Activity Within a Sexual Health Economy: Observational Study.

BACKGROUND: Regular testing for sexually transmitted infections (STIs) is important to maintain sexual health. Self-sampling kits ordered online and delivered in the post may increase access, convenience, and cost-effectiveness. Sexual health economies may target limited resources more effectively by signposting users toward Web-based or face-to-face services according to clinical need. OBJECTIVE: The aim of this paper was to investigate the impact of two interventions on testing activity across a whole sexual health economy: (1) the introduction of open access Web-based STI testing services and (2) a clinic policy of triage and signpost online where users without symptoms who attended clinics for STI testing were supported to access the Web-based service instead. METHODS: Data on attendances at all specialist public sexual health providers in an inner-London area were collated into a single database. Each record included information on user demographics, service type accessed, and clinical activity provided, including test results. Clinical activity was categorized as a simple STI test (could be done in a clinic or online), a complex visit (requiring face-to-face consultation), or other. RESULTS: Introduction of Web-based services increased total testing activity across the whole sexual health economy by 18.47% (from 36,373 to 43,091 in the same 6-month period-2014-2015 and 2015-2016), suggesting unmet need for testing in the area. Triage and signposting shifted activity out of the clinic onto the Web-based service, with simple STI testing in the clinic decreasing from 16.90% (920/5443) to 12.25% (511/4172) of total activity, P<.001, and complex activity in the clinic increasing from 69.15% (3764/5443) to 74.86% (3123/4172) of total activity, P<.001. This intervention created a new population of online users with different demographic and clinical profiles from those who use Web-based services spontaneously. Some triage and signposted users (29.62%, 375/1266) did not complete the Web-based testing process, suggesting the potential for missed diagnoses. CONCLUSIONS: This evaluation shows that users can effectively be transitioned from face-to-face to Web-based services and that this introduces a new population to Web-based service use and changes the focus of clinic-based activity. Further development is underway to optimize the triage and signposting process to support test completion.

Can text messages increase safer sex behaviours in young people? Intervention development and pilot randomised controlled trial.

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

A systematic review of risk factors for neonatal mortality in adolescent mother's in Sub Saharan Africa.

BACKGROUND: Worldwide, approximately 14 million mothers aged 15 - 19 years give birth annually. The number of teenage births in Sub Saharan Africa (SSA) is particularly high with an estimated 50% of mothers under the age of 20. Adolescent mothers have a significantly higher risk of neonatal mortality in comparison to adults. The objective of this review was to compare perinatal/neonatal mortality in Sub Saharan Africa and it's associated risk factors between adolescents and adults. RESULTS: We systematically searched six databases to determine risk factors for perinatal/neonatal mortality, and pregnancy outcomes, between adolescent and adults in SSA. Article's quality was assessed and synthesized as a narrative. Being single and having a single parent household is more prevalent amongst adolescents than adults. Nearly all the adolescent mothers (97%) were raised in single parent households. These single life factors could be interconnected and catalyze other risky behaviors. Accordingly, having co-morbidities such as Sexually Transmitted Infections, or not going to school was more prevalent in younger mothers. CONCLUSIONS: Inter-generational support for single mothers in SSA communities appears essential in preventing both early pregnancies and ensuring healthy outcomes when they occur during adolescence. Future studies should test related hypothesis and seek to unpack the processes that underpin the relationships between being single and other risk indicators for neonatal mortality in young mothers. Current policy initiatives should account for the context of single African women's lives, low opportunity, status and little access to supportive relationships, or practical help.

Using educational outreach and a financial incentive to increase general practices' contribution to chlamydia screening in South-East London 2003-2011.

BACKGROUND: The London Boroughs of Lambeth and Southwark have high levels of sexually transmitted infections including Chlamydia trachomatis. Modelling studies suggest that reductions in the prevalence of chlamydia infection will require a high level of population screening coverage and positivity among those screened. General practice has a potentially important role to play in delivering these levels of coverage since large numbers (up to 60%) of young people visit their general practice every year but previous work suggests that there are barriers to delivering screening in this setting. The aim of this study was to evaluate an intervention to increase chlamydia screening in general practice within Primary Care Trusts (PCTs) of Lambeth and Southwark, a strategy combining financial incentives and supportive practice visits to raise awareness and solve problems. METHODS: Data on age, gender, venue and chlamydia result for tests on under 25 s in Lambeth from 2003-11 was obtained from the National Chlamydia Screening Programme. We analysed the number and percentage of tests generated in general practice, and looked at the number of practices screening more than 10% of their practice cohort of 15-24 year olds, male/female ratio and positivity rates across other screening venues. We also looked at practices screening less than 10% and studied change over time. We compared data from Lambeth and Southwark with London and England. We also studied features of the level and type of educational and financial incentive interventions employed. RESULTS: Chlamydia tests performed in general practice increased from 23 tests in 2003-4 to 4813 tests in 2010-11 in Lambeth. In Southwark they increased from 5 tests in 2003/04 to 4321 in 2010/11. In 2011, 44.6% of tests came from GPs in Lambeth and 46% from GP's in Southwark. In Lambeth 62.7% of practices tested more than 10% of their cohort and in Southwark this was 55.8%. In Lambeth, postivity rate in 2010/11 was 5.8% in men and 6.0% in women. In Southwark positivity rate was 3.9% in men and 5.3% in women. In 2003/04 13% tests in general practice (Lambeth) were from men, this increased to 25% in 2010/11. In Southwark this increased from 20% in 2003/04 to 27.6% in 2010/11. We compared the results with London and national data and showed significant differences between GP testing in Lambeth and Southwark, and GP testing in London and the rest of England. CONCLUSIONS: General practices can be important potential providers of chlamydia tests.With a combination of sustained support, financial incentives and feedback on performance, general practice may be able to test a large percentage of 15-24 year olds. General practice is also a potentially important provider of chlamydia tests to young men.

