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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07631559
Enrollment
50
Registered
2026-06-08
Start date
2026-09-01
Completion date
2027-06-30
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use Disorders, Harm Reduction, Healthcare Access, HEPATITIS C (HCV), Opioid Use Disorder, Substance Use Disorder (SUD)

Keywords

People who inject drugs (PWID), Partner navigation, Dyadic intervention, Post-treatment healthcare engagement, Behavioral intervention, HCV treatment, Injecting partnerships, Feasibility pilot, Substance use

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.

Interventions

BEHAVIORALPartner 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the booster session1 weekParticipant-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.
Feasibility: recruitment rateup to 25 weeksProportion of eligible dyads who consent and enroll, calculated as the number enrolled divided by the number approached and screened.
Feasibility: retention rateup to 25 weeksProportion of enrolled dyads who complete the booster session, calculated as session completion rate among enrolled participants.
Fidelity to session protocol1 hourAdherence to the adapted booster session protocol assessed by trained observer using a structured fidelity checklist; reported as proportion of session components delivered as intended.

Countries

United States

Contacts

CONTACTMeghan Morris, PhD, MPH
meghan.morris@ucsf.edu415-574-0651
PRINCIPAL_INVESTIGATORMeghan Morris, PhD, MPH

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026