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Abstract
Objective This trial aimed to evaluate effects of structured contraceptive counselling among non-migrants, foreign-born migrants and second-generation migrants.
Methods A cluster randomised controlled trial was conducted in 2017–2019 at abortion, youth and maternal health clinics in Stockholm, Sweden (the LOWE trial). Patients were eligible if they were 18 years or older, could understand Swedish or English (or if assisted by an interpreter), were sexually active or planning to be, and were seeking contraception for pregnancy prevention. We randomised clinics at a 1:1 allocation ratio to give either structured contraceptive counselling (intervention) or to maintain standard contraceptive counselling (control). Blinding was not deemed feasibile. A study-specific package for structured contraceptive counselling was used and comprised an educational video, an effectiveness chart, four key questions and a box with contraceptive models. Outcomes were effects of the intervention on long-acting reversible contraception (LARC) choice, initiation and use, and satisfaction with the intervention material among the participants.
Results We involved 14 clinics in each of the intervention and control groups, respectively. A total of 1295 participants were included: 1010 non-migrants, 169 foreign-born migrants and 116 second-generation migrants. Participants in the intervention group chose LARC to a higher extent than the control group (adjusted OR (aOR) 2.85, 95% CI 2.04–3.99), had higher LARC initiation rates (aOR 2.90, 95% CI 1.97 to 4.27) and higher LARC use within the 12-month follow-up period (aOR 2.09, 95% CI 1.47 to 2.96). The majority of the participants who received the intervention package found all the different parts to be supportive in contraceptive choice. The effectiveness chart was the only part of the package that a higher proportion of foreign-born migrants (58/84, 69%) and second-generation migrants (40/54, 74.1%) found supportive in contraceptive choice compared to non-migrants (259/434, 59.7%) (p = 0.048).
Conclusions Structured contraceptive counselling increased LARC choice, initiation and use, controlled for participants’ migration background. The effectiveness chart was found to be significantly more supportive among foreign-born migrants and second-generation migrants compared to non-migrants when choosing contraceptive methods.
Trial registration number NCT03269357.
- long-acting reversible contraception
- contraceptive effectiveness
- counseling
- patient satisfaction
- randomized controlled trial
Data availability statement
Data are available upon reasonable request. Deidentified participant data are available upon reasonable request from the corresponding authorkarin.emtell.iwarsson@ki.se.
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- long-acting reversible contraception
- contraceptive effectiveness
- counseling
- patient satisfaction
- randomized controlled trial
Data availability statement
Data are available upon reasonable request. Deidentified participant data are available upon reasonable request from the corresponding authorkarin.emtell.iwarsson@ki.se.
Footnotes
Twitter @NiklasEnvall
Contributors KGD was responsible for the study concept, trial protocol and regulatory approvals, and took overall responsibility for the study conduct and funding. KGD is acting as the guarantor. HKK contributed to study design protocol development and in securing funding as well as in supervision of the study. All authors except ECL and IB were involved in the development of study tools and recruitment of participating clinics. NE, KEI and IB acquired the data. KEI, ECL, NE and the statisticians were responsible for data analyses. All authors contributed to the interpretation of the data and manuscript writing.
Funding This project was funded by the Swedish Research Council for Health, Work-Life and Welfare (FORTE) through grant STYA-2016–01063 and by the European Society of Contraception and Reproductive Health (ESC) through grant ESC P-2016-B-02, and Karolinska Institutet and Region Stockholm.
Disclaimer The study funders had no involvement with or influence on trial design or conduct, data analysis, manuscript writing or the decision to submit the article for publication. All authors had full access to all the data in the study and approved submission of the final version of the manuscript.
Competing interests All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/. KEI reports support for attending meetings and/or travel from RemovAid AS; other non-financial interests from Bayer AG. NE reports all support for the present manuscript (eg, funding, provision of study materials, medical writing, article processing charges, etc) from the Swedish Research Council for Health, Working Life and Welfare to the institution; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer AG; receipt of equipment, materials, drugs, medical writing, gifts or other services from Bayer, MSD (materials for education). HKK reports all support for the present manuscript (eg, funding, provision of study materials, medical writing, article processing charges, etc) from the Swedish Research Council for Health, Working Life and Welfare to the institution; consulting fees from Bayer, MSD, Gedeon Richter, Consilient Health, Mithra, Teva; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, MSD, Gedeon Richter, Consilient Health, Mithra, Teva; payment for expert testimony from Bayer, Gedeon Richter, Dynamic Code; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: board member of European Society of Contraception; receipt of equipment, materials, drugs, medical writing, gifts or other services: Azanta, Bayer. KGD reports consulting fees from Bayer, MSD, Gedeon Richter, Mithra, Exeltis, MedinCell, Cirqle, Natural Cycles, Exelgyn, Campus Pharma, HRA-Pharma; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, MSD, Gedeon Richter, Mithra, Exeltis, Exelgyn, Campus Pharma; participation on a Data Safety Monitoring Board or Advisory Board: Gedeon Richter, Bayer; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: FIGO, WHO HRP/SRH, ESC, FIAPAC, FSRH/RCOG UK.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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