NCT06299475

Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC

Structured Online Contraceptive Counseling at Emergency Contraception Pharmacy Provision - A Cluster Randomized Crossover Trial - (The LOWEC Trial)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP).

Detailed description

This pragmatic cluster randomised cross-over controlled trial aims to determine whether the composite intervention of online contraceptive counseling at the time of a pharmacy provision of emergency contraceptive pill (ECP), plus an invitation to a sexual and reproductive health clinic, will result in increased use of subsequent effective contraception (hormonal or intrauterine) compared with standard care. The study will be conducted at approximately 30 pharmacies in the Stockholm Region. Clients who will buy an ECP (without prescription) at one of these pharmacies will be invited by posters and pharmacy personnel to participate in the study. By scanning a quick response (QR) code they will receive more information about the study. Eligible women who choose to participate in the study and give their consent will be allocated to intervention or control group depending on the visited pharmacy's allocation. Participants at the intervention pharmacies will receive an intervention package with online structured contraceptive counseling followed by an online invitation to a clinic for contraceptive provision. While participants at the control pharmacies will purchase the ECP without any further guidance. The order in which the pharmacies will provide the intervention or control will be randomly assigned at a ratio 1:1 by an independent statistician. The recruitment will halter for an intervening period of at least two weeks when the pharmacies switch to the new group depending on their first allocation (cross-over). An online baseline questionnaire and follow-up questionnaires will be collected at 1 and 12 months following the ECP provision for participants both from intervention and control pharmacies. The randomized controlled trial will be conducted together with a process evaluation.

Conditions

• Contraception

Interventions

Type	Name	Description
OTHER	Online counseling and invitation	Online counseling - An educational video including contraceptive models, four key questions and an effectiveness chart (the LOWE intervention material). Invitation to a clinic - access by weblinks to a regional or national website

Timeline

• Start date: 2024-05-27
• Primary completion: 2025-09-11
• Completion: 2026-09-01
• First posted: 2024-03-07
• Last updated: 2026-02-25

Locations

1 site across 1 country: Sweden