NCT03533868

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

May 11, 2018

Last Update Submit

March 30, 2021

Conditions

HIV/AIDS

Keywords

Point-of-careViral load monitoringNigeria

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with VL<1000 copies/mL at month 12 post-initiation of ART (range 11-15 months) in SOC VL versus POC VL

    Proportion of patients that have undetectable viral load at the end of observation (month 12) will be compared by treatment arm

    12 months (range 11-15 months)

Secondary Outcomes (11)

  • Difference in ART adherence patterns in patients in the SOC versus POC VL arms

    From ART initiation to month 12

  • Difference in loss to follow-up rates by 12 months post-initiation of ART between patients monitored with SOC versus POC VL arms

    Month 12

  • Impact of trial site on differences in virologic suppression rates within patients receiving SOC VL monitoring

    Month 12

  • Difference in time from ART initiation to the confirmation of virologic failure in SOC versus POC VL monitoring arms

    ART Initiation to Month 12

  • Difference in time from ART initiation to switch to 2L treatment in patients in VF in SOC versus POC VL monitoring arms

    ART Initiation to Month 12

  • +6 more secondary outcomes

Study Arms (2)

Standard of Care (SOC)

NO INTERVENTION

Patients in this arm will have their viral load monitored using the standard of care method, using the Roche Cobas TaqMan HIV-1® v2 (Roche) assay.

Point-of-care (POC)

EXPERIMENTAL

Patients in this arm will have their follow-up viral loads (after baseline) monitored using a Point-of-care viral load monitoring test, the Cepheid Xpert HIV-1 Viral Load assay.

Diagnostic Test: Point-of-care viral load monitoring test

Interventions

Point-of-care viral load monitoring testDIAGNOSTIC_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).

Point-of-care (POC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All HIV-infected patients newly initiating ART

You may not qualify if:

  • Previous ARV experience
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jos University Teaching Hospital

Jos, Plateau State, Nigeria

Location

Comprehensive Health Care Centre, Zamko

Zamko, Plateau State, Nigeria

Location

Related Publications (5)

  • Fonjungo PN, Boeras DI, Zeh C, Alexander H, Parekh BS, Nkengasong JN. Access and Quality of HIV-Related Point-of-Care Diagnostic Testing in Global Health Programs. Clin Infect Dis. 2016 Feb 1;62(3):369-374. doi: 10.1093/cid/civ866. Epub 2015 Sep 30.

    PMID: 26423384BACKGROUND

  • Fonjungo PN, Osmanov S, Kuritsky J, Ndihokubwayo JB, Bachanas P, Peeling RW, Timperi R, Fine G, Stevens W, Habiyambere V, Nkengasong JN. Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs. AIDS. 2016 May 15;30(8):1317-23. doi: 10.1097/QAD.0000000000001031.

    PMID: 26807969BACKGROUND

  • Chaplin B, Agbaji O, Reyes Nieva H, Olatunde B, Chang C, Mitruka K, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Rawizza H, Kanki P. Timeliness of Point-of-Care Viral Load Results Improves Human Immunodeficiency Virus Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e671-e680. doi: 10.1093/cid/ciac609.

    PMID: 35872644DERIVED

  • Chang C, Agbaji O, Mitruka K, Olatunde B, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Chaplin B, Kanki P. Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e681-e691. doi: 10.1093/cid/ciac605.

    PMID: 35867672DERIVED

  • Meloni ST, Agbaji O, Chang CA, Agaba P, Imade G, Oguche S, Mukhtar A, Mitruka K, Cox MH, Zee A, Kanki P. 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. BMC Infect Dis. 2019 May 2;19(1):368. doi: 10.1186/s12879-019-3983-6.

    PMID: 31046695DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Phyllis Kanki, DVM, DSc

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients will be randomized to have their viral load monitored by either the standard of care or point-of-care method at their follow-up clinical visits up to 12 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Immunology & Infectious Diseases

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

April 9, 2018

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

The study data set from the proposed trial, stripped of all identifying information and anonymized to protect patient confidentiality, will be available upon request within 30 months of the end of data collection.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Within 30 months of the end of data collection
Access Criteria
Reasonable request via secondary data use application per review of project Principal Investigators.

Locations

NG(2)