Undisclosed Antiretroviral Drug Use in a Multinational Clinical Trial (HIV Prevention Trials Network 052)

Fogel, Jessica M.; Wang, Lei; Parsons, Teresa L.; Ou, San San; Piwowar‐Manning, Estelle; Chen, Ying; Mudhune, Victor; Hosseinipour, Mina C.; Kumwenda, Johnstone; Hakim, James; Chariyalertsak, Suwat; Panchia, Ravindre; Sanne, Ian; Kumarasamy, Nagalingeswaran; Grinsztejn, Beatriz; Makhema, Joseph; Pilotto, José Henrique; Santos, Breno; Mayer, Kenneth H.; McCauley, Marybeth; Gamble, Theresa; Bumpus, Namandjé N.; Hendrix, Craig W.; Cohen, Myron S.; Eshleman, Susan H.

doi:10.1093/infdis/jit390

Cited by 70 publications

(80 citation statements)

References 9 publications

(12 reference statements)

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“…There are many reasons pre-ART individuals may present as aviraemic. A detailed discussion of this phenomenon is beyond the scope of this article, but undisclosed ART use dispensed from a different facility and transient virological control are just two common causes that may confound the use of VL as a confirmatory tool [19–20]. In these aviraemic individuals, further serological testing is required, but our calculation suggests that this tandem VL-ELISA approach is 10 times more costly than simply confirming every positive RDT with ELISA alone.…”

Section: Resultsmentioning

confidence: 99%

Misdiagnosed HIV infection in pregnant women initiating universal ART in South Africa

Hsiao

Zerbe

Phillips

et al. 2017

Journal of the International AIDS Society

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Introduction: Rapid diagnostic tests (RDTs) are the primary diagnostic tools for HIV used in resource-constrained settings. Without a proper confirmation algorithm, there is concern that false-positive (FP) RDTs could result in misdiagnosis of HIV infection and inappropriate antiretroviral treatment (ART) initiation, but programmatic data on FP are few. Methods: We examined the accuracy of RDT diagnosis among HIV-infected pregnant women attending public sector antenatal services in Cape Town, South Africa. We describe the proportion of women found to have started on ART erroneously due to FP RDT results based on pre-ART viral load (VL) testing and enzyme-linked immunosorbent assay (ELISA). Results: We analysed 952 consecutively enrolled pregnant women diagnosed as HIV infected based on two RDTs per local guideline and found 4.5% (43/952) of pre-ART VL results to be <50 copies/ml. After excluding 6 women who had detectable virus on subsequent VL measurements, ELISA was performed on the 37 remaining women. Of these, 3/952 (0.3%) HIV RDT diagnoses were found to be FP. We estimate that using ELISA to confirm all positive RDTs would cost $1110 (uncertainty interval $381–$5382) to identify one patient erroneously initiated on ART, while it costs $3912 for a lifetime of antiretrovirals with VL monitoring for one person. Conclusions: Compared to the cost of confirming the RDT-based diagnoses, the cost of HIV misdiagnosis is high. While testing programmes based on RDT should strive for constant quality improvement, where resources permit, laboratory confirmation algorithms can play an important role in strengthening the quality of HIV diagnosis in the era of universal ART.

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Section: Resultsmentioning

confidence: 99%

Misdiagnosed HIV infection in pregnant women initiating universal ART in South Africa

Hsiao

Zerbe

Phillips

et al. 2017

Journal of the International AIDS Society

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“…Nondisclosure of HIV status and/or ART use has been identified previously in other settings, including in other HIV prevention trials and in STI clinics. 64–66 Some participants in HPTN 061 also did not agree to HIV testing or did not have samples stored for confirmation of HIV status, and some men with HIV infection were missing CD4 cell count data. Finally, because the current analyses used data collected in a large HIV prevention study, it was not possible to assess all factors or barriers potentially associated with testing.…”

Section: Discussionmentioning

confidence: 99%

Infrequent HIV Testing and Late HIV Diagnosis Are Common Among a Cohort of Black Men Who Have Sex With Men in 6 US Cities

Mannheimer

Wang

Wilton

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Objective US guidelines recommend at least annual HIV testing for those at risk. This analysis assessed frequency and correlates of infrequent HIV testing and late diagnosis among black men who have sex with men (BMSM). Methods HIV testing history was collected at enrollment from participants in HPTN 061, an HIV prevention trial for at-risk US BMSM. Two definitions of late HIV diagnosis were assessed: CD4 cell count <200 cells/mm3 or <350 cells/mm3 at diagnosis. Results HPTN 061 enrolled 1553 BMSM. HIV testing questions were completed at enrollment by 1284 (98.7%) of 1301 participants with no prior HIV diagnosis; 272 (21.2%) reported no HIV test in prior 12 months (infrequent testing); 155 of whom (12.1% of the 1284 with testing data) reported never testing. Infrequent HIV testing was associated with: not seeing a medical provider in the prior 6 months (relative risk [RR]: 1.08, 95% confidence intervals [CI]: 1.03–1.13), being unemployed (RR 1.04, CI: 1.01–1.07), and having high internalized HIV stigma (RR: 1.03, CI: 1.0–1.05). New HIV diagnoses were more likely among infrequent testers compared to men tested in the prior year (18.4% vs. 4.4%; OR: 4.8, 95% CI: 3.2–7.4). Among men with newly diagnosed HIV, 33 (39.3%) had a CD4 cell count <350 cells/mm;3 including 17 (20.2%) with CD4 <200 cells/mm.3 Conclusions Infrequent HIV testing, undiagnosed infection, and late diagnosis were common among BMSM in this study. New HIV diagnoses were more common among infrequent testers, underscoring the need for additional HIV testing and prevention efforts among US BMSM.

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“…6 Although HIV testing is not usually performed for individuals with a prior HIV diagnosis, it may occur in clinical settings or clinical trials to confirm self-reported HIV status or to determine HIV status in individuals who are aware of their HIV infection but choose not to disclose this information. 7–9 …”

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confidence: 99%

Failure to Identify HIV-Infected Individuals in a Clinical Trial Using a Single HIV Rapid Test for Screening

Piwowar‐Manning¹,

Fogel²,

Laeyendecker³

et al. 2014

HIV Clinical Trials

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Background In the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing. Objectives To evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression. Methods Plasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay. Results Of the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test. Conclusions In clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections.

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Undisclosed Antiretroviral Drug Use in a Multinational Clinical Trial (HIV Prevention Trials Network 052)

Cited by 70 publications

References 9 publications

Misdiagnosed HIV infection in pregnant women initiating universal ART in South Africa

Misdiagnosed HIV infection in pregnant women initiating universal ART in South Africa

Infrequent HIV Testing and Late HIV Diagnosis Are Common Among a Cohort of Black Men Who Have Sex With Men in 6 US Cities

Failure to Identify HIV-Infected Individuals in a Clinical Trial Using a Single HIV Rapid Test for Screening

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