Background Point-of-care (POC) rapid HIV tests have sensitivity during the “window period” comparable only to earliest generation EIAs. To date, it is unclear whether any POC test performs significantly better than others. Objective Compare abilities of POC tests to detect early infection in real time. Study Design Men who have sex with men (MSM) were recruited into a prospective, cross-sectional study at two HIV testing sites and a research clinic. Procedures compared four POC tests: one performed on oral fluids and three on fingerstick whole blood specimens. Specimens from participants with negative POC results were tested by EIA and pooled nucleic acid amplification testing (NAAT). McNemar’s exact tests compared numbers of HIV-infected participants detected. Results Between February 2010 and May 2013, 104 men tested HIV-positive during 2479 visits. Eighty-two participants had concordant reactive POC results, 3 participants had concordant non-reactive POC tests but reactive EIAs, and 8 participants had acute infection. Of 12 participants with discordant POC results, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids identified fewer infections than OraQuick performed on fingerstick (p=.005), Uni-Gold Recombigen HIV Test (p=.01), and Determine HIV-1/2 Ag/Ab Combo (p=.005). Conclusions These data confirm that oral fluid POC testing detects fewer infections than other methods and is best reserved for circumstances precluding fingerstick or venipuncture. Regardless of specimen type, POC tests failed to identify many HIV-infected MSM in Seattle. In populations with high HIV incidence, the currently approved POC antibody tests are inadequate unless supplemented with p24 antigen tests or NAAT.

Background Pilot studies showed lower tenofovir plasma concentrations during PrEP use among transgender women (TGW) using feminizing hormones compared with cisgender men (CGM). Tenofovir diphosphate (TFV-DP) concentrations in TGW and transgender men (TGM) using gender affirming hormones and on directly observed dosing of PrEP have not been studied. Methods TGM and TGW on at least 6 months of stable sex hormone therapy containing testosterone or estradiol (respectively) were enrolled in a 4-week study of directly observed dosing of daily oral co-formulated emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). TFV-DP in dried blood spots and sex hormones in serum were measured at weekly intervals. TFV-DP was compared with 2 and 4 week samples from DOT-DBS (NCT02022657). Results From May 2017 to June 2018, 24 TGM and 24 TGW were enrolled; one TGM withdrew prior to 4 weeks of PrEP. Ethnicity (non-exclusive) was 27 (57%) white, 10 (21%) black, and 15 (32%) latinx. The median age was 31 (IQR 28 to 40). Of TGW, 9 (38%) took spironolactone in addition to estradiol. Testosterone (total and free) and estradiol concentrations were comparable before and after 4 weeks of PrEP use in TGM and TGW respectively. Historical controls comprised of 17 cisgender women (CGW) and 15 CGM. TFV-DP concentrations at week 4 were comparable between TGW and TGM (mean difference -6%; 95% CI -21% to 12%; P=0.47), comparable between TGW and CGM (mean difference -12%; 95% CI -27% to 7%; P=0.21) and were lower among TGM compared with CGW (mean difference -23%; 95% CI -36% to -7%; P=0.007). All persons in all groups were projected to reach the TFV-DP threshold that has been associated with high protection from HIV. There were no associations between serum estradiol or free testosterone concentrations and TFV-DP. Conclusion CGM, TGM, and TGW had comparable TFV-DP concentrations in DBS after 4 weeks of directly observed daily FTC/TDF PrEP use. Serum hormone concentrations were not affected by FTC/TDF PrEP use.

Background and Objective The Rapid Test Study was a real-time comparison of point-of-care (POC) HIV tests to determine their abilities to detect early HIV infection. Study Design Men and transgender persons reporting sex with men in the prior year were recruited at the Public Health – Seattle & King County STD Clinic, Gay City Health Project, and University of Washington Primary Infection Clinic. Study tests included the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids and tests performed on fingerstick whole blood specimens including OraQuick, Uni-Gold Recombigen HIV Test, Determine HIV-1/2 Ag/Ab Combo, and INSTI HIV-1 Rapid Antibody Test. Specimens from subjects with negative results were sent for EIA and nucleic acid amplification testing. McNemar's exact tests compared the numbers of HIV-infected subjects detected. Results Between February 2010 and August 2014, there were 3438 study visits. Twenty-four subjects had discordant POC results with at least one reactive and one non-reactive test, including one subject with a reactive Determine p24 antigen. OraQuick performed on oral fluids identified fewer persons compared to all fingerstick tests. OraQuick performed on fingerstick whole blood detected fewer persons compared to the Determine Combo antibody component (p=.008) and Combo overall (p=.004), and there was a trend when compared to INSTI (p=.06). The Determine Combo specificity was 98.99%. Conclusions As reported by others, Determine Combo underperforms compared to laboratory-based testing, but it did detect one acute infection. If these results are validated, the specificity of Determine Combo may limit its usefulness in populations with lower HIV incidence.

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.