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

May 13, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya, 614-40100
        • Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age 25 years or older
  • Known HIV seropositive status
  • On antiretroviral therapy for > 90 days prior to enrollment
  • Weight ≥50 Kg at study entry*
  • Positive HPV screening test and within 4-8 weeks of thermal ablation
  • Ability to provide informed consent
  • Planning to stay within the study locale during the duration of the study (24 weeks)
  • Agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study

Exclusion Criteria

  • Current pregnancy or breastfeeding status
  • Current or past history of invasive cervical cancer
  • History of total hysterectomy
  • Currently receiving systemic chemotherapy or radiation therapy for another cancer
  • Current use of systemic immunosuppressants or steroids (>10 mg of prednisone or equivalent)
  • Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin
  • Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation
  • Prior chemotherapy within 30 days prior to day 1 of study treatment
  • Male at birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Artesunate vaginal inserts
Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.
Placebo Comparator: 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).
Drug: Placebo vaginal inserts
Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance of type-specific HPV genotype(s)
Time Frame: 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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 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.
Week 6
Acceptability measured by acceptability questionnaire
Time Frame: 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.
Week 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake
Time Frame: Baseline
Number of screen-eligible participants who agree to enroll in the study.
Baseline
Accrual rate
Time Frame: 24 weeks
Number of participants that enrolled in the trial divided by time from the first enrollment to the last enrollment in months.
24 weeks
Retention rate
Time Frame: 24 weeks
Retention rate: Number of women in each study arm retained in the study.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)
Kenya Medical Research Institute
Maseno University School of Medicine, Kenya

Investigators

  • Principal Investigator: Chemtai Mungo, MD, MPH, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Actual)

April 8, 2026

Study Completion (Actual)

April 8, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2330
  • R34CA284983 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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