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

NCT06299475 | Active Not Recruiting

• 1 other identifier: 2023-06755-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Contraception

Keywords

eHealth; Emergency Contraception; Over-the-counter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Contraceptive use

  within 12 months follow-up

• Incidence of pregnancy and abortion

  within 12 months follow-up

• Satisfaction with the intervention

  At 1 month follow-up from the pharmacy visit

• Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups

  within 12 months follow-up

• Process evaluation

  within 12 months follow-up

Study Arms (2)

Online counseling and invitation

EXPERIMENTAL

Participants receive structured online contraceptive counseling and an online invitation to a clinic for contraceptive provision

Other: Online counseling and invitation

Control

NO INTERVENTION

Participants receive standard praxis i.e. no contraceptive counseling or online invitation

Interventions

Online counseling and invitation OTHER

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

Online counseling and invitation

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \* Ongoing pregnancy

Sponsors & Collaborators

• Karolinska Institutet: lead
• the Swedish Pharmacy Association: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 171 76, Sweden

Location

Study Officials

• Karin Emtell Iwarsson, PhD

  WHO-centre, Karolinska Institutet, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered nurse-midwife, PhD, Principal Investigator

Model Details: A cluster randomized crossover trial

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: March 7, 2024
• Study Start: May 27, 2024
• Primary Completion: September 11, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2025 - 2027
• Access Criteria: Some unidentified participant data can be shared on request

Locations

SE (1)