Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:19 PM
Study NCT ID:
NCT04878328
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2021-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-10', 'size': 174235, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-14T10:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The investigators will conduct a randomized trial to assess the effectiveness of an onsite Point-of-Care testing and education intervention (O-PoC) compared to standard of care (SoC) at The Fortune Society (Fortune). The current SoC includes a referral to offsite community testing. Guided by Social Cognitive Theory, in O-PoC we will employ CHWs with lived experience of incarceration to provide: 1) COVID-19 education; 2) SARS-CoV-2 testing with Cepheid XpertXpress PCR tests at Fortune facilities; 3) Needs assessments and facilitated access to masks and hygiene supplies; 4) Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters, or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5) Supportive counseling."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Testing uptake', 'timeFrame': '12 months', 'description': 'Testing uptake will be defined as the number and proportion of tests performed and will be determined using Program logs and healthcare record extraction. For all participants, the proportion of tests will be calculated from the total possible denominator of 5 tests (at times 0, 3, 6, 9, and 12 months). Receipt of test results will be defined as the number and proportion of test received and will be determined by self-report'}], 'secondaryOutcomes': [{'measure': 'Mitigation measures', 'timeFrame': '12 months', 'description': 'For mitigation measures, participants will be asked: Which of the following have you done in the last 14 days to keep yourself safe from coronavirus? Worn a mask or other face covering; Washed your hands with soap or used hand sanitizer; Avoided contact with people who could be high-risk; Avoided public spaces, gatherings, or crowds.For answers to which the answer is yes: The investigators will ask questions about mitigation measures on a sliding Likert scale regarding the last 14 days that will be programmed into Ethica software. Likert scales will include a legend with both numbers (1 day-14 days). The investigators will assign a score with higher adherence to mitigation measures as higher scores (from 1 to 14) and create a composite score averaging 2-week questionnaire conducted over the course of the 3 months following PoC intervention visits for each mitigation measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19', 'justice-involved individuals', 'Point-of-care testing', 'community based organization'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32240582', 'type': 'BACKGROUND', 'citation': 'Akiyama MJ, Spaulding AC, Rich JD. Flattening the Curve for Incarcerated Populations - Covid-19 in Jails and Prisons. N Engl J Med. 2020 May 28;382(22):2075-2077. doi: 10.1056/NEJMp2005687. Epub 2020 Apr 2. No abstract available.'}, {'pmid': '32197116', 'type': 'BACKGROUND', 'citation': "Kinner SA, Young JT, Snow K, Southalan L, Lopez-Acuna D, Ferreira-Borges C, O'Moore E. Prisons and custodial settings are part of a comprehensive response to COVID-19. Lancet Public Health. 2020 Apr;5(4):e188-e189. doi: 10.1016/S2468-2667(20)30058-X. Epub 2020 Mar 17. No abstract available."}, {'pmid': '12021677', 'type': 'BACKGROUND', 'citation': 'Lim YW, Andersen R, Leake B, Cunningham W, Gelberg L. How accessible is medical care for homeless women? Med Care. 2002 Jun;40(6):510-20. doi: 10.1097/00005650-200206000-00008.'}, {'pmid': '32496864', 'type': 'BACKGROUND', 'citation': "Reinhart E, Chen DL. Incarceration And Its Disseminations: COVID-19 Pandemic Lessons From Chicago's Cook County Jail. Health Aff (Millwood). 2020 Aug;39(8):1412-1418. doi: 10.1377/hlthaff.2020.00652. Epub 2020 Jun 4."}, {'type': 'BACKGROUND', 'citation': 'USICH. 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Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD013705. doi: 10.1002/14651858.CD013705.'}, {'pmid': '32422408', 'type': 'BACKGROUND', 'citation': 'Pasomsub E, Watcharananan SP, Boonyawat K, Janchompoo P, Wongtabtim G, Suksuwan W, Sungkanuparph S, Phuphuakrat A. Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019: a cross-sectional study. Clin Microbiol Infect. 2021 Feb;27(2):285.e1-285.e4. doi: 10.1016/j.cmi.2020.05.001. Epub 2020 May 15.'}], 'seeAlsoLinks': [{'url': 'https://coronavirus.jhu.edu/map.html', 'label': 'Johns Hopkins University. COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU)'}, {'url': 'https://www.bop.gov/about/statistics/statistics_inmate_ethnicity.jsp', 'label': 'Federal Bureau of Prisons - Inmate Ethnicity Statistics'}, {'url': 'https://www.themarshallproject.org/2020/05/01/a-state-by-state-look-at-coronavirus-in-prisons', 'label': 'The Marshall Project. A State-by-State Look at Coronavirus in Prisons'}, {'url': 'https://www.aclu.org/sites/default/files/field_document/aclu_covid19-jail-report_2020-8_1.pdf', 'label': 'American Civil Liberties Union. COVID-19 Model Finds Nearly 100,000 More Deaths Than Current Estimates, Due to Failures to Reduce Jails'}, {'url': 'https://www.prisonpolicy.org/blog/2020/05/14/jails-vs-prison-update/', 'label': 'Prison Policy Initiative - Jails versus Prison'}, {'url': 'http://www.columbia.edu/~mu2166/stu_covid19/slides_stu_covid19.pdf', 'label': 'Covid-19: Testing Inequality in New York City'}, {'url': 'https://abcnews.go.com/Health/covid-19-tests-prisoners-center-york-outbreak-court/story?id=69969077', 'label': 'No COVID-19 tests available for prisoners at center of New York outbreak, court documents show'}, {'url': 'https://www.nydailynews.com/new-york/ny-brooklyn-mdc-covid-19-testing-shortage-oig-report-20201110-mniz4ygxnbbglhrjotaxin4tfq-story.html', 'label': 'Audit of Brooklyn federal jail claims lack of COVID-19 tests may have masked size of outbreak New York Daily News.'}, {'url': 'https://csgjusticecenter.org/house-appropriations-committee-approves-21-funding-for-doj-programs/', 'label': "Nelson J. House Appropriations Committee Approves '21 Funding for DOJ Programs"}, {'url': 'https://www.cepheid.com/coronavirus', 'label': 'Cepheid. Sars-cov-2-test-development-information'}, {'url': 'https://www.medrxiv.org/content/10.1101/2020.04.20.20054726v2.', 'label': 'Evidence-Based, Cost-Effective Interventions To Suppress The COVID-19 Pandemic: A Systematic Review'}, {'url': 'https://www.medrxiv.org/content/10.1101/2020.04.01.20049528v1.', 'label': 'Facemasks and similar barriers to prevent respiratory illness such as COVID-19'}, {'url': 'https://covid19.healthdata.org/united-states-of-america?view=daily-deaths&tab=trend.', 'label': 'The Institute for Health Metrics and Evaluation - Daily deaths during the pandemic'}, {'url': 'https://nationalreentryresourcecenter.org/reentry-services-directory/', 'label': 'The National Reentry Resource Center. Reentry Services Directory'}, {'url': 'https://avalonecon.com/wp-content/uploads/2020/04/COVID-19-QALYs-v3.pdf.', 'label': 'Estimating QALY losses associated with deaths in hospital (COVID-19)'}]}, 'descriptionModule': {'briefSummary': 'Given the likelihood of COVID-19 remaining an endemic disease among high-risk populations, establishing effective mitigation interventions will be critical to stemming community transmission. Criminal justice-involved individuals are extremely important to reducing community-based SARS-CoV-2 transmission due to their increased risk of contracting SARS-CoV-2 while incarcerated and their likelihood of living in congregate settings after incarceration. The investigators will evaluate an onsite Point-of-Care SARS-CoV-2 testing and education strategy in a corrections-focused community-based organization and its impact on improving testing uptake, mitigation behaviors(e.g. mask wearing, hand hygiene, social distancing, vaccine uptake when available), and cost-effectiveness.', 'detailedDescription': 'The United States(U.S.) has experienced higher mortality than any other nation due to COVID-19 with nearly 13.5 million cases and over 268,103 deaths. Due to the limited ability to socially distance, poor ventilation, and limited hygiene supplies, U.S. prisons and jails have observed explosive transmission of SARS-CoV-2 accounting for the 10 largest U.S. outbreaks. Because 95% of criminal justice-involved individuals reenter societyCOVID-19 