Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS5 Rwanda

Fred Hutchinson Cancer Center (FHCC)

Status: Begins enrollment this month

Conditions: HPV; Cervical Precancer; HIV (Human Immunodeficiency Virus)

Treatments: Procedure: Thermal ablation (TA) with 2 probes; Procedure: Thermal ablation (TA) with 1 probe

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07390916

UG1CA275402 (U.S. NIH Grant/Contract)

RG1124082 (C1001P-CS5 Rwanda)

U24CA275417 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 25-49 years old
2. Living with HIV

Inclusion criteria specific to the feasibility study

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Group 1 (TA with 1 probe)

Experimental group

Description:

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.

Treatment:

Procedure: Thermal ablation (TA) with 1 probe

Group 2 (TA with 2 probes)

Experimental group

Description:

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.

Treatment:

Procedure: Thermal ablation (TA) with 2 probes