Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-02-27 @ 3:54 PM
Study NCT ID:
NCT01571128
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2012-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017280', 'term': 'Condoms'}, {'id': 'D003267', 'term': 'Contraception'}, {'id': 'D005193', 'term': 'Family Planning Services'}, {'id': 'D065129', 'term': 'Pre-Exposure Prophylaxis'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D060909', 'term': 'Economics, Behavioral'}], 'ancestors': [{'id': 'D003275', 'term': 'Contraceptive Devices, Male'}, {'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D034121', 'term': 'Reproductive Health Services'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011584', 'term': 'Psychology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2012-02-08', 'studyFirstSubmitQcDate': '2012-04-02', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility of administering cash transfer to keep girls in school', 'timeFrame': '12 months', 'description': 'Conditional Cash Transfer to reduce HIV risk by staying in school.'}], 'primaryOutcomes': [{'measure': 'Intervention Uptake (acceptability) and Coverage (feasibility)', 'timeFrame': '6 months', 'description': '* Coverage: The proportion of youth in the community who attend each mobile event (estimated from youth population denominator)\n* Enrollment: The number of participants who consent to being enrolled in the study during each mobile event.\n* Uptake: The number of participants who choose one or more components of their tailored combination package (and which components).\n* Intervention Acceptability: Satisfaction with mobile event services'}], 'secondaryOutcomes': [{'measure': 'Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months', 'timeFrame': '12 months', 'description': '* Adherence to once daily Truvada (PrEP) among HIV-uninfected eligible females and patterns of adherence and sexual HIV acquisition risk exposure (PrEP cohort participants only). Measured by self-report, eCAPs, and clinical assessments; monthly for first 6 months and every 3 months for the following 6 months and DBS for analysis of TFV/FTC: TFV-DP/FTC-TP at months 2 and 9.\n* Adherence to ART for positives (HIV+ cohort participants only). Measured by self-report monthly SMS: 0, 3, 6,9,12 months). POC CD4 and baseline viral load by dried blood spot will be measured at mobile event baseline and repeated at 12 months.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Prevention & Control', 'Intervention Studies', 'Adolescent', 'Gender', 'Combination prevention', 'Pre-Exposure Prophylaxis', 'Cash Transfer', 'Medical Male Circumcision', 'HIV Testing', 'Mobile Health'], 'conditions': ['HIV', 'Adolescent Behavior', 'Gender']}, 'referencesModule': {'references': [{'pmid': '28274904', 'type': 'DERIVED', 'citation': 'Buttolph J, Inwani I, Agot K, Cleland CM, Cherutich P, Kiarie JN, Osoti A, Celum CL, Baeten JM, Nduati R, Kinuthia J, Hallett TB, Alsallaq R, Kurth AE. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol. JMIR Res Protoc. 2017 Mar 8;6(3):e22. doi: 10.2196/resprot.5833.'}]}, 'descriptionModule': {'briefSummary': 'MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific combination HIV prevention package for youth (aged 15-24) in high burden settings. The study aims to pilot a combination package of gender-specific interventions in western Kenya in a mobile health delivery format using integrated services delivery.', 'detailedDescription': "The MP3-Youth study will provide critical information for design and evaluation of combination HIV prevention intervention packages that are sensitive to gender-specific risks among this most-at-risk population in high-HIV burden African settings. Our team of biobehavioral and clinical scientists, mathematical modelers, and trial design specialists will:\n\nAim 1: Identify gender (sex)-specific drivers of HIV acquisition risk, including pregnancy among females, for youth in sub-Saharan Africa, and interventions to best address those risks.\n\nAim 2: Conduct mathematical modeling to select optimal combination intervention package components and to assess potential population-level impact.\n\nAim 3: In partnership with a highly-productive nongovernmental organization (NGO) that is delivering PEPFAR-funded HIV prevention services, develop and pilot a combination HIV prevention package specific for female and for male youth - 'MP3-Youth' - in Nyanza Province, Kenya.\n\nAim 4: Design a phase IV study protocol for testing the effectiveness of a gender-specific youth HIV prevention package in sub-Saharan Africa. We will disseminate these research protocol recommendations, and study instruments including the mathematical modeling tool, as a combination prevention intervention research toolkit.