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减少差距的阿巴拉契亚伙伴关系(目标 2)

2026年10月21日 更新者:Wake Forest University Health Sciences

利用同伴导航和 mHealth 的力量来减少阿巴拉契亚的健康差异

By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia.

Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.

研究概览

详细说明

This CBPR study will advance prevention science and practice through testing an innovative intervention to promote and support the use of needed HIV, STI, and HCV prevention and care services among GBMSM and transgender women; and developing priorities and recommendations to improve their health that will be disseminated to inform public health practice, research, and policy. By integrating peer navigation and mHealth strategies, the proposed study provides a unique opportunity to improve health among vulnerable, hidden, and neglected populations living in rural Appalachia. Findings from this research may inform strategies and approaches to address other health disparities in other rural populations.

研究类型

介入性

注册 (实际的)

141

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • Wake Forest University Health Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • reside in one of the rural Appalachian catchment counties
  • be ≥18 years of age
  • report being assigned male sex at birth and having had sex with at least 1 man in past 12 months
  • provide informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:intervention group

7 community health leaders; 56 social network members

First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services.

Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention

In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate "in-real-time" via social media about the process of participating in a syringe services program or accessing PrEP.

有源比较器:delayed-intervention

7 community health leaders; 56 social network members

First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services.

Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention

In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate "in-real-time" via social media about the process of participating in a syringe services program or accessing PrEP.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
接受过人类免疫缺陷病毒 (HIV) 检测的参与者人数
大体时间:基线
基线
接受过性传播感染 (STI) 检测的参与者人数
大体时间:基线
基线
接受过丙型肝炎病毒 (HCV) 检测的参与者人数
大体时间:基线
基线
接受 HIV 检测的参与者人数
大体时间:干预后即刻(基线后 12 个月)
干预后即刻(基线后 12 个月)
进行性传播感染检测的参与者人数
大体时间:干预后即刻(基线后 12 个月)
干预后即刻(基线后 12 个月)
进行丙型肝炎病毒检测的参与者人数
大体时间:干预后即刻(基线后 12 个月)
干预后即刻(基线后 12 个月)
接受 HIV 检测的参与者人数
大体时间:12 个月的随访(基线后 24 个月)
12 个月的随访(基线后 24 个月)
进行性传播感染检测的参与者人数
大体时间:12 个月的随访(基线后 24 个月)
12 个月的随访(基线后 24 个月)
进行丙型肝炎病毒检测的参与者人数
大体时间:12 个月的随访(基线后 24 个月)
12 个月的随访(基线后 24 个月)

次要结果测量

结果测量
措施说明
大体时间
使用预防的参与者人数——暴露前预防(PrEP)
大体时间:基线、干预后立即(基线后 12 个月)和 12 个月随访(基线后 24 个月)。
基线、干预后立即(基线后 12 个月)和 12 个月随访(基线后 24 个月)。
使用预防——注射器服务的参与者人数
大体时间:基线、干预后立即(基线后 12 个月)和 12 个月随访(基线后 24 个月)。
基线、干预后立即(基线后 12 个月)和 12 个月随访(基线后 24 个月)。
Number of participants who use HIV care services
大体时间:baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction

baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Number of participants who use STI treatment services
大体时间:baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction

baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Number of participants who use HCV treatment services
大体时间:baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction

baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Number of participants who use gender-affirming care services
大体时间:baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction

baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Scott D. Rhodes, Ph.D, MPH、Wake Forest University Health Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年4月1日

初级完成 (实际的)

2026年5月31日

研究完成 (实际的)

2026年5月31日

研究注册日期

首次提交

2020年5月4日

首先提交符合 QC 标准的

2020年5月4日

首次发布 (实际的)

2020年5月7日

研究记录更新

最后更新发布 (实际的)

2026年10月26日

上次提交的符合 QC 标准的更新

2026年10月21日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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