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| Name | Class |
|---|---|
| the Swedish Pharmacy Association | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online counseling and invitation | Experimental | Participants receive structured online contraceptive counseling and an online invitation to a clinic for contraceptive provision |
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| Control | No Intervention | Participants receive standard praxis i.e. no contraceptive counseling or online invitation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive use | Contraceptive use, including long-acting reversible contraception (LARC) (self-reported use in a digital questionnaire) | within 12 months follow-up |
| Incidence of pregnancy and abortion |
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Inclusion Criteria:
Exclusion Criteria:
* Ongoing pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Karin Emtell Iwarsson, PhD | WHO-centre, Karolinska Institutet, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 171 76 | Sweden |
Some unidentified participant data can be shared on request
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2025 - 2027
Some unidentified participant data can be shared on request
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A cluster randomized crossover trial
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Pregnancy and abortion (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up)
| 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 | 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) | within 12 months follow-up |
| Process evaluation | How context affects the implementation and outcomes among participants and pharmacy personnel (individual interviews) | within 12 months follow-up |