Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02497456
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2015-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2015-07-06', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.', 'timeFrame': '6 months'}, {'measure': 'The time between HIV diagnosis and linkage to pre-ART care.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care', 'timeFrame': '6 months'}, {'measure': 'The time between learning that a participant is eligible for ART and ART initiation', 'timeFrame': '6 months'}, {'measure': 'The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Counselling', 'Care', 'antiretroviral therapy', 'linkage', 'Uganda', 'Africa'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '29052344', 'type': 'DERIVED', 'citation': 'Ruzagira E, Grosskurth H, Kamali A, Baisley K. Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda. J Int AIDS Soc. 2017 Oct;20(2):e25014. doi: 10.1002/jia2.25014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.', 'detailedDescription': 'Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The few existing data suggest that only 13% to 54% of HIV-infected persons identified through HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care in Masaka, south-western Uganda.\n\nThe study is a cluster randomised trial of the effectiveness of referral to pre-ART care and follow-up counselling (intervention) compared to referral to pre-ART care only (control), for individuals diagnosed with HIV through HBHCT. The intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters (14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the HIV-infected participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'HIV-infected participants\n\nInclusion Criteria:\n\n1. HIV-infected adult (≥18 years)\n2. Willing to provide informed consent\n3. Willing to receive follow-up counselling at home\n\nExclusion Criteria:\n\n1. Previous or current receipt of HIV care from an ART provider\n2. On-going participation in other health-related research\n3. Intending to change residence in the next 6 months\n4. Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness\n\nHIV-uninfected participants\n\nInclusion criteria:\n\n1. HIV negative adult (≥18 years)\n2. Willing to provide informed consent\n3. Willing to receive follow-up counselling at home\n\nExclusion criteria:\n\n1. Intending to change residence in the next 6 months\n2. Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness'}, 'identificationModule': {'nctId': 'NCT02497456', 'briefTitle': 'The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'MRC/UVRI and LSHTM Uganda Research Unit'}, 'officialTitle': 'The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda', 'orgStudyIdInfo': {'id': 'Linkage to pre-ART care'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Follow-up counselling', 'description': 'Participants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis.', 'interventionNames': ['Behavioral: Follow-up counselling']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.'}], 'interventions': [{'name': 'Follow-up counselling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Follow-up counselling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Masaka', 'country': 'Uganda', 'facility': 'MRC/UVRI Uganda Research Unit on Aids', 'geoPoint': {'lat': -0.33379, 'lon': 31.73409}}], 'overallOfficials': [{'name': 'Eugene Ruzagira', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MRC/UVRI and LSHTM Uganda Research Unit', 'class': 'OTHER'}, 'collaborators': [{'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}