EAPoC-VL: East Africa Point of Care Viral Load Study

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05048472

Collaborator

Karolinska Institutet (Other), Kilimanjaro Christian Medical Centre, Tanzania (Other), Amsterdam Institute for Global Health and Development (Other), National Institute for Medical Research, Tanzania (Other), Kenya Medical Research Institute (Other), University of Rwanda (Other), Uganda National Health Research Organization (Other)

1,440

Enrollment

Arms

35.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the project is to examine the feasibility, acceptability, and effectiveness of using point of care viral load (PoC VL) monitoring to improve viral load suppression among children and adolescents (age ≤19 years) living with HIV in Kenya, Rwanda, Tanzania and Uganda.

Condition or Disease	Intervention/Treatment	Phase
HIV Viral Load Point of Care Monitoring	Diagnostic Test: Abbott HIV-1/2 VL Point of care Device	N/A

Detailed Description

Main Study Aims:

To determine the effectiveness of PoC VL monitoring in improving viral suppression among children and youth living with HIV in East Africa.
To evaluate feasibility and acceptability of using PoC VL monitoring among children and adolescents living with HIV in East Africa.

Objectives of Aim 1:

Primary objective i. To estimate the effect of PoC VL monitoring on viral load suppression among children and adolescents living with HIV in East Africa at 6 and 12 months of follow-up.

Secondary objectives i. To describe the effect of PoC VL monitoring on the proportion of children and adolescents living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up.

To describe the effect of PoC VL monitoring on time to initiation of intensive adherence counselling following virological failure among children and adolescents living with HIV.
To estimate the effect of PoC VL monitoring on the proportion of children and adolescents living with HIV that experiences change of antiretroviral therapy (ART) regimen within 6 and 12 months of follow-up.
To determine the effect of PoC VL monitoring on the proportion of children and adolescents living with HIV that is retained in care at 6 and 12 months.

Objectives of Aim 2 i. To assess the acceptability of the implementation and scale-up of PoC VL testing and monitoring from the perspective of children, adolescents and their caregivers.

To assess the critical determinants that may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers.
To assess potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring among children and adolescents living with HIV.
To assess the incremental cost-effectiveness of PoC VL from a modified societal perspective using established models, with data collected alongside the implementation of the intervention combined with data estimated based on existing studies.

Design: A cluster randomized controlled trial with 10 intervention clusters and 10 control clusters.

Study Sites: Twenty (20) health facilities spread across 4 countries as follows: Uganda (6), Kenya (4), Tanzania (6), and Rwanda (4).

Population: The study will be conducted among three population sub-groups

Study population 1: children and adolescents (≤19 years) living with HIV in participating countries in East Africa.
Study population 2: Care givers/ guardians and treatment supporters of children and adolescents living with HIV in participating countries in East Africa
Study population 3: Health care workers attending to children and adolescents living with HIV, and policy makers.

Study Intervention: PoC VL monitoring using the Abbott platform Control: Standard-of-care / centralized HIV VL monitoring

Duration: The whole project will take 48 months including 24 months of data collection. Each participant will be followed up for a minimum of 12 months and maximum 24 months.

Sample size The study will enroll 1440 children and youth (0-24years); with 720 in 10 intervention clusters and 720 in 10 control clusters (72 participants per cluster). The effect of the intervention and 95% confidence intervals (CIs) will be estimated using cluster-level summary methods and a power of 80%. To ensure equal distribution of the participants across the ages, we aim to split the enrollment proportionally according to the cluster sizes into three age groups of (0-5 years, 6-12 years and 13-19 years).

Statistical Analysis Aim 1

To investigate the effect of the intervention on viral suppression our analysis will be carried out at the cluster level as follows:

Reduce clusters to independent observations and provide summary statistics by comparing those in the intervention arm to those in the non-intervention arm.
Use fixed effects regression to take into account unobserved time-invariant heterogeneity and the treatment effects across the clusters
Analyze the main outcome (viral suppression) using time to event comparison of the two arms from enrollment to failure or completion of the follow-up time (2 years).

