Article Text
Abstract
Background A package of care reduces mortality from advanced HIV disease (AHD) but is poorly implemented. We are assessing feasibility of its implementation, using point-of-care Omega VISITECT CD4 (VISITECT) to identify CD4>200cells/µL or ≤200cells/µL, within two TB-triage studies in South Africa and Lesotho. During near-facility passive case-finding (TB TRIAGE+ ACCURACY, n=1,392), implementers found AHD package implementation feasible, despite challenges. Here, we report feasibility and outcomes during community-based active case-finding within the ongoing TB TRIAGE+ TRIAL (current n=3,304).
Methods All people living with HIV (PLHIV) are offered VISITECT testing, and if CD4≤200cells/µL a urine Alere Determine tuberculosis lipoarabinomannan (TB-LAM) and Immy cryptococcal antigen (CrAg) test. Same-day community initiation of anti-retrovirals, cotrimoxazole and TB-preventive therapy is provided. We assessed procedural compliance and have conducted one group discussion with implementers in South Africa.
Results Between September 2022-April 2023, in South Africa and Lesotho respectively, 416/1306 (31.9%) and 439/1998(22.0%) of enrolled participants were PLHIV, among whom 16/416 (3.8%) and 20/439 (4.6%) newly diagnosed. In South Africa and Lesotho respectively, 331 (79.6%) and 368 (83.8%) among PLHIV received VISITECT, and in 23 (6.9%) and 32 (8.3%) VISITECT indicated CD4≤200cells/µL. In South Africa and Lesotho respectively, TB-LAM was performed in 23/23 (100%) and 32/32 (100%), and CrAg in 23/23 (100%) and 30/32 (93.8%). TB-LAM and CrAg were positive in 1 (4.3%) person in South Africa. Since April 2023, VISITECT testing was interrupted following batch recall due to suboptimal specificity. The main challenges reported (long procedural duration and results reading of VISITECT) reflected findings from facility-based implementation. However, implementers did not recommend the package after the recall.
Conclusion During community-based provision of the AHD care package, compliance with most procedures was good. The principal barrier was VISITECT inaccuracy, leading to overreporting of CD4≤200cells/µL and interruption of testing. An accurate, rapid, user-friendly point-of-care CD4-test is necessary for community implementation of this package.
Funding: EDCTP2 grant number: RIA2018D-2498; TB TRIAGE+