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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI195193 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Yale University | OTHER |
| West Virginia University | OTHER |
| University of San Diego | OTHER |
| Cepheid |
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This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (control arm) | Active Comparator | Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV. |
|
| Single-visit POC test & treat (intervention arm) | Experimental | Sites randomized to the single-visit point-of-care test (POC) & treat arm will undergo fingerstick POC HCV RNA, HIV antibody/antigen, and HBsAg and for those with detectable HCV RNA, HCV treatment will be initiated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cepheid GeneXpert HCV Test | Device | Cepheid Xpert HCV Test, performed on the GeneXpert Xpress system, in an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of Hep C (HCV) RNA in human fingerstick. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who complete the Hepatitis C Virus (HCV) care cascade within 24 weeks of study entry in intervention versus Standard of Care (SOC) arm. | Proportion of participants in the primary analysis population (as defined as detectable HCV RNA on dried blood spot testing at screening) who complete the HCV care cascade within 24 weeks of study entry in intervention versus SOC arm. Completion of the care cascade will be defined as HCV RNA\ | 24 weeks from study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only) | Proportion of participants initiating same-visit DAA treatment following enrollment (intervention arm only) | Day 1 |
| Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report | 12 and 24 weeks | |
| Health-related quality of life (EQ5D) and social functioning through week 60 | Week 60 | |
Inclusion Criteria:
Exclusion Criteria:
Retreatment Inclusion Criteria:
Retreatment Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanna Naggie, MD, MHS | Duke University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35026142 | Background | Solomon SS, Wagner-Cardoso S, Smeaton L, Sowah LA, Wimbish C, Robbins G, Brates I, Scello C, Son A, Avihingsanon A, Linas B, Anthony D, Nunes EP, Kliemann DA, Supparatpinyo K, Kityo C, Tebas P, Bennet JA, Santana-Bagur J, Benson CA, Van Schalkwyk M, Cheinquer N, Naggie S, Wyles D, Sulkowski M. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):307-317. doi: 10.1016/S2468-1253(21)00397-6. Epub 2022 Jan 10. | |
| 37116714 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C000604171 | velpatasvir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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| INDUSTRY |
| Gilead Sciences | INDUSTRY |
| Abbott | INDUSTRY |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Flinders University International Centre for Point-of-care Testing | UNKNOWN |
| Kirby Institute | OTHER_GOV |
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| Abbott Determine HIV - 1/2 Ag/Ab | Device | Abbott Determine HIV - 1/2 Ag/Ab combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus type-1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV type-1 and type-2 in fingerstick. Intended use is point-of-care test to aid in the diagnosis of infection. |
|
| Abbott Determine HbsAg 2 | Device | Determine HBsAg 2 is an in vitro, visually read, qualitative immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human fingerstick. The test is intended as an aid to detect HBAg from infected individuals. |
|
| Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] | Drug | Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed. |
|
|
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. |
| 12 weeks |
| Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry | HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | 24 |
| Time from enrollment to treatment initiation | HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | up to 24 weeks |
| Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry | HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. | 24 weeks |
| Proportion of participants achieving sustained virologic response (SVR4+) within 60 weeks of entry | HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. | 60 weeks |
