TwySHE—an mHealth peer-navigator intervention to increase PrEP and contraceptive use among female university students in Zambia: study protocol of a hybrid effectiveness-implementation randomized controlled trial

Trainings for the research team and peer navigators delivering the intervention are complete. The trial began enrolling participants on March 14th, 2025. As of May 6, 2025, 105 participants have been enrolled. The findings of this study will establish the effectiveness and implementation of a novel peer navigator mhealth intervention to increase PrEP and modern contraception use and persistence. If effective, the intervention has the potential to ultimately contribute to efforts in Zambia and elsewhere to reduce unintended pregnancy and HIV acquisition among high-risk sub-populations of in-school AGYW. TRIAL REGISTRATION {2A; 2B}: The study has been prospectively registered in ClinicalTrials.gov (NCT06852508). Registered on February 28, 2025, https://clinicaltrials.gov/study/NCT06852508?term=NCT06852508&rank=1.