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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
Status
Not yet recruiting
NCT ID
NCT07645352
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.
Intervention
Thermal ablation (TA) with 1 probe, Thermal ablation (TA) with 2 probes
Condition
HIV (Human Immunodeficiency Virus), HPV, Cervical Precancer, Cervical Neoplasia
Investigators
Rachel L Winer, PhD, MPH, Margaret M Madeleine, PhD, MPH, Leeya Pinder, MD, MPH, Bothwell Guzha, MBChB, Zvavahera Mike Chirenje, MD, FRCOG
CT Research Area
Symptom Science

See list of participating sites