Clinical trial NCT03533868: Reaching 90% HIV Suppression: The Role of POC Viral Load Monitoring in Nigeria
Official title: Reaching 90% Target of HIV Viral Suppression: The Role of Point-of-Care Viral Load Monitoring in Resource-Constrained Settings in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Point-of-care
Viral load monitoring
Nigeria
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Jos University Teaching Hospital
name: Centers for Disease Control and Prevention
First posted: 2018-05-23
Enrollment: 543
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The investigators will conduct an un-blinded randomized implementation trial comparing POC VL monitoring, using the Cepheid Gene Xpert HIV-1 VL®, to SOC VL monitoring, using the Roche AmpliPrep/COBAS Taqman system. The trial will be conducted at two sites in Plateau State, Nigeria.

ART-naïve patients initiating ART will be randomized on a 1:1 basis to the SOC VL monitoring control arm or the POC VL monitoring arm. VL monitoring will occur according to the current Nigerian ART guidelines-recommended algorithm, with the addition of a baseline VL test. For the month 6 and 12 visits, patients that are enrolled in the POC VL monitoring arm will be provided their VL results. Participants in the SOC arm will receive their Roche VL test results after the results become available per SOC protocol. All other aspects of their HIV care and treatment will be identical to services that they would normally receive at these treatment centers.

The investigators will follow all patients up through their Month 12 follow-up visit. At trial exit, the investigators will ask patients, caregivers of patients under the age of 18 years, and providers for their participation in surveys on the operational performance and acceptability of the POC versus SOC VL monitoring. Following that time point, the patients will continue receiving HIV care and treatment utilizing the SOC procedures for the clinic.

Eligibility criteria: Inclusion Criteria:

-All HIV-infected patients newly initiating ART

Exclusion Criteria:

* Previous ARV experience
* Pregnant

Primary outcomes:
measure: 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
timeFrame: 12 months (range 11-15 months)
Secondary outcomes:
measure: Difference in ART adherence patterns in patients in the SOC versus POC VL arms
timeFrame: From ART initiation to month 12
measure: Difference in loss to follow-up rates by 12 months post-initiation of ART between patients monitored with SOC versus POC VL arms
timeFrame: Month 12
measure: Impact of trial site on differences in virologic suppression rates within patients receiving SOC VL monitoring
timeFrame: Month 12
measure: Difference in time from ART initiation to the confirmation of virologic failure in SOC versus POC VL monitoring arms
timeFrame: ART Initiation to Month 12
measure: Difference in time from ART initiation to switch to 2L treatment in patients in VF in SOC versus POC VL monitoring arms
timeFrame: ART Initiation to Month 12
measure: Difference in time from specimen collection to availability of VL results in patient charts in SOC versus POC VL monitoring arms
timeFrame: All follow-up visits at which VL monitored up to Month 12
measure: Difference in time from specimen collection to delivery of VL results to patient in SOC versus POC VL monitoring arms
timeFrame: All follow-up visits at which VL monitored up to Month 12
measure: Difference in time from lab confirmation of first unsuppressed VL to adherence counseling provided and switch to 2L in SOC versus POC VL monitoring arms
timeFrame: All follow-up visits at which VL monitored up to Month 12
measure: Difference in HIV DRM patterns in patients failing 1L ART in the SOC versus POC VL monitoring arm
timeFrame: Month 12
measure: Health care worker (HCW) satisfaction level with POC versus SOC VL monitoring
timeFrame: Month 12
measure: POC VL arm patient satisfaction with POC vs SOC VL testing
timeFrame: Month 12
Other outcomes:
Locations:
city: Jos
country: Nigeria
facility: Jos University Teaching Hospital
state: Plateau
city: Zamko
country: Nigeria
facility: Comprehensive Health Care Centre, Zamko
state: Plateau
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Phyllis Kanki, DVM, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.