Genotype-Informed Versus Empiric Management of VirEmia

Summary

HIV infection can be effectively controlled with antiretroviral therapy (ART). However, children and adolescents living with HIV and receiving ART suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT) to determine which drug combinations are likely to be effective, this diagnostic tool is relatively costly and labour-intensive and is not routinely available in most resource-limited settings.

GIVE MOVE is a multi-country (Lesotho, Tanzania) randomised clinical trial assessing if rapid GRT after detecting an unsuppressed viral load improves the clinical management and thus health outcomes for children and adolescents living with HIV. Children and adolescents with an unsuppressed viral load despite ART are enrolled and randomly allocated to a control or an intervention arm (50% of participants in each arm). The control arm receives care according to the current standard of care, consisting of three sessions of enhanced adherence counselling at monthly intervals, followed by a second viral load test. Onward treatment is informed by the outcome of this viral load test alongside empirical guidelines and clinical judgement. The intervention arm receives GRT and GRT-informed onward therapy. Participants in the intervention arm also receive three sessions of enhanced adherence counselling, which is informed by GRT results (i.e., if no drug resistance is detected, there is a high chance of suboptimal adherence to ART and this can be directly addressed).

This trial will assess if the rapid provision of GRT improves participants' health outcomes at 9 months after enrolment. A nested study will assess the cost and cost-effectiveness of GRT. Thus, this trial will provide evidence on whether the provision of GRT for children and adolescents with HIV should be prioritised in resource-limited settings.

Conditions

• HIV-1-infection

Interventions

OTHER

Clinical management informed by HIV-1 genotypic resistance testing

The study intervention will consist of the following components: 1. Genotypic resistance testing (GRT); 2. Review of GRT results by an expert committee providing a treatment recommendation; 3. GRT-based decision on further therapy (switch or maintain current ART regimen; choice of regimen); and 4. GRT-informed adherence support.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  collaborator OTHER

• University of Basel

  collaborator OTHER

• SolidarMed, Partnerships for Health

  collaborator UNKNOWN

• Seboche Mission Hospital

  collaborator UNKNOWN

• Ifakara Health Institute

  collaborator OTHER

• Baylor College of Medicine Children's Foundation

  collaborator UNKNOWN

• Swiss Tropical & Public Health Institute

  lead OTHER

Principal Investigators

• Niklaus D Labhardt, MD, MIH · Swiss Tropical & Public Health Institute

• Jennifer A Brown, PhD · Swiss Tropical & Public Health Institute

• Thomas Klimkait, PhD · University of Basel

• Josephine Muhairwe, MD, MPH · SolidarMed, Partnerships for Health

• Buntshi P Kayembe, MD · Baylor College of Medicine Children's Foundation Lesotho

• Mosa M Hlasoa, MD · Baylor College of Medicine Children's Foundation Lesotho

• Isaac Ringera, MPH, RN · SolidarMed, Partnerships for Health

• Maja Weisser, MD · Swiss Tropical & Public Health Institute

• Ezekiel Luoga, MD · Ifakara Health Institute

• Tracy R Glass, PhD · Swiss Tropical & Public Health Institute

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-03

Primary Completion

2023-03-15

Completion

2023-07-08

Countries

• Lesotho
• Tanzania

Study Locations