A website to help choose contraception - a pilot trial

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 CONDITION: Specialty: Reproductive health and childbirth, Primary sub‐specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Pregnancy with abortive outcome ; Urological and Genital Diseases ; Reproductive Health ‐ contraception choices PRIMARY OUTCOME: 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. 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 SECONDARY OUTCOME: 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