Implementation of a package of care using point of care testing for HIV diagnosis, CD4 count and detection of fungal and other opportunistic infections in argentina

Justification: in argentina, more than one third of people living with HIV (plhiv) are diagnosed in late stages of the disease (advanced HIV [AH]). Improved access to early diagnosis of HIV and widespread availability of point of care (POC) tests, could increase the proportion of individuals rapidly starting antiretroviral therapy (art), and reduce the incidence of opportunistic infections such as histoplasmosis, cryptococcosis, tuberculosis (TB), among others. Rapid HIV tests, usually based on lateral flow technologies, have several advantages over laboratory-based diagnostic tools including simplicity, portability, and rapid turnaround for results. Who and local guidelines recommend the initiation art as soon as possible after HIV diagnosis, including same-day initiation when feasible and acceptable. In aids patients with meningeal cryptococcosis or TB with central nervous system involvement, immediate art initiation is associated with a higher frequency of adverse outcome, as compared with later initiation. The use of highly sensitive and specific tests to rapidly diagnose disseminated TB and/or cryptococcal infection may significantly contribute to the identification of patients who are not candidates for immediate, same-day art initiation. Due to the high morbidity and mortality associated with these opportunistic infections in the context of HIV and the limitations of the available tests for rapid diagnosis, our objective is to monitor the implementation of an immediate, same-day art initiation program. A package of sequential POC assays will be implemented, including rapid diagnosis of HIV infection in people who do not know their status, or the determination of the immune status on people with HIV; followed by the rapid screening of opportunistic infections, histoplasmosis, cryptococcosis and TB. Study design: will be a prospective study aimed to evaluate the feasibility of implementation of a HIV package of care strategy in an infectious diseases outpatient following up unit. The first phase will consist of two years of this study implementation at the hospital DR. Juan a. Fernández, located in buenos aires, argentina. According to the phase one results, a second phase (years 3 to 5) will be proposed, and will include other medical centers of the autonomous city of buenos aires. Our long term goal is to implement this strategy across the whole argentinean territory. Study procedures include: 1) clinical data collection; 2) rapid HIV infection confirmation (HIV-RDT); 3) POC for immunological stratification; 4) POC for screening of histoplasmosis (HAG-LFA), cryptococcosis (crag-LFA) and TB (LAM-LFA) among symptomatic individuals and asymptomatic individuals with a CD4=200 cells/ΜL; 5) standard of care procedures; 6) managing and clinical decisions; and 7) staff training. Analysis plan: the general objective will be evaluated through the following indicators: a) feasibility: availability of resources and staff training to implement the proposed algorithm. B) efficiency: laboratory and clinical indicators.