Evaluation of Geenius HIV-1/2 Confirmatory Assay for the confirmatory and differential diagnosis of HIV-1/HIV-2 in Japan and reliability of the Geenius Reader in the diagnosis of HIV-2.

BACKGROUND: NEW LAV BLOT I and II (LAV I and LAV II), they were only option for human immunodeficiency virus (HIV) confirmatory test, following HIV screening test using HIV Ag/Ab combination test in Japan. We evaluated the performance of Geenius HIV-1/2 Confirmatory Assay (Geenius), both as a confirmatory test and for differentiation between HIV-1 and HIV-2, in comparison with LAV I and LAV II. METHODS: Eighty-nine HIV-1-positive plasma specimens, one anti-HIV-1 low-titer performance panel, 10 seroconversion panels, and two anti-HIV-1/2 combo performance panels were tested. The results were read with the Geenius Reader and by visual reading. RESULTS: All 89 HIV-1-positive plasma specimens were identified as HIV-1-positive using Geenius; this 100% success rate was superior to that with LAV I (95.5% using WHO criteria, 98.9% using CDC criteria). The HIV-1-positive specimens showed low cross-reactivity with HIV-2 lines in Geenius. The sensitivity of Geenius for HIV-1 detection was the same as or greater than that of LAV I, but less than that of Genscreen HIV Ag-Ab ULT, in our analysis of the commercial performance and seroconversion panels. In contrast, five of the 13 HIV-2-positive specimens that had been identified as HIV-positive untypable by visual reading because of their cross-reactivity to HIV-1 lines were successfully identified by the Geenius Reader as HIV-2-positive with cross-reactivity. CONCLUSIONS: Geenius provides strong performance for HIV confirmatory tests and HIV-1 differentiation tests. However, when visual reading is used, its performance in HIV-2 differentiation is less reliable. Because HIV-2 infection has been sporadically reported in Japan, the use of the Geenius Reader is preferable to ensure more reliable HIV-1/HIV-2 differentiation.

Continuous quality monitoring in the field: an evaluation of the performance of the Fio Deki Reader™ for rapid HIV testing in South Africa.

BACKGROUND: Rapid diagnostic tests (RDTs) are a cornerstone of HIV diagnosis and rely on good quality processing and interpretation, particularly in the era of test and treat. The Deki Reader (Fio Corporation®, Toronto, Ontario, Canada) is a portable device designed specifically for analysing RDTs and was selected for evaluation in South Africa in the context of HIV RDT analysis. METHODS: This study consisted of a laboratory evaluation and two-part field evaluation of the Deki Reader v100, covering two RDT testing algorithms, and an evaluation of the continuous quality monitoring through the Fionet™ web portal. Based on user feedback from the field evaluation, the device underwent hardware and software redesign, and the Deki Reader v200 was evaluated in the laboratory. Ethics approval for this evaluation was obtained from the University of the Witwatersrand Human Research Ethics Committee: M150160. RESULTS: The intra- and inter-device laboratory precision of the Deki Reader v100 were 98.3 and 99.2% respectively, and 99.3 and 100% for the Deki Reader v200. The laboratory concordances compared to standard-of-care reporting were 99.5 and 98.0% for the two respective models, while sensitivity and specificity were 99.5 and 99.4% for the Deki Reader V100 and 100 and 93.1% for the Deki Reader V200 respectively. Screening and confirmatory concordances in the field were 99.3 and 96.5% under algorithm 1 and 99.7 and 100% under algorithm 2. Sensitivity and specificity for the field evaluation were 99.8 and 97.7%. Overall robustness of the device was acceptable and continuous quality monitoring through Fionet™ was feasible. CONCLUSIONS: The Deki Reader provides an option for improved and reliable quality assessment for rapid diagnosis of HIV using RDTs to enhance the quality of healthcare at the point-of-care. However, the introduction of new RDTs and modification of current algorithms necessitates ongoing and agile RDT reader adjustments, which will require cost modelling to ensure sustainability of devices implemented into national HIV programs.

Effectiveness of self-testing kits availability on improving HIV testing frequency for chinese men who have sex with men and their sexual partners: a protocol for a multicenter randomised controlled trial.

