NCT07390916

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

January 29, 2026

Last Update Submit

April 24, 2026

Conditions

HIV (Human Immunodeficiency Virus)HPVCervical Precancer

Keywords

HIVCervical cancer screeningTreatment of Cervical PrecancerThermal ablationHuman papillomavirus

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with persistent HPV at 6 months

    hrHPV positive at 0 and 6 months

    From enrollment to follow up at 6 months

Study Arms (2)

Group 1 (TA with 1 probe)

EXPERIMENTAL

Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo with 1 probe at month 0.

Procedure: Thermal ablation (TA) with 1 probe

Group 2 (TA with 2 probes)

EXPERIMENTAL

Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo with 2 probes at month 0.

Procedure: Thermal ablation (TA) with 2 probes

Interventions

Thermal ablation (TA) with 2 probesPROCEDURE

Undergo TA with 2 probes

Group 2 (TA with 2 probes)
Thermal ablation (TA) with 1 probePROCEDURE

Undergo TA with 1 probe

Group 1 (TA with 1 probe)

Eligibility Criteria

Age25 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Living with HIV
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research for Development (RD) Rwanda

Kigali, Rwanda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Rachel L Winer, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Margaret M Madeleine, PhD, MPH

    Fred Hutchinson Cancer Center

    STUDY CHAIR

  • Leeya Pinder, MD, MPH

    University of Cincinnati

    STUDY CHAIR

Central Study Contacts

Araceli Loera, MPH

CONTACT

+1 206-667-5816aloera@fredhutch.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Clinical Site staff involved in provision of clinical care, recruitment, or follow-up will be blinded to allocation until after visual inspection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Research data will be shared in a timely manner, with appropriate privacy and confidentiality protections, using the policies and procedures outlined in the NIH Guidelines for Sharing Research Data. Guidelines, oversight, and requirements for sharing data are based on the institutional policies, IRB rules, and local, state, and federal laws and regulations. In all cases, the privacy and confidentiality of all people who participate in the research will be protected. Clinical data on women living with HIV generated during the study will be made available to researchers in both the private and public sector free or for a nominal charge.

Time Frame
Deidentified data, the study protocol, and the data dictionary will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes, for up to 5 years.
Access Criteria
Requestors will be required to obtain IRB approval and sign a data use agreement before data will be released. The data use agreement must include the following commitments: a commitment to using the data for research purposes only and not to identify any individual participants; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; and a commitment to meet any additional requirements that might be stipulated by the RNEC or Fred Hutch regulatory review committees or NCI.

Locations

RW(1)