“When a Thorn Comes Into Your Body, You Must Remove It”. A Socio-Ecological Analysis of the Acceptability of Intravaginal Artesunate as Cervical Precancer Treatment in a Phase 1 Clinical Trial

Introduction: Innovative strategies are crucial to meet the World Health Organization's 90/70/90 cervical cancer elimination targets and to prevent millions of deaths by 2030. Women in low-and middle-income countries (LMICs) bear the greatest burden of cervical cancer yet have limited access to cervical precancer treatment. Scalable solutions, such as self-administered intravaginal therapies, can help close this treatment gap. In an ongoing Phase 1 trial of intravaginal artesunate pessaries as primary treatment for cervical intraepithelial neoplasia grade 2 or 3 (CIN 2/3), we evaluated the acceptability of this intervention among trial participants. Methods: Seventeen participants completed in-depth interviews in their preferred language, focusing on their experiences with artesunate self-administration and contextual factors that impacted acceptability. We conducted a thematic analysis using the socioecological framework to analyze product, individual, partner, community, and cultural factors related to acceptability of intravaginal artesunate. Results: Participants in this Phase 1 trial were primarily low-income women with limited formal education, and the majority were also living with HIV and had been on antiretrovirals for over a decade. Despite minimal prior experience with vaginal self-administration of medication, participants found the pessary acceptable and were highly motivated to get treatment for cervical precancer. Social support, educational interventions, and faith were crucial in enabling participants to complete the treatment protocol successfully. Conclusion: Kenyan women found self-administered intravaginal artesunate for treating CIN2/3 to be highly acceptable. Randomized studies of intravaginal artesunate and other topical therapies are needed to further evaluate their efficacy and acceptability in LMICs. Clinical Trials Registration: Clinicaltrials.gov NCT06165614.