Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-01 @ 12:24 PM
Study NCT ID:
NCT02579135
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2015-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D012746', 'term': 'Sexual Abstinence'}], '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'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmwidman@ncsu.edu', 'phone': '919-513-2546', 'title': 'Dr. Laura Widman', 'organization': 'North Carolina State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Project HEART', 'description': 'Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.\n\nSafer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.\n\nNo adverse events.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 0, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control: Project Growing Minds', 'description': 'Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.\n\nGrowth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.\n\nNo adverse events.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 0, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6-item Self-report of Program Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Project HEART', 'description': 'Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.\n\nSafer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.'}], 'classes': [{'title': 'Would return to site', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Recommend to friend', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'Use Information in Future', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': 'Liked program a lot', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Learned a lot', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Program kept attention a lot', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediate post-test at completion of intervention', 'description': 'Program acceptability was assessed through a questionnaire that was adapted from prior acceptability surveys. Specifically, six items were included to assess six aspects of acceptability: (i) an intent to return to the website, (ii) whether one would recommend the program to a friend, (iii) whether one would use information from the program in the future, (iv) how much one liked the program, (v) how much one learned from the program and (vi) how much one felt the program kept their attention. The first three questions were coded with dichotomous response options (yes/no-unsure), whereas the last three items used a four point Likert-type scale ranging from 1=not at all to 4=a lot. For analyses, these last 3 items were dichotomized into 1=a lot and 0=not a lot.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on acceptability only analyzed among girls who completed the Project HEART intervention'}, {'type': 'PRIMARY', 'title': '7-item Self-report of Sexual Communication Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Project HEART', 'description': 'Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.\n\nSafer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.'}, {'id': 'OG001', 'title': 'Control: Project Growing Minds', 'description': 'Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.\n\nGrowth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.62', 'spread': '.47', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': 'Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).'}], 'paramType': 'MEAN', 'timeFrame': 'Immediate post-test at completion of intervention and 3-month follow-up', 'description': 'We used the validated Self-Efficacy for HIV Prevention Scale to assess communication self-efficacy. Seven items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Participants responded from 1 for "couldn\'t do it" to 4 for "very sure." Scores were averaged with higher scores indicating greater confidence in communicating about sex (alpha = 0.82).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '3-item Self-report of Sexual Communication Intentions Over Next 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Project HEART', 'description': 'Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.\n\nSafer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.'}, {'id': 'OG001', 'title': 'Control: Project Growing Minds', 'description': 'Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.\n\nGrowth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.0', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '78.5', 'spread': '27.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta', 'ciNumSides': 'TWO_SIDED', 'paramValue': '8.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.71', 'groupDescription': 'We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).'}], 'paramType': 'MEAN', 'timeFrame': 'Immediate post-test at completion of intervention and 3-month follow-up', 'description': 'We assessed intentions to communicate about sex with items from the AIDS Risk Behavior Assessment. Three items captured the likelihood of communicating with a partner in the next 3 months about (1) sexual limits and boundaries, (2) STDs and pregnancy, and (3) condom use. Options ranged from 0% to 100% to indicate the likelihood of communicating with a partner. We averaged scores to create a composite (possible range 0-100); higher scores indicated greater likelihood of sexual communication (alpha = 0.84).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Project HEART', 'description': 'Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.\n\nSafer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.'}, {'id': 'FG001', 'title': 'Control: Project Growing Minds', 'description': 'Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.\n\nGrowth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Project HEART', 'description': 'Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.\n\nSafer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.'}, {'id': 'BG001', 'title': 'Control: Project Growing Minds', 'description': 'Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.