Avoiding Contraceptive Controversy. Ensuring task Shifting through Standardization of Contraceptive Implant removals.

Improving contraceptive access is important to improve the health of women and children worldwide. Among the most effective reversible methods are contraceptive implants. These are small rods inserted underneath the skin of the upper arm of women, ensuring long term contraception through gradual hormonal release. Contraceptive implants are being inserted at a high rate by an increasingly diverse group of providers in order to address the global unmet need for family planning. Implant insertions are performed by doctors, nurses and midwives, and in some countries where resources are scarce, health extension workers who are trained to safely and effectively insert contraceptive implants. In order to provide responsible scale-up of implant insertions, removal services must be equally readily available. The removal procedure is more complex than insertion and is therefore unsuited for the task sharing/task shifting as is practiced with insertions. The ultimate goal of the ACCESS-CI project (Avoiding contraceptive controversy. Ensuring task shifting through standardization of contraceptive implant removals) is to facilitate task sharing. Our strategy to achieve this is three-fold: we have constructed RemovAid(TM), a medical device that aims to standardize the removal procedure. The device may replace scalpels and forceps that are used in the removal procedure today, and importantly it may reduce the need for general surgical skills of the operator. It will also protect the user against unintentional sharps injuries. At the end of the project we have submitted the technical file for regulatory approval (CE mark) for RemovAid(TM), a medical device class IIa that facilitate the removal of contraceptive implants. We have conducted two clinical pilots in Sweden, and have included 124 clients in a randomized controlled trial in Kampala, Uganda. The latter trial is currently paused due to the covid-19 pandemic. The investigation is a collaboration between RemovAid, Karolinska Institute and FHI360. We are planning to complete the inclusion of subjects after the formal project closure.

RemovAid is ISO 13485:2016 Certified The technical file for RemovAid device is submitted for European regulatory approval (CE mark) Two clinical pilots (REVALID and REVALID02) have been completed in Sweden, Results were recently published in Contraception One randomized controlled trial has been initiated (Dec 2019), and was paused in March 2020 due to the ongoing covid-19 pandemic after inclusion of 124 subjects (55% of total). The trial compares the RemovAid device to the standard procedure when performed by highly experienced midwives in Kampala, Uganda. A patent application (16727213.7 in Europe) was filed in June 2015, and has been granted in Europe, the US and the ARIPO region. The patent is valid until 2036 and covers any subdermal implant.

Increasing global access to family planning is an important and prioritized component in reducing maternal and child mortality. Among the most effective reversible methods of contraception is the contraceptive implant. This is a small rod fitted just ben eath the skin in a woman?s upper arm, providing slow hormone release to prevent pregnancy for up to five years depending on the brand. During the past few years, there has been a global surge in the use of contraceptive implants to meet the global challe nges associated with unwanted pregnancy. Several cadres of health care workers are qualified in the insertion of implants. However, only the highest cadres (doctors, nurses) are performing the more complex removal procedure. Access to removal services is limited in low- and middle income countries due to a lack of qualified health care personnel. Our aim is to enable all cadres that currently perform insertions in safely and effectively removing implants using novel technology. During the ACCESS-CI proj ect, RemovAid will improve and adjust existing technology to meet the requirements of low- and middle income countries. Thereafter, we will investigate the safety and efficacy of the technlogy in close collaboration with world leading partners in the repr oductive health sector through clinical trials. The trials will be designed to evaluate both staff currently performing removal services and to investigate the whether the technology may enable a favourable task shift toward lower cadre health workers to increase access to implant removal in low- and middle income countries.