Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:03 AM
Study NCT ID:
NCT07451067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Vasectomy: Right for Me?" Decision Support Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}, {'id': 'D043762', 'term': 'Reproductive Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant knowledge about vacectomy', 'timeFrame': 'Up to 45 minutes', 'description': 'Participant responses to 10 True/False items adapted from previously published studies of vasectomy knowledge and informed by in-depth interviews with men about vasectomy decision making. Items assess knowledge about vasectomy and alternative contraception options and will be coded as correct vs. incorrect, with "Don\'t Know" being coded as an incorrect response. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%.'}, {'measure': 'Participant decisional conflict in contraceptive choice', 'timeFrame': 'Up to 45 minutes', 'description': 'Assessed by participant responses to the low literacy version of the Decisional Conflict Scale (DCS). The DCS is a validated measure to assess participants\' decisional conflict in medical decision-making. The DCS low literacy version includes 10 items about experience of conflict, with "Yes" = 0, "unsure" = 2 and "No" = 4. All 10 items are a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).'}], 'secondaryOutcomes': [{'measure': 'Interest in vasectomy', 'timeFrame': 'Up to 45 minutes', 'description': 'Assessed by participant responses to the question, "Which of the following best describes how you feel about getting a vasectomy?" Answers will consist of a 5-point Likert scale where 1="Definitely want a vasectomy" and 5="Definitely do not want a vasectomy." A summary score is calculated as an average of all items with a range of 1-5, with a higher score reflecting a lower level of interest in vasectomy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vasectomy', 'Decision aid'], 'conditions': ['Vasectomy', 'Contraception', 'Contraception Behavior', 'Reproductive Behavior']}, 'descriptionModule': {'briefSummary': "The goal of this trial is to learn if a web-based decision aid designed to provide evidence-based information about vasectomy and other birth control options helps improve users' decision-making about birth control. The main questions it aims to answer are:\n\n* Do people who use the decision aid have better knowledge about vasectomy?\n* Do people who use the decision aid have lower conflict with their decision?\n\nParticipants will:\n\n* Use the decision aid (if they are assigned to the intervention arm).\n* Answer survey questions about their knowledge, decision-making, interest in vasectomy, and healthcare navigation experiences.", 'detailedDescription': "This study seeks to test a web-based decision support tool developed to enhance men's ability to make informed decisions about vasectomy that align with their preferences, values and reproductive goals. Half of participants will take their T1 survey immediately following randomization, while the other half will first use the web-based decision aid. The investigators hypothesize that compared to men who do not use the decision aid, men randomized to the decision aid arm will have greater knowledge about vasectomy and alternative options, lower decisional conflict, and will report greater interest in getting a vasectomy."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are assigned male at birth\n* 21-55 years of age\n* Comfortable reading in English or Spanish\n* Live in the United States\n* Are considering vasectomy\n* Have not had a vasectomy\n\nExclusion Criteria:\n\n* Are not assigned male at birth\n* Are less than 21 or more than 55 years of age\n* Is not comfortable reading English nor Spanish\n* Do not live in the United States\n* Are not considering vasectomy\n* Have had a vasectomy\n* Once a racial or economic sub-group recruitment number has been reached, no other subjects fitting that ethnicity or income group will be enrolled.'}, 'identificationModule': {'nctId': 'NCT07451067', 'briefTitle': '"Vasectomy: Right for Me?" Decision Support Tool', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Addressing Factors Related to Disparities in Vasectomy', 'orgStudyIdInfo': {'id': 'STUDY23070159'}, 'secondaryIdInfos': [{'id': 'R01HD110557', 'link': 'https://reporter.nih.gov/quickSearch/R01HD110557', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decision Aid Arm', 'description': 'Participants will use the web-based decision aid.', 'interventionNames': ['Behavioral: "Vasectomy: Right for Me?" decision aid']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Participants will be asked to take their T1 survey directly after randomization, without using the decision aid.'}], 'interventions': [{'name': '"Vasectomy: Right for Me?" decision aid', 'type': 'BEHAVIORAL', 'description': 'The vasectomy decision aid is a web-based decision aid designed to help men make informed and value-concordant decisions about vasectomy.', 'armGroupLabels': ['Decision Aid Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94129', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Jeanette Cunningham Rottas, MA', 'role': 'CONTACT', 'email': 'jeanetterottas@resoundrh.org', 'phone': '202-271-2607'}, {'name': 'Kari White, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Resound Research for Reproductive Health, a project of the Tides Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Michaella Wu, MPH', 'role': 'CONTACT', 'email': 'mlw160@pitt.edu', 'phone': '704-502-3395'}, {'name': 'Sonya Borrero, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CONVERGE Toward Sexual and Reproductive Health Equity', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Sonya Borrero, MD, MS', 'role': 'CONTACT', 'email': 'borrsp@upmc.edu', 'phone': '412-216-1104', 'phoneExt': '+1'}, {'name': 'Kari White, PhD, MPH', 'role': 'CONTACT', 'email': 'kariwhite@resoundrh.org', 'phone': '203-435-4238', 'phoneExt': '+1'}], 'overallOfficials': [{'name': 'Sonya Borrero, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Kari White, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resound Research for Reproductive Health'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Publication of results will occur upon completion of the study. De-identified survey data will be made available within four years after the completion of data collection. No end date.', 'ipdSharing': 'YES', 'description': 'De-identified participant data will be used for publication. De-identified survey data will be made available, and NIH policies and procedures that permit and encourage open access to study data will be followed. The survey data will be de-identified and sent to the NIH program officer for distribution as a data set within four years after the completion of data collection. For outside investigators to fully utilize the survey data correctly, we will provide assistance whenever feasible. Additionally, the study statistician will annotate, document, and merge datasets generated from this proposal for data archiving to facilitate the use of study data.', 'accessCriteria': 'De-identified participant data will be used for publication. Access to de-identified data may be granted to other investigators whose proposed use of the data has been approved by an independent review committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Resound Research for Reproductive Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Sonya Borrero', 'investigatorAffiliation': 'University of Pittsburgh'}}}}