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NCT Number: NCT06519994

Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment 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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Cervical Precancer Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HIV Infections Human Papillomavirus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Precancerous Conditions RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building

Kisumu, 614-40100, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate vaginal inserts

Drug

Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.

Placebo vaginal inserts

Drug

Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Uptake

    Time frame: Baseline

    Number of screen-eligible participants who agree to enroll in the study.

  2. 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.

  3. Retention rate

    Time frame: 24 weeks

    Retention rate: Number of women in each study arm retained in the study.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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