A website to help choose contraception - a pilot trial

ISRCTN	ISRCTN13247829
DOI	https://doi.org/10.1186/ISRCTN13247829
Protocol serial number	33563
Sponsor	University London College Hospital
Funder	National Institute for Health Research

Submission date: 03/04/2017
Registration date: 06/04/2017
Last edited: 10/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Control of fertility is crucial to the health and wellbeing of women, but unintended pregnancy remains common and costly for both health services and individuals. In the UK, despite a range of freely available effective contraceptive methods, abortion rates have changed little over two decades, and England still has the highest rate of teenage pregnancy in Western Europe. A key report on the economics of sexual health concluded that it should be feasible to improve contraception and abortion services in ways that better meet the preferences of service users and that this could lead to a net saving of up to £1 billion over 15 years. In addition to the economic burden of unintended pregnancy and abortion to the NHS, and the emotional burden to individual women, unintended pregnancy plays a prominent role in persistent health inequalities in the UK and globally. Preventing unintended pregnancy involves many steps, including timely education, awareness and socially patterned behaviours that lead women to seek, choose, and use contraception consistently and correctly. Long-acting reversible contraceptive (LARC) methods, including intrauterine devices, depo injection and subdermal implants, offer women the most effective protection against pregnancy. The vast majority of young people have access to digital technology through Internet or mobile phones, which offers huge potential for health promotion. It is known that younger women are likely to turn to digital resources for information on contraception. The aim of this study is to look at the acceptability of a website designed to increase the acceptability, uptake and adherence to long-acting reversible contraceptive (LARC) methods in young women.

Who can participate?
Women aged 15-30 who are in need or current or future contraception.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive access to standard contraceptive care only. Those in the second group are given access to the study website, displayed on a tablet computer. The website includes general information about contraceptives, including side effects and benefits of different types; videos of women and health professionals discussing contraceptive experiences, concerns and misconceptions; an interactive tool that helps women to choose a method of contraceptive for themselves; and a page offering a link to NHS clinics, information websites and support websites. Participants in both groups are asked to complete questionnaires online after three and six months via an automated email. At the end of the study, the number of those who took part and participant views on the website are collected in order to see if a full scale study would be possible.

What are the possible benefits and risks of participating?
Participants may benefit from increased awareness about the different types of contraception available and what they involve. Contraception may be viewed as a sensitive or embarrassing topic by some people, although the study questions about contraception do not differ from those that are asked in routine contraceptive consultations. If participants express discomfort, anxiety or distress while completing the questionnaire, this will reported by the researcher or clinic / pharmacy staff as an adverse event. All concerns will be discussed with at least one other member of the research team, and consider referral to social services if this is felt to be in the person's best interests (even if this is against their wishes), particularly if they are under the age of 18.

Where is the study run from?
1. Margaret Pyke Centre (UK)
2. British Pregnancy Advisory Service (UK)
3. Green Light Pharmacy (UK)
4. Clerkenwell Medical Practice (UK)

When is the study starting and how long is it expected to run for?
June 2016 to March 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Anasztazia Gubijev
a.gubijev@ucl.ac.uk

