Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-28 @ 7:32 AM
Study NCT ID:
NCT04774835
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2021-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assisted Partner Services and HIVST in Western Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4941}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2021-02-14', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants testing for the first time', 'timeFrame': '1 year', 'description': "Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants choosing to get HIV tested for the first time."}, {'measure': 'Number of newly diagnosed HIV-infected or known positive and not in care', 'timeFrame': '1 year', 'description': "Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants newly being diagnosed with HIV after participation, or those known to be positive but not currently under care."}, {'measure': 'Linking a new positive or known positive not in care to a treatment center', 'timeFrame': '1 year', 'description': "Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that are linked to care at a treatment center."}, {'measure': 'Initiating ART, or re-initiating ART if previously lost to follow-up', 'timeFrame': '1 year', 'description': "Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that initiate (or re-initiate) ART."}], 'secondaryOutcomes': [{'measure': 'Difficulty of using the HIVST kit', 'timeFrame': '1 year', 'description': 'Understand the ease of using HIV self-testing kits in this population and setting, via a survey question with a 4 point Likert scale ranging from "very easy" to "very "hard".'}, {'measure': 'Difficulty of interpreting the HIVST results', 'timeFrame': '1 year', 'description': 'Understand the readability of HIV self-testing results in this population and setting, via a survey question.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV self-testing', 'Assisted partner services', 'Acceptability', 'Implementation Science'], 'conditions': ['Hiv']}, 'referencesModule': {'references': [{'pmid': '38965976', 'type': 'DERIVED', 'citation': 'Roy Paladhi U, Katz DA, Otieno G, Hughes JP, Lagat H, Masyuko S, Sharma M, Macharia P, Bosire R, Mugambi M, Kariithi E, Farquhar C. Effectiveness of HIV self-testing when offered within assisted partner services in Western Kenya (APS-HIVST Study): a cluster randomized controlled trial. J Int AIDS Soc. 2024 Jul;27 Suppl 1(Suppl 1):e26298. doi: 10.1002/jia2.26298.'}]}, 'descriptionModule': {'briefSummary': 'This study includes different designs with Aim 1 being a cluster randomized controlled trial to investigate the use of HIV self-testing (HIVST) as a mode of HIV testing in Western Kenya in addition to the standard of care, assisted partner services (aPS). Aim 2 includes focus group discussions, in-depth interviews, semi-structured interviews, direct observation of facility infrastructure and clinic procedures, and data extraction from facility and county/national databases and expenditure reports to study acceptability, costs, and implementation aspects of HIVST within the aPS framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAim 1:\n\n* Men and women\n* Tests HIV positive and is not in care or on treatment\n* ≥18 years old\n* Willing and able to provide informed consent\n* Able to provide locator information for sexual partners\n\nAim 2:\n\n* ≥18 years old\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\nAim 1:\n\n* Pregnancy\n* Reports intimate partner violence during last month\n* \\<18 years old\n\nAim 2:\n\n• \\<18 years old'}, 'identificationModule': {'nctId': 'NCT04774835', 'briefTitle': 'Assisted Partner Services and HIVST in Western Kenya', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya', 'orgStudyIdInfo': {'id': 'STUDY00002420'}, 'secondaryIdInfos': [{'id': 'R01AI134130', 'link': 'https://reporter.nih.gov/quickSearch/R01AI134130', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard aPS', 'description': 'Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor.', 'interventionNames': ['Diagnostic Test: Standard aPS']}, {'type': 'EXPERIMENTAL', 'label': 'aPS + HIVST', 'description': 'Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor as well as the option to do HIV self-testing (HIVST) instead of testing at the local HTS location.', 'interventionNames': ['Diagnostic Test: HIVST']}], 'interventions': [{'name': 'HIVST', 'type': 'DIAGNOSTIC_TEST', 'description': 'aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV self-testing by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.', 'armGroupLabels': ['aPS + HIVST']}, {'name': 'Standard aPS', 'type': 'DIAGNOSTIC_TEST', 'description': 'aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV testing at their local HTS location by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.', 'armGroupLabels': ['Standard aPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Carey Farquhar, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Kenyatta National Hospital', 'class': 'OTHER_GOV'}, {'name': 'University of Nairobi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, School of Medicine: Global Health', 'investigatorFullName': 'Carey Farquhar', 'investigatorAffiliation': 'University of Washington'}}}}