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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Partner Navigation Booster SessionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 week
2

Feasibility: recruitment rate

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

Time frame
up to 25 weeks
3

Feasibility: retention rate

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

Time frame
up to 25 weeks
4

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.

Time frame
1 hour

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

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