Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT01643005
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Couple-Based Relationship Strengthening HIV Intervention for Young Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2012-07-12', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High risk sexual behavior', 'timeFrame': 'Baseline', 'description': 'Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy'}, {'measure': 'High risk sexual behavior', 'timeFrame': '4 months', 'description': 'Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy'}, {'measure': 'High risk sexual behavior', 'timeFrame': '8 months', 'description': 'Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy'}], 'secondaryOutcomes': [{'measure': 'Relationship Functioning at 4 months', 'timeFrame': '4 months'}, {'measure': 'Relationship Dissolution at 4 months', 'timeFrame': '4 months'}, {'measure': 'Change from Baseline in relationship based determinants at 4 months', 'timeFrame': '4 months', 'description': 'Attachment, Intimacy, Communication, Equity, Relationship Conflict'}, {'measure': 'Relationship Functioning at 8 months', 'timeFrame': '8 months'}, {'measure': 'Relationship Dissolution at 8 months', 'timeFrame': '8 months'}, {'measure': 'Change from Baseline in relationship based determinants at 8 months', 'timeFrame': '8 months', 'description': 'Attachment, Intimacy, Communication, Equity, Relationship Conflict'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This study seeks to develop, implement, and assess an innovative 15-session couple-based intervention to be delivered in a group format to young parents that aims to strengthen relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce HIV/STD risk (concurrency, number of partners, unprotected sex), strengthen relationships, and improve parenting among young parenting heterosexual couples.', 'detailedDescription': 'This study develops a couple-based HIV prevention intervention that is innovative and important because it integrates an intervention that improves sexual health, relationship functioning, and parenting skills. Our intervention will be integrated with an existing community based parenting program. By targeting high risk heterosexual couples experiencing an important life transition that increases their stress, conflict, and sexual risk, the investigators can provide maximum benefit to the men, women, and children in our communities. Using the guiding framework of Attachment Theory and the principles of Emotion Focused Therapy, the investigators will directly address issues of emotion, intimacy,and relationship functioning to create an intervention that strengthens romantic relationships and reduces HIV risk behavior. The investigators will conduct a small pilot randomized controlled trial of 50 parenting couples randomized to either the relationship strengthening HIV prevention intervention or an active control. The intervention will last 15 weeks and each session will be approximately 1.5 hours long. The investigators will assess couples at baseline, 4-months, and 8-months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women's age between 14 and 25\n* Men's age 14 or older\n* Have a child that is 0-1 year old\n* In a romantic relationship with the mother/father of the baby\n* Not known to be HIV positive\n* English speaking\n\nExclusion Criteria:\n\n* Child older than 1 year\n* HIV positive"}, 'identificationModule': {'nctId': 'NCT01643005', 'briefTitle': 'A Couple-Based Relationship Strengthening HIV Intervention for Young Parents', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Pilot Phase of Couples-Based Intervention to Reduce HIV/STD Risk (Concurrency, Number of Partners, Unprotected Sex), Strengthen Relationships, and Improve Parenting Among Young Parenting Heterosexual Couples', 'orgStudyIdInfo': {'id': '1105008508'}, 'secondaryIdInfos': [{'id': 'R34MH094354', 'link': 'https://reporter.nih.gov/quickSearch/R34MH094354', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control Group', 'description': 'For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.', 'interventionNames': ['Behavioral: Parenting Program Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Relationship Strengthening HIV Prevent.', 'description': 'The relationship strengthening HIV intervention will build on the structure of the Nurturing Parenting Groups and will be integrated so that participants will receive the Nurturing Parenting Groups plus the relationship strengthening HIV intervention.', 'interventionNames': ['Behavioral: Relationship Strengthening HIV Prevention Intervention']}], 'interventions': [{'name': 'Relationship Strengthening HIV Prevention Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Partners in Life'], 'description': 'The relationship strengthening HIV intervention will build on the structure of the Nurturing Parenting Groups and will be integrated so that participants will receive the Nurturing Parenting Groups plus the relationship strengthening HIV intervention.', 'armGroupLabels': ['Relationship Strengthening HIV Prevent.']}, {'name': 'Parenting Program Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Nurturing Parenting'], 'description': 'Nurturing Parenting curriculum delivered in a group format.', 'armGroupLabels': ['Active Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06515', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': "Children's Community Programs of Connecticut", 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Trace S Kershaw, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}