Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-26 @ 1:11 AM
Study NCT ID:
NCT02411357
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2015-04-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005298', 'term': 'Fertility'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.heil@uvm.edu', 'phone': '802-656-8712', 'title': 'Sarah H. Heil, PhD', 'organization': 'University of Vermont'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 26, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Contraceptive Services', 'description': 'The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 42, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Contraceptive Services + Incentives', 'description': 'The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 36, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Adverse events not categorized by organ system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 46, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 176, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 230, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Ruptured ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection secondary to surgical incision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Opioid overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest secondary to probable bupropion overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for depression/suicidality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.'}, {'id': 'OG001', 'title': 'Contraceptive Services', 'description': 'The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.'}, {'id': 'OG002', 'title': 'Contraceptive Services + Incentives', 'description': 'The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Cochran-Armitage Chi-square trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.'}, {'id': 'FG001', 'title': 'Contraceptive Services', 'description': 'The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.'}, {'id': 'FG002', 'title': 'Contraceptive Services + Incentives', 'description': 'The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.'}, {'id': 'BG001', 'title': 'Contraceptive Services', 'description': 'The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.'}, {'id': 'BG002', 'title': 'Contraceptive Services + Incentives', 'description': 'The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '32.0', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '31.4', 'spread': '5.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'One or more unintended pregnancies in lifetime', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-17', 'size': 311813, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-19T15:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2015-04-02', 'resultsFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-19', 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment', 'timeFrame': '6 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Contraception', 'Unintended pregnancy', 'HIV risk', 'Sexually transmitted infections', 'Women', 'Pregnancy', 'Neonatal health', 'Drug use', 'Drug treatment', 'Opioids'], 'conditions': ['Contraceptive Usage', 'Opioid Dependence']}, 'referencesModule': {'references': [{'pmid': '34259798', 'type': 'DERIVED', 'citation': 'Heil SH, Melbostad HS, Matusiewicz AK, Rey CN, Badger GJ, Shepard DS, Sigmon SC, MacAfee LK, Higgins ST. Efficacy and Cost-Benefit of Onsite Contraceptive Services With and Without Incentives Among Women With Opioid Use Disorder at High Risk for Unintended Pregnancy: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Oct 1;78(10):1071-1078. doi: 10.1001/jamapsychiatry.2021.1715.'}]}, 'descriptionModule': {'briefSummary': 'Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women at risk of unintended pregnancy.', 'detailedDescription': 'The rate of unintended pregnancy among opioid-dependent women is extremely high: nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended, a rate 2-3 times that of the general population. Despite these dire statistics, there is a dearth of scientific knowledge about contraceptive use in this population and about how to promote use of more effective contraceptives (e.g., birth control pills, intrauterine devices (IUDs), implants).\n\nThe aim of this Stage II Behavioral and Integrative Treatment Development Program application is to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained (OM) women. OM women at risk for unintended pregnancy (N=195) will be randomly assigned to one of three conditions: (1) usual care, (2) the World Health Organization (WHO) contraception protocol, and (3) the WHO contraception protocol + financial incentives. Participants in the usual care condition will receive a referral to local contraceptive providers. Participants in the WHO alone condition will receive the WHO contraceptive initiation protocol and their choice of prescription contraceptive in consultation with a nurse practitioner. These participants will also subsequently be offered the opportunity to attend 13 follow-up visits where vital signs and a urine pregnancy test will be administered. Side effects of any prescription contraception will also be assessed and participants will have the option to change their prescription contraceptive method at any time. Participants in the WHO + incentives condition will also receive the WHO contraceptive initiation protocol and their choice of prescription contraceptive in consultation with a nurse practitioner. These participants will also subsequently be offered the opportunity to attend 13 follow-up visits where vital signs and a urine pregnancy test will be administered. Side effects of any prescription contraception will be assessed and participants will have the option to change their prescription contraceptive method at any time. Participants in the WHO + incentives condition participants will also earn vouchers exchangeable for goods and services for attending these visits. Contraceptive use by all participants will be evaluated at assessments scheduled 1, 3, 6, and 12 months after trial intake.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-44 years of age\n* pre-menopausal and have no history of tubal ligation or hysterectomy\n* have had heterosexual vaginal sex in the past 3 months\n* have no plans to become pregnant in the next 6 months\n* be medically eligible to use prescription contraceptives\n* report no prescription contraceptive use (i.e., no use of pill, patch, ring, implants, or IUDs in the past 7 days or injections in the past 3 months)\n* be in opioid maintenance treatment\n* at least 8 weeks postpartum\n* not be facing imminent incarceration\n* have no plans to leave the area in the next 12 months\n* be English-speaking\n\nExclusion Criteria:\n\n* failure to meet the aforementioned inclusion criteria\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT02411357', 'briefTitle': 'Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II', 'orgStudyIdInfo': {'id': 'R01DA036670', 'link': 'https://reporter.nih.gov/quickSearch/R01DA036670', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.', 'interventionNames': ['Behavioral: Treatment as usual']}, {'type': 'EXPERIMENTAL', 'label': 'WHO contraception protocol', 'description': "The WHO contraception protocol condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits.", 'interventionNames': ['Behavioral: Treatment as usual', 'Behavioral: WHO contraception protocol']}, {'type': 'EXPERIMENTAL', 'label': 'WHO contraception protocol + incentives', 'description': "The WHO + incentives condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits, but will also receive financial incentives contingent on attending those follow-up visits.", 'interventionNames': ['Behavioral: Treatment as usual', 'Behavioral: WHO contraception protocol', 'Behavioral: Incentives']}], 'interventions': [{'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'General information about contraceptive options and referral to contraceptive service providers', 'armGroupLabels': ['Treatment as usual', 'WHO contraception protocol', 'WHO contraception protocol + incentives']}, {'name': 'WHO contraception protocol', 'type': 'BEHAVIORAL', 'description': "World Health Organization's contraception protocol", 'armGroupLabels': ['WHO contraception protocol', 'WHO contraception protocol + incentives']}, {'name': 'Incentives', 'type': 'BEHAVIORAL', 'description': 'Financial incentives contingent on follow-up visit attendance', 'armGroupLabels': ['WHO contraception protocol + incentives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Vermont Center on Behavior and Health', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Sarah H. Heil, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sarah Heil', 'investigatorAffiliation': 'University of Vermont'}}}}