Clinical trial NCT06299475: Structured Online Contraceptive Counseling (LOWE Trial) At Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC
Official title: Structured Online Contraceptive Counseling At Emergency Contraception Pharmacy Provision - a Cluster Randomized Crossover Trial - (The LOWEC Trial)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Contraception
Keywords: eHealth
Emergency Contraception
Over-the-counter
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: the Swedish Pharmacy Association
First posted: 2024-03-07
Enrollment: 600
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A cluster randomized crossover trial
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of effective contraception
timeFrame: at 1 month follow-up from the pharmacy visit
Secondary outcomes:
measure: Contraceptive use
timeFrame: within 12 months follow-up
measure: Incidence of pregnancy and abortion
timeFrame: within 12 months follow-up
measure: Satisfaction with the intervention
timeFrame: At 1 month follow-up from the pharmacy visit
measure: Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups
timeFrame: within 12 months follow-up
measure: Process evaluation
timeFrame: within 12 months follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: WHO-centre, Karolinska Institutet, Sweden
name: Karin Emtell Iwarsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: