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NCT Number: NCT07631559

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.

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Key information

Conditions

HEPATITIS C (HCV) Behavior Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Drug Use Disorders Flaviviridae Infections Harm Reduction Healthcare Access Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders RNA Virus Infections Substance Use Disorder (SUD) Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quaker Meeting House

San Francisco, California, 94103, United States

Location contact

Meghan Morris, PhD

PRINCIPAL_INVESTIGATOR

Morris Meghan, PhD

CONTACT

[email protected]

415-574-0651

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partner navigation intervention booster session

Behavioral

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.

Primary outcomes

  1. Acceptability of the booster session

    Time frame: 1 week

    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.

  2. Feasibility: recruitment rate

    Time frame: up to 25 weeks

    Proportion of eligible dyads who consent and enroll, calculated as the number enrolled divided by the number approached and screened.

  3. Feasibility: retention rate

    Time frame: up to 25 weeks

    Proportion of enrolled dyads who complete the booster session, calculated as session completion rate among enrolled participants.

  4. Fidelity to session protocol

    Time frame: 1 hour

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Meghan Morris, PhD, MPH

CONTACT

[email protected]

415-574-0651

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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