Using artesunate vaginal inserts to treat cervical precancer in Kenya
Self-administered Artesunate Pessaries for Treatment of Cervical Precancer in Kenya
This study is testing whether self-administered artesunate vaginal inserts can safely treat cervical precancer in women in Kenya, especially for those who can't access surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT06165614 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of self-administered artesunate vaginal pessaries for treating cervical precancer in women from low and middle-income countries, particularly Kenya. The research aims to provide an alternative to the surgical Loop Electrosurgical Excision Procedure (LEEP), which is often inaccessible to women in rural areas. By allowing women to self-administer treatment, the study seeks to improve access to care while minimizing the risks associated with surgical procedures. The study will include both HIV-positive and HIV-negative women diagnosed with cervical precancer.
Who should consider this trial
Good fit: Ideal candidates are women with a CIN2/3 diagnosis on biopsy, weighing at least 50 kg, and able to provide informed consent.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a history of invasive cervical cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more accessible option for women with cervical precancer, potentially reducing cervical cancer rates in low-resource settings.
How similar studies have performed: While this approach is novel, similar studies exploring self-administered treatments for cervical precancer have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy 2. Weight ≥50 kg 3. Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age. 4. Ability and willingness to provide informed consent. Exclusion Criteria: 1. Current pregnancy or breastfeeding status. 2. Current or past history of invasive cervical cancer. 3. History of total hysterectomy. 4. CD4 count less than 200 cells/mm3. 5. Presence of adenocarcinoma in situ on cervical biopsy 6. Currently receiving systemic chemotherapy or radiation therapy for another cancer 7. Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent) 8. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation. 9. Prior chemotherapy within 1 month prior to day 1 of study treatment 10. Male at birth
Where this trial is running
Kisumu
- Lumumba Sub-County Hospital — Kisumu, Kenya (Recruiting)
Study contacts
- Principal investigator: Chemtai Mungo, MD, MPH, FACOG — Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
- Study coordinator: Chemtai P Mungo, MD, MPH, MSc
- Email: cmungo@email.unc.edu
- Phone: 919-966-5280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.