Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:20 PM
Study NCT ID:
NCT05669534
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune 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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065129', 'term': 'Pre-Exposure Prophylaxis'}, {'id': 'D056990', 'term': 'Post-Exposure Prophylaxis'}], 'ancestors': [{'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Multiphase Optimization Strategy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Drug Test via Urine toxicology', 'timeFrame': 'conducted at Week 1', 'description': 'Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses'}, {'measure': 'Drug Test via Urine toxicology', 'timeFrame': 'conducted at twice weekly during the 4-week intervention phase', 'description': 'Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses'}, {'measure': 'Drug Test via Urine toxicology', 'timeFrame': 'conducted at 3-month follow-up', 'description': 'Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses'}, {'measure': 'Drug Test via Urine toxicology', 'timeFrame': 'conducted at 6-month follow-up', 'description': 'Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses'}, {'measure': 'Drug Test via Urine toxicology', 'timeFrame': 'conducted at 9-month follow-up', 'description': 'Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses'}], 'primaryOutcomes': [{'measure': 'Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)', 'timeFrame': 'PrEP adherence DBS measured at week 4', 'description': 'Dried Blood Spots will test the amount of active PrEP components in the participants blood.'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)', 'timeFrame': 'PrEP adherence DBS measured at the 3-month post-intervention follow-up', 'description': 'Dried Blood Spots will test the amount of active PrEP components in the participants blood.'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)', 'timeFrame': 'PrEP adherence DBS measured at the 6-month post-intervention follow-up', 'description': 'Dried Blood Spots will test the amount of active PrEP components in the participants blood.'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)', 'timeFrame': 'PrEP adherence DBS measured at the 9-month post-intervention follow-up', 'description': 'Dried Blood Spots will test the amount of active PrEP components in the participants blood.'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via pharmacy refill data', 'timeFrame': 'PrEP adherence pharmacy refill data measured at week 4', 'description': 'Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via pharmacy refill data', 'timeFrame': 'PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up', 'description': 'Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via pharmacy refill data', 'timeFrame': 'PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up', 'description': 'Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via pharmacy refill data', 'timeFrame': 'PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up', 'description': 'Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via self-report scale', 'timeFrame': 'PrEP adherence pharmacy self report measured at week 4', 'description': 'Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via self-report scale', 'timeFrame': 'PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups', 'description': 'Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via self-report scale', 'timeFrame': 'PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups', 'description': 'Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence'}, {'measure': 'Pre-Exposure Prophylaxis Adherence via self-report scale', 'timeFrame': 'PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups', 'description': 'Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence'}], 'secondaryOutcomes': [{'measure': 'HIV risk behaviors questionnaire', 'timeFrame': 'HIV risk behaviors measured at Week 1', 'description': 'Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.'}, {'measure': 'HIV risk behaviors questionnaire', 'timeFrame': 'HIV risk behaviors measured at Week 4', 'description': 'Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.'}, {'measure': 'HIV risk behaviors questionnaire', 'timeFrame': 'HIV risk behaviors measured at the 3-month post-intervention follow-up', 'description': 'Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.'}, {'measure': 'HIV risk behaviors questionnaire', 'timeFrame': 'HIV risk behaviors measured at the 6-month post-intervention follow-up', 'description': 'Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.'}, {'measure': 'HIV risk behaviors questionnaire', 'timeFrame': 'HIV risk behaviors measured at the 9-month post-intervention follow-up', 'description': 'Self-report oof "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.'}, {'measure': 'HIV prevention IMB model constructs questionnaire', 'timeFrame': 'HIV prevention IMB model constructs measured at Week 1', 'description': 'self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills'}, {'measure': 'HIV prevention IMB model constructs questionnaire', 'timeFrame': 'HIV prevention IMB model constructs measured at Week 4', 'description': 'self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills'}, {'measure': 'HIV prevention IMB model constructs questionnaire', 'timeFrame': 'HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up', 'description': 'self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills'}, {'measure': 'HIV prevention IMB model constructs questionnaire', 'timeFrame': 'HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up', 'description': 'self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills'}, {'measure': 'HIV prevention IMB model constructs questionnaire', 'timeFrame': 'HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up', 'description': 'self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['people who inject drugs', 'HIV', 'cognitive dysfunction', 'pre-exposure prophylaxis', 'multiphase optimization strategy', 'medication for opioid use disorder', 'opioid use disorder'], 'conditions': ['Hiv', 'Opioid Use Disorder']}, 'referencesModule': {'references': [{'pmid': '37399447', 'type': 'DERIVED', 'citation': 'Mistler CB, Shrestha R, Gunstad J, Collins L, Madden L, Huedo-Medina T, Sibilio B, Copenhaver NM, Copenhaver M. Application of the multiphase optimisation strategy (MOST) to optimise HIV prevention targeting people on medication for opioid use disorder (MOUD) who have cognitive dysfunction: protocol for a MOST study. BMJ Open. 2023 Jun 30;13(6):e071688. doi: 10.1136/bmjopen-2023-071688.