Structured Online Contraceptive Counseling (LOWE Trial) At Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC
NCT ID: NCT06299475
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
600 participants
INTERVENTIONAL
2024-05-27
2026-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Online counseling and invitation
Participants receive structured online contraceptive counseling and an online invitation to a clinic for contraceptive provision
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
Control
Participants receive standard praxis i.e. no contraceptive counseling or online invitation
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
FEMALE
Yes
Sponsors
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the Swedish Pharmacy Association
UNKNOWN
Karolinska Institutet
OTHER
Responsible Party
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Karin Emtell Iwarsson
Registered nurse-midwife, PhD, Principal Investigator
Principal Investigators
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Karin Emtell Iwarsson, PhD
Role: PRINCIPAL_INVESTIGATOR
WHO-centre, Karolinska Institutet, Sweden
Locations
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Karolinska Institutet
Stockholm, , Sweden
Countries
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Other Identifiers
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2023-06755-01
Identifier Type: -
Identifier Source: org_study_id
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