Accuracy and operational feasibility of point-of-care (PoC) viral load monitoring of HIV-positives mothers at delivery in the context of HIV vertical transmission reduction in Mozambique

Meggi, Bindiya (2022): Accuracy and operational feasibility of point-of-care (PoC) viral load monitoring of HIV-positives mothers at delivery in the context of HIV vertical transmission reduction in Mozambique. Dissertation, LMU München: Medizinische Fakultät

Abstract

Background: Many resource-limited countries face challenges in implementing HIV viral load testing within their public health programs due to suboptimal laboratory infrastructure and limited human resources. HIV point-of-care viral load (PoC VL) testing in pregnant and breastfeeding women could provide an opportunity for faster identification and management of virologic failure in mothers, which in turn may contribute to higher effectiveness in preventing mother-to-child transmission. The objective of this research project was to describe the diagnostic accuracy, feasi-bility and usability of PoC VL for pregnant and breastfeeding women in primary health care clinics in southern and central region of Mozambique. Methods: HIV-infected pregnant and postpartum women were included in the first cross-sectional study. Each participant was tested using both on-site m-PIMA PoC VL and referral la-boratory-based VL assays. In the second study, mother/child pairs were recruited in maternity wards in 14 primary health facilities. Half of those mothers were tested with PoC VL at delivery (Intervention Arm). The other half (Control Arm) saw samples collected and sent to the central laboratory for referral viral load testing. Three months post-delivery, all mothers had a viral load performed (laboratory based or PoC). Linear regression analysis and Bland-Altman plots were used to describe diagnostic accuracy in the first study and generalized linear mixed-effects models were used for to account for clustered data in the second study. Results: The sensitivity and specificity of the m-PIMA PoC VL assay were 95.0% (95% CI: 91.6-97.3%) and 96.5% (95% CI: 94.2-98.0%), respectively at a threshold of 1,000 copies/mL. In the intervention arm, 1906 (92.7%) of women had a viral load processed via PoC VL on site by nurses and of which 1891 (99.2%) results were communicated to the patients on the same day. There was no effect of PoC VL (intervention arm) in terms of viral suppression at week 12 [OR 1.25 (95% CI: 0.86-1.82); p=0.235] nor in transmission rate at by week 12 in the intervention arm compared to the control arm [1.69 (95% CI: 1.11-2.26) versus 1.49 (95% CI: 0.92 -2.05)]. Conclusions: M-PIMA PoC VL is accurate and operationally feasible in maternity wards of pri-mary healthcare settings in Mozambique. Nevertheless, having the viral load result available might not be sufficient to have an impact on maternal viral suppression rate or in transmission rates at 12 weeks post-delivery. Other operational aspects should be considered such as quality of adherence counselling and social support for improved adherence and early second line regimen switches to see a greater impact of PoC viral load monitoring at delivery.

• Dokumententyp: Dissertationen (Dissertation, LMU München)
• Keywords: HIV transmission, Point-of-Care, Viral load, Diagnostic accuracy
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften ; 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• Fakultäten: Medizinische Fakultät
• Sprache der Hochschulschrift: Englisch
• Datum der mündlichen Prüfung: 18. November 2022
• 1. Bericht­erstatter:in: Saathoff, Elmar