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Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH). The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.
Official title: Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
Key Details
Gender
FEMALE
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-22
Completion Date
2026-04-08
Last Updated
2025-12-17
Healthy Volunteers
No
Interventions
Artesunate vaginal inserts
Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.
Placebo vaginal inserts
Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.
Locations (1)
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, Kenya