| Cumulative incidence of HCV reinfection following sustained virologic response (SVR4+) within 60 weeks of entry | HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. | within 60 weeks |
| Cumulative retreatment following sustained virologic response (SVR4+) or relapse within 60 weeks of entry | HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. This analysis for retreatment is limited to participants 18 years old and older. | within 60 weeks |
| Proportion of participants with HCV RNA not detected based on dried blood spot at week 24 and week 60 | HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | Week 24 and 60 |
| Proportion of participants who have received any HIV test result within 24 weeks of entry | HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. | 24 weeks of entry |
| Proportion of participants who initiate PrEP within 24 weeks of entry | HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. | 24 weeks of entry |
| Proportion of participants with HIV who commence direct-acting antiviral (DAA) therapy within 24 weeks of entry | HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. | 24 weeks of entry |
| Proportion of participants with HIV not on antiretroviral therapy (ART) at screening who commence ART within 24 weeks of entry | HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms. | 24 weeks of entry |
| Proportion of participants with HIV on antiretroviral therapy (ART) at screening who remain on ART at week 24 and week 60 | HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | Week 24 and 60 |
| Time from enrollment to PrEP initiation | HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | up to 60 weeks |
| All cause and liver specific hospitalizations through week 60 | Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | 60 weeks |
| All cause and liver specific mortality through week 60 | Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | Week 60 |
| On direct-acting antiviral (DAA) treatment serious suspected adverse events leading to discontinuation of sofosbuvir/velpatasvir | Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | 60 weeks |
| Adverse maternal and fetal outcomes for those on direct-acting antiviral (DAA) at any time during pregnancy | Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | up to 60 weeks |
| Adverse device effects related to study devices | Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. | up to 60 weeks |
| Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60 |
| from baseline to Week 24 and 60 |
| Among participants pregnant at time of enrollment: Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 and 24 weeks of entry | Weeks 12 and 24 |
| Among participants pregnant at time of enrollment: Proportion of participants completing DAA therapy within 24 weeks of entry and achieving SVR4+ within 60 weeks of entry | Week 24 and 60 |
| Background |
| Sheehan Y, Cunningham EB, Cochrane A, Byrne M, Brown T, McGrath C, Lafferty L, Tedla N, Dore GJ, Lloyd AR, Grebely J. A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study. J Hepatol. 2023 Sep;79(3):635-644. doi: 10.1016/j.jhep.2023.04.019. Epub 2023 Apr 26. |
| 30633811 | Background | Coyle C, Moorman AC, Bartholomew T, Klein G, Kwakwa H, Mehta SH, Holtzman D. The Hepatitis C Virus Care Continuum: Linkage to Hepatitis C Virus Care and Treatment Among Patients at an Urban Health Network, Philadelphia, PA. Hepatology. 2019 Aug;70(2):476-486. doi: 10.1002/hep.30501. Epub 2019 Mar 26. |
| 37816531 | Background | Mahase E. Hepatitis C: Egypt makes "unprecedented progress" towards elimination. BMJ. 2023 Oct 10;383:2353. doi: 10.1136/bmj.p2353. No abstract available. |
| 33911328 | Background | Dore GJ. Elimination of hepatitis C in Australia by 2030: a decade and counting. Aust Prescr. 2021 Apr;44(2):36-37. doi: 10.18773/austprescr.2021.003. Epub 2021 Apr 1. No abstract available. |
| 35285851 | Background | Eckhardt B, Mateu-Gelabert P, Aponte-Melendez Y, Fong C, Kapadia S, Smith M, Edlin BR, Marks KM. Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial. JAMA Intern Med. 2022 May 1;182(5):494-502. doi: 10.1001/jamainternmed.2022.0170. |
| 35821731 | Background | Eckhardt B, Kapadia SN, Mateu-Gelabert P, Pai M, Fong C, Aponte-Melendez Y, Marks KM. Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial. Open Forum Infect Dis. 2022 May 7;9(7):ofac225. doi: 10.1093/ofid/ofac225. eCollection 2022 Jul. |
