Background: The number of people living with HIV (PLHIV) in need of treatment monitoring in low-and-middle-income countries is rapidly expanding, straining existing laboratory capacity. Point-of-care viral load (POC VL) testing can alleviate the burden on centralized laboratories and enable faster delivery of results, improving clinical outcomes. However, implementation costs are uncertain and will depend on clinic testing volume. We sought to estimate the costs of decentralized POC VL testing compared to centralized laboratory testing for adults and children receiving HIV care in Kenya. Methods: We conducted microcosting to estimate the per-patient costs of POC VL testing compared to known costs of centralized laboratory testing. We completed time-and-motion observations and stakeholder interviews to assess personnel structures, staff time, equipment costs, and laboratory processes associated with POC VL administration. Capital costs were estimated using a 5 year lifespan and a 3% annual discount rate. Results: We estimated that POC VL testing cost USD $24.25 per test, assuming a clinic is conducting 100 VL tests per month. Test cartridge and laboratory equipment costs accounted for most of the cost (62% and 28%, respectively). Costs varied by number of VL tests conducted at the clinic, ranging from $54.93 to $18.12 per test assuming 20 to 500 VL tests per month, respectively. A VL test processed at a centralized laboratory was estimated to cost USD $25.65. Conclusion: POC VL testing for HIV treatment monitoring can be feasibly implemented in clinics within Kenya and costs declined with higher testing volumes. Our cost estimates are useful to policymakers in planning resource allocation and can inform cost-effectiveness analyses evaluating POC VL testing.
Background Viral suppression (VS) is a marker of effective HIV therapy, and viral load (VL) testing is critical for treatment monitoring, especially in high-risk groups such as children and pregnant/postpartum women. Although routine VL testing, via centralized laboratory networks, was implemented in Kenya starting in 2014, optimization and sustainable scale up of VL testing are still needed. Methods We conducted a mixed methods study to evaluate the impact of higher frequency, point-of-care (POC) VL testing in optimizing VS among children and pregnant/postpartum women on antiretroviral treatment (ART) in five HIV treatment facilities in western Kenya in the Opt4Kids and Opt4Mamas studies. We conducted 68 key informant interviews (KIIs) from December 2019 to December 2020 with children and pregnant women living with HIV, child caregivers, providers, laboratory/facility leadership, and county- or national-level policymakers. Our KII guide covered the following domains: (1) barriers and facilitators to ART use and VS, (2) literacy and experiences with VL in routine care and via study, and (3) opinions on how to scale up VL testing for optimal programmatic use. We used inductive coding and thematic analysis to identify dominant themes with convergent and divergent subthemes. Results Three main themes regarding VL testing emerged from our analysis. (1) Key informants uniformly contrasted POC VL testing’s faster results turnaround, higher accessibility, and likely cost-effectiveness against centralized VL testing. (2) Key informants also identified areas of improvement for POC VL testing in Kenya, such as quality control, human resource and infrastructure capacity, supply chain management, and integration of VL testing systems. (3) To enable successful scale-up of VL testing, key informants proposed expanding the POC VL testing scheme, electronic medical records systems, conducting quality checks locally, capacity building and developing strong partnerships between key stakeholders. Conclusion The more accessible, decentralized model of POC VL testing was deemed capable of overcoming critical challenges associated with centralized VL testing and was considered highly desirable for optimizing VS for children and pregnant/postpartum women living with HIV. While POC VL testing has the potential to improve VS rates among these populations, additional research is needed to develop strategies for ensuring the sustainability of POC VL testing programs. Trial registration NCT03820323, 29/01/2019
Background Pregnant and postpartum women living with HIV (WLHIV) are a priority population for virologic monitoring and efforts to ensure viral suppression to reduce the risk for vertical-transmission and poor maternal health outcomes. Few studies have examined the role of parity on viral suppression during periconception in WLHIV. Methods We present data from the ongoing Opt4Mamas study which enrolled pregnant women with HIV on antiretroviral therapy between March and November 2019 attending antenatal care in five public health facilities in Kisumu County, Kenya. We evaluated associations between various sociodemographic and psychosocial factors and periconception viral suppression (< 40 copies/mL) within 12 months of study enrollment. We conducted univariate and multivariate logistic regressions, calculating odds ratios (OR) and 95% confidence intervals (CI). Results Among 497 women enrolled, mean age 29.9 years, 301 (61%) had viral load results available within 12 months of study enrollment. Viral loads were available a median of 18 days from conception (interquartile range 71 days before to 90 days after conception), and 237 women (79%) were virally suppressed. The majority (90%) of women were on a non-nucleoside reverse transcriptase inhibitor and 23 (9%) were on a protease inhibitor-containing regimen. In univariate analysis, women younger than 25 and primigravida women were less likely to be virally suppressed (OR 0.31, 95% CI [0.16 - 0.60] and OR 0.25, 95% CI [0.11 - 0.61] respectively; Table 1). The relationship between primigravida and periconception viral suppression is modified by age and duration on ART. Primigravida women who were younger than 25 years or who had less than 1 year of ART had significantly reduced odds of achieving viral suppression in the past year compared to primigravida women who were older or who had more experience taking ART (OR 0.09, 95%CI [0.03-0.31] and OR 0.09, 95%CI [0.02-0.48] respectively; Table 2). Table 1: Comparison of Pregnant Women with HIV by Periconception Viral Suppression Table 2: Interaction Effects with Primigravida Status Conclusion Risk factors for non-suppression around the time of conception in WLHIV include primigravida status, which is modified by age and duration on ART. Interventions targeting viral suppression among WLHIV leading up to their first pregnancy are needed, particularly among those who are newly initiated onto ART or younger age. Disclosures All Authors: No reported disclosures
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