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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA053325-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).
After an initial ramp-up phase to ensure intervention materials and protocols meet the needs of the target population and organizational setting, we will apply a stratified randomized design to enroll 250 adult PWID with recently diagnosed HCV infection ("index") and their primary injecting partner("partner") into a randomized control efficacy trial of a two-session partner navigation intervention, compared to standard of care. The primary endpoint is starting HCV treatment. Recruitment will over sample PWID between 18-30 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | In addition to standard HCV results disclosure for the comparator arm, intervention participants will have two counseling sessions: Session 1: Immediately after HCV results disclosure, a staff-facilitated session with the index to (1) Establish HCV Treatment Goals, fostering commitment, and (2) Engage the Injecting Partner, identifying ways to support treatment initiation. Session 2: One week later, involving both the index and injecting partner, to (1) Enhance Partner Support with specific strategies for HCV treatment initiation and (2) Collaborative Navigation Mapping, using a "navigation map" tool. By Session 2's end, both will have a completed navigation map, a visual guide for the HCV treatment journey. Both sessions stress communication and dyadic coordination. The "navigation map" tool ensures a personalized plan for the index's treatment initiation and the partner's supportive navigator role. |
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| Control | No Intervention | Standard of care HCV disclosure. This staff-facilitated session follows the California HIV/HCV test counselor certification protocol with the Index alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partner Navigation Intervention | Behavioral | A two-session, disclosure counselor-led, behavioral intervention to enable the injecting partner to support and navigate the adult PWID to start HCV treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention efficacy | Assessed by comparing the proportion of those enrolled in the intervention group who initiated treatment to the proportion of those enrolled in the control group who initiated treatment at 6 months, 12 months, and 24 months after HCV infection disclosure visit. | 6 months, 12 months, and 24 months after HCV infection disclosure visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Partner Support (Intervention mechanism) | Self-reported level of partner support measured at baseline, 1 week, 1 month, 3 months, and 6 months. Partner support is measured with a validated survey scale (range 1-5) where the higher the value the higher the partner support. | 1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meghan D Morris, MPH, PhD | Contact | 415-574-0651 | meghan.morris@ucsf.edu | |
| Claire McDonell, MS | Contact | claire.mcdonell@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Meghan D Morris, MPH, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39844334 | Derived | Morris MD, Tan JY, McDonell CC, Scarpetta M, Nguyen TN, Price JC, Neilands TB. A single-site randomized controlled trial of partner navigation to HCV treatment for people who inject drugs: a study protocol for the You're Empowered for Treatment Initiation (YETI) partner trial. Trials. 2025 Jan 22;26(1):26. doi: 10.1186/s13063-024-08662-0. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Behavioral intervention: two counseling based sessions
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| HCV Treatment Completion | The proportion of participants who complete treatment, by randomized group | Point of HCV treatment initiation up to 3 years |
| Sustained Virologic Response at 12 weeks post treatment completion (SVR12) | Proportion of participants who achieve sustained virologic response at 12 weeks post treatment (SVR12), by randomized group | Point of HCV treatment initiation up to 3 years |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |