ContraceptionLOWECNCT06299475
Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC
A study testing Online counseling and invitation in people with Contraception, run by Karolinska Institutet at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Online counseling and invitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 27 May 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ongoing pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structured Online Contraceptive Counseling at Emergency Contraception Pharmacy Provision - A Cluster Randomized Crossover Trial - (The LOWEC Trial)
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).
Read the 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.
- Conditions
- Contraception
- Being tested
- Online counseling and invitation
- Keywords
- eHealth, Emergency Contraception, Over-the-counter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online counseling and invitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Online counseling and invitation | Experimental | Participants receive structured online contraceptive counseling and an online invitation to a clinic for contraceptive provision Receives: Other: Online counseling and invitation |
| Control | No intervention | Participants receive standard praxis i.e. no contraceptive counseling or online invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of effective contraception
Participant´s self-reported use in a digital questionnaire of regular effective contraception (hormonal or intrauterine)
Measured: at 1 month follow-up from the pharmacy visit
Secondary outcomes (5)
Contraceptive use
Contraceptive use, including long-acting reversible contraception (LARC) (self-reported use in a digital questionnaire)
Measured: within 12 months follow-up
Incidence of pregnancy and abortion
Pregnancy and abortion (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up)
Measured: within 12 months follow-up
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
Measured: At 1 month follow-up from the pharmacy visit
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)
Measured: within 12 months follow-up
Process evaluation
How context affects the implementation and outcomes among participants and pharmacy personnel (individual interviews)
Measured: within 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start27 May 2024
- Primary completion11 Sep 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cluster randomized crossover trial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- the Swedish Pharmacy Association
- Responsible party
- Principal investigator, Karin Emtell Iwarsson, Karolinska Institutet
- Investigators
- Karin Emtell Iwarsson, PhD, Principal investigator, WHO-centre, Karolinska Institutet, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299475
- Sponsor's protocol ID
- 2023-06755-01
- Other IDs
- 2023
- Acronym
- LOWEC
- Status last verified
- Aug 2025
- First submitted
- 25 Jan 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Some unidentified participant data can be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Online Contraceptive Counseling at Emergency Contraception Pharmacy Provision - A Cluster Randomized Crossover Trial - (The LOWEC Trial)
- ClinicalTrials.gov ID
- NCT06299475
- Acronym / sponsor ID
- LOWEC / 2023-06755-01
- Conditions
- Contraception
- Keywords
- eHealth, Emergency Contraception, Over-the-counter
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- the Swedish Pharmacy Association
- Study start
- 27 May 2024 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| Online counseling and invitation | Experimental | Other: Online counseling and invitationParticipants receive structured online contraceptive counseling and an online invitation to a clinic for contraceptive provision |
| Control | No intervention | –Participants receive standard praxis i.e. no contraceptive counseling or online invitation |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Ongoing pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online counseling and invitationOnline 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 | Other | Online counseling and invitation |
Primary outcome
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)
5 secondary outcomes
Contraceptive use
Time frame: within 12 months follow-up
Incidence of pregnancy and abortion
Time frame: within 12 months follow-up
Satisfaction with the intervention
Time frame: At 1 month follow-up from the pharmacy visit
Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups
Time frame: within 12 months follow-up
Process evaluation
Time frame: within 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. Some unidentified participant data can be shared on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Emtell Iwarsson, PhD principal investigator
WHO-centre, Karolinska Institutet, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online counseling and invitation in people with Contraception, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of effective contraception (time frame: at 1 month follow-up from the pharmacy visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.