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临床试验/NCT05817370
NCT05817370招募中不适用

Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2023年5月2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
试验地点
1
主要终点
Change in HSIL detection

研究概览

简要总结

The study is a feasibility pilot trial testing 2 types of training protocols on a single physician. The first training protocol is the current standard and was developed in high-income settings. The second training protocol will be developed so tailored to the Nigerian setting. Investigators will test if the physician performs differently in their ability to conduct anal cancer screening and treatment between the 2 training protocols.

详细描述

In Aim 1, anal cancer screening and treatment based on standard training protocols of how to screen and treat high-grade intraepithelial lesions (HSILs) to prevent anal cancer as developed in high-income settings will be conducted. Investigators will identify barriers and facilitators with learning the procedure with standard training using the Consolidated Framework for Implementation Research (CFIR). In Aim 2, Investigators will identify strategies to modify the standard training to improve learning on a complicated procedure using the Expert Recommendations for Implementing Change (ERIC) framework. An implementation science committee will co-design and develop an enhanced training on Screening and Treatment of HSIL (e-STH) by matching the barriers identified with CFIR with strategies in ERIC. Investigators will then take an iterative improvement approach to test and refine the implementation of the enhanced training intervention to ensure that HSIL screening and treatment is readily adopted and maintained as part of HIV care. In Aim 3 (CLINICAL TRIAL AIM), Investigators will conduct a Hybrid Type 2 trial using an interrupted time series design to monitor and evaluate outcomes along the implementation continuum. The trial will be conducted at a single clinic to minimize variability. The participant (Physician) will have a pre-period of HSIL screening and treatment for 12 months after standard training. Next, investigators will roll out e-STH for 6 months. Then there will be a post-period of screening for 12 months to evaluate the impact of e-STH. Lastly, there will be 6 months of screening and treatment with minimal involvement of the investigative team to evaluate sustainability.

The study will compare e-STH to standard training in proportion of HSIL detected and treated with secondary outcomes evaluating reach, efficacy, implementation, and sustainability.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Possess a medical degree in medical sciences (MBBS or equivalent)
  • At least 2-5 years of experience working with clinical HIV/AIDS community
  • Must be registered with the medical and dental council of Nigeria
  • Possess a current medical practicing license
  • Willing to work with the Sexual Gender Minority Community

排除标准

  • 未提供

研究组 & 干预措施

Standard Screening and treatment of HSIL

No Intervention

The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society

Enhanced Training on screening and treatment of HSIL (e-STH)

Experimental

Tailored training developed to overcome key barriers and promote facilitators unique to implementing HSIL screening and treatment. The development will be driven by the implementation science committee over 3 iterations every 4 months for up to a year to refine the adoption of strategies with the greatest breadth to facilitate implementation.

干预措施: Enhanced Training on screening and treatment of HSIL (e-STH) (Behavioral)

结局指标

主要结局

Change in HSIL detection

时间窗: 12 months and 30 months

Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)

Change in HSIL treatment

时间窗: 12 months and 30 months

Evaluate change in HSIL treated between the pre and post period (standard vs e-STH)

次要结局

  • Change in Reach of intended population(12 months and 30 months)
  • Change in Implementation of HSIL screening and treatment(12 months and 30 months)
  • Change in Efficacy of conducting HSIL screening and treatment(12 months and 30 months)
  • Change in Maintenance of HSIL screening and treatment(18 months and 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Nowak

Assistant Professor

University of Maryland, Baltimore

研究点 (1)

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