Contraceptive uptake and compliance after structured contraceptive counseling - secondary outcomes of the LOWE trial.

INTRODUCTION: Highly effective long-acting reversible contraceptive (LARC) methods reduce unintended pregnancy rates; however, these methods are underutilized. The LOWE trial intervention provided structured contraceptive counseling resulting in increased uptake of LARC. This longitudinal follow up of the LOWE study assessed the long-term impact of the intervention by investigating the contraceptive use at 12 months with a focus on continued use of LARC. MATERIAL AND METHODS: In the cluster randomized LOWE trial, abortion, youth, and maternal health clinics were randomized to provide either structured contraceptive counseling (intervention) or standard contraceptive counseling (control). The intervention consisted of an educational video on contraceptive methods, key questions asked by the health care provider, a tiered effectiveness chart and a box of contraceptive models. Women ≥ age 18, who were sexually active or planned to be in the upcoming 6 months, could participate in the study. We assessed self-reported contraceptive use at three, six and 12 months. Contraceptive choice and switches were analyzed with descriptive statistics. Contraceptive use at 12 months and continued use of LARC were analyzed using mixed logistic regressions, with clinic included as a random effect. Analysis with imputed values were performed for missing data to test the robustness of results. RESULTS: Overall, at 12 months, women in the intervention group were more likely to be using a LARC method (aOR 1.90, 95% CI: 1.31-2.76) and less likely to be using a short-acting reversible contraceptive (SARC) method (aOR 0.66, 95% CI: 0.46-0.93) compared to the control group. Women counseled at abortion (aOR 2.97, 95% CI: 1.36-6.75) and youth clinics (aOR 1.81, 95% CI: 1.08-3.03) were more likely to be using a LARC method, while no significant difference was seen in maternal health clinics (aOR 1.84, 95% CI: 0.96-3.66). Among women initiating LARC, continuation rates at 12 months did not differ between study groups (63.9% vs. 63.7%). The most common reasons for contraceptive discontinuation were wish for pregnancy, followed by irregular bleeding, and mood changes. CONCLUSIONS: The LOWE trial intervention resulted in increased LARC use also at 12 months. Strategies on how to sustain LARC use needs to be further investigated.

Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial.

STUDY QUESTION: Is a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWER: In terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADY: An easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATION: From December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODS: We randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCE: We recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. LIMITATIONS, REASONS FOR CAUTION: We tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. WIDER IMPLICATIONS OF THE FINDINGS: The study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. STUDY FUNDING/COMPETING INTEREST(S): Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. TRIAL REGISTRATION NUMBER: NCT04120337. TRIAL REGISTRATION DATE: 9 October 2019. DATE OF FIRST PATIENT'S ENROLMENT: 23 December 2019.

Long-acting reversible contraception and satisfaction with structured contraceptive counselling among non-migrant, foreign-born migrant and second-generation migrant women: evidence from a cluster randomised controlled trial (the LOWE trial) in Sweden.

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.

Evaluation of satisfaction with a model of structured contraceptive counseling: Results from the LOWE trial.

INTRODUCTION: Intervention trials of structured contraceptive counseling have proved to increase use of long-acting reversible contraceptives (LARCs) and decrease numbers of unintended pregnancies. However, these interventions have not been evaluated from a user perspective. This study aimed to evaluate both healthcare providers' and participants' satisfaction with an intervention used in a large trial in Sweden. MATERIAL AND METHODS: A cross-sectional study on the intervention group from a cluster randomized trial conducted at 28 clinics in Stockholm, Sweden. Clinics were randomized (1:1 allocation ratio) to provide either structured contraceptive counseling (intervention) or standard contraceptive counseling (control). The intervention consisted of four parts; an educational video to be seen by the participant prior to contraceptive counseling, key questions to be asked by the healthcare provider, an effectiveness chart, and a box of contraceptive models. Eligible participants were 18 years or older, sexually active without a wish to conceive, and with the main purpose of contraceptive use being pregnancy prevention. Healthcare providers completed an electronic semi-structured survey to evaluate the intervention. This study analyses provider and participant satisfaction with the counseling material used in the intervention and if the intervention was found to be supportive in contraceptive counseling and contraceptive choice. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03269357). RESULTS: Fourteen intervention clinics enrolled 658 participants from September 2017 to May 2019. Response rate among providers was 88.0% (55/62) and among participants 97.1% (639/658). Providers found the intervention to be supportive in their counseling. Each separate part of the intervention package received high ratings from both providers and participants. Participants found the educational video and the effectiveness chart to be more helpful than the box of contraceptive models in their contraceptive choice. Providers reported the time taken to complete the intervention outside the study to be time-neutral to standard counseling, and most providers wished to continue to use all parts of the intervention package. CONCLUSIONS: The intervention of structured contraceptive counseling had high provider and participant satisfaction. The structured counseling package could be used in several clinical settings to improve quality in contraceptive counseling and to enhance informed decision making about use of contraceptive methods.

Contraceptive use among migrant, second-generation migrant and non-migrant women seeking abortion care: a descriptive cross-sectional study conducted in Sweden.

INTRODUCTION: The objective of this study was to compare ever-in life contraception use, use of contraception at current conception, and planned use of contraception after an induced abortion, among three groups of women: migrants, second-generation migrants and non-migrant women, and to compare the types of contraception methods used and intended for future use among the three groups of women. METHODS: The cross-sectional study administered a questionnaire face-to-face to women aged 18 years and older who were seeking abortion care at one of six abortion clinics in Stockholm County from January to April 2015. RESULTS: The analysis included 637 women. Migrants and second-generation migrants were less likely to have used contraception historically, at the time of the current conception, and to plan to use contraception after their induced abortion compared with non-migrant women. Historically, non-migrants had used pills (89%) and withdrawal (24%) while migrants had used the copper intrauterine device (24%) to a higher extent compared to the other two groups of women. Both the migrants (65%) and second-generation migrants (61%) were more likely than the non-migrants (48%) to be planning to use long-acting reversible contraception. CONCLUSIONS: Lower proportions of contraception use were found in migrants and second-generation migrants than in non-migrants. In addition, there were significant differences in the types of contraception methods used historically and intended for future use.