NCT03533868: POC

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

Completed NA Last updated 1 April 2021

What this trial tests

NA trial testing Point-of-care viral load monitoring test in HIV/AIDS in 543 participants. Completed in 28 February 2021.

Timeline

9 April 2018

Primary endpoint
28 February 2021

28 February 2021

Quick facts

Lead sponsor	Harvard School of Public Health (HSPH)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	543
Start date	9 April 2018
Primary completion	28 February 2021
Estimated completion	28 February 2021
Sites	2 locations across Nigeria

Drugs / interventions tested

• Point-of-care viral load monitoring test

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Harvard School of Public Health (HSPH)

Who can join

Eligibility, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response.
   Drain PK, Dorward J, Bender A, Lillis L, et al · · 2019 · cited 103× · PMID 31092508 · DOI 10.1128/cmr.00097-18
2. Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial.
   Drain PK, Dorward J, Violette LR, Quame-Amaglo J, et al · · 2020 · cited 91× · PMID 32105625 · DOI 10.1016/s2352-3018(19)30402-3
3. Antiretroviral adherence for adolescents growing up with HIV: understanding real life, drug delivery and forgiveness.
   Foster C, Ayers S, Fidler S. · · 2020 · cited 30× · PMID 32523693 · DOI 10.1177/2049936120920177
4. Point-of-care viral load tests to detect high HIV viral load in people living with HIV/AIDS attending health facilities.
   Ochodo EA, Olwanda EE, Deeks JJ, Mallett S. · · 2022 · cited 18× · PMID 35266555 · DOI 10.1002/14651858.cd013208.pub2
5. The role of point-of-care viral load monitoring in achieving the target of 90% suppression in HIV-infected patients in Nigeria: study protocol for a randomized controlled trial.
   Meloni ST, Agbaji O, Chang CA, Agaba P, et al · · 2019 · cited 13× · PMID 31046695 · DOI 10.1186/s12879-019-3983-6
6. Timeliness of Point-of-Care Viral Load Results Improves Human Immunodeficiency Virus Monitoring in Nigeria.
   Chaplin B, Agbaji O, Reyes Nieva H, Olatunde B, et al · · 2023 · cited 8× · PMID 35872644 · DOI 10.1093/cid/ciac609
7. Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria.
   Chang C, Agbaji O, Mitruka K, Olatunde B, et al · · 2023 · cited 8× · PMID 35867672 · DOI 10.1093/cid/ciac605