NCT07468695

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Female
• Age: 25 Years – 49 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV (Human Immunodeficiency Virus)
• HPV
• Cervical Precancer

Interventions

Type	Name	Description
PROCEDURE	Thermal ablation (TA) with 1 probe	Undergo TA with 1 probe
PROCEDURE	Thermal ablation (TA) with 2 probes	Undergo TA with 2 probes

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Kenya