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临床试验/NCT04462679
NCT04462679Unknown不适用

COMMIT HIV Acceptability and Feasibility Trial

Possible1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年2月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
86
试验地点
1
主要终点
CD4 count

研究概览

简要总结

Community Healthcare Workers (CHWs), who live in the communities they serve, have the potential to reach patients who poorly engage in their care. Motivational Interviewing (MI) is a special type of interactional approach that focuses on improving the person's motivation to engage in healthy behaviors, such as keeping their clinic appointments and regularly taking medications. In this study, we will develop a mobile health tool that will assist CHWs in two tasks while they utilize MI to assist patients' engagement in care: 1) follow prompts on the mobile device to deliver MI; and 2) record consented conversations between CHWs and patients so that MI specialists can review the audiotape and provide feedback to maintain the MI skills.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Inclusion criteria for patient population: 1) having a documented HIV diagnosis, 2) living in the community health worker catchment area at the Nepal research site and , 3) having poor adherence (missed a clinic visit by more than 2 weeks, <95% adherence from visual analogue scale and/ or failed to refill their antiretroviral medications 1 week past the expected date)
  • Inclusion criteria for community health worker or a community health worker supervisor: living/working at the Nepal research site who has received motivational interviewing training as part of the intervention, and are involved directly in program implementation process.

排除标准

  • Exclusion criteria for patient population: includes decision from the patient to not receive care delivered by care provider at the Nepal research site or not to participate in the study
  • Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

结局指标

主要结局

CD4 count

时间窗: 9 months

Individual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold

HIV viral load

时间窗: 9 months

Individual HIV viral load count, measured at baseline and endline, with viral load suppression or \>2 log drop in viral load as binary suppressed/not threshold

Self-reported HIV treatment adherence

时间窗: 9 months

Individual ART medication adherence over past month as measured by the self-reported HIV visual analogue scale (scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to a stronger outcome; patients asked to self-report what proportion of prescribed medications did the patient take over the past month).

次要结局

  • Application error/crash percentage(9 months)
  • Application access and completion percentage(9 months)
  • Patient encounter duration(9 months)

研究者

发起方
Possible
申办方类型
Other
责任方
Sponsor

研究点 (1)

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