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      Use of antiretroviral drug testing to assess the accuracy of self-reported data from HIV-infected people who inject drugs

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          Abstract

          We used antiretroviral (ARV) drug testing to evaluate the accuracy of self-reported data for HIV status and antiretroviral treatment (ART) among people who inject drugs (PWID) enrolled in an HIV prevention trial. ARV drugs were detected in enrollment samples from 72/482=14.9% HIV-infected participants (39/52=75.0% who reported being on ART; 33/430=7.7% who reported not being on ART). Overall, 213/482=44.2% participants indicated that they were not aware of their HIV-positive status prior to study entry; of those, 30 had ARV drugs detected at enrollment, including 15 who also had ARV drugs detected at the screening visit. These participants were likely aware of their HIV-positive status at study entry but did not report this to study staff. This study shows that self-reported data on HIV testing history and ART may not be accurate and that ARV drug testing can help identify persons who are aware of their HIV-positive status and are on ART.

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          Undisclosed antiretroviral drug use in a multinational clinical trial (HIV Prevention Trials Network 052).

          Jessica Fogel, Lei Wang, Teresa L. Parsons … (2013)
          The HIV Prevention Trials Network 052 study enrolled serodiscordant couples. Index participants infected with human immunodeficiency virus reported no prior antiretroviral (ARV) treatment at enrollment. ARV drug testing was performed retrospectively using enrollment samples from a subset of index participants. ARV drugs were detected in 45 of 96 participants (46.9%) with an undetectable viral load, 2 of 48 (4.2%) with a low viral load, and 1 of 65 (1.5%) with a high viral load (P < .0001); they were also detected in follow-up samples from participants who were not receiving study-administered treatment. ARV drug testing may be useful in addition to self-report of ARV drug use in some clinical trial settings.
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            Whoonga: potential recreational use of HIV antiretroviral medication in South Africa.

            David Grelotti, Elizabeth Closson, Jennifer Smit … (2014)
            Whoonga is a drug cocktail in South Africa rumored to contain illicit drugs and HIV antiretroviral (ARV) medication. Although its use may adversely impact adherence to HIV treatment and may have the potential to generate ARV resistance, there is a paucity of research characterizing whoonga. We learned of whoonga during semi-structured interviews about substance abuse and HIV risk at "club-events" known as inkwaris in an urban township of Durban, South Africa. Whoonga was an emerging theme spontaneously identified as a problem for the community by 17 out of 22 informants. Perceptions of whoonga suggest that it is highly addictive, contains ARVs (notably efavirenz), is used by individuals as young as 14, and poses a threat to the health and safety of those who use it, including increasing the risk of HIV infection. Our informants provide preliminary evidence of the dangers of whoonga and reinforce the need for further study.
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              A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study

              Tran V Ha, Kathryn Lancaster, David S Metzger … (2018)
              Background: People who inject drugs (PWID) experience high HIV incidence, limited access to antiretroviral therapy (ART) and medication-assisted treatment (MAT), and high mortality. We report the effect of an integrated, flexible intervention on HIV and substance use outcomes. Methods: HIV Prevention Trials Network 074 was a randomized, controlled vanguard study conducted in Ukraine, Indonesia, and Vietnam and designed to assess the feasibility of a future trial. HIV-infected PWID index participants (indexes) were enrolled with ≥1 HIV-uninfected injection partner. Indexes were randomly assigned (ratio=3:1) to standard of care (SOC) or an intervention comprising systems navigation, psychosocial counseling, and ART at any CD4 count. Local ART and MAT services were used. Outcomes included retention, ART use, viral suppression, MAT use, mortality, and injection partner HIV incidence. Findings: 502 indexes and 806 partners were enrolled. At 52 weeks, most living indexes (86%) and partners (80%) were retained. At week 52, self-reported ART use was higher among intervention indexes (72%) than SOC indexes (43%) (probability ratio (PR) 1.7, 95% confidence interval (CI): 1.4, 1.9). Viral suppression also increased (intervention: 41%, SOC: 24%; PR: 1.7, 95% CI: 1.3, 2.2). Intervention indexes reported more MAT use at 52 weeks (41%; SOC 25%; PR: 1.7, 95% CI: 1.3, 2.2). Mortality was reduced with the intervention (indexes: hazard ratio (HR): 0.47, 95% CI: 0.22, 0.90; partners: HR: 0.17, 95% CI: 0.01, 0.84). All incident HIV infections occurred in SOC partners (intervention (0 cases): 0.0/100 person-years; 95% CI: 0, 1.7; SOC (7 cases): 1.0/100 person-years, 95% CI: 0.4, 2.1; incidence rate difference: −1.0/100 person-years (95% CI: −2.1, 1.1)). Interpretation: This randomized, controlled vanguard trial provides strong evidence that a flexible, scalable intervention increases ART and MAT use and reduces mortality among PWID. The intervention may also reduce HIV transmission to injection partners.
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                Author and article information

