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

Официальное название

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

Обзор

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.

Подробное описание

Participants will first undergo HPV testing or visual assessment with acetic acid at screening. Participants with positive screening results undergo a clinical exam comprising visual inspection with acetic acid, digital imaging, brush biopsies of the ectocervix and the endocervix, and assessment for TA treatment. Participants who have a type 1 transformation zone (TZ1) and are otherwise eligible for TA will receive TA with either one or two probes. Screen positive women will be randomized to:

GROUP 1: TA with 1 probe. GROUP 2: TA with 2 probes.

Participants are followed up at 6 months with an HPV test, brush biopsies, and visual assessment of the cervix.

Participants who are not TA eligible will be referred to local care.

Вмешательства

• Процедура Thermal ablation (TA) with 1 probe
  Undergo TA with 1 probe
• Процедура Thermal ablation (TA) with 2 probes
  Undergo TA with 2 probes

Первичные конечные точки

• Proportion of participants with persistent HPV at 6 months [Срок оценки: From enrollment to follow up at 6 months]

Критерии участия

Критерии включения

• 25-49 years old
• Living with HIV

Inclusion criteria specific to the feasibility study

• Intact cervix
• Willing to return to facility at 6 months
• Willing and able to provide informed consent
• Positive hrHPV or VIA test within 3 months of enrollment
• Type 1 transformation zone (TZ1)
• Thermal ablation eligible

Критерии исключения

• Screened for cervical cancer outside of study in last 6 months
• Currently pregnant or less than 6 weeks postpartum
• Prior diagnosis of cervical cancer
• A history of treatment for cervical precancer
• Total hysterectomy
• Currently receiving treatment for any cancer
• Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study
• Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Zimbabwe · 1 центр

• University of Zimbabwe, Centre for Research — Harare

Идентификаторы

NCT: NCT07645352 · RG1124082 (C1001P-CS7 Zim) · 5UG1CA284918-03 · U24CA275417 · UG1CA275402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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