Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04427202
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mpho@bsd.uchicago.edu', 'phone': '773-834-3689', 'title': 'Mai T. Pho, MD MPH', 'organization': 'University of Chicago Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Study period from baseline to 24-month follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.', 'otherNumAtRisk': 306, 'deathsNumAtRisk': 306, 'otherNumAffected': 0, 'seriousNumAtRisk': 306, 'deathsNumAffected': 4, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'Deaths', 'notes': 'Overdose death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidial Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Participants Who Received Referrals to the Harm Reduction Services Organization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Participants who have not previous engaged at the HRSO'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Number of participants who accept referral to the intervention (divided by the total enrolled who did not have previous engagement prior to the study with the harm reduction services organization).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These participants who did not have previous engagement prior to the study with the harm reduction services organization.'}, {'type': 'SECONDARY', 'title': 'Number of Locations Where Participants Received Most of Syringes or Needles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Number of unique zip codes that participants received most of their syringes or needles based on mobile unit delivery.', 'unitOfMeasure': 'Unique zip codes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'This was counted as the number of visits made by the hard reduction service organization to distribute sterile syringes and/or equipment.', 'unitOfMeasure': 'Visits', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': '"How many times (encounters) in the past 30 days did you inject using a syringe or needle that you know had been used by somebody else?"', 'unitOfMeasure': 'Encounters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Times Participants Used a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing That They Knew Was Used by Somebody Else', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '9.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': '"How many times (encounters) in the past 30 days did you use a cotton, cooker, spoon or water for rinsing or mixing that you know had been used by somebody else?"', 'unitOfMeasure': 'Encounters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '8.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': '"How many times (encounters) in the past 30 days did you let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after you used it?"', 'unitOfMeasure': 'Encounters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Number of participants with drive time less than 30 minutes to nearest syringe or needle exchange.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Currently Have Naloxone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': '"Do you currently have naloxone or Narcan with you or at home?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Total number of participants who received a substance use disorder referrals made by the hard reduction services organization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Participants Who Received an HIV Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Total number of tests that participants screened for HIV, from baseline to follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who already knew their HIV+ diagnoses prior to this study (n=4) and thus, removed from the denominator.'}, {'type': 'SECONDARY', 'title': 'Total Number of Participants Who Received an HCV Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Total participants screened for HCV at least once during baseline and follow-up. For those who had a HCV reactive test were then later referred to further services.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who already were told they had HCV prior to this study (n=76) were removed from the denominator.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Knowledge of PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': '"Have you ever heard of medicine people can take to prevent HIV?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants did not respond to question (n=5)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Diagnosed With HIV Who Have Access to HIV Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Total number of participants who were newly diagnosed with HIV during the study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Diagnosed With HCV Who Have Access to HCV Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Total number of participants who were newly diagnosed with chronic Hep C who were referred to Hep C care.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants who had a positive confirmatory HCV test (e.g. positive viral load).'}, {'type': 'SECONDARY', 'title': 'Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Total participants who responded at baseline up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '16.