                Journal
                Journal ID (nlm-journal-id): 9712133
                Journal ID (pubmed-jr-id): 21042
                Journal ID (nlm-ta): AIDS Behav
                Journal ID (iso-abbrev): AIDS Behav
                Title: AIDS and behavior
                ISSN (Print): 1090-7165
                ISSN (Electronic): 1573-3254
                Publication date Nihms-submitted: 4 January 2019
                Publication date (Print): August 2019
                Publication date PMC-release: 01 August 2020
                Volume: 23
                Issue: 8
                Pages: 2101-2108
                Affiliations
                [1 ]Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
                [2 ]Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
                [3 ]Science Facilitation Department, FHI 360, Durham, NC, USA
                [4 ]Department of Health Behavior, Gilings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
                [5 ]Ukrainian Institute on Public Health Policy, Kiev, Ukraine
                [6 ]Departments of Hematology, Medical Oncology, and Medicine, University of Indonesia/Cipto Mangunkusumo Hospital, Jakarta, Indonesia
                [7 ]Department of Medicine, University of North Carolina Chapel Hill School of Medicine, Chapel Hill, NC, USA
                [8 ]Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA
                Author notes
                Corresponding author: Susan H. Eshleman, Dept. of Pathology, The Johns Hopkins Medical Institutions, Ross Building, Room 646, 720 Rutland Avenue, Baltimore, MD 21205, USA, Phone: +1 (410) 614-4734, seshlem@ 123456jhmi.edu

                Authors’ contributions

                All of the authors contributed to manuscript preparation and reviewed the manuscript before submission. Additional author contributions are shown in the table below.

                Author Role
                JMF Designed the study, analysed data; prepared the manuscript
                YZ Assisted with data analysis and presentation
                PJP Assisted with data analysis and presentation
                XG HPTN 074 data analyst; performed statistical analysis
                WC Provided scientific oversight for antiretroviral drug testing
                AB Performed antiretroviral drug testing
                PR HPTN Laboratory Center QAQC Representative for HPTN 074; responsible for laboratory activities in HPTN 074
                EPM HPTN Laboratory Center QAQC Representative for HPTN 074; responsible for laboratory activities in HPTN 074
                ELH Study Coordinator for HPTN 074
                TVH HPTN 074 Site PI
                KD HPTN 074 Site PI
                ZD HPTN 074 Site PI
                IH HPTN 074 Protocol Co-Chair
                BH HPTN 074 Statistician
                WCM HPTN 074 Protocol Chair
                SHE HPTN 074 Virologist; designed the study, analysed data; prepared the manuscript

                Article
                Accession ID: PMC6602865 Pmcid ID: PMC6602865 Pmc-uid ID: 6602865 Manuscript ID: nihpa1517685
                DOI: 10.1007/s10461-018-2379-8
                PMC ID: 6602865
                PubMed ID: 30600453
                SO-VID: d89c9ac8-5421-4ab5-87fb-cef3f771117c
                History
                Categories
                Subject: Article

                Keywords: self-report,PWID,HIV,ART,Ukraine,Vietnam,Indonesia
                Data availability:
                Keywords: self-report, PWID, HIV, ART, Ukraine, Vietnam, Indonesia

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