Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya

Phase 2

Recruiting

• Conditions: Cervical Precancer; Human Immunodeficiency Virus; Human Papillomavirus
• Interventions: Drug: Artesunate vaginal inserts; Drug: Placebo vaginal inserts

• Registration Number: NCT06519994
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed Description

WLWH face up to six times increased risk of cervical cancer, as a result, cervical cancer is a leading cause of death in this population. Cervical cancer is caused by persistent infection with the human papillomavirus (HPV), resulting in precancerous changes that if not adequately treated, progress to cancer. Thermal ablation is a commonly used treatment for cervical precancer in Kenya and other low- and middle-income countries (LMICs). Current treatments for HPV or cervical precancer, including thermal ablation, are associated with high rates of treatment failure in WLWH. In a recent study from Zambia, only 44% of WLWH had cleared HPV at six months following thermal ablation treatment. Other studies have demonstrated up to 30% recurrence rate of high-grade cervical precancer at 12 to 24 months after treatment. Persistent infection with HPV following precancer treatment is a key risk factor for treatment disease recurrence.

Study Timeline

• Study Start: 2024-07-04
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artesunate vaginal inserts	Artesunate vaginal inserts	Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).
Placebo vaginal inserts	Placebo vaginal inserts	Participants will self-administer the study placebo nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).

Primary Outcome Measures

Name	Time	Method
Clearance of type-specific HPV genotype(s)	24 weeks	The number and proportion of women in each study arm who demonstrate clearance of the specific HPV genotype, or genotypes (if multiple) between baseline and six months will be reported.

Secondary Outcome Measures

Name	Time	Method
Acceptability measured by acceptability questionnaire	Week 6	Acceptability will be evaluated based on a close-ended structured acceptability questionnaire. The responses will be on a Likert score, between 1-5, and higher scores represent better accepted.
Adherence	Week 6	Adherence will be evaluated based on the number and proportion of women confirmed self-administration of at least 80% (12 of 15) vaginal inserts.

Trial Locations

Locations (1)

Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building; 🇰🇪 Kisumu, Kenya