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': '"In the last 30 days, how many times did you have vaginal or anal sex without a condom?"', 'unitOfMeasure': 'Encounters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A number of participants did not respond to this question (n=10).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort', 'description': 'Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}]}]}, {'title': '12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}]}, {'title': '18 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}]}, {'title': '24 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort', 'description': 'Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '297', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex', 'categories': [{'title': 'Male', 'measurements': [{'value': '199', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Intersex', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '296', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '230', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who consented and completed the baseline survey.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-17', 'size': 529213, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-20T17:20', 'hasProtocol': True}, {'date': '2024-09-20', 'size': 218274, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-20T17:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2020-06-08', 'resultsFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-18', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Participants Who Received Referrals to the Harm Reduction Services Organization', 'timeFrame': '2 years', 'description': 'Number of participants who accept referral to the intervention (divided by the total enrolled who did not have previous engagement prior to the study with the harm reduction services organization).'}], 'secondaryOutcomes': [{'measure': 'Number of Locations Where Participants Received Most of Syringes or Needles', 'timeFrame': '2 years', 'description': 'Number of unique zip codes that participants received most of their syringes or needles based on mobile unit delivery.'}, {'measure': 'Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention', 'timeFrame': '2 years', 'description': 'This was counted as the number of visits made by the hard reduction service organization to distribute sterile syringes and/or equipment.'}, {'measure': 'Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else', 'timeFrame': '2 years', 'description': '"How many times (encounters) in the past 30 days did you inject using a syringe or needle that you know had been used by somebody else?"'}, {'measure': 'Number of Times Participants Used a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing That They Knew Was Used by Somebody Else', 'timeFrame': '2 years', 'description': '"How many times (encounters) in the past 30 days did you use a cotton, cooker, spoon or water for rinsing or mixing that you know had been used by somebody else?"'}, {'measure': 'Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it', 'timeFrame': '2 years', 'description': '"How many times (encounters) in the past 30 days did you let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after you used it?"'}, {'measure': 'Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange', 'timeFrame': '2 years', 'description': 'Number of participants with drive time less than 30 minutes to nearest syringe or needle exchange.'}, {'measure': 'Number of Participants That Currently Have Naloxone', 'timeFrame': '2 years', 'description': '"Do you currently have naloxone or Narcan with you or at home?"'}, {'measure': 'Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals', 'timeFrame': '2 years', 'description': 'Total number of participants who received a substance use disorder referrals made by the hard reduction services organization.'}, {'measure': 'Total Number of Participants Who Received an HIV Screening', 'timeFrame': '2 years', 'description': 'Total number of tests that participants screened for HIV, from baseline to follow-up.'}, {'measure': 'Total Number of Participants Who Received an HCV Screening', 'timeFrame': '2 years', 'description': 'Total participants screened for HCV at least once during baseline and follow-up. For those who had a HCV reactive test were then later referred to further services.'}, {'measure': 'Number of Participants With Knowledge of PrEP', 'timeFrame': '6 months', 'description': '"Have you ever heard of medicine people can take to prevent HIV?"'}, {'measure': 'Number of Participants Diagnosed With HIV Who Have Access to HIV Care', 'timeFrame': '2 years', 'description': 'Total number of participants who were newly diagnosed with HIV during the study period.'}, {'measure': 'Number of Participants Diagnosed With HCV Who Have Access to HCV Care', 'timeFrame': '2 years', 'description': 'Total number of participants who were newly diagnosed with chronic Hep C who were referred to Hep C care.'}, {'measure': 'Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)', 'timeFrame': '6 months', 'description': '"In the last 30 days, how many times did you have vaginal or anal sex without a condom?"'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Hepatitis C', 'Opioid-use Disorder', 'Injection Drug Use', 'Harm Reduction Services'], 'conditions': ['HIV', 'Hepatitis C', 'Opioid-use Disorder', 'Injection Drug Use']}, 'referencesModule': {'references': [{'pmid': '36403075', 'type': 'DERIVED', 'citation': 'Rains A, York M, Bolinski R, Ezell J, Ouellet LJ, Jenkins WD, Pho MT. Attitudes toward harm reduction and low-threshold healthcare during the COVID-19 pandemic: qualitative interviews with people who use drugs in rural southern Illinois. Harm Reduct J. 2022 Nov 19;19(1):128. doi: 10.1186/s12954-022-00710-9.'