Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria

Abstract

Background Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC versus standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert® or SOC Roche COBAS® (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and health care workers (HCWs) evaluated acceptability. Results During April 2018 –October 2019, 268 SOC and 273 POC patients enrolled in the trial. VS at <1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (p = 0.096) in ITT analysis, and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (p = 0.012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (p = 0.02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCW thought it facilitated patient care. Conclusions POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care.

Optimising HIV drug resistance testing laboratory networks in Kenya: insights from systems engineering modelling

“…By having closer POC DRT facilities to the spoke facilities than the national laboratory, this issue of batching delay is overcome by a network that includes POC DRT hubs. Since direct data about the impact of POC DRT testing on results utilisation have not been studied, parallels with POC VL testing may be useful: although POC VL testing has not necessarily consistently improved viral suppression,21 46–48 improved turnaround times are highly motivating for providers and patients49 and result utilisation appears to improve as well 20 47 50…”

Point-of-Care Viral Load Testing to Manage HIV Viremia During the Rollout of Dolutegravir-Based ART in South Africa: A Randomized Feasibility Study (POwER)

“… 21 In this study, all participants were on first-line efavirenz-based regimens, there were few participants with viral failure (16 of 390, 4.1%), and the research team conducted clinical management in the intervention arm, meaning it is difficult to determine the contribution of point-of-care testing within the overall implementation strategy. Trials among children in Kenya, 17 adolescents in Haiti, 18 and adults in Nigeria 19 , 20 found that point-of-care VL testing improved time to receipt of VL results by 2, 4, and 20 weeks, respectively, with improved switching to second-line ART. However, none of these trials found a clear impact on viral suppression.…”

“…To date, 2 point-of-care assays have been approved as accurate by the WHO for use in LMICs 13,14 and have been evaluated in our setting. 15,16 Clinical trials of these assays among children, 17 adolescents, 18 and adults [19][20][21] have demonstrated shorter turnaround times, but effects on clinical outcomes have been mixed.…”

Impact of point‐of‐care HIV viral load and targeted drug resistance mutation testing on viral suppression among Kenyan pregnant and postpartum women: results from a prospective cohort study (Opt4Mamas)

“…A South African randomized controlled trial compared 3monthly POC VL testing to 6-monthly SOC laboratory-based VL testing among postpartum women living with HIV on firstline ART, and found no significant difference in VL suppression rates [23]. Similarly, a study among Nigerian adults initiating ART reported that POC VL monitoring did not improve 12-month VS, but it did improve retention and VS documentation and was favoured by the majority of patients and healthcare workers [24]. Other studies demonstrated some benefits to POC VL.…”