Supplementary file 1_Impact of contraceptive initiation on the cervicovaginal mucosa: results from the UMPALA multicentre, partially randomized patient-preference interventional trial.pdf

Background<p>Long-acting contraceptives are widely used, providing superior efficacy and systemic safety; however, the impact of contraceptive initiation on female genital tract function and health has been understudied.</p>Methods<p>Non-pregnant, HIV-uninfected women aged 18–50 years were enrolled in a dual-centre partially randomized patient-preference interventional trial (NCT04814927) and allowed to choose one of four contraceptive options, etonogestrel contraceptive implant, depot medroxyprogesterone acetate subcutaneous injection, levonorgestrel intrauterine device, and copper IUD, with a minimum target of 12 participants per arm and site.

Sampling took place at baseline, 1 and 3 months after contraceptive initiation, and 1 month post-contraceptive discontinuation. Primary outcomes focused on mucosal function and health, while secondary and tertiary outcomes pertained to systemic and mucosal susceptibility to HIV-1 and HSV-2.</p>Results<p>Cervicovaginal samples from 112 enrolled participants showed transient, statistically significant changes in endpoints comparing baseline vs. 1 and 3 months after contraceptive initiation.