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

Обзор

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.

Вмешательства

• Поведенческое Partner navigation intervention booster session
  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

Первичные конечные точки

• Acceptability of the booster session [Срок оценки: 1 week]
• Feasibility: recruitment rate [Срок оценки: up to 25 weeks]
• Feasibility: retention rate [Срок оценки: up to 25 weeks]
• Fidelity to session protocol [Срок оценки: 1 hour]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Quaker Meeting House — San Francisco

Публикации

• 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. PMID 31150518
• 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. PMID 37799636
• 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. PMID 26460140
• 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. PMID 35875251
• 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. PMID 28402827
• 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. PMID 35130059
• 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. PMID 29641546
• 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. PMID 37862013

Идентификаторы

NCT: NCT07631559 · 027290055 · K24DA061103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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