Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-27 @ 12:25 AM
Study NCT ID:
NCT00489034
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2007-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Engaging Care for HIV-infected Adolescent Females.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012309', 'term': 'Risk-Taking'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2007-06-19', 'studyFirstSubmitQcDate': '2007-06-19', 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engagement in Care among Index Participants', 'timeFrame': 'Baseline, 6 months, 12 months, and 18 months', 'description': 'Engagement in care will be operationalized as the number of clinic visits attended and will be assessed through the qualitative interviews.'}], 'secondaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': 'Baseline, 6 months, 12 months, and 18 months', 'description': 'As assessed through the qualitative interviews for index and network participants.'}, {'measure': 'Sexual Risk Behaviors', 'timeFrame': 'Baseline, 6 months, 12 months, and 18 months', 'description': 'As assessed through the qualitative interviews for index and network participants.'}, {'measure': 'Substance Use', 'timeFrame': 'Baseline, 6 months, 12 months, and 18 months', 'description': 'As assessed through the qualitative interviews for index and network participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'adolescent females', 'adherence', 'clinical care', 'risk behaviors'], 'conditions': ['HIV Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.atnonline.org', 'label': 'Adolescent Medicine Trials Network for HIV/AIDS Interventions Website'}]}, 'descriptionModule': {'briefSummary': 'The proposed multi-site, longitudinal study will examine the correlation of substance use, mental health disorders, and social networks to engagement in care for HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months, and suggest ways to promote adherence and retention in treatment, care, and prevention programs. Qualitative and quantitative data collection methods will be used with index participants and network members.', 'detailedDescription': "The primary outcome examined in the proposed study is engagement in care, operationalized as the number of clinical visits attended. Clinic visits will be monitored on a weekly basis. Secondary outcomes of interest include medication adherence, sexual risk behaviors, and substance use. For the quantitative study, formal psychological testing will be conducted with index adolescent females, and biological specimens will be collected to validate self-reported drug use. CD-4 counts and viral load will be monitored every three months via chart review.\n\nIndex adolescents will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for eighteen months while network members will be interviewed at baseline and one year.\n\nQualitative interviews in the Ethnographic Study will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of at least 18 months. Qualitative interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and to guide their progression.\n\nQualitative Interviews in the Gender Substudy will be conducted with a subsample of index participants. These qualitative interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey to be administered to all index participants from sites participating in this substudy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months will be followed to examine the correlation of substance use, mental health disorders, and social networks to engagement in care and suggested ways to promote adherence and retention in treatment, care, and prevention.', 'healthyVolunteers': False, 'eligibilityCriteria': "Quantitative Study Inclusion Criteria\n\nIndex Participants:\n\n1. Female.\n2. Age 13 years, 0 months - 23 years, 11 months (364 days).\n3. All race/ethnicities.\n4. English or Spanish speaking.\n5. Non-perinatal, non-transfusion acquired HIV.\n6. Unknown transmission status with study personnel approval.\n\nNetwork Participants:\n\nParents/Guardians of Index Participants:\n\n1. Know patient's HIV status\n2. Male or female.\n3. All race/ethnicities\n4. English or Spanish speaking.\n5. Serve a parental or guardian-like role.\n\nClose Friend of Index Participants:\n\n1. Close friend of index subject.\n2. Male or female.\n3. Minimum age 13 years, 0 months.\n4. All race/ethnicities\n5. English or Spanish speaking\n\nEthnographic Sub-Sample\n\nInclusion Criteria:\n\nIndex Participants:\n\n1. Enrolled in Quantitative NIDA study.\n2. English-speaking at Miami, New York, Chicago, and New Orleans sites.\n3. English or Spanish-speaking at Los Angeles USC site\n\nNetwork Participants:\n\n1. English-speaking at Miami, New York, Chicago, and New Orleans sites.\n2. English or Spanish-speaking at Los Angeles USC site.\n3. Know index serostatus.\n\nGender Sub-Sample\n\nInclusion Criteria:\n\n1. Age 18 years, 0 months - 23 years, 11 months.\n2. Enrolled in quantitative study.\n3. English-speaking.\n4. Female."}, 'identificationModule': {'nctId': 'NCT00489034', 'briefTitle': 'Engaging Care for HIV-infected Adolescent Females.', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': "Drug Use and HIV-Infected Female Adolescents' Care Use", 'orgStudyIdInfo': {'id': 'ATN 009'}, 'secondaryIdInfos': [{'id': '1R01DA014706-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA014706-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Index Participants', 'description': 'HIV-infected females, ages 13- 23 years, recruited from ATN sites in New York, Chicago, Miami, Los Angeles, and New Orleans will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic and/or gender interviewing.', 'interventionNames': ['Behavioral: Quantitative Interview', 'Behavioral: Ethnographic Interview', 'Behavioral: Gender Interview']}, {'label': 'Network Participants', 'description': "Closest friends of index participants s and parents/guardians of index participants who know the index participant's HIV status will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic interviewing.", 'interventionNames': ['Behavioral: Quantitative Interview', 'Behavioral: Ethnographic Interview']}], 'interventions': [{'name': 'Quantitative Interview', 'type': 'BEHAVIORAL', 'description': "Index participants will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for 18 months while network members will be interviewed at baseline and one year. Interviews will consist of in-depth face-to-face and audio computer-assisted interviews (ACASIs) and a structured diagnostic interview to assess engagement in care (number of clinical visits attended), substance use, attitudes about substance use, friend's substance use, sexual risk behaviors, PTSD (for index participants only), support of index participants care use (network participants only), attitudes about healthcare (network participants only), index participant's adherence (network participants only), own functioning (network participants only), and family functioning (network participants only). At Baseline only, a urine sample will be collected from index participants for drug testing to assess the agreement between urine and ACASI.", 'armGroupLabels': ['Index Participants', 'Network Participants']}, {'name': 'Ethnographic Interview', 'type': 'BEHAVIORAL', 'description': "Qualitative interviews will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of 18 months. Interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and guide their progression.", 'armGroupLabels': ['Index Participants', 'Network Participants']}, {'name': 'Gender Interview', 'type': 'BEHAVIORAL', 'description': 'Qualitative interviews will be conducted with a sub-sample of index participants. These interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey.', 'armGroupLabels': ['Index Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Universtiy of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33101', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Stroger Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Lori Perez, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Westat'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}