INTRODUCTION: HIV epidemic is increasing among men who have sex with men (MSM) in China, yet HIV testing uptake remains low. As an emerging approach, HIV self-testing (HIVST) has the potential to promote HIV testing coverage and frequency in this population. However, evidence of the effectiveness on implementation of HIVST among Chinese MSM and their sexual partners is scarce. METHODS AND ANALYSIS: The randomised controlled trial will be performed in Changsha, Changde, Shaoyang and Yiyang, Hunan province, China, recruiting 184 recent testers (men who had at least one HIV test within the past 2 years) and 26 non-recent testers (men who did not have HIV tests within 2 years or never had an HIV test). Eligible men will be randomly divided 1:1 into two groups: intervention (with free HIVST kits plus site-based HIV testing services) and control (site-based HIV testing services only). Participants in the intervention group will be provided with two free finger-prick-based HIVST kits, and can apply for two to four kits every 3 months for 1 year.Participants in both groups will complete questionnaires via WeChat at five separate times: baseline, third, sixth, ninth and twelfth month. The primary outcome is the mean number of HIV tests for MSM over the 12-month study period. The secondary outcome is the mean number of HIV tests for sexual partners of MSM over the 12-month study period. The tertiary outcomes are the self-reported proportion of consistent condom usage for anal sex, and the numbers of sexual partners during the 12-month study period. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Review Board of Behavioural and Nursing Research in Xiangya School of Nursing of Central South University, China (2018002). Study results will be disseminated through conferences and academic journals. TRIAL REGISTRATION NUMBER: ChiCTR1800015584; Pre-results.

Performance and usability evaluation of the INSTI HIV self-test in Kenya for qualitative detection of antibodies to HIV.

BACKGROUND: HIV testing is often undermined by lack of confidentiality, stigma, shortage of counselors and long distances to testing centers. Self-testing has the potential to circumvent these constraints. OBJECTIVE: To determine the performance and usability characteristics of the INSTI® HIV-1/HIV-2 Self-Test. METHODS: The performance evaluation was a cross sectional study and the usability a mixed methods study. For method comparison, Bioelisa HIV-1+2 Ag/Ab test was used as the reference test. When the test results were discrepant, results from Alere Determine™ HIV-1/2 and First Response HIV-1-2 Antibody tests were used for confirmation of status. RESULTS: Sensitivity of the INSTI HIV Self-Test was 98.99% (95% CI 96.05-99.75%), and specificity 98.15% (95% CI 95.63-99.23%). The concordance was therefore 97.27%. A total of 354 participants took part in the usability study. Of those, 343 (98.00%) found instructions for use easy to follow, 330 (94.29%) found the finger prick device easy to use, 303 (86.57%) were confident while performing the test, 342 (97.71%) felt result interpretation was easy, while 304 (86.86%) declared results within the recommended five minutes. Three hundred and forty two (342, 97.71%) were willing to use the test again while 344 (98.29%) would recommend the kit to a sexual partner. None of the 350 participants quit the process at any stage. Three hundred and eighteen (318, 91.12%) participants felt the test needed no further improvement. All 91 lay users correctly identified cartridges that showed positive, negative and invalid results. Only 31 (34.07%) participants correctly identified weak positive dummy test results. CONCLUSION: The excellent performance and usability characteristics of INSTI HIV-1/HIV-2 self-test make the kit a viable option for HIV self-testing. To improve the identification of weak positive results, the manufacturer should indicate on the IFU that even a faint test spot should be interpreted as positive.

Prospective observational study to evaluate the performance of the BioSure HIV Self-Test in the hands of lay users.

