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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception
• Intervention / Treatment: Other: Online counseling and invitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women >/=15 years visiting a pharmacy to buy ECP for her own use
• Has a smartphone with an electronic identification and ability to scan a QR code
• Ability to read Swedish or English
• Willing and able to provide informed consent
• Willing to participate in the follow-up

Exclusion Criteria:

* Ongoing pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online counseling and invitation; Participants receive structured online contraceptive counseling and an online invitation to a clinic for contraceptive provision	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
No Intervention: Control; Participants receive standard praxis i.e. no contraceptive counseling or online invitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of effective contraception	Participant´s self-reported use in a digital questionnaire of regular effective contraception (hormonal or intrauterine)	at 1 month follow-up from the pharmacy visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraceptive use	Contraceptive use, including long-acting reversible contraception (LARC) (self-reported use in a digital questionnaire)	within 12 months follow-up
Incidence of pregnancy and abortion	Pregnancy and abortion (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up)	within 12 months follow-up
Satisfaction with the intervention	Participants' satisfaction with the intervention package (self-reported use in a digital questionnaire) Assessed as: very satisfied, satisfied, neither nor, dissatisfied, very dissatisfied	At 1 month follow-up from the pharmacy visit
Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups	Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups such as youths and migrants, compared to non-migrants and older participants (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up)	within 12 months follow-up
Process evaluation	How context affects the implementation and outcomes among participants and pharmacy personnel (individual interviews)	within 12 months follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: the Swedish Pharmacy Association
• Investigators: Principal Investigator: Karin Emtell Iwarsson, PhD, WHO-centre, Karolinska Institutet, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): September 11, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: eHealth; Emergency Contraception; Over-the-counter
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2023-06755-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Some unidentified participant data can be shared on request
• IPD Sharing Time Frame: 2025 - 2027
• IPD Sharing Access Criteria: Some unidentified participant data can be shared on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No