“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
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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 like 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
17 participants completed in-depth interviews in their preferred language, focusing on their experiences with artesunate self-administration, including their interactions with the health system, partners, and community while on treatment. In the qualitative study, acceptability was defined as “satisfaction with the product and willingness to use it in the future” as well as “correct and consistent use during the study.” We conducted a thematic analysis using the socioecological framework.
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 in LMICs are needed to evaluate their use in closing the treatment gaps in these settings.
Ethics Statement
This clinical trial received ethical approval from the following Institutional Review Boards and regulatory authorities: the University of North Carolina at Chapel Hill (USA; approval #23-0902); Amref Health Africa Ethics and Scientific Review Committee (Kenya; approval #P1457/2023); the Kenya Pharmacy and Poisons Board (approval #ECCT/23/09/05), the National Commission for Science, Technology, and Innovation (NACOSTI) (Kenya; approval #NACOSTI/P/24/33045); and the Department of Health Services Kisumu County (approval #GN133VOL.XV/502). Written informed consent was obtained from all study participants before participation.
