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Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya

RecruitingNAAges 25 Years - 49 YearsFemaleFred Hutchinson Cancer Center
NCT07468695 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. 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 ef

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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
Coptic Hope Center
Nairobi, Kenya
🤝 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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