OBJECTIVES: In order to assess whether the BioSure HIV Self-Test could be reliably performed by users at home and to determine whether they were able to perform and correctly interpret the test, we carried out an evaluation study among attendees at a sexual health service. METHODS: A prospective observational study of clinic attendees to determine their ability to follow the instructions, complete the test on themselves and correctly interpret the results. The evaluation included interpretation of three dummy (contrived) devices, chosen at random from a sample of 12 devices, to ensure that a sufficient number of all possible test outcomes were included. RESULTS: Two hundred participants were recruited. 97.0% (95% CI 93.5 to 98.9) conducted the test so as to achieve a valid result. 99.5% correctly identified the test result. Participants correctly interpreted the result of 94.0% (95% CI 91.4 to 95.9) of 586 contrived devices. CONCLUSIONS: The majority of participants were able to follow the instructions and perform the test in order to get a valid result. Interpretation of the test results was good and the majority of participants were able to correctly read the result of their own and contrived tests. The availability of HIV self-tests will provide another option to increase access to testing particularly for those who may not wish or are unable to access clinical services.

Contamination with HIV antibody may be responsible for false positive results in specimens tested on automated platforms running HIV 4th generation assays in a region of high HIV prevalence.

INTRODUCTION: In South Africa where the prevalence of HIV infection is very high, 4th generation HIV antibody/p24 antigen combo immunoassays are the tests of choice for laboratory based screening. Testing is usually performed in clinical pathology laboratories on automated analysers. To investigate the cause of false positive results on 4th generation HIV testing platforms in public sector laboratories, the performance of two automated platforms was compared in a clinical pathology setting, firstly on routine diagnostic specimens and secondly on known sero-negative samples. METHODS: Firstly, 1181 routine diagnostic specimens were sequentially tested on Siemens and Roche automated 4th generation platforms. HIV viral load, western blot and follow up testing were used to determine the true status of inconclusive specimens. Subsequently, known HIV seronegative samples from a single donor were repeatedly tested on both platforms and an analyser was tested for surface contamination with HIV positive serum to identify how suspected specimen contamination could be occurring. RESULTS: Serial testing of diagnostic specimens yielded 163 weakly positive or discordant results. Only 3 of 163 were conclusively shown to indicate true HIV infection. Specimen contamination with HIV antibody was suspected, based on the following evidence: the proportion of positive specimens increased on repeated passage through the analysers; viral loads were low or undetectable and western blots negative or indeterminate on problem specimens; screen negative, 2nd test positive specimens tested positive when reanalysed on the screening assay; follow up specimens (where available) were negative. Similarly, an increasing number of known negative specimens became (repeatedly) sero-positive on serial passage through one of the analysers. Internal and external analyser surfaces were contaminated with HIV serum, evidence that sample splashes occur during testing. CONCLUSIONS: Due to the extreme sensitivity of these assays, contamination with minute amounts of HIV antibody can cause a negative sample to test positive. Better contamination control measures are needed on analysers used in clinical pathology environments, especially in regions where HIV sero-prevalence is high.

Staging of recent HIV-1 infection using Geenius rapid confirmatory assay compared to INNO-LIA, New Lav and Blot 2.2 assays.

BACKGROUND: Besides confirmation of HIV seropositivity, Western Blot (WB) assays play an important role for identification of recent infection based on incomplete antibody reactivity and lack of p31 band. OBJECTIVES: We evaluated the capacities of the Geenius™ HIV1/2 Confirmatory Assay (Bio-Rad), a new generation rapid confirmatory assay based on immune-chromatography and automated reading, for staging of HIV-1 infection. STUDY DESIGN: Sixteen samples collected during early HIV-1 infections (Fiebig stage III-VI) were tested using the Geenius assay, and compared to HIV Blot 2.2 WB assay (MP Diagnostics), New Lav Blot I WB assay (Bio-Rad) and INNO-LIA™ HIV I/II Score Dot Blot assay (Fujirebio). Results obtained with Geenius and INNO LIA in 47 newly diagnosed chronic HIV-1 infections were also compared. RESULTS: The p24 band was less frequently detected in early HIV-1 infections using the Geenius (3/16) compared to the New Lav (15/16, p<0.0001), INNO-LIA (13/16, p=0.0011), and Blot 2.2 (13/16, p=0.0011). Testing samples collected during chronic infection allowed to confirm that p31 band and complete Gag, Pol, Env profiles were less frequently observed using the Geenius assay compared to the INNO LIA assay (p=0.027 for p31, and p=0.0015 for complete profile). CONCLUSIONS: The Geenius assay is a simple and rapid test showing a high sensitivity to detect Env bands and to confirm HIV-1 seropositivity during the early phases of infection. However, this test is less suitable for distinguishing between later stages of acute and chronic infections because of a reduced sensitivity to detect the p31 and p24 bands compared to INNO LIA and New Lav assays.

