Clinical effect and cost-effectiveness of incorporation of point-of-care assays into early infant HIV diagnosis programmes in Zimbabwe: a modelling study

Abstract

Background: New point-of-care (POC) assays for early infant HIV diagnosis (EID) are costlier than conventional total nucleic acid assays, but may increase access to testing, shorten time to result-return, and expedite ART initiation. Methods:We used the Cost Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model to examine the clinical benefits, costs, and cost-effectiveness of replacing conventional EID assays with POC EID assays at 6 weeks of age in Zimbabwe. We simulated two EID strategies: conventional and POC. Modelled assays differed in sensitivity, specificity, time for and probability

Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant

“…Our total sample was relatively small; and we observed very few positive infants. Outcomes for HIV-positive infants-including timing of ART initiation and long term outcomes for HIV-positive infants-are an important aspect of evaluations for testing methods [31,32]. While very low yield of positive infants' results reflect the high coverage of antenatal ART and will likely continue to decrease, globally, as we strive towards elimination of mother-to-child transmission, it does prevent assessment of these critical impact data and forces us to rely on proxy measures such as timing of caregiver notification of results.…”

“…POC diagnostic technologies such as GeneXpert HIV-1 Qual [ 15 ] and Alere m-PIMA [ 16 ] are cartridge-based tests that can be processed at the hospital by trained clinical or laboratory staff and can result in more rapid turnaround times of results, more infants being identified as HIV-positive and more infants initiated on ART at younger ages than traditional testing strategies [ 17 – 22 ]. Studies have shown high sensitivity and specificity of POC testing and found that POC implementation is feasible in hospital-based settings in Kenya [ 23 , 24 ], South Africa [ 18 , 25 – 27 ], Mozambique [ 28 ], and Tanzania [ 29 ]; is acceptable to providers [ 26 ] and patients [ 30 ]; and may be a cost-effective option for EID [ 31 , 32 ]. Based on the promising evidence supporting POC, the World Health Organization (WHO) conditionally recommended the introduction of POC for EID in 2016 [ 33 ].…”

“We Need it the Same Day”: A Qualitative Study of Caregivers and Community Members' Perspectives Toward the Use of Point-of-Care Early Infant Diagnosis

“…Point-of-care technologies have been shown to rapidly return test results and facilitate early HIV treatment for far greater numbers of infants living with HIV (82). These platforms are easy to use in a variety of service delivery settings and do not require specialized laboratory technicians.…”

Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration

“…For example, in Thailand, researchers studying the HIV reservoirs and public health officers collaborated as part of the Active Case Management Network to increase the numbers of infants on ART and lower the age at ART initiation. 48 Measures are being taken to strengthen EID programs and point of care virologic testing is gaining momentum, 10 , 49 – 51 and applications now extend to monitoring of pediatric and adult HIV treatment. 52 , 53 Over the past several years, new efforts have been made to find safe and potent ARVs with appropriate formulations and dosing for neonates and young infants 54 , 55 ( clinicaltrials.gov NCT01828073; NCT 02778204).…”