Pre-Clinical Evaluation of a Task-Shifting Contraceptive Implant Insertion Device for Use in Low- and Middle-Income Countries

Abstract

Worldwide, 225 million women have unmet contraceptive needs which, every year, leads to 52 million unintended pregnancies. A challenge to providing universal access to contraception is the large proportion of the population living in rural, difficult to access settings in low- and middle-income countries. The availability and delivery of effective contraception in rural areas is limited by the lack of trained healthcare providers. Barriers to the use of long-acting contraceptives in rural areas are more pronounced due to the advanced skill and training to administer. In this study, we describe the design and testing of the SubQ Assist, a task-shifting contraceptive implant insertion device that aims to reduce the training requirements for administering contraceptive implants while simultaneously ensuring safe and high quality administration. Cadaver testing in conjunction with ultrasound depth measurements were used to evaluate the efficacy of the SubQ Assist. Implant insertion between the SubQ Assist and a trained physician are compared. Cadaver testing and ultrasound depth measurements demonstrate that the SubQ Assist results in implant insertions that are statistically equivalent to implants inserted by a trained physician. Additionally, the results show that the lateral positioning of these implants would facilitate uncomplicated removal at a later date. These findings demonstrate proof of concept for the SubQ Assist and provide evidence for moving towards clinical testing. They demonstrate that the SubQ Assist may be an effective method of task-shifting the insertion of contraceptive implants to minimally trained providers in order to expand access in rural areas.