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临床试验/NCT07050745
NCT07050745招募中不适用

Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya

Kenyatta National Hospital1 个研究点 分布在 1 个国家目标入组 1,980 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,980
试验地点
1
主要终点
Primary implementation outcome: Cervical cancer screening uptake

研究概览

简要总结

This study aims to test the use of a multi-component care strategy (DADA LINK) designed to improve cervical cancer screening and linkage to treatment. The duration of the trial is 12 months, with a 6-month follow-up period to evaluate intervention costs and measure maintenance of the care strategies. Study staff at each clinic will abstract data on cervical cancer screening and triage/treatment. Clinics randomized to the intervention arm will have care coordinators who motivate clinic staff to adhere to cervical cancer care guidelines, conduct patient exit surveys to assess intervention fidelity, and support care coordination through use of the mHealth platform (WEMA).

详细描述

The highest global incidence of cervical cancer is in sub-Saharan Africa, and it is the leading cause of cancer mortality among women in Kenya. Barriers to cervical cancer screening and treatment have been identified at the patient-, provider-, and facility-level, demonstrating the need for a multi-strategy approach to enhance cervical cancer control. In this research study, formative qualitative research and clinic mapping processes were conducted with primary care clinics in Nairobi County to select contextually appropriate strategies targeting the primary barriers to cervical cancer screening and linkage to treatment in Nairobi, Kenya. This study seeks to evaluate the implementation and effectiveness of a care package designed to enhance the early detection and treatment of precancerous cervical lesions among women aged 25-49 years in Kenya.

Trained study staff will abstract patient data from existing clinic records to monitor and assess rates of cervical cancer screening and linkage to treatment.

Study staff at the intervention clinics (i.e., care coordinators) will motivate and support clinic staff to adhere to cervical cancer care guidelines. Care coordinators will use a mHealth platform (i.e., WEMA) tailored for use in primary care clinics in Kenya to track patient exit interview responses regarding uptake of HPV self-sampling kits and to support clinic staff by tracking cervical cancer screening, follow-up, and linkage to treatment, when appropriate. WEMA will serve as an information management system in the intervention clinics, providing a data dashboard to track patient follow-up and enable text communication with patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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 ages 25-49 years

排除标准

  • •Pregnant women
  • •Women ≤6 weeks postpartum
  • •Women already confirmed to have cervical cancer

研究组 & 干预措施

Routine standard of care for cervical cancer screening, linkage and treatment

No Intervention

Clinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment

DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth support

Experimental

Intervention facilities will receive the DADA-LINK multi-component integrated care package comprised of HPV self-sampling, care navigation, and mHealth support.

干预措施: DADA LINK (Behavioral)

结局指标

主要结局

Primary implementation outcome: Cervical cancer screening uptake

时间窗: 1 day (on the day of clinic visit)

Binary endpoint (Yes/No) based on completion of the HPV self-sampling (return of the self-collected HPV swab) or having conducted VIA

Primary effectiveness outcome: Receipt of triage and/or treatment

时间窗: within 12 months

Binary endpoint (Yes/No) based on receipt of triage and/or treatment

次要结局

  • Secondary effectiveness outcomes: Form of triage and/or treatment received(within 12 months)
  • Communication of HPV test result to patients via mHealth messages(Within 10 days of results being made available)
  • Secondary effectiveness outcomes: Form of triage and/or treatment received(within 12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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