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Active, Not Recruiting

NCT Number: NCT06299475

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Contraception

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 76, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Use of effective contraception

    Time frame: at 1 month follow-up from the pharmacy visit

    Participant´s self-reported use in a digital questionnaire of regular effective contraception (hormonal or intrauterine)

Secondary outcomes

  1. Contraceptive use

    Time frame: within 12 months follow-up

    Contraceptive use, including long-acting reversible contraception (LARC) (self-reported use in a digital questionnaire)

  2. Incidence of pregnancy and abortion

    Time frame: within 12 months follow-up

    Pregnancy and abortion (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up)

  3. Satisfaction with the intervention

    Time frame: At 1 month follow-up from the pharmacy visit

    Participants' satisfaction with the intervention package (self-reported use in a digital questionnaire) Assessed as: very satisfied, satisfied, neither nor, dissatisfied, very dissatisfied

  4. Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups

    Time frame: within 12 months follow-up

    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)

  5. Process evaluation

    Time frame: within 12 months follow-up

    How context affects the implementation and outcomes among participants and pharmacy personnel (individual interviews)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • the Swedish Pharmacy Association

Registry information

Official study title

Structured Online Contraceptive Counseling at Emergency Contraception Pharmacy Provision - A Cluster Randomized Crossover Trial - (The LOWEC Trial)

Acronym: LOWEC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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