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

November 16, 2020 updated by: Biomedical Research and Training Institute, Zimbabwe

Community Based Virus Load Differentiated Care in Rural Africa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
    • Mashonaland West
      • Karoi, Mashonaland West, Zimbabwe
        • Chidamoyo Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 26 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- HIV positive children and adolescents on ART

Exclusion Criteria:

  • Unable to consent
  • Less than one year on ART

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral load suppression
Time Frame: 48 weeks
Viral load suppression
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with confirmed virology failure who switched regimens
Time Frame: 96 weeks
Change to second line regimen after confirmed virological failure
96 weeks
Drug resistance mutations
Time Frame: 96 weeks
Provider initiated genotyping
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomedical Research and Training Institute, Zimbabwe

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Shungu Munyati, PhD, Biomedical Research and Training Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ACTUAL)

June 15, 2020

Study Completion (ACTUAL)

November 15, 2020

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (ACTUAL)

June 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AP142/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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