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
Abstract Background Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigatin...
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| Format: | Article |
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BMC
2025-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-08662-0 |
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| author | Meghan D. Morris Judy Y. Tan Claire C. McDonell Maia Scarpetta Tiffany N. Nguyen Jennifer C. Price Torsten B. Neilands |
| author_facet | Meghan D. Morris Judy Y. Tan Claire C. McDonell Maia Scarpetta Tiffany N. Nguyen Jennifer C. Price Torsten B. Neilands |
| author_sort | Meghan D. Morris |
| collection | DOAJ |
| description | Abstract Background Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors. Methods The You’re Empowered for Treatment Initiation (YETI) Partner trial is a single-site randomized controlled trial evaluating the efficacy of a two-session behavioral intervention that engages injecting partners as peer navigators for HCV treatment. We aim to recruit 250 PWID and their primary injecting partners in San Francisco, California, randomizing them 1:1 to either a control or intervention group. The primary outcome is the initiation of HCV treatment, with secondary outcomes including treatment completion and sustained virologic response 12 weeks post-treatment. Data will be collected through questionnaires and electronic health records and analyzed using intention-to-treat and mixed-effects models. Discussion This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment. If successful, the intervention could inform public health strategies and policies to address HCV in marginalized populations. Trial registration ClinicalTrials.gov NCT06179498. Registered on December 22, 2023. |
| format | Article |
| id | doaj-art-22d3152facc34135a04229fedaa8e950 |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-22d3152facc34135a04229fedaa8e9502025-01-26T12:51:08ZengBMCTrials1745-62152025-01-0126111310.1186/s13063-024-08662-0A 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 trialMeghan D. Morris0Judy Y. Tan1Claire C. McDonell2Maia Scarpetta3Tiffany N. Nguyen4Jennifer C. Price5Torsten B. Neilands6Department of Epidemiology & Biostatistics, University of CaliforniaCancer Research Center for Health Equity, Division of Population Sciences, Department of Biomedical Sciences, Cedars-Sinai Medical CenterDepartment of Epidemiology & Biostatistics, University of CaliforniaDepartment of Epidemiology & Biostatistics, University of CaliforniaDepartment of Epidemiology & Biostatistics, University of CaliforniaDepartment of Medicine, University of CaliforniaCenter for AIDS Prevention Sciences, Division of Prevention Science, University of CaliforniaAbstract Background Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors. Methods The You’re Empowered for Treatment Initiation (YETI) Partner trial is a single-site randomized controlled trial evaluating the efficacy of a two-session behavioral intervention that engages injecting partners as peer navigators for HCV treatment. We aim to recruit 250 PWID and their primary injecting partners in San Francisco, California, randomizing them 1:1 to either a control or intervention group. The primary outcome is the initiation of HCV treatment, with secondary outcomes including treatment completion and sustained virologic response 12 weeks post-treatment. Data will be collected through questionnaires and electronic health records and analyzed using intention-to-treat and mixed-effects models. Discussion This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment. If successful, the intervention could inform public health strategies and policies to address HCV in marginalized populations. Trial registration ClinicalTrials.gov NCT06179498. Registered on December 22, 2023.https://doi.org/10.1186/s13063-024-08662-0Hepatitis CHCVHCV treatmentPeople who inject drugsDyad interventionPartner support |
| spellingShingle | Meghan D. Morris Judy Y. Tan Claire C. McDonell Maia Scarpetta Tiffany N. Nguyen Jennifer C. Price Torsten B. Neilands 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 Hepatitis C HCV HCV treatment People who inject drugs Dyad intervention Partner support |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Hepatitis C HCV HCV treatment People who inject drugs Dyad intervention Partner support |
| url | https://doi.org/10.1186/s13063-024-08662-0 |
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