Infant/child rapid serology tests fail to reliably assess HIV exposure among sick hospitalized infants.

BACKGROUND: The WHO guidelines for infant and child HIV diagnosis recommend the use of maternal serology to determine child exposure status in ages 0-18 months, but suggest that infant serology can reliably be used to determine exposure for those less than 4 months. There is little evidence about the performance of these recommendations among hospitalized sick infants and children. METHODS: Within a clinical trial (NCT02063880) in Kenya, among children 18 months or younger, maternal and child rapid serologic HIV tests were performed in tandem. Dried blood spots were tested using HIV DNA PCR for all children whose mothers were seropositive, irrespective of child serostatus. We characterized the performance of infant/child serology results to detect HIV exposure in three age groups: 0-3, 4-8, and 9-18 months. RESULTS: Among 65 maternal serology positive infants age 0-3 months, 48 (74%), 1 (2%) and 16 (25%) had positive, indeterminate and negative infant serology results, respectively. Twelve (25%), 0 and 4 (25%) of those with positive, indeterminate and negative infant serology results, respectively, were HIV-infected by DNA PCR. Among 71 maternal serology positive infants age 4-8 months, 31 (44%), 8 (11%) and 32 (45%) had positive, indeterminate and negative infant serology results, respectively. Fourteen (45%), 2 (25%) and 7 (22%) infants with positive, indeterminate and negative infant serology results, respectively, were HIV-infected. Among 67 maternal serology positive infants/children age 9-18 months, 40 (60%), 2 (3%) and 25 (37%) had positive, indeterminate and negative infant serology results, respectively. Thirty-six (90%), 2 (100%) and 2 (8%) infants with positive, indeterminate and negative infant serology results, respectively, were HIV-infected. In the 0-3, 4-8 and 9-18 month age groups, use of maternal serology to define HIV exposure identified 33% [95% confidence interval (CI) 10-65%], 44% (95% CI 20-70%) and 5% (95% CI 0.1-18%) more HIV infections, respectively. CONCLUSION: Maternal serology should preferentially be used for screening among hospitalized infants of all ages to improve early diagnosis of children with HIV.

Performance characteristics of an antibody-based multiplex kit for determining recent HIV-1 infection.

The availability of reliable laboratory methods for determining recent HIV infection is vital for accurate estimation of population-based incidence. The mean duration of recent infection (MDRI) and false recent rate (FRR) are critical parameters for HIV incidence assays, as they impact HIV incidence estimates and provide a measure of assay performance. The HIV-1 Multiplex assay is an in-house developed, magnetic bead-based assay that measures virus-specific antibody levels and avidity to multiple analytes. To ensure quality control and to facilitate transfer of the assay to external laboratories or testing facilities, the in-house assay has been adapted and produced in kit form. Here, we describe the performance characteristics of the multiplex kit and demonstrate the stability of the kit components over a one-year period. Two statistical methods were employed to estimate the MDRI of the individual analytes and five different algorithms, combining multiple analyte values. The MDRI estimates for the individual analytes and five algorithms were all between 200 and 300 days post-seroconversion, with no notable difference between the two statistical approaches. All five algorithms exhibited a 0% FRR with specimens from long-term, subtype B HIV-1-infected individuals. The assay parameters described in this study provide the necessary tools to implement the HIV-1 multiplex assay and improves the utility of the assay for field use.

Novel pH sensing semiconductor for point-of-care detection of HIV-1 viremia.

The timely detection of viremia in HIV-infected patients receiving antiviral treatment is key to ensuring effective therapy and preventing the emergence of drug resistance. In high HIV burden settings, the cost and complexity of diagnostics limit their availability. We have developed a novel complementary metal-oxide semiconductor (CMOS) chip based, pH-mediated, point-of-care HIV-1 viral load monitoring assay that simultaneously amplifies and detects HIV-1 RNA. A novel low-buffer HIV-1 pH-LAMP (loop-mediated isothermal amplification) assay was optimised and incorporated into a pH sensitive CMOS chip. Screening of 991 clinical samples (164 on the chip) yielded a sensitivity of 95% (in vitro) and 88.8% (on-chip) at >1000 RNA copies/reaction across a broad spectrum of HIV-1 viral clades. Median time to detection was 20.8 minutes in samples with >1000 copies RNA. The sensitivity, specificity and reproducibility are close to that required to produce a point-of-care device which would be of benefit in resource poor regions, and could be performed on an USB stick or similar low power device.

Availability and Use of HIV Monitoring and Early Infant Diagnosis Technologies in WHO Member States in 2011-2013: Analysis of Annual Surveys at the Facility Level.

BACKGROUND: The Joint United Nations Programme on HIV and AIDS (UNAIDS) 90-90-90 targets have reinforced the importance of functioning laboratory services to ensure prompt diagnosis and to assess treatment efficacy. We surveyed the availability and utilization of technologies for HIV treatment monitoring and early infant diagnosis (EID) in World Health Organization (WHO) Member States. METHODS AND FINDINGS: The survey questionnaire included 14 structured questions focusing on HIV testing, cluster of differentiation 4 (CD4) testing, HIV viral load (VL) testing, and EID and was administered annually from 2012 to 2014 through WHO country offices, with each survey covering the previous 12-mo period. Across 127 targeted countries, survey response rates were 60% in 2012, 67% in 2013, and 78% in 2014. There were encouraging trends towards increased procurement of CD4 and VL/EID instruments in reporting countries. Globally, the capacity of available CD4 instruments was sufficient to meet the demand of all people living with HIV/AIDS (PLWHA), irrespective of treatment status (4.62 theoretical tests per PLWHA in 2013 [median 7.33; interquartile range (IQR) 3.44-17.75; median absolute deviation (MAD) 4.35]). The capacity of VL instruments was inadequate to cover all PLWHA in many reporting countries (0.44 tests per PLWHA in 2013 [median 0.90; IQR 0.30-2.40; MAD 0.74]). Of concern, only 13.7% of existing CD4 capacity (median 4.3%; IQR 1.1%-12.1%; MAD 3.8%) and only 36.5% of existing VL capacity (median 9.4%; IQR 2.3%-28.9%; MAD 8.2%) was being utilized across reporting countries in 2013. By the end of 2013, 7.4% of all CD4 instruments (5.8% CD4 conventional instruments and 11.0% of CD4 point of care [POC]) and 10% of VL/EID instruments were reportedly not in use because of lack of reagents, the equipment not being installed or deployed, maintenance, and staff training requirements. Major limitations of this survey included under-reporting and/or incomplete reporting in some national programmes and noncoverage of the private sector. CONCLUSION: This is the first attempt to comprehensively gather information on HIV testing technology coverage in WHO Member States. The survey results suggest that major operational changes will need to be implemented, particularly in low- and middle-income countries, if the 90-90-90 targets are to be met.

A Finger-Stick Whole-Blood HIV Self-Test as an HIV Screening Tool Adapted to the General Public.

BACKGROUND: In 2013, the French Health Authority approved the use of HIV self-tests in pharmacies for the general public. This screening tool will allow an increase in the number of screenings and a reduction in the delay between infection and diagnosis, thus reducing the risk of further infections. We previously compared 5 HIV-self test candidates (4 oral fluid and one whole blood) and demonstrated that the whole blood HIV test exhibited the optimal level of performance (sensitivity/specificity). We studied the practicability of an easy-to-use finger-stick whole blood HIV self-test "autotest VIH®", when used in the general public. METHODS AND MATERIALS: This multicenter cross-sectional study involved 411 participants from the Parisian region (AIDES and HF association) between April and July 2014 and was divided into 2 separate studies: one evaluating the capability of participants to obtain an interpretable result using only the information notice, and a second evaluating the interpretation of test results, using a provided chart. RESULTS: A total of 411 consenting participants, 264 in the first study and 147 in the second, were included. All participants were over 18 years of age. In the first study, 99.2% of the 264 participants correctly administered the auto-test, and 21.2% needed, upon their request, telephone assistance. Ninety-two percent of participants responded that the test was easy/very easy to perform, and 93.5% did not find any difficulty obtaining a sufficient good quantity of blood. In the second study, 98.1% of the 147 participants correctly interpreted the results. The reading/interpretation errors concerned the negative (2.1%) or the indeterminate (3.3%) auto-tests. CONCLUSIONS: The success rate of handling and interpretation of this self-test is very satisfactory, demonstrating its potential for use by the general public and its utility to increase the number of opportunities to detect HIV patients.

Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria.

OBJECTIVE: To determine the laboratory-based performance and operational characteristics of three dual rapid diagnostic tests (RDTs) for testing HIV and syphilis. METHODS: Three dual RDTs (SD Bioline, Chembio, and MedMira) were evaluated using 1514 serum specimens archived at laboratories or collected from clinics in China and Nigeria to determine sensitivity and specificity, with 95% confidence intervals. Concordance of testing results read by two technicians, stability of testing results read at two time points, and test operation characteristics were also assessed. RESULTS: All three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%-99.6% for HIV and 98.3%-99.0% for syphilis, and a combined specificity ranging from 97.9%-99.0% for HIV and 97.2%-99.6% for syphilis. Concordance of testing results between two technicians and stability of testing results read within and one hour past the recommended reading period showed excellent agreement, with Kappa greater than or equal to 0.98. CONCLUSIONS: All the tests were found to be very or fairly easy to use and easy to interpret the results. Further evaluations of these dual RDTs with whole blood in field settings, and more studies on the implication of introduction of these tests in HIV and syphilis control programs are needed.

The diagnostic performance evaluation of the SD BIOLINE HIV/syphilis Duo rapid test in southern Ethiopia: a cross-sectional study.

OBJECTIVE: To determine the diagnostic performance of the SD BIOLINE HIV/syphilis Duo rapid test. DESIGN: A hospital-based cross-sectional study. SETTING: This evaluation was conducted at one of the largest hospitals in southern Ethiopia. PARTICIPANTS: Serum samples obtained from clients attending the antiretroviral therapy and voluntary counselling and testing centres were used. Sera were originally collected for the purpose of investigating syphilis epidemiology. The performance of the test to detect HIV was evaluated using 400 sera (200 HIV positives and 200 HIV negatives). Also, its performance to detect syphilis was evaluated using 85 syphilis positive and 100 syphilis negative serum samples. Individuals <15 years of age or syphilis treated or those with ≤50 cells/µL CD4 cell count were originally excluded. OUTCOME MEASURES: HIV screening was carried out according to the national rapid diagnostic testing (RDT) algorithm: Shenghai Kehua Bioengineering (KHB) test kit as a screening test, followed by the HIV1/2 STAT-PAK assay if positive. Where the result of the STAT-PAK is discordant with KHB, Unigold HIV is used as a tiebreaker to determine the result. We also used ELISA to resolve discordant HIV results. Syphilis serostatus was determined using the Treponema pallidum haemagglutination assay (TPHA). RESULTS: The respective sensitivity, specificity, positive predictive value and negative predictive value of the SD BIOLINE HIV/syphilis Duo test were 100, 99.5, 99.5 and 100% for HIV and 97.6, 96, 95.4 and 98% for syphilis testing, respectively. In reference to TPHA, the test kit reported 4 false positives and 2 false negative results for syphilis. The κ values were 0.99 for HIV testing and 0.94 for syphilis testing. CONCLUSIONS: The excellent performance of the SD BIOLINE HIV/syphilis Duo test to detect HIV as well as syphilis facilitates the integration of syphilis testing and treatment to the already established HIV prevention programme, ultimately contributing to the dual HIV and syphilis elimination goal.

Black men who have sex with men, sexual risk-taking, and willingness to use rapid home HIV tests.

