Adherence to and reasons for discontinuation of long-acting reversible contraception within Catalonia's access improvement plan

ISRCTN	ISRCTN82695603
DOI	https://doi.org/10.1186/ISRCTN82695603
Sponsor	Institut Universitari d'Investigació en Atenció Primària Jordi Gol
Funder	Investigator initiated and funded

Submission date: 09/10/2026
Registration date: 31/10/2026
Last edited: 13/10/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pablo Rodriguez Coll
Principal investigator, Public, Scientific

Carrer marques de campo sagrado, 27 5-1
Barcelona
08015
Spain

ORCID ID	0000-0002-9296-4178
Phone	+34633136676
Email	Prodriguezc.bcn.ics@gencat.cat

Study information

Primary study design	Observational
Observational study design	Cohort study
Participant information sheet	50430_Protocol [Spanish]_v05_17Jan2023.pdf
Scientific title	Evaluation of the plan to improve access to long-acting reversible contraception: adherence and reasons for discontinuation of LARCs
Study acronym	STAY-LARC
Study objectives	Long-acting contraceptives (copper IUD, implant) are very effective, but some people have them removed within a year. Since 2023 Catalonia has offered both free to priority groups. 1. Identify the reasons for starting a LARC. 2. Identify the reasons for discontinuing it. 3. Analyse the relationship between adherence and: 3.1. Motivation to start and to stop 3.2. Type of LARC 3.3. Level of information received 3.4. Side effects experienced 3.5. Satisfaction with the method
Ethics approval(s)	Approved 30/09/2026, Ethics Committee for Medicinal Products at University Research Institute for Primary Care (Institut Universitari d’Investigació en Atenció Primària (IDIAP) Jordi Gol) (Gran via corts catalans 587, Barcelona, 08007, Spain; +3493 4824604; Cei@idiapjgol.org), ref: Ceim 26/271-Eom
Health condition(s) or problem(s) studied	Early (within a year) removal of long-acting contraceptives (copper IUD, implant)
Methodology	Recruitment: Midwives at ASSIR Dreta invite eligible users to take part when they decide to start a LARC under the Plan. After an explanation and signed informed consent, they enter the study. Sample: About 375 participants (95% confidence, 5% margin of error). The protocol also plans to recruit extra participants to compensate for losses. Baseline data: Participants complete a digital questionnaire on motivations and information received (Q1) by QR code on their phone. The midwife completes a baseline questionnaire on clinical and sociodemographic data (Q2). Follow-up: Every 3 months for 1 year, participants get an automatic email from the DataGHenderS platform asking if they still use the method. If yes, they answer an experience questionnaire (Q3): satisfaction, bleeding pattern, side effects, quality of life (SEC-QoL), healthcare follow-up and adaptation. If no, they answer a discontinuation questionnaire (Q4), and their participation ends. Data protection: Data are coded with a unique study ID. The link between identity and code is held by the care centres. The research team works only with coded data, and the platform is hosted in Spain (ISO 27001). Loss to follow-up: Reminders are sent, and non-response is treated as withdrawal.
Intervention type	Other
Primary outcome measure(s)	Discontinuation of the LARC (yes/no) and time to removal measured using self-administered online questionnaire asking whether the person still uses the method (yes/no) and, if not, the date of removal. Reported as the proportion still using the method at 12 months and as time to discontinuation (Kaplan-Meier), at 3, 6, 9 and 12 months after device placement Reasons for starting a LARC measured using multiple-choice list of motives (Q1, item 2), plus who took part in the decision (item 3), at baseline Reasons for discontinuation measured using multiple-choice list of reasons, side effects, and who took part in the decision (Q4, items 2 and 3), at discontinuation, within the 12 months Level of information on the method measured using Q1 item 5. It covers knowledge of side effects, insertion, duration and removal (Likert 1-10), the sources of information, and the information received before choosing and current knowledge (Likert 1-5), at baseline Experience of device placement measured using pain (Likert 1-5) and satisfaction with the procedure (Likert 1-5) (Q1, item 6) at baseline Satisfaction with the method measured using type (checklist), severity and whether the person felt supported, and by whom (Q3 section 3; Q4 item 2.1) at every 3 months, and at discontinuation Bleeding pattern changes measured using whether it changed, the type of change, satisfaction and impact on quality of life (Q3 section 2; Q4 section 5) at every 3 months, and at discontinuation Quality of life measured using Spanish Society of Contraception Quality-of-Life Questionnaire (SEC-QoL) questionnaire (Q3 section 4) at every 3 months Healthcare follow-up measured using the number of consultations and their main reason (Q3 section 5) at every 3 months Adaptation and perceived safety measured using time to adapt, whether the person considered stopping and why, and perceived safety (Q3 section 6), at every 3 months Effects after removal measured using 5-point change scales for menstrual cycle, mood, physical health, sexual experience and general health (Q4 section 6) at discontinuation Factors associated with adherence measured using Log-linear analysis and Kaplan-Meier survival analysis, by side effects, method type and level of information at the end of follow-up (12 months)
Key secondary outcome measure(s)
Completion date	09/11/2028

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	All
Target sample size at registration	375
Key inclusion criteria	1. Using a publicly funded copper IUD or implant through the Plan 2. Can answer in Catalan or Spanish 3. Autonomous 4. Signed consent
Key exclusion criteria	No internet access or unwilling to use it
Date of first enrolment	02/11/2026
Date of final enrolment	09/11/2027

Locations

Countries of recruitment

Spain

Study participating centre

Assir dreta

-
Barcelona
-
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 05	17/01/2023	12/10/2026	No	Yes
Protocol file	version 05	17/01/2023	12/10/2026	No	No
Statistical Analysis Plan	version 05	17/01/2023	12/10/2026	No	No

Additional files

50430_Protocol [Spanish]_v05_17Jan2023.pdf: Protocol file
50430_Protocol [Spanish]_v05_17Jan2023.pdf: Statistical Analysis Plan
50430_Protocol [Spanish]_v05_17Jan2023.pdf: Participant information sheet

Editorial Notes

13/10/2026: Study’s existence confirmed by the Ethics Committee for Medicinal Products at University Research Institute for Primary Care (Institut Universitari d’Investigació en Atenció Primària (IDIAP) Jordi Gol), Spain.