Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299475
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-07
First Post:
2024-01-25
Brief Title:
Structured Online Contraceptive Counseling LOWE Trial At Emergency Contraception EC Pharmacy Provision LOWEECLOWEC
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Structured Online Contraceptive Counseling At Emergency Contraception Pharmacy Provision - a Cluster Randomized Crossover Trial - The LOWEC Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOWEC
Brief Summary:
To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and thus womens 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 pharmacys 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 11 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
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 pharmacys 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None