Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-28 @ 10:33 PM
Study NCT ID:
NCT00119093
Status:
TERMINATED
Last Update Posted:
2012-09-11
First Post:
2005-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based AIDS Care Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007753', 'term': 'Laboratories'}], 'ancestors': [{'id': 'D000072182', 'term': 'Non-Medical Public and Private Facilities'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'whyStopped': 'Terminated by IRB for non-compliance with human subject regulations.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-10', 'studyFirstSubmitDate': '2005-07-08', 'studyFirstSubmitQcDate': '2005-07-11', 'lastUpdatePostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Equivalence of 3 different monitoring regimens for ART'}], 'secondaryOutcomes': [{'measure': 'Sexual risk behavior'}, {'measure': 'medication adherence'}, {'measure': 'quality of life'}, {'measure': 'depression'}, {'measure': 'cost-effectiveness'}, {'measure': 'viral load'}, {'measure': 'CD4 cell count'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antiretroviral therapy', 'HIV', 'Adherence', 'Viral Load', 'Opportunistic illness'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '23547778', 'type': 'DERIVED', 'citation': 'Ekwaru JP, Campbell J, Malamba S, Moore DM, Were W, Mermin J. The effect of opportunistic illness on HIV RNA viral load and CD4+ T cell count among HIV-positive adults taking antiretroviral therapy. J Int AIDS Soc. 2013 Apr 1;16(1):17355. doi: 10.7448/IAS.16.1.17355.'}, {'pmid': '22423133', 'type': 'DERIVED', 'citation': 'Campbell JD, Moore D, Degerman R, Kaharuza F, Were W, Muramuzi E, Odongo G, Wetaka M, Mermin J, Tappero JW. HIV-infected ugandan adults taking antiretroviral therapy with CD4 counts >200 cells/muL who discontinue cotrimoxazole prophylaxis have increased risk of malaria and diarrhea. Clin Infect Dis. 2012 Apr;54(8):1204-11. doi: 10.1093/cid/cis013. Epub 2012 Mar 14.'}, {'pmid': '22074711', 'type': 'DERIVED', 'citation': 'Mermin J, Ekwaru JP, Were W, Degerman R, Bunnell R, Kaharuza F, Downing R, Coutinho A, Solberg P, Alexander LN, Tappero J, Campbell J, Moore DM. Utility of routine viral load, CD4 cell count, and clinical monitoring among adults with HIV receiving antiretroviral therapy in Uganda: randomised trial. BMJ. 2011 Nov 9;343:d6792. doi: 10.1136/bmj.d6792.'}, {'pmid': '18778241', 'type': 'DERIVED', 'citation': 'Weidle PJ, Moore D, Mermin J, Buchacz K, Were W, Downing R, Kigozi A, Ndazima V, Peters P, Brooks JT. Liver enzymes improve over twenty-four months of first-line non-nucleoside reverse transcriptase inhibitor-based therapy in rural Uganda. AIDS Patient Care STDS. 2008 Oct;22(10):787-95. doi: 10.1089/apc.2008.0020.'}]}, 'descriptionModule': {'briefSummary': 'The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. This study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements.', 'detailedDescription': 'In Uganda, the high cost and complexity of administering antiretroviral therapy is an obstacle to full implementation country-wide. The Home-based AIDS care program (HBAC) pilot project was designed to deliver and monitor ARV and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. In addition, the cost and complexity of frequent laboratory monitoring of viral load and CD4 cell counts is a major impediment to widespread use of ARV therapies in Uganda and other resource-limited settings. Nested within the Home-Based AIDS Care (HBAC) project, is a randomized study of strategies for monitoring ARV therapy that involves 3 arms: 1) Quarterly CD4 cell counts, viral loads and home visits by trained lay persons; 2) Quarterly CD4 cell counts and home visits; and 3) Home visits alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n* CD4 cell count \\<250 or symptomatic AIDS\n* Age \\>13 years\n* Karnofsky score \\>40%\n* AST or ALT \\< 5 times normal values\n* Creatinine clearance \\>25 ml/min'}, 'identificationModule': {'nctId': 'NCT00119093', 'briefTitle': 'Home-based AIDS Care Project', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Home-based AIDS Care Project, Tororo, Uganda', 'orgStudyIdInfo': {'id': 'CDC-NCHSTP-3666'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laboratory and clinical monitoring regimens', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tororo', 'state': 'Tororo', 'country': 'Uganda', 'facility': 'Tororo Hospital/CDC-Uganda', 'geoPoint': {'lat': 0.69299, 'lon': 34.18085}}], 'overallOfficials': [{'name': 'Rebecca E Bunnell, ScD, MEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}, {'name': 'Jonathan H Mermin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}, {'name': 'Alex Coutinho, MBChB, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The AIDS Support Organization'}, {'name': 'David Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CDC-Uganda and University of British Columbia'}, {'name': 'Jordan Tappero, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'The AIDS Support Organization', 'class': 'OTHER'}, {'name': 'Ministry of Health, Uganda', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}