\n\nDesign: Study activities comprise systematic review and meta-analysis of the HIV prevention literature for youth in sub-Saharan Africa; development of a mathematical modeling tool; and a community-based HIV combination prevention pilot that will take place in western Kenya. These activities will culminate in a testable combination HIV prevention trial protocol for youth, which is the main study deliverable.\n\nPopulation: Aim 1: Focus groups will be held with male and female youth, parents, teachers, religious and community leaders. Aim 3: Pilot study will include male and female youths (ages 15-24) from Nyanza Province, Kenya.\n\nDeliverables: Study deliverables include selection procedures for a population-specific combination HIV prevention package; measurement instruments, mobile prevention delivery protocols, mathematical modeling tools, and a testable study trial protocol. The entire MP3-Youth Package will be placed on a web site for open access."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any male or female between the ages of 15-24.\n* Able to understand spoken English or Kiswahili or Dholuo.\n* Willing to give informed consent or if younger than 18 years of age has a parent or guardian willing to provide consent in addition to the minor's assent\n* Willing to be tested for HIV.\n* Willing to get participant ID based on biometric finger scan.\n\nExclusion Criteria:\n\n* Any male or female younger than 15 or older than 24.\n* Unable to understand spoken English, or Kiswahili or Dholuo.\n* If under 18 and not an emancipated minor, unable to get parental consent."}, 'identificationModule': {'nctId': 'NCT01571128', 'acronym': 'MP3-Youth', 'briefTitle': 'Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)', 'organization': {'class': 'OTHER', 'fullName': 'New York University'}, 'officialTitle': 'Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)', 'orgStudyIdInfo': {'id': '1R01AI094607-1'}, 'secondaryIdInfos': [{'id': '1R01AI094607', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI094607', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Male-Specific Intervention Package', 'description': 'Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.', 'interventionNames': ['Other: Male-Specific Intervention Package']}, {'type': 'EXPERIMENTAL', 'label': 'Female-Specific Intervention Package', 'description': 'Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.', 'interventionNames': ['Other: Female-Specific Intervention Package']}, {'type': 'NO_INTERVENTION', 'label': 'HIV Positive Cohort (Males and Females)', 'description': 'Behavioral data on HIV positive youth. Longitudinal Arm.'}, {'type': 'EXPERIMENTAL', 'label': 'Pre-Exposure Prophylaxis (Females)', 'description': 'PrEP adherence and feasibility. Longitudinal Arm.', 'interventionNames': ['Drug: Pre-Exposure Prophylaxis (Females)']}, {'type': 'EXPERIMENTAL', 'label': 'Cash Transfer Cohort (Females)', 'description': 'School attendance, behavioral data, and feasibility. Longitudinal Arm', 'interventionNames': ['Behavioral: Cash Transfer Cohort (Females)']}], 'interventions': [{'name': 'Male-Specific Intervention Package', 'type': 'OTHER', 'otherNames': ['HIV Counseling and Testing (HTC)', 'Facilitated linkage to care for HIV+: ART/PMTCT', 'Condoms', 'Voluntary Medical Male Circumcision (VMMC)'], 'description': 'Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.', 'armGroupLabels': ['Male-Specific Intervention Package']}, {'name': 'Female-Specific Intervention Package', 'type': 'OTHER', 'otherNames': ['HIV Counseling and Testing (HTC)', 'Facilitated linkage to care for HIV+: ART/PMTCT', 'Contraception/Family Planning (FP)', 'Pre-exposure Prophylaxis (PrEP)', 'Conditional Cash Transfer (CCT)'], 'description': 'Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.', 'armGroupLabels': ['Female-Specific Intervention Package']}, {'name': 'Pre-Exposure Prophylaxis (Females)', 'type': 'DRUG', 'otherNames': ['Truvada', 'Emtricitabine', 'Tenofovir disoproxil fumarate'], 'description': 'Females 18-24 who are out of school.', 'armGroupLabels': ['Pre-Exposure Prophylaxis (Females)']}, {'name': 'Cash Transfer Cohort (Females)', 'type': 'BEHAVIORAL', 'otherNames': ['Behavioral Economics', 'Conditional Cash Transfer'], 'description': 'Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.', 'armGroupLabels': ['Cash Transfer Cohort (Females)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Impact Research and Development Organization', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Nairobi', 'country': 'Kenya', 'facility': 'University of Nairobi', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}], 'overallOfficials': [{'name': 'Irene Inwani, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kenyatta National Hospital: University of Nairobi, Kenya'}, {'name': 'Ann Kurth, PhD, CNM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}, {'name': 'Jasmine Buttolph, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New York University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nairobi', 'class': 'OTHER'}, {'name': 'Impact Research & Development Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}