Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs
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
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Meghan Morris, PhD, MPH
- 电话号码:415-574-0651
- 邮箱:meghan.morris@ucsf.edu
学习地点
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California
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San Francisco、California、美国、94103
- Quaker Meeting House
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接触:
- Morris Meghan, PhD
- 电话号码:415-574-0651
- 邮箱:morris.meghan@ucsf.edu
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首席研究员:
- Meghan Morris, PhD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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 |
|---|---|
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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.
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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.
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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 |
|---|---|---|
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Acceptability of the booster session
大体时间:1 week
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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.
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1 week
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Feasibility: recruitment rate
大体时间:up to 25 weeks
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Proportion of eligible dyads who consent and enroll, calculated as the number enrolled divided by the number approached and screened.
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up to 25 weeks
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Feasibility: retention rate
大体时间:up to 25 weeks
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Proportion of enrolled dyads who complete the booster session, calculated as session completion rate among enrolled participants.
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up to 25 weeks
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Fidelity to session protocol
大体时间:1 hour
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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.
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1 hour
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合作者和调查者
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
一般刊物
- Bailey ZD, Krieger N, Agenor M, Graves J, Linos N, Bassett MT. Structural racism and health inequities in the USA: evidence and interventions. Lancet. 2017 Apr 8;389(10077):1453-1463. doi: 10.1016/S0140-6736(17)30569-X.
- Morris MD, Andrew E, Tan JY, Maher L, Hoff C, Darbes L, Page K. Injecting-related trust, cooperation, intimacy, and power as key factors influencing risk perception among drug injecting partnerships. PLoS One. 2019 May 31;14(5):e0217811. doi: 10.1371/journal.pone.0217811. eCollection 2019.
- Morris MD, McDonell C, Kim RG, Laguardia Y, Kanner R, Price JC. A pilot study to understand and respond to loss, theft, and misplacement of hepatitis C treatment medication for people who inject drugs. Clin Liver Dis (Hoboken). 2023 May 16;22(3):81-84. doi: 10.1097/CLD.0000000000000042. eCollection 2023 Sep.
- Morris MD, Bates A, Andrew E, Hahn J, Page K, Maher L. More than just someone to inject drugs with: Injecting within primary injection partnerships. Drug Alcohol Depend. 2015 Nov 1;156:275-281. doi: 10.1016/j.drugalcdep.2015.09.025. Epub 2015 Sep 30.
- Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race/ethnicity reporting and representation in US clinical trials: a cohort study. Lancet Reg Health Am. 2022 Jul;11:100252. doi: 10.1016/j.lana.2022.100252. Epub 2022 Apr 10.
- Yearby R, Clark B, Figueroa JF. Structural Racism In Historical And Modern US Health Care Policy. Health Aff (Millwood). 2022 Feb;41(2):187-194. doi: 10.1377/hlthaff.2021.01466.
- Facente SN, Grebe E, Burk K, Morris MD, Murphy EL, Mirzazadeh A, Smith AA, Sanchez MA, Evans JL, Nishimura A, Raymond HF; End Hep C SF. Estimated hepatitis C prevalence and key population sizes in San Francisco: A foundation for elimination. PLoS One. 2018 Apr 11;13(4):e0195575. doi: 10.1371/journal.pone.0195575. eCollection 2018.
- Morris MD, McDonell C, Luetkemeyer AF, Thawley R, McKinney J, Price JC. Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2338792. doi: 10.1001/jamanetworkopen.2023.38792.
- Morris MD, Evans J, Montgomery M, Yu M, Briceno A, Page K, Hahn JA. Intimate injection partnerships are at elevated risk of high-risk injecting: a multi-level longitudinal study of HCV-serodiscordant injection partnerships in San Francisco, CA. PLoS One. 2014 Oct 6;9(10):e109282. doi: 10.1371/journal.pone.0109282. eCollection 2014.
- Morris MD, Neilands TB, Andrew E, Maher L, Page KA, Hahn JA. Development and validation of a novel scale for measuring interpersonal factors underlying injection drug using behaviours among injecting partnerships. Int J Drug Policy. 2017 Oct;48:54-62. doi: 10.1016/j.drugpo.2017.05.030. Epub 2017 Aug 9.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 027290055
- K24DA061103 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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