Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,019
- 试验地点
- 1
- 主要终点
- VIA follow-up and treatment when indicated (screen and treat)
研究概览
简要总结
The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.
This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.
Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.
详细描述
A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.
The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with no previous history of hysterectomy
- •aged 25-49 years old
- •no previous history of treatment for cervical cancer
- •provided written informed consent.
排除标准
- •Women who are under 25 or over 49 years of age,
- •who have previously had a hysterectomy or been treated for cervical cancer
- •unable to provided informed consent.
结局指标
主要结局
VIA follow-up and treatment when indicated (screen and treat)
时间窗: Outcome measured within 6 weeks of self-collection for HPV test
Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type
次要结局
- Barriers and facilitators of engagement in care(FGDs within 3 months of recruitment completion)
- Identify mediators of engagement of care(Outcome measured within 6 weeks of self-collection for HPV test)
- HPV prevalence(Baseline)
- STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)(Baseline)
- HPV and co-morbid conditions(Baseline)
研究者
Gina Ogilvie
Principal Investigator
University of British Columbia