A website to help choose contraception - a pilot trial
Research type
Research Study
Full title
Increasing uptake and adherence to long-acting reversible contraceptive (LARC) methods in young women OR Designing a digital intervention to help when choosing contraception
IRAS ID
213559
Contact name
Judith Stephenson
Contact email
Sponsor organisation
University College London (UCL)
Clinicaltrials.gov Identifier
Z6364106/2016/12/10 , Data Protection Registration
Duration of Study in the UK
2 years, 2 months, 2 days
Research summary
Reducing unintended pregnancy is a national and global priority, and improving women’s choice of contraception is a vital step.
Increasingly, women turn to digital resources for information on healthcare and NHS services need to respond accordingly.
In Phase 1 of this study (completed) we developed a self-guided IDI (or website) that will present a number of contraceptive options in response to input of personal information through a touch-screen tablet or computer design for use in clinic waiting areas or pharmacy consulting areas.
In Phase 2, we will assess feasibility of the IDI in five sites:
An NHS sexual health service (Margaret Pyke Centre, MPC)
A local general practice
An abortion service (bpas)
A maternity service (Ashford & St Peter's Hospitals NHS Foundation Trust)
A community pharmacy (Greenlight)
Phase Two will take 15 months including:
• Conducting a randomised pilot trial in each of the five settings
• Conducting a qualitative process evaluation of the IDI, of NHS implementation issues and of research procedures
• Analysis, reporting and dissemination of study findings
• Preparation of outputs, including a protocol for a definitive RCT to increase uptake and adherence of LARC that is informed by both quantitative and qualitative findings (below).
In each setting we will recruit 80 women aged 15-30 years (40 randomised to intervention and 40 to control) and follow them up by online questionnaire at 3 and 6 months (or 2 months after delivery for post-partum women).
Data collection:
All quantitative data will be collected online. Using methodology we developed and implemented for a similar pilot trial, eligibility will be checked with a few screening questions, then eligible women will be asked for informed consent, demographic information, baseline sexual health outcomes, an email address and mobile phone number. A computer algorithm will automatically assign participants randomly to intervention or control group. All participants will be offered vouchers (by email) worth £20 on completion of follow-up at 6 months.
The outcome measure on which the sample size calculation is based is the follow-up rate at 6 months since this is a key unknown variable for a definitive trial. The sample size is based on estimating an expected follow-up rate at 6 months of 70% to within 10% precision (95% CI 60% to 80%) for each setting. We will analyse the follow-up rate for each site (combining intervention and control), for each arm (pooling across sites) and test for difference between arms in the follow-up rate by pooling the data and adjusting for site.
Secondary Quantitative Outcomes include
• recruitment rate;
• contraceptive method at 6 months (or 2 months postpartum);
• satisfaction with the method at 6 months (or 2 months post-partum);
• pregnancy
• sexual quality of life and utility scores for calculating quality adjusted life year (QALY’s);
• health service and out-of-pocket costs for contraception and other sexual health services;
We will assess the feasibility of collecting the relevant cost and outcomes of the IDI and contraceptive methods in each setting including costs to third sector organisations and any out of pocket costs to patients. We will also calculate the cost of the development of the IDI and number of potential future users to estimate the cost per patient of the IDI.
Qualitative Outcomes include
• women’s views and experience of the intervention and trial procedures, specifically including socially disadvantaged young people
• provider’s views about impacts on the service and trial procedures.
Assessment of trial feasibility:
Feasibility will be assessed and reported in terms of intervention acceptability and key process measures for a definitive RCT including: recruitment and follow-up rates and qualitative assessment of contextual factors, including comparative ease of implementation in different settings. Particular attention will be paid to aspects of feasibility relating to implementation in routine NHS practice and other settings of an IDI that is internet based.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
17/LO/0112
Date of REC Opinion
9 Feb 2017
REC opinion
Further Information Favourable Opinion