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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06299475
Other study ID # 2023-06755-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date September 2026

Study information

Verified date March 2024
Source Karolinska Institutet
Contact Kristina Gemzell Dannielsson, PhD
Phone +46 (0)72 254 23 85
Email kristina.gemzell@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date September 2026
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet the Swedish Pharmacy Association

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Contraceptive use Contraceptive use, including long-acting reversible contraception (LARC) (self-reported use in a digital questionnaire) within 12 months follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary Process evaluation How context affects the implementation and outcomes among participants and pharmacy personnel (individual interviews) within 12 months follow-up
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