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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

RecruitingNAAges 25 Years - 49 YearsFemaleFred Hutchinson Cancer Center
NCT07645352 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Thermal ablation (TA) with 1 probe
  • Thermal ablation (TA) with 2 probes
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Where

1 site
University of Zimbabwe, Centre for Research
Harare, Zimbabwe
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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