Mixed method Analysis Aim 2 Acceptability and feasibility will be investigated using a combined qualitative and quantitative approach, consisting of thematic content analyses of observations, in-depth interviews and focus group discussions, triangulated and generalized with descriptive statistics of survey data. As part of the feasibility study, the impact of a range of values in sensitivity analyses using each of the respective sites' 2020 per capita Gross Domestic Product (GDP) as a benchmark cost-effectiveness threshold will be evaluated to be able to estimate the incremental cost-effectiveness of the POC VL compared to the standard of care. Quality adjusted life years (QALYS) will be calculated based on weights derived from the Global Burden of Disease.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Intervention arm will use point of care viral load monitoring (Abbott PoC devices) while the control arm will use the standard of care (centralized viral load monitoring).Intervention arm will use point of care viral load monitoring (Abbott PoC devices) while the control arm will use the standard of care (centralized viral load monitoring).

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Implementation of Point of Care HIV Viral Load Monitoring to Improve Viral Load Suppression Among Children and Adolescents Living With HIV in East Africa

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Use of point of care viral load monitoring (Abbott PoC devices)	Diagnostic Test: Abbott HIV-1/2 VL Point of care Device Point of care viral load monitoring
No Intervention: Control Use of the standard of care viral load monitoring (centralized viral load monitoring)

Arm

Intervention/Treatment

Experimental: Intervention

Use of point of care viral load monitoring (Abbott PoC devices)

Diagnostic Test: Abbott HIV-1/2 VL Point of care Device

Point of care viral load monitoring

No Intervention: Control

Use of the standard of care viral load monitoring (centralized viral load monitoring)

Outcome Measures

Primary Outcome Measures

The proportion of children and adolescents living with HIV that achieves viral suppression at 6 and 12 months of follow-up. [36 months]
The proportion of children and adolescents living with HIV that achieves viral suppression at 6 and 12 months of follow-up
The time between enrolment into the study and viral suppression. [36 months]
The time between enrolment into the study and viral suppression.

Secondary Outcome Measures

The proportion of children and adolescents living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up [36 months]
The proportion of children and adolescents living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up
The time between enrolment into the study and initiation of intensive adherence counselling following virological failure. [36 months]
The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.
The proportion of children and adolescents living with HIV that experiences change of ART regimen within 6 and 12 months of follow-up [36 months]
The proportion of children and adolescents living with HIV that experiences change of ART regimen within 6 and 12 months of follow-up
The proportion of children and adolescents living with HIV that is retained in care at 6 and 12 months. [36 months]
The proportion of children and adolescents living with HIV that is retained in care at 6 and 12 months.

Other Outcome Measures

The proportion of children, adolescents and their care givers who accept implementation of PoC VL testing and monitoring [36 months]
The proportion of children, adolescents and their care givers who accept implementation of PoC VL testing and monitoring.
The number of factors which may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers. [24 months]
The number of factors which may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers.
The number of potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring identified by children and adolescents living with HIV. [36 months]
The number of potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring identified by children and adolescents living with HIV.
The incremental cost-effectiveness of PoC VL from a modified societal perspective [36 months]
The incremental cost-effectiveness of PoC VL from a modified societal perspective

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 6 months - 19 years
Documented evidence of HIV infection
Receiving ART for treatment of HIV infection for at least 6 months.
Has had a detectable VL of >1000 copies/ml in the last 6 months.
Guardian, parent or legal representative able and willing to give voluntary consent and sign/mark an informed consent document.
Willing and able to comply with protocol requirements/study procedures.

Exclusion Criteria:

Any medical conditions that require pausing of ART for more than three months.
Potential participant already enrolled in another study which may interfere with the study outcome or participation as per investigator's judgement.
Child or adolescent already enrolled and completed follow up in the current study.
Any medical or other condition in the potential participant or their parent/ guardian that precludes provision of informed consent/ assent or that may hinder achieving study objectives as per investigator's judgement.

Contacts and Locations

Locations

No locations specified.

Investigators

Principal Investigator: Pontiano Kaleebu, MRC/UVRI & LSHTM Uganda Research Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

MRC/UVRI and LSHTM Uganda Research Unit

ClinicalTrials.gov Identifier:

NCT05048472

Other Study ID Numbers:

RGPK210909

First Posted:

Sep 17, 2021

Last Update Posted:

Sep 17, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by MRC/UVRI and LSHTM Uganda Research Unit

Children

Adolescents

East Africa

Study Results

No Results Posted as of Sep 17, 2021