Title: Increasing uptake and adherence to long-acting reversible contraceptive (LARC) methods in young women
Funder: Department of Health and Social Care

Abstract: Study Design has two phases: Phase One • Systematic literature review • Qualitative research with key stakeholders including contraceptive service users, service providers and policy makers • Development of a self-guided interactive digital intervention (IDI) for use in multiple service settings and identification of suitable comparator/s Phase Two Randomised feasibility trial in 5 settings with outcomes that inform the design of a definitive trial. Setting: 5 settings: general practice, sexual & reproductive health service, abortion service, community pharmacy and maternity service. Strategy for literature review: a systematic search for qualitative and quantitative evidence on: • Barriers and facilitators to uptake and adherence to LARC • Intervention design and effectiveness • Theoretical literature on processes of decision making Target Population: Women aged 15 to 30 years at risk of unintended pregnancy Health technologies being assessed: Individual-level interventions that provide information about contraceptive options including LARC and tailored decision support. We will co-develop, with users, providers and experts, an interactive digital intervention (IDI) for contraceptive decision making, based on review of evidence of effectiveness, and acceptability and feasibility to women and service providers. Suitable comparator/s will be identified through qualitative work with stakeholders. Outcomes: Phase One • Definition of core design and content of an IDI for further development and appropriate comparator/s • Fully developed and user-tested IDI ready for testing in a randomised feasibility trial • Manuals for implementation of the IDI tailored to each study setting Phase Two Main outcomes are • Follow-up rate at 6 months (or 2 months post-partum) • Recruitment rate • Preference for a LARC method immediately post-intervention • Attendance for LARC fitting at 6 months • Removal of LARC by 6 months • Satisfaction with chosen contraceptive method at 6 months • Sexual quality of life (SQoL) and utility scores for calculating quality adjusted life years (QALYs) • Health service and out-of-pocket costs for contraception and other sexual health services • Patient views and experience of the intervention and trial procedures • Provider views about impacts on the service and trial procedures Sample size: Based on a previous study of a purely online intervention that achieved 77% follow-up at 3 months, we propose to recruit 80 women in each setting to estimate an expected follow-up rate of 70% at 6 months to within 10% precision (95% CI 60% to 80%). Health economics: feasibility and optimisation of methods for collecting cost and outcome data to inform the design of a cost-effectiveness analysis as part of a full RCT Project timetables: months 0-15: systematic review, information from contraceptive service staff and users, intervention development and manualisation; months 16-30: randomised feasibility trial in 5 service settings leading to protocol for definitive trial. Our team is ideally placed to carry out this work with its strong track record of internationally recognised high quality research and successful development and evaluation of interactive digital interventions. We will build on successes and lessons learnt from the development and evaluation of two IDI: the MRC funded Sexunzipped project and HTA funded Men's Safer Sex website project

Lay abstract: The study aims to develop and test ways of supporting women to make informed choices of contraception including long-acting reversible contraceptive (LARC) methods. These include the intrauterine device (IUD or coil), intrauterine system (IUS or Mirena), implant and injection. We know that LARC methods are at least 20 times better at preventing pregnancy than pills or condoms. But uptake of LARC has been slow and many women are not even aware of these methods. Other women have unfounded concerns about the effects of LARC e.g. on weight gain or future fertility. So, improving choice and use of LARC could have a big impact on reducing unintended pregnancies. We will do the study in 5 NHS settings - GP, a sexual health service, abortion service, community pharmacy and maternity service - because nearly all women get their contraception from one or other of these services. This includes women at highest risk of unintended pregnancy who attend abortion services or go to community pharmacies for emergency contraception. (Around 3 out of 4 contraceptive visits take place in general practice and 1 in 4 younger women go to specialist community clinics. Pharmacy is where most young women go for emergency contraception, 4 out of 5 women give birth and 1 in 3 women end up having an abortion in their lifetime). To complete the study we will: 1. review previous studies about how to help women choose a suitable method of contraception, including LARC, that is best for them. 2. ask women using contraceptive services and clinic staff providing contraceptive care what they feel works well in helping women choose a contraceptive method that is best for them. 3. use what we find in 1 and 2 to pick the best approach to support informed decision-making. 4. develop that approach with women and test how practical it is by recruiting 80 women in each of the contraceptive service - 40 women randomised (picked by chance) to get the intervention and 40 to get usual care - and following them up for 6 months. 5. use all the information to design a bigger study of the approach to improve informed choice of contraception, including LARC methods, in women up to 30 years old. The approach we will pursue is an interactive digital intervention (IDI). Interactive means asking for information so that advice can be personally tailored to each woman. A digital intervention is an online interactive source of information, available on computers and mobile devices. We plan to focus on IDI because 1) young women are likely to turn to digital resources for information about contraception 2) studies from the USA suggest that IDI can improve contraceptive choice and continuation, but 3) no NHS services are using these approaches yet and 4) our team has a lot of expertise in developing and testing digital interventions for sexual health. We will develop and put in place one IDI that could be used across different NHS services. We will test how acceptable and practical the IDI is in the five settings by monitoring recruitment and follow-up rates at 6 months, by asking women what they felt about using the IDI and by asking clinic staff what it was like having the IDI in their busy clinics. We will use all this information to design a bigger study to see whether the IDI helps women choose and continue with LARC methods, and to look at value for money. Throughout the study we will have an Advisory Group of service users and experts to guide our work.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH