跳至主要内容
临床试验/NCT06128304
NCT06128304招募中不适用

ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services

University of California, San Diego2 个研究点 分布在 2 个国家目标入组 2,436 人开始时间: 2023年11月13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
2,436
试验地点
2
主要终点
Sustainment

研究概览

简要总结

While there has been a significant increase in the uptake of antiretroviral therapy among women living with HIV (WLHIV) in many low- and-middle income countries (LMICs), the coverage of cervical cancer screening and treatment (CCST) among WLHIV remains low. This study aims to leverage the available infrastructure for HIV care and treatment programs in Nigeria to integrate cervical cancer screening and treatment and conduct a cluster randomized, hybrid type III trial design to assess the comparative effectiveness of a Core set of implementation strategies versus a Core+ (enhanced) set of implementation strategies to implement cervical cancer screening, onsite treatment, referral and referral completion, treatment, and retention in care among WLHIV. The overarching goal is to improve the health and life expectancy of WLHIV with co-occurring cervical cancer.

详细描述

Nigeria has one of the largest HIV epidemics in the world with 1.8 million people living with HIV infection. With an estimated female population of 102 million and HIV prevalence of 1.6% among adult females, Nigeria has the largest population of women and the 4th largest number of women living with HIV (WLHIV) in Africa. Although access to antiretroviral therapy (ART) among WLHIV in Nigeria has increased over the years, with over 98% of the 960,000 WLHIV on ART, AIDS-related mortality remains high. In 2020, 16,000 WLHIV died from AIDS- related illnesses including cervical cancer. A pilot implementation program in Nigeria demonstrated that leveraging the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) supported HIV programs for the provision of evidence-based cervical cancer screen-and-treat interventions in WLHIV is feasible. The pilot program demonstrated, however, that tailored implementation strategies will be needed to address specific multilevel barriers along the cancer control continuum in order to address adoption, reach, and sustainability that are necessary for successful scale-up. However, in many African countries with a high burden of both HIV and cervical cancer, there is a paucity of evidence-based implementation strategies to inform effective integration of HIV and cervical cancer services delivery. Objectives of this proposal are to: 1) Refine strategies to integrate cervical cancer screening, treatment and management within existing comprehensive HIV treatment programs and determine implementation readiness; 2) Determine the comparative effectiveness of a Core set of implementation strategies versus Core+ enhanced implementation strategies; and 3) assess sustainment of the integration of cervical cancer screening, treatment, and management intervention into HIV programs. The investigators have assembled a strong team from University of California San Diego, the University of Nigeria, Nsukka, and Northeastern University with expertise in implementation science, HIV care and research, and cancer care and research. Our proposal is responsive to the NCI request for applications (RFA) and consistent with the World Health Organization global plan of elimination of cervical cancer by 2030. If effective, the proposed project will result in a set of feasible, culturally adaptable, and sustainable implementation strategies to integrate evidence-based cervical cancer screening and treatment into HIV programs in order to improve the health and life expectancy of WLHIV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
25 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women living with HIV

排除标准

  • 未提供

研究组 & 干预措施

Core+ Enhanced Implementation Strategies

Experimental

Includes all of the Core implementation strategies and adds:

5. Community engagement using Health Beginning Initiative Model

6. Smart Cards to facilitate patient engagement

干预措施: Core+ Enhanced Implementation Strategies (Other)

Core Implementation Strategies

Active Comparator

Core Implementation Strategies

  1. Ongoing consultation
  2. Educational meetings
  3. Strengthen referral system
  4. Prepare patients to be active participants

干预措施: Core Implementation strategies (Other)

Core Implementation Strategies

Active Comparator

Core Implementation Strategies

  1. Ongoing consultation
  2. Educational meetings
  3. Strengthen referral system
  4. Prepare patients to be active participants

干预措施: Core+ Enhanced Implementation Strategies (Other)

结局指标

主要结局

Sustainment

时间窗: 3 months prior to study completion

Provider Report of Sustainment Scale (PRESS; Moullin et al., 2021). The PRESS has 3-items scored from 0 "not at all" to 4 "to a very great extent" where higher scores indicate better evidence-based practice sustainment.

Reach

时间窗: 12 months after enrollment

Percent of WLHIV who had cervical cancer (CC) screening

次要结局

  • CCST Effectiveness(15 months after treatment of pre-invasive cancer)

研究者

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

Gregory Aarons

Professor

University of California, San Diego

研究点 (2)

Loading locations...

相似试验