Reaching 90% HIV Suppression: The Role of POC Viral Load Monitoring in Nigeria

Summary

The UNAIDS 90-90-90 goals represents an ambitious strategy to end the acquired immunodeficiency syndrome (AIDS) epidemic by 2020 \[UNAIDS, 2015\]. While viral load (VL) quantification is the gold standard of HIV treatment monitoring, it is only routinely available and employed in resource-rich countries. The use of an affordable, reliable, point-of-care (POC) VL assay has been considered a "game-changer", where increased access, minimal lab worker training, and same day results could be addressed in a single solution. To date, POC VL assays have been evaluated by their manufacturers with reference panels of samples with some in-country laboratory evaluations. While these are appropriate and critical first steps, it is also important to evaluate the impact of this new technology against the standard of care (SOC) method of VL monitoring in an actual resource-limited setting.

Nigeria has the second highest burden of HIV in the world, with an estimated 3.2 million infected and serves as a relevant setting for testing feasibility and efficacy of POC VL monitoring \[UNAIDS, 2016\]. In order to present the case for implementing the use of POC VL testing across Nigeria, data on the acceptability, feasibility and efficacy of using POC testing for VL monitoring are needed. To address this need, the investigators have designed a randomized controlled trial comparing POC VL to monitoring to the SOC, which follows the Nigerian National Guidelines, to provide operational evidence for implementation of POC VL testing in Nigeria. This trial is aimed at testing the hypothesis that using POC versus SOC VL monitoring in HIV-infected patients newly initiating ART will improve overall ART outcomes, increase ART adherence and program retention rates, and result in faster switches to second-line treatment of patients failing first-line ART.

Conditions

• HIV/AIDS

Interventions

DIAGNOSTIC_TEST

Point-of-care viral load monitoring test

For enumerating viral load for patients in the POC arm, we will use the Cepheid Xpert® HIV-1 Viral Load test, a quantitative assay with a quantification range of 40 to 10,000,000 copies/mL. Based on the GeneXpert® technology, Xpert HIV-1 VL automates the test process, including RNA extraction, purification, reverse transcription and cDNA real-time quantitation in one fully integrated cartridge. The pre-loaded disposable single-use cartridges provide a visual read-out within 90 minutes. The assay requires 1 mL of plasma using a precision pipette (1.2 mL using a transfer pipette).

Sponsors & Collaborators

• Jos University Teaching Hospital

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Phyllis Kanki, DVM, DSc · Harvard School of Public Health (HSPH)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-09

Primary Completion

2021-02-28

Completion

2021-02-28

Countries

• Nigeria

Study Locations