ABSTRACT
Our objective was to evaluate the effectiveness of initiated or reinitiated antiretroviral therapy (ART) in HIV-positive active drug users receiving integrated HIV and addiction care in a harm reduction setting. We performed a study of HIV-positive persons who use drugs (PWUD) in a harm reduction unit in Madrid, Spain. Participants received HIV care integrated into addiction care and received at least one dose of observed ART based on medication-assisted treatment between January 2013 and December 2019. Individuals newly diagnosed with HIV (n = 13) had a greater median CD4 cell count at baseline were less likely to be late presenters, had a greater CD4 cell count increase, and were less likely to have AIDS in comparison to those who were aware of their HIV status (n = 87) at initiation or reinitiation of ART. The overall VS was 73% in the intention-to-treat (ITT) analysis and 92.4% in the modified intention-to-treat (mITT) analysis. People who were engaged in OST, people with >90% adherence to ART, and older people were positively associated with VS in the multivariate analysis. An HIV care model integrated into a harm reduction facility demonstrated a high uptake of HIV treatment, retention in care, improvement in adherence, and achievement of VS.
Acknowledgements
We acknowledge patients’ involvement in this study and the NGO “Madrid Positivo.” The authors thank Danielle Guy (ISGlobal) for writing assistance in the preparation of the manuscript. JVL acknowledges support to ISGlobal from the Spanish Ministry of Science, Innovation and Universities through the “Centro de Excelencia Severo Ochoa 2019-2023” Programme (CEX2018-000806-S), and from the Government of Catalonia through the “CERCA Programme.”
JV, PR: study concept and design, JV, PR, JT, GC, IE, and IC: patients’ selection and clinical data acquisition, JV, AM, and PR: statistical analysis and interpretation of data, JV and PR: write the manuscript; JV, PR, JVL, JT, JT, IE, and IC: critical revision of the manuscript for relevant intellectual content, and JV, PR, and JVL: supervision and visualization. All authors read and approved the final manuscript.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Declarations and ethics
Ethics approval and consent to participate
The study was conducted following the Declaration of Helsinki. Data from study participants were anonymized with an alphanumeric code that was unique for each individual. Thus, participants could not be identified and linked to the registered information. When being admitted to the low threshold mobile harm reduction unit and before start OAT, all individuals signed various documents, including informed consents for blood tests and forms for standard follow-up and analysis of data at the harm reduction mobile unit.
The Institutional Investigation and Ethics Review Board of Infanta Leonor University Hospital (CEI-ILUH) approved the study (Code ILUH 048-20) on 11 June 2020.
Data availability statement
Datasets used and analyzed during the current study are available from the “Subdireccion General de Adicciones” (Madrid, Spain) Institutional Data Access for researchers who meet the criteria for confidential data.