[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07631559":3,"trial-entities:NCT07631559":141,"trial-summary:NCT07631559":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":34,"primary_purpose":13,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":47,"secondary_outcomes":63,"sex":64,"minimum_age":65,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":66,"std_ages":80,"locations":83,"central_contacts":102,"overall_officials":106,"references":108,"see_also_links":140},"NCT07631559","027290055","Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs","NOT_YET_RECRUITING","2027-06-30","2026-06","2026-06-08","2026-09-01","University of California, San Francisco","OTHER",false,"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.\n\nThe 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.\n\nParticipants 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.\n\nThis 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.",null,[18,19,20,21,22,23],"HEPATITIS C (HCV)","Opioid Use Disorder","Substance Use Disorder (SUD)","Drug Use Disorders","Healthcare Access","Harm Reduction",[25,26,27,28,29,30,31,32,33],"People who inject drugs (PWID)","Partner navigation","Dyadic intervention","Post-treatment healthcare engagement","Behavioral intervention","HCV treatment","Injecting partnerships","Feasibility pilot","Substance use","INTERVENTIONAL",[36],"NA",{"count":38,"type":39},50,"ESTIMATED",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45},"BEHAVIORAL","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 partner communication skills.",[46],"Partner Navigation Booster Session",[48,52,56,59],{"measure":49,"description":50,"timeFrame":51},"Acceptability of the booster session","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",{"measure":53,"description":54,"timeFrame":55},"Feasibility: recruitment rate","Proportion of eligible dyads who consent and enroll, calculated as the number enrolled divided by the number approached and screened.","up to 25 weeks",{"measure":57,"description":58,"timeFrame":55},"Feasibility: retention rate","Proportion of enrolled dyads who complete the booster session, calculated as session completion rate among enrolled participants.",{"measure":60,"description":61,"timeFrame":62},"Fidelity to session protocol","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",[],"ALL","18 Years",{"inclusion":67,"exclusion":76,"raw_text":79},[68,69,70,71,72,73,74,68,72,73,75],"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","Primary injecting partner of an enrolled index participant:","has context menu",[77,78],"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","Inclusion criteria:\n\nFor index participants:\n\n* 18 years of age or older at enrollment\n* History of injecting drug use\n* Completed HCV treatment within the past 3 months\n* Report a primary injecting partner willing to participate\n* Willing and able to provide informed consent\n* English or Spanish speaking\n\nFor primary injecting partners:\n\n* Primary injecting partner of an enrolled index participant:\n* 18 years of age or older at enrollment\n* Willing and able to provide informed consent\n* English or Spanish speaking\n* has context menu\n\nExclusion criteria:\n\nFor both index participants and injecting partners:\n\n* Unable to provide informed consent due to cognitive impairment or acute intoxication at the time of enrollment\n* Previously participated in this study in any capacity",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":99},"Quaker Meeting House","San Francisco","California","94103","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Morris Meghan, PhD","CONTACT","415-574-0651","morris.meghan@ucsf.edu",{"name":97,"role":98},"Meghan Morris, PhD","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},37.77493,-122.41942,[103],{"name":104,"role":93,"phone":94,"email":105},"Meghan Morris, PhD, MPH","meghan.morris@ucsf.edu",[107],{"name":104,"affiliation":12,"role":98},[109,113,116,119,122,125,128,131,134,137],{"pmid":110,"type":111,"citation":112},"31150518","BACKGROUND","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\u002Fjournal.pone.0217811. eCollection 2019.",{"pmid":114,"type":111,"citation":115},"37799636","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\u002FCLD.0000000000000042. eCollection 2023 Sep.",{"pmid":117,"type":111,"citation":118},"26460140","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\u002Fj.drugalcdep.2015.09.025. Epub 2015 Sep 30.",{"pmid":120,"type":111,"citation":121},"35875251","Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race\u002Fethnicity reporting and representation in US clinical trials: a cohort study. Lancet Reg Health Am. 2022 Jul;11:100252. doi: 10.1016\u002Fj.lana.2022.100252. Epub 2022 Apr 10.",{"pmid":123,"type":111,"citation":124},"28402827","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\u002FS0140-6736(17)30569-X.",{"pmid":126,"type":111,"citation":127},"35130059","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\u002Fhlthaff.2021.01466.",{"pmid":129,"type":111,"citation":130},"29641546","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\u002Fjournal.pone.0195575. eCollection 2018.",{"pmid":132,"type":111,"citation":133},"37862013","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\u002Fjamanetworkopen.2023.38792.",{"pmid":135,"type":111,"citation":136},"25286346","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\u002Fjournal.pone.0109282. eCollection 2014.",{"pmid":138,"type":111,"citation":139},"28804051","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\u002Fj.drugpo.2017.05.030. Epub 2017 Aug 9.",[],{"nct_id":4,"conditions":142,"biomarkers":145},[143,144],"Hepatitis C Infection","Substance use disorder",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]