Reaching 90% HIV Suppression: The Role of POC Viral Load Monitoring in Nigeria
NCT ID: NCT03533868
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
543 participants
INTERVENTIONAL
2018-04-09
2021-02-28
Brief Summary
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Nigeria has the second highest burden of HIV in the world, with an estimated 3.2 million infected and serves as a relevant setting for testing feasibility and efficacy of POC VL monitoring \[UNAIDS, 2016\]. In order to present the case for implementing the use of POC VL testing across Nigeria, data on the acceptability, feasibility and efficacy of using POC testing for VL monitoring are needed. To address this need, the investigators have designed a randomized controlled trial comparing POC VL to monitoring to the SOC, which follows the Nigerian National Guidelines, to provide operational evidence for implementation of POC VL testing in Nigeria. This trial is aimed at testing the hypothesis that using POC versus SOC VL monitoring in HIV-infected patients newly initiating ART will improve overall ART outcomes, increase ART adherence and program retention rates, and result in faster switches to second-line treatment of patients failing first-line ART.
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Detailed Description
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ART-naïve patients initiating ART will be randomized on a 1:1 basis to the SOC VL monitoring control arm or the POC VL monitoring arm. VL monitoring will occur according to the current Nigerian ART guidelines-recommended algorithm, with the addition of a baseline VL test. For the month 6 and 12 visits, patients that are enrolled in the POC VL monitoring arm will be provided their VL results. Participants in the SOC arm will receive their Roche VL test results after the results become available per SOC protocol. All other aspects of their HIV care and treatment will be identical to services that they would normally receive at these treatment centers.
The investigators will follow all patients up through their Month 12 follow-up visit. At trial exit, the investigators will ask patients, caregivers of patients under the age of 18 years, and providers for their participation in surveys on the operational performance and acceptability of the POC versus SOC VL monitoring. Following that time point, the patients will continue receiving HIV care and treatment utilizing the SOC procedures for the clinic.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard of Care (SOC)
Patients in this arm will have their viral load monitored using the standard of care method, using the Roche Cobas TaqMan HIV-1® v2 (Roche) assay.
No interventions assigned to this group
Point-of-care (POC)
Patients in this arm will have their follow-up viral loads (after baseline) monitored using a Point-of-care viral load monitoring test, the Cepheid Xpert HIV-1 Viral Load assay.
Point-of-care viral load monitoring test
For enumerating viral load for patients in the POC arm, we will use the Cepheid Xpert® HIV-1 Viral Load test, a quantitative assay with a quantification range of 40 to 10,000,000 copies/mL. Based on the GeneXpert® technology, Xpert HIV-1 VL automates the test process, including RNA extraction, purification, reverse transcription and cDNA real-time quantitation in one fully integrated cartridge. The pre-loaded disposable single-use cartridges provide a visual read-out within 90 minutes. The assay requires 1 mL of plasma using a precision pipette (1.2 mL using a transfer pipette).
Interventions
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Point-of-care viral load monitoring test
For enumerating viral load for patients in the POC arm, we will use the Cepheid Xpert® HIV-1 Viral Load test, a quantitative assay with a quantification range of 40 to 10,000,000 copies/mL. Based on the GeneXpert® technology, Xpert HIV-1 VL automates the test process, including RNA extraction, purification, reverse transcription and cDNA real-time quantitation in one fully integrated cartridge. The pre-loaded disposable single-use cartridges provide a visual read-out within 90 minutes. The assay requires 1 mL of plasma using a precision pipette (1.2 mL using a transfer pipette).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant
ALL
No
Sponsors
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Jos University Teaching Hospital
OTHER
Centers for Disease Control and Prevention
FED
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Phyllis Kanki
Professor of Immunology & Infectious Diseases
Principal Investigators
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Phyllis Kanki, DVM, DSc
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Jos University Teaching Hospital
Jos, Plateau State, Nigeria
Comprehensive Health Care Centre, Zamko
Zamko, Plateau State, Nigeria
Countries
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References
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Fonjungo PN, Boeras DI, Zeh C, Alexander H, Parekh BS, Nkengasong JN. Access and Quality of HIV-Related Point-of-Care Diagnostic Testing in Global Health Programs. Clin Infect Dis. 2016 Feb 1;62(3):369-374. doi: 10.1093/cid/civ866. Epub 2015 Sep 30.
Fonjungo PN, Osmanov S, Kuritsky J, Ndihokubwayo JB, Bachanas P, Peeling RW, Timperi R, Fine G, Stevens W, Habiyambere V, Nkengasong JN. Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs. AIDS. 2016 May 15;30(8):1317-23. doi: 10.1097/QAD.0000000000001031.
Chaplin B, Agbaji O, Reyes Nieva H, Olatunde B, Chang C, Mitruka K, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Rawizza H, Kanki P. Timeliness of Point-of-Care Viral Load Results Improves Human Immunodeficiency Virus Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e671-e680. doi: 10.1093/cid/ciac609.
Chang C, Agbaji O, Mitruka K, Olatunde B, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Chaplin B, Kanki P. Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e681-e691. doi: 10.1093/cid/ciac605.
Meloni ST, Agbaji O, Chang CA, Agaba P, Imade G, Oguche S, Mukhtar A, Mitruka K, Cox MH, Zee A, Kanki P. The role of point-of-care viral load monitoring in achieving the target of 90% suppression in HIV-infected patients in Nigeria: study protocol for a randomized controlled trial. BMC Infect Dis. 2019 May 2;19(1):368. doi: 10.1186/s12879-019-3983-6.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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UNAIDS. Ambitious treatment targets: writing the final chapter of the AIDS epidemic. 2015.
WHO. The Availability and Use of HIV Diagnostics: A 2012/2013 WHO Survey in Low- and Middle-Income Countries. Geneva. 2014.
UNAIDS. Country factsheets: Nigeria, 2016.
FMOH Nigeria. National Guidelines for Prevention Treatment and Care. 2016.
Other Identifiers
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CDC-CGH-2018-059
Identifier Type: -
Identifier Source: org_study_id
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