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NOT YET RECRUITING
NCT07645352
NA

Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment 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 and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.

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

Key Details

Gender

FEMALE

Age Range

25 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-10

Completion Date

2027-05-31

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

PROCEDURE

Thermal ablation (TA) with 1 probe

Undergo TA with 1 probe

PROCEDURE

Thermal ablation (TA) with 2 probes

Undergo TA with 2 probes

Locations (1)

University of Zimbabwe, Centre for Research

Harare, Zimbabwe