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NCT Number: NCT07390916

Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda

Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. This is even more important at a time when Rwanda has launched a National Cervical Cancer Screening Program (NCCSP) with human papillomavirus (HPV) testing and treatment, mainly using TA with unknown outcomes. Therefore, we will conduct a feasibility study (C1001P-CS5) among 300 Rwandan WLWH to provide evidence needed to launch a future effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030. Rwanda hopes to achieve this goal early, in 2027 under Mission 2027.

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Key information

Conditions

HIV (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 HPV 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–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Research for Development (RD) Rwanda

Kigali, Rwanda

Location contact

Fidel Rubagumya, MD, MPH

CONTACT

[email protected]

+250788824442

Fidel Rubagumya, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

Participants will first undergo HPV testing or visual inspection with acetic acid at screening. Participants with positive screening results undergo a clinical exam comprising visual inspection with acetic acid, digital imaging, brush biopsies of the ectocervix and the endocervix, and assessment for TA treatment. Participants who have a type 1 transformation zone (TZ1) and are otherwise eligible for TA will receive TA with either one or two probes. Screen positive women will be randomized to:

GROUP 1: TA with 1 probe. GROUP 2: TA with 2 probes.

Participants are followed up at 6 months with an HPV test, brush biopsies, and visual assessment of the cervix.

Participants who are not TA eligible will be referred to local care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 25-49 years old
  • Living with HIV

Inclusion criteria

specific to the feasibility study

  • Intact cervix
  • Willing to return to facility at 6 months
  • Willing and able to provide informed consent
  • Positive hrHPV or VIA test within 3 months of enrollment
  • Type 1 transformation zone (TZ1)
  • Thermal ablation eligible

Exclusion criteria

  • Screened for cervical cancer outside of study in last 6 months
  • Currently pregnant or less than 6 weeks postpartum
  • Prior diagnosis of cervical cancer
  • A history of treatment for cervical precancer
  • Total hysterectomy
  • Currently receiving treatment for any cancer
  • Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study
  • Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled

Treatment and study plan

Thermal ablation (TA) with 1 probe

Procedure

Undergo TA with 1 probe

Thermal ablation (TA) with 2 probes

Procedure

Undergo TA with 2 probes

Primary outcomes

  1. Proportion of participants with persistent HPV at 6 months

    Time frame: From enrollment to follow up at 6 months

    hrHPV positive at 0 and 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Araceli Loera, MPH

CONTACT

[email protected]

+1 206-667-5816

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Frontier Science & Technology Research Foundation, Inc.
  • National Cancer Institute (NCI)
  • University of Cincinnati
  • University of Rwanda
  • University of Washington

Registry information

Official study title

Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Apr 29, 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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