}, {'pmid': '35468860', 'type': 'DERIVED', 'citation': 'Walters SM, Bolinski RS, Almirol E, Grundy S, Fletcher S, Schneider J, Friedman SR, Ouellet LJ, Ompad DC, Jenkins W, Pho MT. Structural and community changes during COVID-19 and their effects on overdose precursors among rural people who use drugs: a mixed-methods analysis. Addict Sci Clin Pract. 2022 Apr 25;17(1):24. doi: 10.1186/s13722-022-00303-8.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the referral to harm reduction services (HRS) including syringe services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD testing and referral and linkage to care through capacity building of existing programs through client services data.', 'detailedDescription': 'This is a prospective longitudinal Type 1 Hybrid Implementation Effectiveness Study on the expansion of harm reduction services for people who inject drugs (PWID) and people who use opioids (PWUO) residing in high risk areas of rural southern Illinois. This study record describes one component of the larger Ending transmission of HIV, HCV, and STDs and overdose in rural communities of people who inject drugs (ETHIC) study Community Response Plan (CRP) framework, specifically the expansion of harm reduction services intervention (HRS). The aim is to assess the effectiveness of expansion of evidenced based harm reduction services through our CRP framework comprising: a) geographically targeted recruitment based on hot spot and vulnerability analyses, b) community engagement, c) recruitment via Respondent Driven Sampling (RDS), d) expanded surveillance for HIV and HCV, and e) concomitant HCV and opioid use treatment capacity expansion through the Extension of Community Healthcare Outcomes (ECHO) model. Examination of facilitators and barriers impacting implementation of service delivery is evaluated through mixed methods process evaluation. The Type 1 Hybrid design is supported by conditions including the existing evidence based for benefits and minimal harm of "harm reduction services" and strong base for applicability of this intervention in the study setting (ie rural opioid use)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15 years of age and older\n* Injected any drug in the past 30 days\n* Used any opioids non-medically in the past 30 days\n* English speaking\n* Able to provide informed consent at the time of the study visit\n\nExclusion Criteria:\n\n* Less than 15 years of age\n* Not injected any drug in the past 30 days\n* Not used any opioids non-medically in past 30 days\n* Non-English speaking\n* Has not injected any opioid drug to get high in the past 30 days\n* Unable to provide informed consent at the time of the study visit'}, 'identificationModule': {'nctId': 'NCT04427202', 'acronym': 'ETHIC', 'briefTitle': 'Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)', 'orgStudyIdInfo': {'id': 'IRB17-1630'}, 'secondaryIdInfos': [{'id': '4UH3DA044829-03', 'link': 'https://reporter.nih.gov/quickSearch/4UH3DA044829-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Referral to harm reduction services', 'description': 'Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.', 'interventionNames': ['Behavioral: Referral to harm reduction services']}], 'interventions': [{'name': 'Referral to harm reduction services', 'type': 'BEHAVIORAL', 'description': 'Participants are referred to harm reduction services', 'armGroupLabels': ['Referral to harm reduction services']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62901', 'city': 'Carbondale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University', 'geoPoint': {'lat': 37.72727, 'lon': -89.21675}}, {'zip': '62966', 'city': 'Murphysboro', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Community Action Place, Inc.', 'geoPoint': {'lat': 37.7645, 'lon': -89.33509}}], 'overallOfficials': [{'name': 'Mai Pho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available at the DCC for the time frame indicated in the data use agreement.', 'ipdSharing': 'YES', 'description': 'The ETHIC study is participating site of the Rural Opioid Initiative (ROI), a collaborative funded by NIDA. The ROI includes a Data Coordinating Center (DCC) housed at the University of Washington. The University of Chicago will submit de-identified data from the study to the DCC as covered under a data use agreement for the purposes of performing cross-site analyses using a harmonized data set. No parties outside of the ROI will have access to the combined dataset. All project proposals will be subject to approval by the ROI. The data will be available after encrypted submission to the DCC and will remain for the duration in accordance to the data use agreement.', 'accessCriteria': 'Data will be shared among researchers in the Rural Opioid Initiative (ROI) cooperative agreement as described above'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Illinois University', 'class': 'OTHER'}, {'name': 'Community Action Place, Inc.', 'class': 'OTHER'}, {'name': 'New York University', 'class': 'OTHER'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}