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.
We thank the participants of this study, community pharmacists who recruited women for the study, and health-care professionals at the sexual and reproductive health service clinics who assisted with the study implementation. We thank Deirde Sally, Nicola Stewart, and Maria Nunez for the support with study implementation at the local site in London and Kristina Saunders for support with the process evaluation. We also thank Sarah Cameron and Lorna Aucott (senior statistician, the Centre for Healthcare Randomised Trials) for support and Katherine Lewis, Laura Flett, and Judith Parker for trial management support. List of study pharmacies in Edinburgh: Newington Pharmacy, Boots Princes Street, Boots Shandwick Place, Boots Earl Grey Street, Boots Gyle, Boots St Patrick Street, Boots Multrees Walk, Boots Ocean Terminal, Boots Edinburgh Fort Retail Park, Boots Cameron Toll, Boots Craigleith, and Bristo Square Pharmacy. List of study pharmacies in London: Peace Pharmacy, Westbury Chemist, Baba Chemist, Lings Chemist, Streatham Day Lewis, Morrisons—Aylesham Centre, Evergreen Pharmacy, Greenlight Pharmacy, Sandylight Pharmacy, Greenfields, JP Pharmacy, Boots Goodge Street, Boots Tottenham Court Road, and Boots Holborn. Additionally, Asda Pharmacy (Perth), Boots High Street and Boots Perth Road (Dundee). List of sexual and reproductive health clinics: Chalmers
Sexual and Reproductive Health Service, NHS Lothian (Edinburgh), Tayside Sexual and Reproductive Health Service, Ninewells Hospital (Dundee), Camberwell Sexual Health Centre, Mortimer Market Centre, the Margaret Pyke Centre, and the Archway Centre (London).
Declaration of interests:
STC reports grants from the National Institute for Health Research (Health Technology Assessment [NIHR HTA] Programme), during the conduct of the study. AG is a consultant to HRA Pharma. AR reports receiving research grants from Gilead Sciences, Bristol-Myers Squibb, AbbVie, and Roche; honorariums from Gilead Sciences; and personal fees from AbbVie. LM and SP report funding from the UK Medical Research Council and Scottish Government Chief Scientist Office (Central Statistics Office) at the University of Glasgow (MC_UU_12017/11, SPHSU11). PB is a clinical director of the not-for profit community interest company SH:24, that provides online sexual health services in partnership with the UK National Health Service. KC reports being an employee of Boots UK, during the conduct of this study. AleM reports grants from NIHR HTA,
during the conduct of this study. AleM is a clinical support bank midwife for SH:24 and a research midwife at Oxford University. JN was a deputy chair of the NIHR HTA General Board Committee (2016–19). All other authors declare no competing interests. This research is funded by the NIHR HTA project 15/113/01.