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Point-of-care (POC) nucleic acid tests (NATs) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis or antiretroviral therapy (ART). POC NATs have not yet been evaluated in the US.From June 2018-March 2019, we conducted a cross-sectional evaluation of the Simple Amplification-Based Assay version II (SAMBA II) POC NAT. People with HIV (PWH) and persons testing for HIV were tested with the SAMBA II qualitative (Qual) whole blood (WB) test. From April-September 2019, the Qual test was used on persons who were ART-naive, and SAMBA II Semi-quantitative (Semi-Q) WB was used with ART-experienced PWH. Both were performed on unprocessed venipuncture (VP) and, when indicated by protocol, fingerstick (FS) WB and plasma. SAMBA results were compared with Abbott RealTime HIV-1 polymerase chain reaction results on plasma. We calculated sensitivity, specificity, and concordance between tests.SAMBA was used in 330 visits among 280 participants: 202 (61.2%) visits from PWH, and 128 (38.8%) from HIV-negative persons. Qual test sensitivity with ART-naive participants was 91.4% [32/35, 95% confidence interval (CI): 77.6% to 97.0%] using VP WB and 100% (27/27, 95% CI: 87.5% to 100%) using FS WB. Specificity was 100% using both specimen types. Concordance between the gold standard and Semi-Q at 1000 copies/mL among PWH on ART was 97.7% (86/88, 95% CI: 92.1% to 99.4%) and 100% (30/30, 95% CI: 88.7% to 100%) using VP and FS WB, respectively.The SAMBA II POC NATs showed high sensitivity, specificity, and concordance with the gold standard assay, indicating its potential use in diagnostics and monitoring. Future work will evaluate POC NAT implementation in the US.

We conducted a study comparing the OraQuickADVANCE Rapid HIV-1/2 Antibody Test, Uni-Gold Recombigen HIV Test, Determine HIV 1/2 Ag/Ab Combo, EIA, and pooled nucleic acid amplification testing (NAAT). Men who have sex with men rated tests based on specimen collection method and trust in each test. Among 490 subjects, OraQuick performed on oral fluids ranked highest for specimen collection method but lowest on trust; NAAT scored highest on trust. Among a subset of these subjects, 46% would opt for NAAT if choosing one test. Strategies are needed to increase HIV testing that is accurate and consistent with client preferences.

Serosorting is the practice of preferentially having sex with partners of concordant HIV status or of selectively using condoms with HIV-discordant partners.We evaluated the epidemiology of serosorting among men who have sex with men (MSM) seen in a sexually transmitted disease clinic, Seattle, WA, 2001-2007, and defined the percentage of visits during which MSM tested HIV positive based on whether they reported nonconcordant unprotected anal intercourse (UAI), UAI only with partners thought to be HIV negative (serosorters), no UAI, or no anal intercourse.Men reported serosorting during 3295 (26%) of 12,449 visits. From 2001 to 2007, the proportion of visits during which men reported serosorting increased (P = 0.02); this change was greater among HIV-infected MSM than among HIV-uninfected MSM. Among men who tested HIV negative in the preceding year, HIV tests were positive in 49 (3.5%) of 1386 who reported nonconcordant UAI, 40 (2.6%) of 1526 serosorters, 28 (1.5%) of 1827 who had only protected anal intercourse, and 0 of 410 who had no anal intercourse (P0.0001); 32% of new HIV infections occurred in serosorters. The prevalence of HIV was higher among serosorters tested during 2004-2007 than among those tested during 2001-2003 (0.85% vs. 3.2%, P = 0.03).Serosorting offers MSM limited protection from HIV.

Although many individuals who acquire HIV are symptomatic, primary HIV infection (PHI) is infrequently diagnosed, even after the integration of RNA testing into HIV screening programs. Until more individuals with PHI seek evaluation, the public health impact of RNA testing is likely to be small.To describe knowledge of PHI and attitudes toward health care-seeking behavior for symptoms consistent with PHI in men who have sex with men (MSM).Between April 2004 and March 2005, HIV-negative MSM attending the Public Health-Seattle and King County sexually transmitted disease (STD) clinic completed an anonymous, self-administered, written questionnaire.Ninety-six (64%) of 150 subjects namedor =1 symptom associated with PHI. Only 18 (39%) of 46 men who knew PHI could resemble influenza would seek care for flu-like symptoms. Fifteen (65%) of 23 men reporting a week-long febrile illness with rash in the preceding year sought health care, but only 7 (30%) were tested for HIV.Although most subjects identified some symptoms of PHI, relatively few would seek care for such symptoms. MSM seeking attention for febrile illnesses were infrequently tested for HIV. Increased symptom recognition, health care-seeking behavior, and routine HIV RNA testing are needed if PHI screening programs are to have meaningful impact.