Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs
2 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2027
June 8, 2026
June 1, 2026
6 months
May 26, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
Feasibility: retention rate
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
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
Study Arms (1)
Partner Navigation Booster Session
EXPERIMENTALInjecting 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- For index participants:
- 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:
- years of age or older at enrollment
- Willing and able to provide informed consent
- English or Spanish speaking
- has context menu
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quaker Meeting House
San Francisco, California, 94103, United States
Related Publications (10)
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: 31150518BACKGROUNDMorris 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: 37799636BACKGROUNDMorris 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: 26460140BACKGROUNDTurner 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: 35875251BACKGROUNDBailey 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: 28402827BACKGROUNDYearby 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: 35130059BACKGROUNDFacente 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: 29641546BACKGROUNDMorris 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: 37862013BACKGROUNDMorris 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.
PMID: 25286346BACKGROUNDMorris 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.
PMID: 28804051BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan Morris, PhD, MPH
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2026
First Posted
June 8, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.