'Do it yourself' sexual health care: the user experience.

OBJECTIVES: To describe client experience of self-management within a busy walk-in, sexual health service. Self-management in this context is self-registration and take-home pregnancy tests, chlamydia (Chlamydia trachomatis) and gonorrhoea (Neisseria gonorrhoeae) tests, or condoms dispensed from a free vending machine. METHODS: Twenty-four in-depth, semi-structured interviews with users; 19 structured written reports from mystery shoppers paid to visit the service and report their experience; demographic details of those using the self-management option from the clinic database and 40 h of recorded observation in the clinic waiting room. RESULTS: Between 2 September 2008 and 1 September 2009, 18 657 people had 28 545 attendances at the service. Of these, 1845 (6.5%) attendances were self-managed by 1555 individuals (8.3% of all clients). Of those who self-managed, 646 (35%) obtained a chlamydia and gonorrhoea test only, 597 (32%) obtained condoms only and 488 (27%) obtained a pregnancy test only. Users valued the opportunity to self-manage because of the reduced waiting times, autonomy and privacy that such a service offers. Some prefer the additional support offered within a clinical consultation. Users made personalised decisions about self-management based on time pressure, need for additional services and preferred source of support. Users often required help and advice from client support workers to complete the self-management process. This created problems with confidentiality. CONCLUSIONS: Self-management is an acceptable option within sexual health services if informal support is available. Self-management options in clinical services could mean that 8% of clients at 6% of visits do not need to see a clinician, thus freeing up clinical capacity.

Involving service users in sexual health service development.

OBJECTIVES: The study objectives were to document users' experience of family planning and genitourinary medicine clinics and young people's services working within the time constraints of rapid service development and maximising the utility of this data for service improvement. METHODS: A total of 93 users of family planning and genitourinary medicine services participated in one of 13 facilitated discussion groups. Some 61% of the sample were women, 64% were aged over 25 years and 47% were Black Caribbean or Black African. The clinic journey was drawn on a wall covered with paper and participants added their comments during the discussion. RESULTS: Users had similar concerns across the three service types. Users perceived some receptionists and clinicians as un-friendly and judgmental and described others providing a quality service often under difficult conditions. Reception was insufficiently confidential, waiting environments uncomfortable, waiting times long and more information was needed throughout service use. CONCLUSIONS: Those elements of sexual health services known to be a source of dissatisfaction among young people may also be a problem for older service users and are experienced across different types of sexual health service. This preliminary study demonstrates the feasibility and acceptability of focus group evaluations of sexual health services. This approach generates qualitative data from relatively large numbers of users within a time-scale consistent with service development.

Quality, mainstream services with proactive and targeted outreach: a model of contraceptive service provision for young people.

INTRODUCTION: High teenage pregnancy rates in the UK reflect low levels of contraceptive use. Young people have a negative perception of contraceptive services and experience significant practical barriers to their use. Dedicated young people's services are considered an effective way to improve access. However it is costly to provide two parallel services (one for older and one for young clients) and competition for resources between two services limits the opening hours of both. In this way access by clients of all ages may be reduced. We have piloted an alternative approach. We provide quality mainstream services (open to clients of all ages) with extended hours and no appointment necessary. This is combined with targeted outreach to facilitate access by the under-25s. The outreach programme includes the development of close links between the clinic and local schools, youth services, social services and voluntary sector organisations. This paper presents one part of the evaluation of this service. METHODS: Patients registering in the 6 months before and 18 months after the development of the new service completed an anonymous questionnaire. This collected demographic details and data on their source of information about the service. RESULTS: The number of clients of all age groups registering at the new service in the first year doubled. The number of new users aged under 16 years increased by 12-fold in the first 18 months. The number of young people citing a school sex education class as their source of information about the clinic increased by more than five-fold. CONCLUSION: This model of contraceptive service provision significantly increases service access by young people. It represents an effective alternative to dedicated services for young people.