Community Based Antiretroviral Therapy (CBART) Among Children on Chronic ART
NCT ID: NCT03986099
Last Updated: 2020-11-17
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
451 participants
INTERVENTIONAL
2018-02-01
2020-11-15
Brief Summary
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Detailed Description
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The investigators hypothesize that our proposed package of care will result in a decrease in virologic failure, increase virologic suppression and prevent drug resistance in this key population in a rural ART treatment program. Process and cost data will be collected for subsequent cost-analysis.
HIV infected children and adolescents on ART will be randomized (1:1) to either SOC (300) or a near POC VLDC monitoring. SOC VL is performed by Roche COBAS at the Provincial Hospital Chinhoyi and the results returned to the hospital within 4 weeks. Those randomized to near POC will be tested with the Cepheid GeneXpert assay and results are available within 3 days. Follow-up repeat testing for HIV RNA \> 1,000 copies/ml is offered using the same virologic monitoring system at the next drug/clinic visit within 3 months.
The hypothesis is that viral load monitoring and potentially genotyping to sustain suppression to \< 1,000 copies/ml will reduce treatment failure to \< 15%. Secondary endpoints include the rate of drug switching and the evaluation and prevention of drug resistance. The study will enroll up to 600 children (3 -10) years and adolescents (11-21) years, providing data that will guide strategies for management of children and adolescents who are surviving on ART.
Primary Objective: To determine if implementation of point of care virus load differentiated care (POC virus load), targeted genotyping and mHealth tools will result in improved virologic suppression among children and adolescents (\<21years) on ART.
Sample size: The primary study endpoint is viral load suppression at 48 weeks among PLWHA \< 21 years old, using VLDC implemented as near POC compared to SOC semi- annual virus load testing. The investigators will enroll young PLWHA from eight communities and the Chidamoyo Hospital Clinic as a rolling prospective cohort. The investigators hypothesize that an intervention package of digitized data, local immediate POC Virus load and genotype will result in \> 90% virologic suppression after 1 year. The estimated minimum sample size to detect at least a 15% increase in virologic suppression with 90% power, at significance level α=0.05 assuming 10% loss to follow up rate (LTFU) rate is 356 PLWHA on ART.
Secondary endpoints:
1. rate of switching from 1st to 2nd line.
2. frequency of Drug Resistance Mutations (DRM) among 1st and 2nd line virologic failures.
3. the frequency of Hepatitis B virus infection (HBSag).
In collaboration with Ben Gurion University Global Health, the investigators will perform an ethnographic survey over the course of the primary study. The objective is to develop formative research to understand the individual and community variation in suppression rate and drug switching including differences in virologic failure and adherence by age, gender, rural outreach site, orphan-hood/caregiver and socio-economic status.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Standard of care
SOC viral load
No interventions assigned to this group
Near point of care
POC viral load
Monitoring virus load
Near point of care
Interventions
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Monitoring virus load
Near point of care
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Less than one year on ART
2 Years
26 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Biomedical Research and Training Institute, Zimbabwe
OTHER
Responsible Party
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Principal Investigators
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Shungu Munyati, PhD
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research and Training Institute
Locations
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Chidamoyo Christian Hospital
Karoi, Mashonaland West, Zimbabwe
Countries
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References
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Kouamou V, Machekano R, Mapangisana T, Maposhere C, Mutetwa R, Manasa J, Shamu T, McCarty K, Munyati S, Mutsvangwa J, Bogoshi M, Israelski D, Katzenstein D. Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. PLoS One. 2023 Feb 14;18(2):e0281279. doi: 10.1371/journal.pone.0281279. eCollection 2023.
Kouamou V, Machekano R, Mapangisana T, Maposhere C, Munyati S, Mutsvangwa J, Shamu T, McCarty K, Katzenstein D, Manasa J. Tenofovir, Lamivudine, and Dolutegravir Among Rural Adolescents in Zimbabwe: A Cautionary Tale. AIDS Res Hum Retroviruses. 2022 Oct;38(10):774-778. doi: 10.1089/AID.2021.0140. Epub 2022 Sep 7.
Other Identifiers
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AP142/2017
Identifier Type: -
Identifier Source: org_study_id