Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT05824702
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2023-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Social Network Approach for Improving Medication Assisted Treatment and HIV Prevention and Medical Care Among People Who Inject Drugs in Ukraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are not aware of the other condition'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A pilot randomized clinical trial of behavioral intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Enrolled in drug treatment', 'timeFrame': '3 months', 'description': 'Enrollment in drug treatment among social network members living with HIV'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Drug Treatment'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to pilot a peer education for people on medication assisted treatment (MAT). People on MAT will be trained to be peer educators and provide outreach to the educators social network members who inject drugs, some of whom will be HIV positive.', 'detailedDescription': 'The, goal of the intervention is to increase medication assisted treatment (MAT) uptake and retention in order to enhance as well as HIV medical care and antiretroviral therapy (ART) adherence among those social network members who use drugs and those living with HIV who use drugs. The project will quantitatively and qualitatively assess barriers to MAT and ART uptake and adherence, while using peer educators to promote MAT and ART among their network members. Finally, the project aims to determine the effect size for guiding the planning of larger intervention and the feasibility and acceptability of this intervention for HIV prevention and improvement in HIV-related health outcomes among people living with HIV who inject drugs (PLWH PWID). The intervention will be deployed in Ukraine, a setting with high HIV incidence rates among PWID, low levels of viral suppression among HIV positive PWID, and low rates of MAT uptake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On methadone for at least 1 year and rated by the staff as low risk for relapse\n* Report at least 1 drug network member living with HIV, not on methadone, and seen weekly\n* Willing to talk with drug users in their network about medication for drug dependence and accompany them to methadone clinic\n\nExclusion Criteria:\n\n• Persons that are currently psychotic, suicidal, or cognitively impaired such that they cannot provide informed consent will be excluded from participation.'}, 'identificationModule': {'nctId': 'NCT05824702', 'briefTitle': 'A Social Network Approach for Improving Medication Assisted Treatment and HIV Prevention and Medical Care Among People Who Inject Drugs in Ukraine', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'A Social Network Approach for Improving Medication Assisted Treatment and HIV', 'orgStudyIdInfo': {'id': 'R34DA051316', 'link': 'https://reporter.nih.gov/quickSearch/R34DA051316', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'IRB00024358', 'type': 'OTHER', 'domain': 'JHSPH IRB'}, {'id': 'R34DA051316', 'link': 'https://reporter.nih.gov/quickSearch/R34DA051316', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Peer education and network support', 'description': 'The intervention sessions will consist of 6 group sessions including 1) Introduction to Peer Educator role and peer Communication skills, 2) HIV and drug treatments, 3) using a decision balance tool with network members for drug treatment, 4) Promoting HIV prevention and medical care \\& using text messages as peer educators for promoting MAT and HIV prevention and care, 5) Preventing and responding to relapse, and 6) HIV care retention and medication adherence.', 'interventionNames': ['Behavioral: Peer education & communications']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comparison: Standard of care of health education', 'description': 'The comparison condition will include 5 group sessions focused on: 1) retention in MAT by addressing the myths about MAT; 2) information to MAT clients on finding local MAT and other health services in areas where they migrate; 3) importance of HIV prevention (including PreP) and HIV treatment including adherence to HIV; 4) harm reduction, safe drug use, overdose prevention and first aid in case of overdose; 5) addressing Hepatitis C, chronic conditions and mental health issues by emphasizing the importance of timely addressing these health problems and providing information on available local and national services.', 'interventionNames': ['Behavioral: Standard of care educational']}], 'interventions': [{'name': 'Peer education & communications', 'type': 'BEHAVIORAL', 'description': 'The intervention trains peer educators to promote medication-assisted drug treatment among peer who inject drugs and are living with HIV.', 'armGroupLabels': ['Experimental: Peer education and network support']}, {'name': 'Standard of care educational', 'type': 'BEHAVIORAL', 'description': 'This is an educational equal attention control group', 'armGroupLabels': ['comparison: Standard of care of health education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01001', 'city': 'Kiev', 'state': 'Kyiv Oblast', 'country': 'Ukraine', 'facility': 'Ukrainian Institute on Public Health Policy'}], 'overallOfficials': [{'name': 'Carl A Latkin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ukrainian Institute on Public Health Policy', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}