Contact information

Miss Anasztazia Gubijev
Public

Institute of Women's Health
21 University Street
London
WC1E 6DE
United Kingdom

Phone	+44 (0)20 7679 6509
Email	a.gubijev@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Not Specified, Education or Self-Management, Psychological & Behavioural
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific 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
Study objectives	The aim of the study is to develop and test the feasibility of an online trial of a website to increase the acceptability, uptake and adherence to long-acting reversible contraceptive (LARC) methods in young women. LARC methods include the intrauterine device (IUD), intrauterine system (IUS), subdermal implant (SDI) and depo injection.
Ethics approval(s)	Ethics Board: Camden and King's Cross Research Ethics Committee, 15/02/2017, ref: 17/LO/0112
Health condition(s) or problem(s) studied	Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Pregnancy with abortive outcome
Intervention	Participants are randomised to one of two groups. Intervention group: Women are given access to the intervention website, displayed on a ‘tablet’ computer. This consists of: 1. General information on contraception, including information on each method as well as contraceptive benefits and side-effects and other common concerns 2. Videos of women as well as health professionals discussing contraceptive experiences, concerns and misconceptions 3. An interactive tool to help women choose a method of contraception which provides individually tailored results 4. A page offering a link to NHS clinic finders as well as links to other useful resources, such as further information on sexual health, or websites offering support and advice for sexual abuse for example Whilst in clinic, users allocated to the intervention group will be asked to work through a tailored package of individualised website content. After leaving clinic, the website will be available for them to re-visit and explore freely, and will be accessible on mobile phones as well as desktop computers. Participants will be taken through a series of questions designed to identify appropriate method(s) that best suits individual preferences e.g. for a non-hormonal method, or one that does not require insertion by a health care professional, or one that is invisible, or one that can be forgotten about once inserted. The website will give information to address women’s concerns and barriers to uptake of LARC. A contraceptive choice tool will take account of women’s views and preferences on the benefits and side effects of contraception and three suitable contraceptive options will be recommended with brief annotation, that can be emailed, texted to a mobile phone and used in a subsequent consultation and / or taken home. Control group: Participants will be thanked for their participation and will then access standard contraceptive care only. All women in both intervention and control groups will be asked by automated email to complete the same outcome questionnaires online at 3 and 6 months (or 2 months post-partum). The control group will be offered access to the intervention website at the end of the study (after completion of 6 month follow-up).
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Current primary outcome measures as of 28/09/2018: 1. LARC method in use at 6 months, measured by response to study outcome questionnaire 2. Satisfaction with any chosen method of contraception at 6 months, measured by response to study outcome questionnaire using a Likert scale 1-5. How satisfied are you with the contraception you are using currently? Previous primary outcome measures: Follow up rate is measured by completing (in full or in part) the study outcome questionnaire via an online link sent by email 6 months after randomisation, for participants recruited from the general practice, sexual & reproductive health service, abortion services, and community pharmacy), and 2 months post-partum for women recruited from the maternity service.
Key secondary outcome measure(s)	Current secondary outcome measures as of 28/09/2018: Quantitative: 1. Follow-up rate at 6 months after randomisation 2. Recruitment rate, measured via the trial website as the time taken to recruit (up to 80) women in each site. Recruitment is assessed by completing (in full or in part) the baseline questionnaire. 3. Effectiveness of contraceptive method in use at 6 months, measured by response to study outcome questionnaire and grouped as follows from least to most effective: no method; withdrawal or natural method; condoms or diaphragm; pill, patch or ring; LARC or sterilisation 4. Change in method between baseline and 6 months, indicating whether any change is to a method of greater, lesser or similar effectiveness (based on grouping above) 5. Pregnancy by 6 months, measured by response to study outcome questionnaire at 3 months and at 6 months 6. Sexually transmitted infection diagnosis by 6 months, measured by response to study outcome questionnaire at 3 months and 6 months 7. Health service and out-of-pocket costs for contraception and other sexual health services, measured by response to study outcome questionnaire at 3 months and at 6 months Qualitative 1. Patient views and experience of the intervention and trial procedures, assessed through qualitative interviews at 2 weeks after randomisation with five women at each study site (total 25 interviews) (See Topic Guide). Questions to be explored include: 1.1. Are the online trial procedures acceptable to participants? E.g. the process of online registration and consent, the receipt of incentives, completing online questionnaires, contact and follow up by email and text 1.2. What are women’s views of the intervention? 1.3. How might trial procedures be improved, to optimise retention in a full-scale trial? 2. Provider views about impacts on the service and trial procedures, assessed through qualitative interviews with 15 key staff in total (3 per site), sampling those who have roles in facilitating the study in each setting (e.g. receptionists, practice managers, nurses, midwives, doctors and pharmacists) (see Topic Guide). Questions to be explored include: 2.1. Are recruitment procedures acceptable to staff? 2.2. How might recruitment procedures be improved, to optimise recruitment to a full-scale trial? 2.3. What are staff views on the feasibility and usefulness of a contraception decision website in each clinic setting? Previous secondary outcome measures: 1. Recruitment rate is measured via the trial website as the time taken to recruit (up to 80) women in each site at 6 months 2. Satisfaction with chosen method of contraception is measured using a Likert scale at 3 and 6 months 3. Data completeness and descriptive statistics for questions related to service use and out-of-pocket costs for contraception and other sexual health services is assessed by survey at 3 and 6 months 4. Patient views and experience of the intervention and trial procedures, assessed through qualitative interviews 2 weeks after randomisation with five women at each study site 5. Provider views about impacts on the service and trial procedures, assessed through qualitative interviews with 15 key staff in total (3 per site), sampling those who have roles in facilitating the study in each setting (e.g. receptionists, practice managers, nurses, midwives, doctors and pharmacists) at 6 months
Completion date	31/03/2018

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Female
Target sample size at registration	400
Total final enrolment	927
Key inclusion criteria	1. Women 2. Aged 15 to 30 years 3. In need of current or future contraception 4. Attending one of the study sites 5. Able to read English 6. An active email account and access to the internet
Key exclusion criteria	1. Women unable to provide informed consent (e.g. severe learning difficulties) 2. Women needing a language advocate to understand English since the intervention content is intended to be accessed in private
Date of first enrolment	23/03/2017
Date of final enrolment	23/09/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Margaret Pyke Centre

Mortimer Market Centre
Bloomsbury
London
WC1E 6JB
United Kingdom

British Pregnancy Advisory Service

36 Romford Road
London
E15 4BZ
United Kingdom

Green Light Pharmacy

228-230 Uxbridge Road
London
W12 7DJ
United Kingdom

Clerkenwell Medical Practice

Finsbury Health Centre
Pine Street
London
EC1R 0LP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to the confidential nature of the data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2020	26/01/2021	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 3	23/07/2018	10/10/2022	No	No

Additional files

33469 Protocol V3 23July18.pdf: Protocol file

Editorial Notes

10/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
26/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/11/2018: Publication and dissemination plan and IPD sharing statement added, study contact updated.
28/09/2018: The primary and secondary outcomes were updated.
08/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
22/09/2017: Internal review.