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).', 'detailedDescription': 'Participants will be randomized to one of 16 conditions. In addition to receiving the Core Components of the CHRP behavioral intervention, participants will receive one of the sixteen combinations of four compensatory components that show promise in terms of enhancing the ability to process and utilize HIV prevention content (see conceptual figure above), and that are not currently part of CHRP. The Attention Component includes: (a) Increasing frequency of sessions (more than once per week); (b) Distributed practice (spreading out information across sessions); (c) More structured sessions (well-organized objectives shared with patients); (d) Introducing new information during closure (foreshadow content of next session). The Executive Function Component includes the following strategies: (a) Associating behavior with situational cues (anticipate risky situations); (b) Linking actions to a triggering cue (storytelling techniques using imagery); (c) Planning (identify and organize steps required to meet goal) and (d) Valuing future events (recognize the benefits of drug treatment). Similarly, the Memory Component involves: (a) Memory aids (reminders and cues to be used between sessions); (b) Summarizing/reiterating information (frequent review throughout sessions); (c) Prospective memory (emphasize routine, develop cues, elaborate on positive behaviors); and (d) Environmental engineering (prepare for adverse events). Lastly, the Information Processing Component includes: (a) Mixed methods of presentation (verbal, visual, and hands-on); (b) Simple language (clear, concrete examples aligned with health literacy level); (c) Present content slowly (allow extra time for responses); and (d Immediate feedback following assessment (oral/ written).Of particular note, the investigators are using this framework to examine all combinations of these components (rather than merely testing all four) to promote ecological validity and future implementation. Specifically, our approach will help determine the most resource-efficient intervention, as there are many barriers to adding components to standard of care in these clinical settings. For example, if components targeting only two domains can produce equivalent outcomes as components targeting four, the former would be identified as preferred'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being 18 years or older\n* meeting DSM-V criteria for opioid dependence and being newly prescribed and adherent to Medication for Opioid Use Disorder (e.g., methadone, buprenorphine) at the APT Foundation, Inc.\n* showing mild cognitive impairment based on the Montreal Cognitive Assessment (MoCA) screening\n* having initiated Pre-Exposure Prophylaxis (PrEP) within the past week\n* confirming HIV-negative status through proof of PrEP prescription\n* reporting unsafe injection drug use practices or unprotected sex within the past 3 months\n* having a cell phone\n* being able to read and understand in English\n\nExclusion Criteria:\n\n* unable to provide consent\n* actively suicidal\n* actively homicidal\n* actively psychotic\n* display MoCA scores suggestive of dementia'}, 'identificationModule': {'nctId': 'NCT05669534', 'acronym': 'MOST', 'briefTitle': 'Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP', 'orgStudyIdInfo': {'id': 'H22-0121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Condition 1', 'description': 'Standard CHRP Intervention Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 2', 'description': 'Standard CHRP Intervention Components and Information Processing Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 3', 'description': 'Standard CHRP Intervention Components and Memory Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 4', 'description': 'Standard CHRP Intervention Components, Information Processing Components, and Memory Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 5', 'description': 'Standard CHRP Intervention Components, Executive Functioning Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 6', 'description': 'Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 7', 'description': 'Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 8', 'description': 'Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 9', 'description': 'Standard CHRP Intervention Components and Attention Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 10', 'description': 'Standard CHRP Intervention Components, Information Processing Components, and Attention Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 11', 'description': 'Standard CHRP Intervention Components, Memory Components, and Attention Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 12', 'description': 'Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 13', 'description': 'Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 14', 'description': 'Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 15', 'description': 'Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 16', 'description': 'Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components', 'interventionNames': ['Behavioral: community-friendly health recovery program', 'Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis']}], 'interventions': [{'name': 'community-friendly health recovery program', 'type': 'BEHAVIORAL', 'otherNames': ['CHRP'], 'description': 'Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.', 'armGroupLabels': ['Condition 1', 'Condition 10', 'Condition 11', 'Condition 12', 'Condition 13', 'Condition 14', 'Condition 15', 'Condition 16', 'Condition 2', 'Condition 3', 'Condition 4', 'Condition 5', 'Condition 6', 'Condition 7', 'Condition 8', 'Condition 9']}, {'name': 'Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis', 'type': 'DRUG', 'otherNames': ['PrEP'], 'description': 'Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.', 'armGroupLabels': ['Condition 1', 'Condition 10', 'Condition 11', 'Condition 12', 'Condition 13', 'Condition 14', 'Condition 15', 'Condition 16', 'Condition 2', 'Condition 3', 'Condition 4', 'Condition 5', 'Condition 6', 'Condition 7', 'Condition 8', 'Condition 9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Sibilio, BS', 'role': 'CONTACT', 'email': 'brian.sibilio@uconn.edu', 'phone': '203-781-4690'}], 'facility': 'APT Foundation', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Brian Sibilio, BS', 'role': 'CONTACT', 'email': 'brian.sibilio@uconn.edu', 'phone': '2037814690'}, {'name': 'Tanya Adler, MS', 'role': 'CONTACT', 'email': 'tanya.adler@uconn.edu', 'phone': '2037814690'}], 'overallOfficials': [{'name': 'Michael Copenhaver, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication. No end date', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results will be available upon request.', 'accessCriteria': 'Proposals should be directed to Michael.Copenhaver@uconn.edu To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael Copenhaver', 'investigatorAffiliation': 'University of Connecticut'}}}}