Clinical Trial

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

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07468695
Lead Sponsor Fred Hutchinson Cancer Center
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
Enrollment 300 participants
Start Date 2026-03
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12