Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT01859195
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2013-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monoclonal Antibody-based Multipurpose Microbicides
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scu-uvin@lifespan.org; kate.guthrie@lifespan.org', 'phone': '401-793-4775 or 401-793-8180', 'title': 'Principal Investigator', 'organization': 'The Miriam Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a formative qualitative data study, designed to gather narrative participant-relevant information related to study product development and evaluation.'}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Focus Groups', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cognitive Interviews', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants: Comprehension of Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Participants: Focus Group', 'description': 'Number of participants in focus group stage'}, {'id': 'OG001', 'title': 'Number of Participants: Cognitive Interviews', 'description': 'Number of participants in cognitive interview stage'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Focus groups captured participant understandings (in narrative form) of plant-produced monoclonal antibodies, how they come about, how they are manufactured, how they differ from other anti-HIV actives, etc. Participant-derived language informed development of study materials, including study product instruction sheets and informed consent materials and documents.\n\nCognitive Interview assessed Participant comprehension of language used in insertion instruction materials, and monoclonal antibody education and informed consent materials.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants: Drug Delivery Systems Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Participants: Focus Groups', 'description': 'number of participants who completed focus group stage'}, {'id': 'OG001', 'title': 'Number of Participants: Cognitive Interviews', 'description': 'number of participants who completed cognitive interview stage'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Focus Group Stage', 'description': '\\~20-24 participants, to comprise 3-6 focus groups'}, {'id': 'FG001', 'title': 'Cognitive Interview Stage', 'description': '\\~12-16 participants in individual cognitive interviews'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruited May-Aug 2013 (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth. Volunteers complete prescreen survey. If eligible, each invited to participate in either (1) focus group or (2) individual cognitive interview (first \\~20-24 for focus groups; remaining \\~12-16 for interviews after FGs began).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Focus Groups', 'description': 'Focus Groups'}, {'id': 'BG001', 'title': 'Cognitive Interviews', 'description': 'Cognitive Interviews'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2013-05-14', 'resultsFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-02', 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants: Drug Delivery Systems Evaluations', 'timeFrame': '1 year', 'description': 'Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development'}], 'primaryOutcomes': [{'measure': 'Number of Participants: Comprehension of Study Product', 'timeFrame': '1 year', 'description': 'Focus groups captured participant understandings (in narrative form) of plant-produced monoclonal antibodies, how they come about, how they are manufactured, how they differ from other anti-HIV actives, etc. Participant-derived language informed development of study materials, including study product instruction sheets and informed consent materials and documents.\n\nCognitive Interview assessed Participant comprehension of language used in insertion instruction materials, and monoclonal antibody education and informed consent materials.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV/STI', 'Prevention', 'Microbicides, Topical'], 'conditions': ['HIV', 'Sexually Transmitted Infections (STI)']}, 'descriptionModule': {'briefSummary': "The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. The investigators will ask women to help design the best strategy for applying a vaginal product using a specific kind of applicator. The investigators want to identify designs that women think would be easy to prepare and insert. Women's thoughts and opinions will help researchers develop new products called microbicides that may protect against HIV and other sexually transmitted diseases, that are easy to use, and that will be acceptable to women who use them. If researchers can make products that are easy to use and that women like to use, the products will be used more often, and more infections will be prevented.\n\nWomen who enroll in the project will either participate in a focus group with approximately 3-7 other women or a one-on-one cognitive interview. All participants will complete a brief questionnaire. Some women may enroll in both stages.\n\nEach focus group will take approximately 1.5-2.5 hours. Group leaders will talk to women about their experiences using vaginal products and will provide participants with study products to look at and touch. All participants will be asked to come up with ideas of how to make the products easy to use and acceptable to women who use them. Group leaders will encourage discussion about the different designs. After this, group leaders will talk about a specific type of microbicide and ask women about their opinions. In particular, researchers and participants will talk about the language that would be best understood by women who would use these products or be in studies to evaluate them.\n\nEach cognitive interview will take approximately 1.5-2.5 hours. Each participant will be asked about different product designs and application instructions, and will be asked her thoughts, opinions, and potential concerns about each. She will also evaluate sample language that will be used to help women understand the products and how to use them."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females who are 18-45 years old, HIV negative or unknown (self report), non-pregnant and not intending to get pregnant (self report), and report vaginal sex with a man in the past 12 months.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nWomen who:\n\n* are between the ages of 18 and 45 at prescreening\n* report vaginal sex with a man in the past 12 months at prescreening\n* report negative pregnancy status and no intention to become pregnant during the course of the study\n* report negative or unknown HIV status, and\n* are willing and able to provide informed consent.\n\nExclusion Criteria:\n\nWomen who:\n\n* self-report being pregnant, or intention to become pregnant during the course of the study\n* self-report being HIV-positive\n* self-report an allergy or sensitivity to vaginal contraceptive film (VCF), nonoxynol-9 (N9), or product(s) containing N9\n* are unable or unwilling to give informed consent, or\n* have any condition that, in the opinion of the project leader or principle investigator, would compromise the participant's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT01859195', 'acronym': 'Project WIND', 'briefTitle': 'Monoclonal Antibody-based Multipurpose Microbicides', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'Monoclonal Antibody-based Multipurpose Microbicides', 'orgStudyIdInfo': {'id': 'DAIDS-ES-ID-11941'}, 'secondaryIdInfos': [{'id': 'U19AI096398', 'link': 'https://reporter.nih.gov/quickSearch/U19AI096398', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Focus Group Stage', 'description': '\\~20-24 participants, to comprise 3-6 focus groups'}, {'label': 'Cognitive Interview Stage', 'description': '\\~12-16 participants in individual cognitive interviews'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital - ReproHelath Team', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Kathleen M Morrow, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Miriam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}