Contraception
Conditions
Keywords
eHealth, Emergency Contraception, Over-the-counter
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.
Interventions
OTHEROnline 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
Sponsors
Karolinska Institutet
the Swedish Pharmacy Association
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A cluster randomized crossover trial
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of effective contraception | 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
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive use | within 12 months follow-up | Contraceptive use, including long-acting reversible contraception (LARC) (self-reported use in a digital questionnaire) |
| Incidence of pregnancy and abortion | within 12 months follow-up | Pregnancy and abortion (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up) |
| Satisfaction with the intervention | 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 |
| Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups | 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) |
| Process evaluation | within 12 months follow-up | How context affects the implementation and outcomes among participants and pharmacy personnel (individual interviews) |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORKarin Emtell Iwarsson, PhD
WHO-centre, Karolinska Institutet, Sweden
Outcome results
None listed