HEPATITIS C (HCV)NCT07631559
Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs
A study testing Partner navigation intervention booster session in people with HEPATITIS C (HCV) and Opioid Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HEPATITIS C (HCV), Opioid Use Disorder, Substance Use Disorder (SUD)
- What is being tested?
- Partner navigation intervention booster session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Quaker Meeting House
San Francisco, California, 94103
Morris Meghan, PhD, 415-574-0651, morris.meghan@ucsf.edu
Meghan Morris, PhD
About this study
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.
Read more
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.
- Conditions
- HEPATITIS C (HCV), Opioid Use Disorder, Substance Use Disorder (SUD), Drug Use Disorders, Healthcare Access, Harm Reduction
- Being tested
- Partner navigation intervention booster session
- Keywords
- People who inject drugs (PWID), Partner navigation, Dyadic intervention, Post-treatment healthcare engagement, Behavioral intervention, HCV treatment, Injecting partnerships, Feasibility pilot, Substance use
- Medical subject headings
- Hepatitis C, Opioid-Related Disorders, Substance-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner navigation intervention booster sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Partner Navigation Booster Session | Experimental | Injecting 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. Receives: Behavioral: Partner navigation intervention booster session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 25 weeks
Feasibility: retention rate
Proportion of enrolled dyads who complete the booster session, calculated as session completion rate among enrolled participants.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HEPATITIS C (HCV)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Meghan Morris, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631559
- Sponsor's protocol ID
- 027290055
- Other IDs
- K24DA061103
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31150518Morris 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.
PubMed 37799636Morris 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.
PubMed 26460140Turner 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.
PubMed 35875251Bailey 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.
PubMed 28402827Yearby 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.
PubMed 35130059Facente 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.
PubMed 29641546Morris 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.
PubMed 37862013Morris 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.
PubMed 25286346Morris 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.
PubMed 28804051
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT07631559
- Acronym / sponsor ID
- 027290055
- Conditions
- HEPATITIS C (HCV), Opioid Use Disorder, Substance Use Disorder (SUD), Drug Use Disorders, Healthcare Access, Harm Reduction
- Keywords
- People who inject drugs (PWID), Partner navigation, Dyadic intervention, Post-treatment healthcare engagement, Behavioral intervention, HCV treatment, Injecting partnerships, Feasibility pilot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partner Navigation Booster Session | Experimental | Behavioral: Partner navigation intervention booster sessionInjecting 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partner navigation intervention booster sessionA 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. | Behavioural | Partner Navigation Booster Session |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 31150518Morris 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.
- Background: PubMed 37799636Morris 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.
- Background: PubMed 26460140Morris 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.
- Background: PubMed 35875251Turner 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.
- Background: PubMed 28402827Bailey 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.
- Background: PubMed 35130059Yearby 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.
- Background: PubMed 29641546Facente 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.
- Background: PubMed 37862013Morris 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.
- Background: PubMed 25286346Morris 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.
- Background: PubMed 28804051Morris 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan Morris, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner navigation intervention booster session in people with HEPATITIS C (HCV) and Opioid Use Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan Morris, PhD, MPH (415-574-0651, meghan.morris@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the booster session (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631559, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.