\n\nGrowth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.26', 'spread': '.48', 'groupId': 'BG000'}, {'value': '15.22', 'spread': '.47', 'groupId': 'BG001'}, {'value': '15.24', 'spread': '.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Non-Hispanic', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Black/Non-Hispanic', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Other/Mixed Race-Ethnicity', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2015-10-10', 'resultsFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-20', 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-item Self-report of Program Acceptability', 'timeFrame': 'Immediate post-test at completion of intervention', 'description': 'Program acceptability was assessed through a questionnaire that was adapted from prior acceptability surveys. Specifically, six items were included to assess six aspects of acceptability: (i) an intent to return to the website, (ii) whether one would recommend the program to a friend, (iii) whether one would use information from the program in the future, (iv) how much one liked the program, (v) how much one learned from the program and (vi) how much one felt the program kept their attention. The first three questions were coded with dichotomous response options (yes/no-unsure), whereas the last three items used a four point Likert-type scale ranging from 1=not at all to 4=a lot. For analyses, these last 3 items were dichotomized into 1=a lot and 0=not a lot.'}, {'measure': '7-item Self-report of Sexual Communication Self-efficacy', 'timeFrame': 'Immediate post-test at completion of intervention and 3-month follow-up', 'description': 'We used the validated Self-Efficacy for HIV Prevention Scale to assess communication self-efficacy. Seven items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Participants responded from 1 for "couldn\'t do it" to 4 for "very sure." Scores were averaged with higher scores indicating greater confidence in communicating about sex (alpha = 0.82).'}, {'measure': '3-item Self-report of Sexual Communication Intentions Over Next 3 Months', 'timeFrame': 'Immediate post-test at completion of intervention and 3-month follow-up', 'description': 'We assessed intentions to communicate about sex with items from the AIDS Risk Behavior Assessment. Three items captured the likelihood of communicating with a partner in the next 3 months about (1) sexual limits and boundaries, (2) STDs and pregnancy, and (3) condom use. Options ranged from 0% to 100% to indicate the likelihood of communicating with a partner. We averaged scores to create a composite (possible range 0-100); higher scores indicated greater likelihood of sexual communication (alpha = 0.84).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Condoms', 'Sexual Abstinence', 'Sexual Communication'], 'conditions': ['HIV', 'Sexually Transmitted Diseases']}, 'referencesModule': {'references': [{'pmid': '29161072', 'type': 'DERIVED', 'citation': 'Widman L, Golin CE, Kamke K, Burnette JL, Prinstein MJ. Sexual Assertiveness Skills and Sexual Decision-Making in Adolescent Girls: Randomized Controlled Trial of an Online Program. Am J Public Health. 2018 Jan;108(1):96-102. doi: 10.2105/AJPH.2017.304106. Epub 2017 Nov 21.'}, {'pmid': '27710087', 'type': 'DERIVED', 'citation': 'Widman L, Golin CE, Noar SM, Massey J, Prinstein MJ. ProjectHeartforGirls.com: Development of a Web-Based HIV/STD Prevention Program for Adolescent Girls Emphasizing Sexual Communication Skills. AIDS Educ Prev. 2016 Oct;28(5):365-377. doi: 10.1521/aeap.2016.28.5.365.'}]}, 'descriptionModule': {'briefSummary': "This study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health Education and Relationship Training). Half of participants will receive Project HEART and half of participants will receive Project Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.", 'detailedDescription': "This study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health Education and Relationship Training). Half of participants will receive Project HEART and half of participants will receive Project Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.\n\nPrimary outcomes for this study include 1) acceptability of the program, 2) communication self-efficacy, and 3) communication intentions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10th grade girl\n* Able to read English\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02579135', 'briefTitle': 'Reducing HIV Risk Among Adolescents: Evaluating Project HEART', 'organization': {'class': 'OTHER', 'fullName': 'North Carolina State University'}, 'officialTitle': 'Reducing HIV Risk Among Adolescents: Evaluating Project HEART', 'orgStudyIdInfo': {'id': '57033'}, 'secondaryIdInfos': [{'id': 'R00HD075654', 'link': 'https://reporter.nih.gov/quickSearch/R00HD075654', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Project HEART', 'description': 'Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.', 'interventionNames': ['Behavioral: Safer Sex']}, {'type': 'OTHER', 'label': 'Control: Project Growing Minds', 'description': 'Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.', 'interventionNames': ['Behavioral: Growth Mindsets']}], 'interventions': [{'name': 'Safer Sex', 'type': 'BEHAVIORAL', 'description': 'Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.', 'armGroupLabels': ['Project HEART']}, {'name': 'Growth Mindsets', 'type': 'BEHAVIORAL', 'description': 'Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.', 'armGroupLabels': ['Control: Project Growing Minds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27695', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina State University', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'overallOfficials': [{'name': 'Laura Widman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Carolina State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Carolina State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Laura Widman', 'investigatorAffiliation': 'North Carolina State University'}}}}