| 37439759 | Background | Brooks R, Wegener M, Freeman B, Fowles C, Madden LM, Tetrault JM, Nichols L, Altice FL, Villanueva M. Improving HIV and HCV Testing in Substance Use Disorder Programs (SUDs) That Provide Medications for Opiate Use Disorder (MOUD): Role of Addressing Barriers and Implementing Universal and Site-Specific Approaches. Health Promot Pract. 2023 Sep;24(5):1018-1028. doi: 10.1177/15248399231169791. Epub 2023 Jul 13. |
| 34954493 | Background | Sivakumar A, Madden L, DiDomizio E, Eller A, Villanueva M, Altice FL. Treatment of Hepatitis C virus among people who inject drugs at a syringe service program during the COVID-19 response: The potential role of telehealth, medications for opioid use disorder and minimal demands on patients. Int J Drug Policy. 2022 Mar;101:103570. doi: 10.1016/j.drugpo.2021.103570. Epub 2021 Dec 20. |
| 38746950 | Background | Westgard LK, Sato T, Bradford WS, Eaton EF, Pilcher F, Hale AJ, Singh D, Martin M, Appa AA, Meyer JP, Weimer MB, Barakat LA, Felsen UR, Akiyama MJ, Ridgway JP, Grussing ED, Thakarar K, White A, Mutelayi J, Krsak M, Montague BT, Nijhawan A, Balakrishnan H, Marks LR, Wurcel AG. National HIV and HCV Screening Rates for Hospitalized People who Use Drugs Are Suboptimal and Heterogeneous Across 11 US Hospitals. Open Forum Infect Dis. 2024 Apr 16;11(5):ofae204. doi: 10.1093/ofid/ofae204. eCollection 2024 May. |
| 28214391 | Background | Shrestha R, Karki P, Altice FL, Huedo-Medina TB, Meyer JP, Madden L, Copenhaver M. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017 Apr 1;173:107-116. doi: 10.1016/j.drugalcdep.2016.12.023. Epub 2017 Feb 2. |
| 31563984 | Background | McFarland W, Lin J, Santos GM, Arayasirikul S, Raymond HF, Wilson E. Low PrEP Awareness and Use Among People Who Inject Drugs, San Francisco, 2018. AIDS Behav. 2020 May;24(5):1290-1293. doi: 10.1007/s10461-019-02682-7. |
| 11732009 | Background | Di Martino V, Rufat P, Boyer N, Renard P, Degos F, Martinot-Peignoux M, Matheron S, Le Moing V, Vachon F, Degott C, Valla D, Marcellin P. The influence of human immunodeficiency virus coinfection on chronic hepatitis C in injection drug users: a long-term retrospective cohort study. Hepatology. 2001 Dec;34(6):1193-9. doi: 10.1053/jhep.2001.29201. |
| 28738861 | Background | Escudero DJ, Lurie MN, Mayer KH, King M, Galea S, Friedman SR, Marshall BDL. The risk of HIV transmission at each step of the HIV care continuum among people who inject drugs: a modeling study. BMC Public Health. 2017 Jul 25;17(1):614. doi: 10.1186/s12889-017-4528-9. |
| 25706928 | Background | Skarbinski J, Rosenberg E, Paz-Bailey G, Hall HI, Rose CE, Viall AH, Fagan JL, Lansky A, Mermin JH. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Intern Med. 2015 Apr;175(4):588-96. doi: 10.1001/jamainternmed.2014.8180. |
| 36706775 | Background | Trickey A, Fajardo E, Alemu D, Artenie AA, Easterbrook P. Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Mar;8(3):253-270. doi: 10.1016/S2468-1253(22)00346-6. Epub 2023 Jan 24. |
| 37951006 | Background | Batchelder AW, Heo M, Foley JD, Sullivan MC, Lum P, Pericot Valverde I, Taylor LE, Mehta SH, Kim AY, Norton B, Tsui JI, Feinberg J, Page K, Litwin AH; HERO Study Group. Shame and stigma in association with the HCV cascade to cure among people who inject drugs. Drug Alcohol Depend. 2023 Dec 1;253:111013. doi: 10.1016/j.drugalcdep.2023.111013. Epub 2023 Oct 31. |
| 36892976 | Background | Fleurence RL, Collins FS. A National Hepatitis C Elimination Program in the United States: A Historic Opportunity. JAMA. 2023 Apr 18;329(15):1251-1252. doi: 10.1001/jama.2023.3692. |
| 37380088 | Background | Hernandez-Con P, Wilson DL, Tang H, Unigwe I, Riaz M, Ourhaan N, Jiang X, Song HJ, Joseph A, Henry L, Cook R, Jayaweera D, Park H. Hepatitis C Cascade of Care in the Direct-Acting Antivirals Era: A Meta-Analysis. Am J Prev Med. 2023 Dec;65(6):1153-1162. doi: 10.1016/j.amepre.2023.06.016. Epub 2023 Jun 26. |
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| 33389319 | Background | Rosengren AL, Lelutiu-Weinberger C, Woodhouse EW, Sandanapitchai P, Hightow-Weidman LB. A Scoping Review of HIV Pre-exposure Prophylaxis Stigma and Implications for Stigma-Reduction Interventions for Men and Transwomen Who Have Sex with Men. AIDS Behav. 2021 Jul;25(7):2054-2070. doi: 10.1007/s10461-020-03135-2. Epub 2021 Jan 2. |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018178 | Flaviviridae Infections |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |