Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya

NCT07468695 — Not applicable, Recruiting, 300 participants, Fred Hutchinson Cancer Center

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

Registry	NCT07468695
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	300 (Estimated)
Sponsor	Fred Hutchinson Cancer Center (Other); collaborators: University of Washington, National Cancer Institute (NCI), University of Cincinnati, Frontier Science & Technology Research Foundation, Inc., Emory University, Coptic Hope Center
Conditions	HIV (Human Immunodeficiency Virus), HPV, Cervical Precancer
Interventions	Thermal ablation (TA) with 1 probe, Thermal ablation (TA) with 2 probes (Procedure)
Dates	start 2026-10-12, primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-03-12, last updated 2026-10-20
Locations	1 site in Kenya

-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. In Kenya, the estimated incidence rate of cervical cancer is 31-33 per 100,000 women per year among women without HIV and approximately 70-100 per 100,000 among WLWH.

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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Group 1 (TA with 1 probe)	Experimental	Procedure: Thermal ablation (TA) with 1 probe	Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 1 probe at month 0.
Group 2 (TA with 2 probes)	Experimental	Procedure: Thermal ablation (TA) with 2 probes	Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 2 probes at month 0.

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

+Outcome measures

Primary outcomes

HPV positive [From enrollment to follow up at 6 months]: Proportion of participants with persistent HPV at 6 months

+Eligibility

Sex: Female, ages: 25 Years to 49 Years

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

+Locations (1)

Facility	City	Country	Status
Coptic Hope Center	Nairobi	Kenya	Recruiting

+Investigators

Rachel L Winer, PhD, MPH, Principal investigator, University of Washington
Margaret M Madeleine, PhD, MPH, Study chair, Fred Hutchinson Cancer Center
Leeya Pinder, MD, MPH, Study chair, University of Cincinnati

+Funding

NIH grants: UG1CA275402, U24CA275417, UG1CA275400