Abstract

Background Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), which bear 90% of deaths. Current precancer treatments rely on healthcare workers who may be out of reach for many women. Development of a patient-controlled cervical precancer treatment can significantly improve access in remote areas and promote secondary prevention of cervical cancer.

Methods This is a phase I trial among 18 HIV-positive and HIV-negative women in Kenya, investigating use of artesunate vaginal pessaries as treatment for cervical precancer among women screening positive for cervical precancer who need excisional treatment. The primary objective will be the safety of self-administered artesunate pessaries. Participants will self-administer 200mg of artesunate vaginally daily for 5 days, followed by a drug-free week, repeated for a total of 4 cycles (artesunate self-administration on weeks 1, 3, 5, 7). The total study duration, including participant follow-up is 48 weeks. Safety and adherence will be assessed through review of symptom diaries and biweekly follow-ups during the treatment phase. Data analysis will include quantitative and qualitative methods.

Discussion Considering the challenges associated with excisional treatments for cervical precancer in LMICs where access to care is limited, this study proposes an alternative approach using intravaginal Artesunate. This clinical trial will provide important safety and efficacy data on using artesunate as a topical therapy for both HIV-positive and HIV-negative women.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06165614

Funding Statement

This research was supported by the University of North Carolina Lineberger Comprehensive Cancer Center and Gilead Sciences, Inc. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The study funders have no role in the research.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This clinical trial has full ethics review board approval from the University of North Carolina Chapel Hill and the African Medical and Research Foundation. Written informed consent will be obtained from all study participants.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability Statement

Data

List of abbreviationsLMIClow- and middle-income countriesHIVhuman immunodeficiency virusHPVhuman papillomavirusWLWHwomen living with HIVCIN2/3cervical intraepithelial neoplasia grade 2 and 3LEEPLoop Electrosurgical Excision ProcedureCKCCold Knife ConeDHADihydroartemisininAEsadverse events5FU5-FluorouracilCTCAEU.S National Cancer Institute Common Terminology Criteria for Adverse EventsCIConfidence IntervalCSTsCommunity state typesWHOWorld Health Organization