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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 • ClinicalTrials.gov ID: NCT07645352

Registry updated: 2026-10-19

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Description

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.

Interventions

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

Eligibility criteria

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

Conditions

HIV (Human Immunodeficiency Virus) HPV Cervical Precancer Cervical Neoplasia

Locations

University of Zimbabwe, Centre for Research — Harare, Zimbabwe

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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