Title: A randomised controlled trial to determine the effectiveness of bridging from emergency to regular contraception: The 'Bridge-it' study
Funder: Chief Scientist Office, Scotland

Abstract: This trial aims to test whether a pharmacy-based intervention designed to facilitate uptake of effective contraception after emergency contraception (EC); progestogen only pill(POP) plus expedited access to a Sexual and Reproductive Health (SRH) service increases use of effective contraception and reduces unintended pregnancy compared with standard care. Design: A cluster randomised crossover trial Setting: Community pharmacies in 3 cities Strategy for reviewing literature: We did a literature search of published work (Pubmed since 2008 and NIHR library) and contacted UK, European and US organisations/services and the International and European Emergency Contraception Consortia networks. Only 2 papers described interventions designed to increase contraception after EC; one of these was our own published pilot study(1) (of bridging supply of POP with EC). The other study from Jamaica (voucher that offered reduced price of combined contraceptive pill) was not effective. Target population: Women aged 16 and over presenting to a pharmacy for levonorgestrel(LNG)EC. Inclusion/Exclusion Criteria: Women unwilling to participate or unable to give informed consent, contraindications to POP, already using effective contraception, unavailable for follow-up. Health technologies being assessed: Intervention: Three month supply of POP (75 mcg desogestrel) started the day after EC,with expedited access to a local SRH service (drop-in) for advice and immediate provision of contraception particularly long acting reversible contraception (LARC) Standard care: usually comprises verbal advice to visit a doctor, with/without written information but will be characterised by a mystery shopper study undertaken in participating pharmacies before the trial starts. Measurement of costs and outcomes: Important outcomes: (i)Contraceptive method use determined by telephone contact at 4 months (when POP supply will have run out),(ii)abortion rates at 12 months using record linkage from participants to national registries. Secondary outcomes: (i)adverse events following EC and EC/POP (ii) Contraceptive method use determined by telephone contact at 12 months (iii)unintended pregnancies at 12 months (intendedness measured using London Measure of Unintended Pregnancy-self reported)(iv) assessment of the intervention implementation, fidelity and reach (to understand why the intervention works (or doesn't) and to inform future roll out/ implementation) (v) Cost effectiveness. Sample size: 2080 women from 26 pharmacies Project timetable: 30 months Expertise in team: SRH clinicians/researchers, methodologist/statistician, pharmacists (with public health and commissioning expertise), qualitative researcher, health economist, clinical trials unit, service users. Specifically,we conducted the successful pilot study of bridging contraception after EC. We therefore have undertaken much of the development work and bring this experience to the proposed large RCT. The proposed study will also include many of the community pharmacies who participated in the original trial. The health economist (JT) is a global expert on cost effectiveness of contraception and EC.

Lay abstract: Emergency contraception (EC) is a tablet that can prevent pregnancy for women following unprotected sex or burst condoms etc. Most women who use EC in the UK go to a pharmacy for it. It is really important that women start a regular method of contraception after EC if they don’t want to become pregnant. However, pharmacies cannot usually provide contraception (except condoms) without a prescription. This means that to start regular contraception (eg.implant, pill etc) women must go to a GP or family planning clinic. Getting an appointment can take time and some women fall pregnant during this time. We are planning a research study called the ‘Bridge-it’ study. This study is designed to tell us whether or not pharmacists should be able to give a temporary supply (3 months) of the progestogen only pill (sometimes called ‘POP’) along with EC to women. The idea behind this study is that by giving women a supply of the POP they will have temporary contraception until they can get to a clinic to get their preferred method of contraception. We call this ‘bridging contraception’ since it bridges the gap between getting EC and regular contraception. The POP is very safe with no serious risks. We have previously undertaken a smaller version of a similar study that showed that women who got one month of POP with EC were likely to use the POP and more likely to be using a regular method of contraception 6 weeks later. We had positive feedback from women, doctors, nurses and pharmacists about that study and have designed this new study based on this. We plan to do this study in several parts of the UK so that we can include women from a range of different backgrounds. Women aged 16 and over who attend a participating pharmacy for EC will be invited to take part in the study. The study is designed as a randomised ‘crossover study’ this means that during the study, some pharmacies will give EC as usual, but others will give both EC and POP. After a few months, the treatments given at the pharmacies will switch, so that pharmacies that gave EC only will then switch to both EC and POP and vice versa. In this way, we can increase the chance of getting good quality results and can conduct the study more quickly. Women in the study will be surveyed by text/phone at 4 and 12 months. We will ask them about methods of contraception they have been using, where they got it from, if they used EC again and about any pregnancies they may have had. For women who got the POP we will also ask if they used it, and if they attended the local family planning clinic for contraception. It is really important to obtain as accurate results as possible. Since we would like to know whether providing the POP with EC prevents unintended pregnancies for women, we will check how many women in the study had an abortion within one year of participation. This involves checking existing NHS databases with participants NHS numbers (individual health number that everyone has) and we would ask womens permission to do this. We would also check to see if women attended the local family planning or their GP for contraception. If we find a difference in contraceptive use or numbers of unintended pregnancies amongst women who got the POP, then we would calculate the costs or savings of this to the NHS. During the study we will also interview women and pharmacists about how providing the POP from the pharmacy might work in everyday practice. We will keep the public informed of all results.

Research activity codes: 6.1 PHARMACEUTICALS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH