Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of participants with persistent HPV at 6 months
研究概览
简要总结
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 efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.
详细描述
Participants will first undergo HPV testing or visual inspection 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Clinical Site staff involved in provision of clinical care, recruitment, or follow-up will be blinded to allocation until after visual inspection.
入排标准
- 年龄范围
- 25 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 2 (TA with 2 probes)
Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 2 probes at month 0.
干预措施: Thermal ablation (TA) with 2 probes (Procedure)
Group 1 (TA with 1 probe)
Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 1 probe at month 0.
干预措施: Thermal ablation (TA) with 1 probe (Procedure)
结局指标
主要结局
Proportion of participants with persistent HPV at 6 months
时间窗: From enrollment to follow up at 6 months
次要结局
未报告次要终点
研究者
Margaret M. Madeleine, PhD
Professor
Fred Hutchinson Cancer Center