transmission extends beyond those who are currently incarcerated. As justice-involved individuals reenter the community, they face high rates of homelessness, and many others live in other congregate settings such as converted hotels and halfway houses. The increased risk of SARS-CoV-2 while incarcerated coupled with the likelihood of living in congregate settings after incarceration, create conditions ripe for rapid COVID-19 transmission that will be critical to address in order to gain control of COVID-19 in the U.S. The goal of this study is to test the impact and cost-effectiveness of an intervention to mitigate SARS-CoV-2 transmission among justice-involved individuals recently released from incarceration. The investigators will conduct a randomized trial to compare the effectiveness of an onsite Point-of-Care SARS-CoV-2 testing and education intervention with community health workers (CHWs) as a central component compared to the standard of care at a community-based organization (CBO) that provides services to justice-involved individuals in New York City. The investigators will measure costs of testing, education, and navigation, and explore the cost-effectiveness of the onsite Point-of-Care intervention compared to the standard of care. The specific aims are to:1) Test the effectiveness of an onsite PoC SARS-CoV-2 intervention in a corrections-focused CBO; 2) Model the cost-effectiveness of an onsite PoC SARS-CoV-2 intervention among CJIs compared to SoC. Because testing, education, and navigation will be provided by CHWs in a culturally-sensitive environment and test results will be received in minutes (rather than days), the investigators hypothesize that O-PoC will be associated with improved testing uptake and receipt of test results, mitigation behaviors (mask wearing, hand hygiene, social distancing), and those who attend more O-PoC sessions will have better adherence to mitigation behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fortune Society clients\n* Greater than or equal to 18 years old\n* Fluent in English or Spanish\n* Resident of NYC\n* Released from a jail or a prison system within 90 days\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inability to complete study visits over 12 months\n* Does not plan to reside in the NYC area for the next year\n* Terminal illness'}, 'identificationModule': {'nctId': 'NCT04878328', 'briefTitle': 'Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Leveraging Community Health Workers to Improve COVID-19 Testing and Mitigation Among Criminal Justice-involved Individuals Accessing a Corrections-focused Community-based Organization', 'orgStudyIdInfo': {'id': '2021-12976'}, 'secondaryIdInfos': [{'id': '5R01MD016744', 'link': 'https://reporter.nih.gov/quickSearch/5R01MD016744', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'onsite Point-of-care (o-POC)', 'description': "CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.", 'interventionNames': ['Behavioral: Onsite Point-of-care']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care (SOC)', 'description': "The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation."}], 'interventions': [{'name': 'Onsite Point-of-care', 'type': 'BEHAVIORAL', 'description': "Guided by Social Cognitive Theory, O-PoC will employ CHWs with lived experience of incarceration to provide: 1) COVID-19 education; 2) SARS-CoV-2 testing with Cepheid XpertXpress PCR tests at Fortune facilities; 3) Needs assessments and facilitated access to masks and hygiene supplies; 4) Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters, or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5) Supportive counseling.", 'armGroupLabels': ['onsite Point-of-care (o-POC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11101', 'city': 'Long Island City', 'state': 'New York', 'country': 'United States', 'facility': 'Fortune Society', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Matthew Akiyama, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Fortune Society', 'class': 'UNKNOWN'}, {'name': 'University of Bristol', 'class': 'OTHER'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}, {'name': 'Cepheid', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}