Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT03553693
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2018-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapid HIV Viral Load Monitoring in High Risk 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'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative effectiveness cluster-randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2443}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful VL ordering', 'timeFrame': '1 year', 'description': 'Proportion of patients who had a VL ordered when indicated by country guidelines'}, {'measure': 'VL turnaround time', 'timeFrame': '1 year', 'description': 'Mean turnaround time in days from VL ordering to delivery of results to patient'}], 'secondaryOutcomes': [{'measure': 'VL suppression 12 months after the start of Phase 2 of trial', 'timeFrame': '12 months after the start of Phase 2 of trial', 'description': 'Proportion of subjects suppressed 12 months after start of RAPID-VL participation'}, {'measure': 'Viral re-suppression after positive VL', 'timeFrame': '1 year', 'description': 'Proportion of patients with a positive (unsuppressed) VL whose next subsequent VL was suppressed'}, {'measure': 'Number of patients changed from 1st line to 2nd line ART', 'timeFrame': '1 year', 'description': 'Number of patients who switched to a 2nd line ART regimen for any reason'}, {'measure': 'CPHL integration process', 'timeFrame': '12 months after the start of Phase 2 of trial', 'description': "Establishment of a process for data transfer to Uganda's Central Public Health Laboratory (CPHL) (yes/no)"}, {'measure': 'VL results in CPHL database', 'timeFrame': '12 months after the start of Phase 2 of trial', 'description': 'Proportion of VL results generated in study that are present in CPHL database at study end'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Viral Load', 'Counseling', 'Costs and Costs Analysis', 'Point-Of-Care Systems'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '26633768', 'type': 'BACKGROUND', 'citation': 'Working Group on Modelling of Antiretroviral Therapy Monitoring Strategies in Sub-Saharan Africa; Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, Ellman T, Bonner K, Rousseau C, Garnett G, Cambiano V, Nakagawa F, Ford D, Bansi-Matharu L, Miners A, Lundgren JD, Eaton JW, Parkes-Ratanshi R, Katz Z, Maman D, Ford N, Vitoria M, Doherty M, Dowdy D, Nichols B, Murtagh M, Wareham M, Palamountain KM, Chakanyuka Musanhu C, Stevens W, Katzenstein D, Ciaranello A, Barnabas R, Braithwaite RS, Bendavid E, Nathoo KJ, van de Vijver D, Wilson DP, Holmes C, Bershteyn A, Walker S, Raizes E, Jani I, Nelson LJ, Peeling R, Terris-Prestholt F, Murungu J, Mutasa-Apollo T, Hallett TB, Revill P. Sustainable HIV treatment in Africa through viral-load-informed differentiated care. Nature. 2015 Dec 3;528(7580):S68-76. doi: 10.1038/nature16046.'}, {'pmid': '26278724', 'type': 'BACKGROUND', 'citation': 'Rutstein SE, Golin CE, Wheeler SB, Kamwendo D, Hosseinipour MC, Weinberger M, Miller WC, Biddle AK, Soko A, Mkandawire M, Mwenda R, Sarr A, Gupta S, Mataya R. On the front line of HIV virological monitoring: barriers and facilitators from a provider perspective in resource-limited settings. AIDS Care. 2016;28(1):1-10. doi: 10.1080/09540121.2015.1058896. Epub 2015 Aug 17.'}, {'pmid': '26743094', 'type': 'BACKGROUND', 'citation': 'Roberts T, Cohn J, Bonner K, Hargreaves S. Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges. Clin Infect Dis. 2016 Apr 15;62(8):1043-8. doi: 10.1093/cid/ciw001. Epub 2016 Jan 6.'}, {'pmid': '25423597', 'type': 'BACKGROUND', 'citation': 'Shafiee H, Wang S, Inci F, Toy M, Henrich TJ, Kuritzkes DR, Demirci U. Emerging technologies for point-of-care management of HIV infection. Annu Rev Med. 2015;66:387-405. doi: 10.1146/annurev-med-092112-143017. Epub 2014 Nov 12.'}, {'pmid': '26936666', 'type': 'BACKGROUND', 'citation': 'Ouattara EN, Robine M, Eholie SP, MacLean RL, Moh R, Losina E, Gabillard D, Paltiel AD, Danel C, Walensky RP, Anglaret X, Freedberg KA. Laboratory Monitoring of Antiretroviral Therapy for HIV Infection: Cost-Effectiveness and Budget Impact of Current and Novel Strategies. Clin Infect Dis. 2016 Jun 1;62(11):1454-1462. doi: 10.1093/cid/ciw117. Epub 2016 Mar 1.'}, {'pmid': '23284843', 'type': 'BACKGROUND', 'citation': 'Marseille E, Giganti MJ, Mwango A, Chisembele-Taylor A, Mulenga L, Over M, Kahn JG, Stringer JS. Taking ART to scale: determinants of the cost and cost-effectiveness of antiretroviral therapy in 45 clinical sites in Zambia. PLoS One. 2012;7(12):e51993. doi: 10.1371/journal.pone.0051993. Epub 2012 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'The RAPID-VL study will take place in 20 HIV care health facilities in Southwestern Uganda. The study will test the hypothesis that a multi-component intervention package that targets barriers to efficient and timely HIV viral load (VL) testing will improve test ordering, speed up result turnaround times, and improve the quality of VL results counseling to patients. Phase 1 of the study will consist of a 1-year retrospective medical record review in all participating health facilities. In Phase 2 the intervention will be introduced in 10 randomly chosen health facilities, while the remaining 10 sites will continue with standard VL testing and counseling operations. The study will measure the speed and efficiency of VL testing, experiences of patients and clinicians with the intervention, and the cost of the intervention.', 'detailedDescription': 'We will test the hypothesis that a multi-component intervention grounded in implementation science principles and that targets key barriers to optimal HIV viral load (VL) processing will improve viral load ordering, speed up viral load turnaround, and improve the quality of viral load counseling of results to patients within a Ugandan network of HIV care clinics. Specific objectives are as follows: Objective 1: Determine the comparative effectiveness of the RAPID-VL intervention on VL ordering and VL turnaround time: We will randomize 20 HIV clinics to the RAPID-VL multi-component intervention vs. standard of care VL procedures (n=10 clinics each, 60 patients/health facility). Objective 2: Identify facilitators and barriers to implementation, and perceived utility of the RAPID-VL intervention from both the patient and clinician perspectives. Objective 3: Determine the costs, cost-effectiveness, and incremental change costs of the RAPID-VL intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPhase 1, Intervention and Control Clinics:\n\n"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date, plus the following:\n\n1. Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 1, confirmed by clinic documentation\n2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) no documentation of pregnancy in clinical record\n3. Persons with most recent VL unsuppressed (i.e. detectable): Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of \\>1000 copies/mL on any assay, (3) no documentation of pregnancy in clinical record\n4. Persons with no VL in last one year: Inclusion criteria: (1) any age, (2) last VL is dated \\>1 year ago (if ever started on ART) or no VL on file (if never started ART) (3) no documentation of pregnancy in clinical record\n\n"Non-high-risk" patients (n=20 per clinic): Inclusion criteria (1) adult (age ≥18 years), (2) registered for care, with clinic visit within a year of the Phase 1 start date, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup\n\nPhase 2, Intervention Clinics:\n\nWe will select 60 patients in each of the 10 intervention clinics (600 patients total; different than the 60 patients in each clinic studied in Phase 1), with inclusion criteria as follows:\n\n"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 2 start date; able to consent for study participation; plus the following:\n\n1. Pregnant or breastfeeding women: Inclusion criteria: (1) currently pregnant or breastfeeding, confirmed by clinic standard documentation\n2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) parent/guardian able and willing to provide affirmative consent for study participation, except in the case of mature or emancipated minors, (3) no documentation of pregnancy in the clinic record\n3. Persons with most recent VL unsuppressed: Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of \\>1000 copies/mL on any assay, (3) no documentation of pregnancy in the clinical record\n4. Persons with no VL in last 1 year: Inclusion criteria: (1) any age, (2) last VL is dated \\>1 year ago (if ever started ART) or no VL on file (if never started ART , (3) no documentation of pregnancy in the clinical record\n\n"Non-high-risk" patients (n=20 per clinic): Inclusion criteria: (1) adult (age ≥18 years), (2) registered in the general HIV clinic, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup\n\nPhase 2, Control Clinics:\n\nWe will select 60 patients in each of the 10 control clinics (600 patients total; different than the 60 patients in each clinic studied in Phase 1), with inclusion criteria as follows\n\n"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date; able to provide consent; plus the following:\n\n1. Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 2, confirmed by clinic documentation\n2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) parent/guardian able and willing to provide affirmative consent for study participation, except in the case of mature or emancipated minors, (3) no documentation of pregnancy in clinical record\n3. Persons with most recent VL suppressed: Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of \\>1000 copies/mL on any assay, (3) no documentation of pregnancy in clinical record\n4. Persons with no VL in last 1 year: Inclusion criteria: (1) any age, (2) last VL is dated \\>1 year ago (if ever started ART) or no VL on file (if never started ART), (3) no documentation of pregnancy in clinical record\n\n"Non-high-risk" patients (n=20 per clinic): Inclusion criteria: (1) adult (age ≥18 years), (2) registered for care, with clinic visit within a year of the Phase 2 start date, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup\n\nExclusion criteria: None'}, 'identificationModule': {'nctId': 'NCT03553693', 'acronym': 'RAPID-VL', 'briefTitle': 'Rapid HIV Viral Load Monitoring in High Risk Patients In Uganda', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Optimizing HIV Viral Load Monitoring and Outcomes for High Risk Populations', 'orgStudyIdInfo': {'id': 'RAPID-VL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Clinics', 'description': 'RAPID-VL study intervention testing and counseling package, which includes near point-of-care viral load (VL) testing at local testing hubs, structured VL counseling, forms to track VL ordering and testing, with feedback and performance evaluations at regular intervals.', 'interventionNames': ['Other: RAPID-VL study intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Clinics', 'description': 'Standard of care VL testing and counseling procedures consistent with country guidelines.'}], 'interventions': [{'name': 'RAPID-VL study intervention', 'type': 'OTHER', 'description': '* Viral load (VL) ordering flowsheet with periodic health facility performance feedback\n* Rapid near-point-of-care VL testing and telephone delivery of results\n* Structured VL counseling package', 'armGroupLabels': ['Intervention Clinics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Southwestern Uganda', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'Vivek Jain, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Moses R Kamya, MBChB, MMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'Infectious Diseases Research Collaboration, Uganda', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}