It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.
Ross M BoyceRonnie NdizeyeHerbert NgeleseEmmanuel BagumaBwambale ShemRebecca J RubinsteinEmmanuel RockwellSarah C LotspeichBonnie E Shook-SaMoses NtaroDan NyehanganeDavid Alain WohlMark J SiednerEdgar Mugema MulogoPublished in: PLOS global public health (2023)
Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2-7). Time from sample collection to result was 51 days (IQR = 45-62) for samples sent to the central laboratory and 0 days (IQR = 0-0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lower-level health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study. Trial registration: ClinicalTrials.gov Identifier: NCT04517825, Registered 18 August 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04517825.
Keyphrases
- healthcare
- public health
- south africa
- hiv positive
- antiretroviral therapy
- mental health
- hiv infected
- human immunodeficiency virus
- high throughput
- primary care
- hepatitis c virus
- health information
- case report
- open label
- hiv testing
- clinical trial
- human health
- study protocol
- computed tomography
- randomized controlled trial
- health promotion
- quality improvement
- palliative care
- squamous cell carcinoma
- radiation therapy
- type diabetes
- machine learning
- skeletal muscle
- single molecule
- single cell
- adipose tissue
- metabolic syndrome
- insulin resistance
- phase iii
- rectal cancer
- health insurance