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A website to help choose contraception - a pilot trial

Increasing uptake and adherence to long-acting reversible contraceptive (LARC) methods in young women OR Designing a digital intervention to help when choosing contraception

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13247829
Enrollment
400
Registered
2017-04-06
Start date
2017-03-23
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine

Interventions

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:

Sponsors

University London College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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 tria

Countries

England, United Kingdom

Contacts

Public ContactAnasztazia Gubijev
a.gubijev@ucl.ac.uk+44 (0)20 7679 6509

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026