Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-01-17 @ 10:10 AM
Study NCT ID:
NCT02909218
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2016-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MaxART: Early Access to ART for All in Swaziland
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019908', 'term': 'Proto-Oncogene Proteins c-raf'}], 'ancestors': [{'id': 'D048490', 'term': 'raf Kinases'}, {'id': 'D020930', 'term': 'MAP Kinase Kinase Kinases'}, {'id': 'D017346', 'term': 'Protein Serine-Threonine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011518', 'term': 'Proto-Oncogene Proteins'}, {'id': 'D015513', 'term': 'Oncogene Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2016-07-10', 'studyFirstSubmitQcDate': '2016-09-18', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': '12 months', 'description': 'Proportion of individuals retained in care or on ART at 12 months'}, {'measure': 'Viral suppression', 'timeFrame': '6 months', 'description': 'Proportion of individuals whose viral load is below 1,000 copies/ml (virally suppressed) after 6 months on ART'}], 'secondaryOutcomes': [{'measure': '12-month mortality rate', 'timeFrame': '12 months', 'description': 'mortality rate among clients newly enrolled in or returning to facilities during the standard of care phase is equal to 12-month mortality rate among clients newly enrolled in or returning to facilities during early ART phase'}, {'measure': 'Visit adherence among those initiated on ART', 'timeFrame': '36 months', 'description': 'Proportion of missed visits as a number of scheduled appointments among ART-ineligible clients by end of follow-up'}, {'measure': 'Drug resistance', 'timeFrame': '36 months', 'description': 'Proportion of drug resistance among ART-ineligible clients with two virological failures who have received genotype resistance testing'}, {'measure': 'Tuberculosis', 'timeFrame': '36 months', 'description': 'Proportion of HIV-positive individuals diagnosed with new tuberculosis following enrollment (recurrent and newly incident).'}, {'measure': 'ART uptake among those who are eligible', 'timeFrame': '3 months', 'description': 'Proportion of HIV-positive individuals who are eligible for initiation who are successfully initiated to ART within 1 and 3 months of becoming eligible'}, {'measure': 'Cost per patient per year', 'timeFrame': '12 months', 'description': 'Bottom-up and top-town costing of the patient lifetime cost to test, treat, link, and retain individuals on ART'}, {'measure': 'HIV infection', 'timeFrame': '36 months', 'description': 'Mathematical modeling to estimate the number of new adult HIV infections using empirical data from the primary endpoints'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV/AIDS, Swaziland'], 'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '33107430', 'type': 'DERIVED', 'citation': 'Briggs J, Teyssier N, Nankabirwa JI, Rek J, Jagannathan P, Arinaitwe E, Bousema T, Drakeley C, Murray M, Crawford E, Hathaway N, Staedke SG, Smith D, Rosenthal PJ, Kamya M, Dorsey G, Rodriguez-Barraquer I, Greenhouse B. Sex-based differences in clearance of chronic Plasmodium falciparum infection. Elife. 2020 Oct 27;9:e59872. doi: 10.7554/eLife.59872.'}, {'pmid': '33074097', 'type': 'DERIVED', 'citation': 'Mobegi FM, Leong LE, Thompson F, Taylor SM, Harriss LR, Choo JM, Taylor SL, Wesselingh SL, McDermott R, Ivey KL, Rogers GB. Intestinal microbiology shapes population health impacts of diet and lifestyle risk exposures in Torres Strait Islander communities. Elife. 2020 Oct 19;9:e58407. doi: 10.7554/eLife.58407.'}, {'pmid': '32831169', 'type': 'DERIVED', 'citation': "Steinert JI, Khan S, Mlambo K, Walsh FJ, Mafara E, Lejeune C, Wong C, Hettema A, Ogbuoji O, Vollmer S, De Neve JW, Mazibuko S, Okello V, Barnighausen T, Geldsetzer P. A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini. Elife. 2020 Aug 24;9:e58487. doi: 10.7554/eLife.58487."}, {'pmid': '28821264', 'type': 'DERIVED', 'citation': "Walsh FJ, Barnighausen T, Delva W, Fleming Y, Khumalo G, Lejeune CL, Mazibuko S, Mlambo CK, Reis R, Spiegelman D, Zwane M, Okello V. Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial. Trials. 2017 Aug 18;18(1):383. doi: 10.1186/s13063-017-2128-8."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's government-managed health system.", 'detailedDescription': "The clinical evidence in support of offering antiretroviral treatment (ART) for all HIV-positive individuals to improve patient health outcomes and reduce HIV incidence is building, and the resource-limited countries where this approach could have the biggest impact want to evaluate if this is a feasible and effective intervention to turn the course of their HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's government-managed health system.\n\nThis is a 3-year randomized stepped wedge design with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, and cost per patient per year.\n\nSites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each 4-month step. This balanced design will result in approximately one half of the observations being under an intervention clinic, and the other half under control.\n\nPower calculations were conservatively based on the estimated number of individuals expected to enroll in the study comparing the first 12-month measure of retention and 6-month of viral suppression on ART of those entering clinics during their control stage versus those that will be entering a clinic during intervention period.\n\nA strategic mix of multidisciplinary research methodologies will be applied to meet the study aim, including implementation science, social science research, economic evaluations, and HIV incidence modeling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All ART-naive HIV-positive individuals who are 18 years of age or older - excluding pregnant or breastfeeding women - who attend the health facilities included in the study will be asked for their consent to enroll in the study.\n\nExclusion Criteria:\n\n* All HIV-positive individuals who \\< 18 years of age or older and pregnant or breastfeeding women.\n* All HIV-positive individuals who did not consent to participate or who have already been initiated on ART.'}, 'identificationModule': {'nctId': 'NCT02909218', 'acronym': 'MaxART', 'briefTitle': 'MaxART: Early Access to ART for All in Swaziland', 'organization': {'class': 'OTHER', 'fullName': 'Clinton Health Access Initiative Inc.'}, 'officialTitle': 'MaxART: Early Access to ART for All in Swaziland', 'orgStudyIdInfo': {'id': 'MaxART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'National HIV Treatment Guidelines', 'description': "HIV-positive individuals are offered ART per Swaziland's national treatment guidelines"}, {'type': 'EXPERIMENTAL', 'label': 'Early Access to ART for All', 'description': "HIV-positive individuals are initiated on ART regardless of client's immunological and clinical staging", 'interventionNames': ['Other: Early Access to ART for All']}], 'interventions': [{'name': 'Early Access to ART for All', 'type': 'OTHER', 'description': "All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines.", 'armGroupLabels': ['Early Access to ART for All']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbabane', 'country': 'Eswatini', 'facility': 'Swaziland Ministry of Health', 'geoPoint': {'lat': -26.31667, 'lon': 31.13333}}], 'overallOfficials': [{'name': 'Velephi Okello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Swaziland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinton Health Access Initiative Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Swaziland', 'class': 'OTHER_GOV'}, {'name': 'STOP AIDS NOW! (SAN!)', 'class': 'UNKNOWN'}, {'name': 'Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA)', 'class': 'UNKNOWN'}, {'name': 'Southern African AIDS Information Dissemination Service (SAfAIDS)', 'class': 'UNKNOWN'}, {'name': 'Southern African Centre for Epidemiological Modelling and Analyses (SACEMA)', 'class': 'UNKNOWN'}, {'name': 'University of Amsterdam', 'class': 'OTHER'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}