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Community Based Antiretroviral Therapy (CBART) Among Children on Chronic ART (CBART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03986099
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Gilead Sciences
Information provided by (Responsible Party):
Biomedical Research and Training Institute, Zimbabwe

Brief Summary:
A randomized, open label trial of two strategies for Virus Load Differentiated Care (VLDC) monitoring of virologic outcome in a rural community based treatment program in Zimbabwe.

Condition or disease Intervention/treatment Phase
ART HIV I Infection Diagnostic Test: Monitoring virus load Not Applicable

Detailed Description:

This is an open label randomized trial among HIV infected children and adolescents and young adults receiving ART at 8 treatment outreach sites near their homes provided by Chidamoyo Mission Hospital. The investigators will implement virus load (VL) testing at "near point of care" using either the GeneXpert Quant or the SAMBA to evaluate the safety, clinical and virologic outcomes of near POC monitoring of virus load at the Chidamoyo Christian Hospital in Mashonaland West Zimbabwe.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Patients assigned to either point of care (POC) or standard of care (SOC)
Masking: Single (Participant)
Masking Description: Single blind
Primary Purpose: Diagnostic
Official Title: Community Based Virus Load Differentiated Care in Rural Africa
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : February 15, 2020

Arm Intervention/treatment
No Intervention: Standard of care
SOC viral load
Active Comparator: Near point of care
POC viral load
Diagnostic Test: Monitoring virus load
Near point of care

Primary Outcome Measures :
  1. Viral load suppression [ Time Frame: 48 weeks ]
    Viral load suppression

Secondary Outcome Measures :
  1. Number of participants with confirmed virology failure who switched regimens [ Time Frame: 96 weeks ]
    Change to second line regimen after confirmed virological failure

  2. Drug resistance mutations [ Time Frame: 96 weeks ]
    Provider initiated genotyping

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- HIV positive children and adolescents on ART

Exclusion Criteria:

  • Unable to consent
  • Less than one year on ART

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03986099

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Contact: Caroline Maposhere, MPhil, BA 00263772315180
Contact: Junior Mutsvangwa, PhD 00263772128049

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Chidamoyo Christian Hospital Recruiting
Karoi, Mashonaland West, Zimbabwe
Contact: Kathleen A MacCarty, PhD    00263772416270   
Contact: Ruth , BSc    0771118363      
Sponsors and Collaborators
Biomedical Research and Training Institute, Zimbabwe
Gilead Sciences
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Principal Investigator: Shungu Munyati, PhD Biomedical Research and Training Institute

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Responsible Party: Biomedical Research and Training Institute, Zimbabwe Identifier: NCT03986099     History of Changes
Other Study ID Numbers: AP142/2017
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biomedical Research and Training Institute, Zimbabwe:
Children and adolescents
HIV therapy
Virologic suppression
Point of care