Improving Cervical Cancer Screening in Women Living With HIV Attending Chronic Disease Clinics in Semi-rural Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,974
- 试验地点
- 1
- 主要终点
- Number of WLWH attending CC screening
研究概览
简要总结
This study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). It is to assess the performance of two novel diagnostic tests (QuantiGene-molecular profiling histology (QG-MPH) and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening.
详细描述
Cervical cancer (CC) is the most common cancer among women living with HIV (WLWH) and the leading cause of cancer-related death in women in East Africa. Currently there are around 2800 WLWH in care at the Chronic Disease Clinic of Ifakara (CDCI), of whom only 8% attended CC screening services in the last three years.
This research project is to assess (with a mixed-method, before-/after-study) the impact of a bundle of procedures, which consists of: portable colposcopy, Human Papilloma Virus (HPV) testing and treatment of precancerous cervical lesions by Loop electrosurgical excision procedure (LEEP).
This study is also to analyze the prevalence of cervical disease in the cohort, stratified by stage and co-infections, as well as the acceptability, feasibility and costs.
Additionally, it will assess the performance of two novel diagnostic tests (QG-MPH and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening. This is an implementational study nested within the KIULARCO study consisting of two interacting parts: a pre/post assessment of the impact of the bundle of interventions with mixed-methods study design and the diagnostic tests accuracy (evaluated with a cross-sectional study). The treatment investigated is regarded as standard treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •WLWH enrolled in KIULARCO, who are at least 3 months on Anti-Retroviral Treatment (ART)
- •18-65 years of age
- •Non-pregnant (reported)
- •Signed informed consent
排除标准
- •Pregnancy
- •Known invasive cervical cancer
- •Any condition interfering with visualization of the cervix
结局指标
主要结局
Number of WLWH attending CC screening
时间窗: one time assessment at Screening
Number of WLWH attending CC screening in the period 08/2021 - 06/2022; Attendance of screening: for the pre-phase women undergoing Visual inspection with acetic acid (VIA), for the post- phase women performing cervical self-sampling.
次要结局
- Number of detected patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.(one time assessment at Screening)
- Number of detected High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)(one time assessment at Screening)