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临床试验/NCT07015957
NCT07015957进行中(未招募)4 期

Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

New York University1 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2025年7月8日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
7,000
试验地点
1
主要终点
Difference in prevalence of discussions surrounding methods of cervical cancer prevention

研究概览

简要总结

The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are:

  1. Which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, cervical cancer prevention tools among people receiving HIV care.
  2. What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies.
  3. What is the sustained effect of these implementation strategies. The implementation strategies will be conducted with health workers (clinical officers, nurses, and medical assistants): training, coaching, and a reminder system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Health workers: People who provide medical care and counseling (typically medical assistants, clinical officers, and nurses), and interact with adolescent girls and young women aged 9-24 and/or their parents/caregivers.
  • •Clients: Non-pregnant females aged 9-24 (for those aged 9-17, their male or female parent/guardian will also be eligible for participation) who present for HIV care at a participating health facility during the study period.

排除标准

  • •Health workers: Less than 18 years of age, or not an active and regular provider of medical care or counseling at the facility, or unable or unwilling to provide informed consent.
  • •Clients: <9 or >24 years old, or pregnancy, or unable or unwilling to provide informed consent.

研究组 & 干预措施

Condition 7: Virtual training + Coaching

Experimental

干预措施: Virtual training (Behavioral)

Condition 4: In-person training + Prompt + Coaching

Experimental

干预措施: Prompts (Behavioral)

Condition 6: Virtual training + Prompt

Experimental

干预措施: Virtual training (Behavioral)

Condition 6: Virtual training + Prompt

Experimental

干预措施: Prompts (Behavioral)

Condition 8: Virtual training + Prompt + Coaching

Experimental

干预措施: Virtual training (Behavioral)

Condition 4: In-person training + Prompt + Coaching

Experimental

干预措施: Coaching (Behavioral)

Condition 1: In-person training

Active Comparator

干预措施: In-person training (Behavioral)

Condition 2: In-person training + Prompt

Experimental

干预措施: In-person training (Behavioral)

Condition 2: In-person training + Prompt

Experimental

干预措施: Prompts (Behavioral)

Condition 3: In-person training + Coaching

Experimental

干预措施: Coaching (Behavioral)

Condition 4: In-person training + Prompt + Coaching

Experimental

干预措施: In-person training (Behavioral)

Condition 3: In-person training + Coaching

Experimental

干预措施: In-person training (Behavioral)

Condition 8: Virtual training + Prompt + Coaching

Experimental

干预措施: Prompts (Behavioral)

Condition 5: Virtual training

Experimental

干预措施: Virtual training (Behavioral)

Condition 7: Virtual training + Coaching

Experimental

干预措施: Coaching (Behavioral)

Condition 8: Virtual training + Prompt + Coaching

Experimental

干预措施: Coaching (Behavioral)

结局指标

主要结局

Difference in prevalence of discussions surrounding methods of cervical cancer prevention

时间窗: Months 7-18

Discussions about methods of cervical cancer prevention will be reported by clients following each routine HIV care visit. This rate is defined as the percentage of visits during which there is a discussion about methods of cervical cancer prevention. This rate will be compared between the groups with and without each intervention component.

次要结局

  • Difference in prevalence of completing a cervical cancer prevention program(Months 7-18)
  • Difference in prevalence of initiating a cervical cancer prevention program among those uninitiated(Months 7-18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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