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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
451

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Viral load suppression
Time Frame: 48 weeks
Viral load suppression
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biomedical Research and Training Institute, Zimbabwe

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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