Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-01-17 @ 1:04 AM
Study NCT ID:
NCT04030520
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachel.king@ucsf.edu', 'phone': '+256785304516', 'title': 'Dr Rachel King', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'behavioral intervention', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparison', 'description': 'standard of care', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Initiation of PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'number of participants initiating PrEP'}, {'id': 'OG001', 'title': 'Comparison', 'description': 'number of participants initiating PrEP'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Initiation of PrEP using the pharmacy records indicating PrEP received by participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who initiated PrEP using pharmacy pill count records.'}, {'type': 'PRIMARY', 'title': 'Adherence to PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Uptake of PrEP'}, {'id': 'OG001', 'title': 'Comparison', 'description': 'Uptake of PrEP'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This is the number of participants who took PrEP and had samples tested at endline (12 months)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP\n\nPOPPi behavioral intervention: behavioral intervention with offer of HIV self test'}, {'id': 'FG001', 'title': 'Comparison', 'description': 'participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP\n\nPOPPi behavioral intervention: behavioral intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'we completed the target number', 'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'participants received a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP POPPi behavioral intervention: behavioral intervention with offer of HIV self test'}, {'id': 'BG001', 'title': 'Comparison', 'description': 'participants were not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP POPPi behavioral intervention: behavioral intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '19.5', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '19.5', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', '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': 'Ugandan', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Uganda', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-12', 'size': 434183, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-13T10:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2019-07-08', 'resultsFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-14', 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initiation of PrEP', 'timeFrame': '6 months', 'description': 'Initiation of PrEP using the pharmacy records indicating PrEP received by participants.'}, {'measure': 'Adherence to PrEP', 'timeFrame': '12 months', 'description': 'Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS']}, 'descriptionModule': {'briefSummary': 'The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female age 15- to 24-years old\n* Engaging in high-risk sexual behavior having had sex at least once in last three months, --HlV-negative\n* Agree to participate in a minimum of four interviews over a 12-month period; including baseline\n* Willing to receive services at Good Health for Women Project (GHWP)\n* For those initiating PrEP (Truvada):\n* Participants should have immunity to Hepatitis B infection and serum creatinine before\n* Contra-indications for starting Truvada to be considered include Creatinine \\> 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg.\n\nExclusion Criteria:\n\n* Inability to consent to participation in the study\n* Condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.'}, 'identificationModule': {'nctId': 'NCT04030520', 'acronym': 'POPPi', 'briefTitle': 'Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Improving Uptake and Adherence to HIV Prevention Services With PrEP, HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda', 'orgStudyIdInfo': {'id': 'MH114523'}, 'secondaryIdInfos': [{'id': 'R34MH114523', 'link': 'https://reporter.nih.gov/quickSearch/R34MH114523', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP', 'interventionNames': ['Behavioral: POPPi']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comparison', 'description': 'participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP', 'interventionNames': ['Behavioral: Comparison']}], 'interventions': [{'name': 'POPPi', 'type': 'BEHAVIORAL', 'description': 'behavioral intervention with offer of HIV self test', 'armGroupLabels': ['intervention']}, {'name': 'Comparison', 'type': 'BEHAVIORAL', 'description': 'standard of care', 'armGroupLabels': ['comparison']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Entebbe', 'country': 'Uganda', 'facility': 'Uganda Virus Research Institute', 'geoPoint': {'lat': 0.05621, 'lon': 32.47949}}], 'overallOfficials': [{'name': 'Rachel King, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'MRC/UVRI and LSHTM Uganda Research Unit', 'class': 'OTHER'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}