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Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs

2026年6月1日 更新者:University of California, San Francisco

This study builds upon an ongoing NIH-funded randomized controlled trial (R01DA053325) evaluating a Partner Navigation Intervention to increase hepatitis C virus (HCV) treatment initiation among young adult people who inject drugs (PWID) and their injecting partners in San Francisco. The proposed research includes secondary analyses of existing trial data, additional survey measures, qualitative interviews, and a pilot intervention adaptation.

The study has two primary objectives. First, it examines how racialized discrimination (structural, interpersonal, and internalized) affects HCV treatment initiation and dyadic partner support processes within injecting partnerships. Second, it evaluates whether a brief, adapted "booster" partner navigation session delivered at HCV treatment completion can improve engagement in ongoing healthcare.

Participants include adults (≥18 years) who inject drugs and have been diagnosed with HCV, along with their primary injecting partners. Study activities include longitudinal surveys, qualitative interviews with a subset of participants, and a pilot intervention session with follow-up evaluation.

This research addresses critical gaps in understanding how social relationships and structural inequities influence healthcare engagement among PWID. Findings will inform culturally responsive adaptations to dyadic interventions and improve continuity of care in a population disproportionately affected by HCV and systemic barriers to healthcare.

研究概览

研究类型

介入性

注册 (估计的)

50

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。

学习联系方式

学习地点

    • California
      • San Francisco、California、美国、94103
        • Quaker Meeting House
        • 接触:
        • 首席研究员:
          • Meghan Morris, PhD

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion criteria:

For index participants:

  • 18 years of age or older at enrollment
  • History of injecting drug use
  • Completed HCV treatment within the past 3 months
  • Report a primary injecting partner willing to participate
  • Willing and able to provide informed consent
  • English or Spanish speaking

For primary injecting partners:

  • Primary injecting partner of an enrolled index participant:
  • 18 years of age or older at enrollment
  • Willing and able to provide informed consent
  • English or Spanish speaking
  • has context menu

Exclusion criteria:

For both index participants and injecting partners:

  • Unable to provide informed consent due to cognitive impairment or acute intoxication at the time of enrollment
  • Previously participated in this study in any capacity

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:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Partner Navigation Booster Session
Injecting dyads (index participant and their primary injecting partner) receive one adapted Partner Navigation Intervention booster session at the point of HCV treatment completion, designed to strengthen partnership-based support for sustained healthcare engagement beyond HCV care.
A single adapted dyadic session delivered to PWID and their primary injecting partner at the point of HCV treatment completion. The session builds on the original two-session Partner Navigation Intervention (PNI) developed in the YETI study (R01DA053325) and is adapted to target partnership-based support for broader post-treatment healthcare access, including primary care, mental health, and harm reduction services. Session content includes collaborative goal-setting, barrier identification, and partner communication skills.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Acceptability of the booster session
大体时间:1 week
Participant-reported acceptability of the adapted Partner Navigation Intervention booster session, assessed via via brief 3 item questionnaire with 4-point likert response options. Administered to index participants and their injecting partners following session completion.
1 week
Feasibility: recruitment rate
大体时间:up to 25 weeks
Proportion of eligible dyads who consent and enroll, calculated as the number enrolled divided by the number approached and screened.
up to 25 weeks
Feasibility: retention rate
大体时间:up to 25 weeks
Proportion of enrolled dyads who complete the booster session, calculated as session completion rate among enrolled participants.
up to 25 weeks
Fidelity to session protocol
大体时间:1 hour
Adherence to the adapted booster session protocol assessed by trained observer using a structured fidelity checklist; reported as proportion of session components delivered as intended.
1 hour

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:Meghan Morris, PhD, MPH、University of California, San Francisco

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (估计的)

2026年9月1日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年6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

IPD 计划说明

This is a pilot/feasibility study with a small target enrollment of 15-25 dyads (30-50 individuals). Given the small sample size and the sensitive nature of the study population (PWID, involving disclosure of illegal drug use behaviors and medical history), individual-level data sharing poses meaningful re-identification risk even after de-identification. Aggregate de-identified findings will be reported in peer-reviewed publication and on ClinicalTrials.gov per standard reporting requirements.

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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