The availability of rapid home-based HIV testing (RHT) in the USA has provided us with a valuable, new option in our efforts to identify more people living with HIV and to do so sooner. Furthermore, it is possible that RHT will be or is currently being used as a means of learning one's own and one's partner's HIV status prior to engaging in condomless intercourse. Data regarding knowledge and willingness to use RHT, however, is very limited. In particular, no studies have investigated RHT use among Black men who have sex with men (BMSM). Understanding RHT use among BMSM is critical as we have observed alarming rates of HIV prevalence among this group, and RHT may provide an opportunity to slow HIV transmission among BMSM. In order to better understand RHT, we assessed knowledge, willingness to use and actual use of RHT, HIV testing history, substance use, and sexual risk-taking among 387 HIV-negative BMSM and 157 HIV-positive BMSM attending a community event in the southeastern USA. We used generalized linear modeling to assess factors associated with their willingness to use RHT. Although familiarity with the availability of RHT was somewhat limited among these men, a substantial portion of BMSM did report an interest in using RHT, including with their sex partners. Among HIV-negative BMSM, however, we found a negative relationship between willingness to use RHT and sexual risk-taking, i.e., higher numbers of condomless anal sex acts were associated with a reduction in willingness to use RHT. It appears that men who report the greatest risk-taking for HIV are least interested in RHT. Future research should focus on better understanding concerns regarding RHT among at-risk HIV-negative men and should investigate the usefulness of using RHT as a HIV prevention method.

Evaluation of the SD Bioline HIV/Syphilis Duo assay at a rural health center in Southwestern Uganda.

BACKGROUND: Point-of-care tests have the capacity to improve healthcare delivery by reducing costs and delay associated with care. A novel point-of-care immunochromatographic test for dual diagnosis of both HIV and syphilis by detecting IgG, IgM and IgA antibodies to HIV, and specific and recombinant Treponema pallidum antigens has recently been developed, but has not been evaluated in rural field settings. We evaluated the performance of the SD Bioline Syphilis/HIV Duo (Duo) assay at a healthcare center in rural Uganda. METHODS: A convenience sample of pregnant women attending Kinoni Health Centre IV from March to May, 2013 was enrolled. Venous blood was collected and centrifuged for plasma isolation. Samples were tested with the Duo assay and compared with the Treponema pallidum hemaglutination assay and paired HIV rapid antibody tests as the reference standards. The ease of use and time required for the Duo assay were also assessed by laboratory technicians. RESULTS: Two hundred twenty women were enrolled with a mean age of 25.00 years (SD 5.41). The sensitivity and specificity of the Duo assay were 100% (95% CI 79.0 - 100%) and 100% (95% CI 97.6 - 100.0) respectively, for syphilis, and, 100% (75.9 - 100%) and 99.5% (96.8 - 99.9%) respectively, for HIV. The duo kit was found to be faster and easier to use than the current HIV and syphilis testing techniques. CONCLUSION: The sensitivity and specificity of the SD Bioline HIV/Syphilis Duo test were excellent in a field setting in Uganda. The Duo assay should be further evaluated in alternate populations and with point-of-care specimens (e.g. whole blood from finger stick specimens), but shows promise as a tool for improved HIV and syphilis surveillance, diagnosis, and treatment in field settings.

Marketing the HIV test to MSM: ethnic differences in preferred venues and sources.

Lack of awareness of HIV status is associated with an increased likelihood of HIV transmission. We surveyed 633 men who have sex with men (MSM) from diverse ethnic groups recruited from a variety of community venues in a U.S. Midwestern city with rising HIV infection rates. Our first aim was to describe patterns of sexual risk, annual HIV testing frequency, and venues where information about HIV and HIV testing could be disseminated to inner-city MSM. Our second aim was to identify preferred sources to receive information about HIV testing and determine whether these preferences differed by ethnic background. Results indicated that despite similar proportions of high-sexual risk behaviors, compared with African American and Latino MSM, smaller proportions of non-Hispanic White MSM had received an HIV test in the last 12 months. Despite ethnic differences in health care access, a physician's office was the most common HIV testing site. Overall, a majority conveyed a preference to see advertisements in mainstream media outlets. However, when preferences were stratified by ethnicity, African American MSM were the least likely to prefer receiving information from mainstream media and conveyed a stronger preference to receive information from authority figures than non-Hispanic White and Hispanic MSM.