Tensor-structured decomposition improves systems serology analysis.

Systems serology provides a broad view of humoral immunity by profiling both the antigen-binding and Fc properties of antibodies. These studies contain structured biophysical profiling across disease-relevant antigen targets, alongside additional measurements made for single antigens or in an antigen-generic manner. Identifying patterns in these measurements helps guide vaccine and therapeutic antibody development, improve our understanding of diseases, and discover conserved regulatory mechanisms. Here, we report that coupled matrix-tensor factorization (CMTF) can reduce these data into consistent patterns by recognizing the intrinsic structure of these data. We use measurements from two previous studies of HIV- and SARS-CoV-2-infected subjects as examples. CMTF outperforms standard methods like principal components analysis in the extent of data reduction while maintaining equivalent prediction of immune functional responses and disease status. Under CMTF, model interpretation improves through effective data reduction, separation of the Fc and antigen-binding effects, and recognition of consistent patterns across individual measurements. Data reduction also helps make prediction models more replicable. Therefore, we propose that CMTF is an effective general strategy for data exploration in systems serology.

Deep learning of HIV field-based rapid tests.

Although deep learning algorithms show increasing promise for disease diagnosis, their use with rapid diagnostic tests performed in the field has not been extensively tested. Here we use deep learning to classify images of rapid human immunodeficiency virus (HIV) tests acquired in rural South Africa. Using newly developed image capture protocols with the Samsung SM-P585 tablet, 60 fieldworkers routinely collected images of HIV lateral flow tests. From a library of 11,374 images, deep learning algorithms were trained to classify tests as positive or negative. A pilot field study of the algorithms deployed as a mobile application demonstrated high levels of sensitivity (97.8%) and specificity (100%) compared with traditional visual interpretation by humans-experienced nurses and newly trained community health worker staff-and reduced the number of false positives and false negatives. Our findings lay the foundations for a new paradigm of deep learning-enabled diagnostics in low- and middle-income countries, termed REASSURED diagnostics1, an acronym for real-time connectivity, ease of specimen collection, affordable, sensitive, specific, user-friendly, rapid, equipment-free and deliverable. Such diagnostics have the potential to provide a platform for workforce training, quality assurance, decision support and mobile connectivity to inform disease control strategies, strengthen healthcare system efficiency and improve patient outcomes and outbreak management in emerging infections.

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.

A method to alleviate false-positive results of the Elecsys HIV combi PT assay.

To explore the effects of urea dissociation on reducing false-positive results of  the Elecsys HIV combi PT assay. A retrospective analysis was used to evaluate the false-positive rate of the Elecsys HIV combi PT assay. Six false-positive sera, six positive sera and six sera from patients with early HIV infection were collected. Dissociation was performed using 1 mol/L, 2 mol/L, 4 mol/L, 6 mol/L, or 8 mol/L urea, and HIV screening assay were then detected to select the appropriate concentration of urea dissociation. Next, 55 false-positive sera and 15 sera from early HIV infection were used to verify the best concentration of urea to achieve dissociation. Retrospective analysis showed that the COI of the Elecsys HIV combi PT assay in false-positive sera ranged from 1.0 to 200.0, and approximately 97.01%(227/234) of false-positive sera were in the range of 1.0-15.0. The avidity index (AI) in positive and false-positive sera decreased as the urea dissociation concentration increased. When the dissociation concentration was 6 mol/L, the AI of false-positive serum was between 0.0234 and 0.2567, and the AI of early HIV infection sera was between 0.4325 and 0.5017. The difference in AI between false-positive and positive samples was significant. When negativity was defined as an AI of less than 0.3970, the sensitivity and specificity were 100.0% and 100.0%, respectively. Urea-mediated dissociation could significantly reduce the false-positive rate of the Elecsys HIV combi PT assay with a low COI. Our findings provided a reference for distinguishing positive and false-positive of the Elecsys HIV combi PT assay.

Adolescents' and caregivers' perceptions of caregiver-provided testing and HIV self-testing using oral mucosal transudate tests in Zimbabwe: a short report.

Uptake of HIV testing remains lower among children and adolescents compared to adults. This study explored adolescents' perceptions of HIV self-testing (HIVST) and caregivers' perceptions of testing their children using an oral mucosal transudate (OMT) rapid HIV test (caregiver-provided testing). We conducted 31 interviews with adolescents aged 16-18 years and caregivers of children aged 2-15 years who received an OMT test. Participants described barriers to HIV testing including lack of privacy and the potential for discrimination by community members towards children and adolescents who received an HIV test. Most participants felt caregiver-provided testing and HIVST could address these barriers through increased privacy. Some participants expressed worry about their ability to correctly perform the OMT and their anxious reactions to a positive result. Counseling and assistance from health care workers were viewed as ways to alleviate concerns. Concerns shaped participants' preferences for facility-based HIVST and caregiver-provided testing. Findings demonstrate HIVST performed by adolescents and caregiver-provided testing could increase the uptake of HIV testing. Concerns related to being able to test correctly and the availability of post-test counseling must be addressed in any future delivery mechanisms.

Difference in HIV prevalence by testing venue: results from population level survey in Uganda.

Growing demand for use of Health Facility (HF) HIV testing data, in addition to other testing data to obtain district level HIV prevalence requires understanding the comparability of these various sources. We analysed the 2011 Uganda AIDS indicator survey data to assess: the proportion of people tested for HIV across Uganda by venue of testing; HIV prevalence ratio for those tested in a HF compared to those tested in community setting; [Katz, D., Baptista, J., Azen, S. P., & Pike, M. C. (1978). Obtaining confidence intervals for the risk ratio in cohort studies. International Biometric Society, 34(3), 469-474. https://doi.org/10.2307/2530610] and factors associated with HIV positivity in each subgroup. Of the 11,685 individuals, 8978 (77.1%) had ever tested for HIV in a HF. Fifty nine per cent tested in a HF in the 12 months preceding the survey (female: 5507, 72.7% versus male: 1413, 34.9%). HIV prevalence ratio was 1.8 times among those tested in a HF compared to those tested at community setting (10.9% [95% CI: 10.0-11.7] versus 6.2% [95% CI: 5.4-7.0]). Among HF testers, older age group, previously married and having no sexual partner was associated with significantly higher HIV prevalence. Using facility testing data for planning and decisions should take into consideration the elevated and varying HIV prevalence among individuals accessing HIV testing services at HFs as well as differences in their social-demographic characteristics.

Longitudinal Viral Load Monitoring Using Home-Collected Dried Blood Spot Specimens of MSM Living with HIV: Results from a Feasibility Pilot Study.

Novel viral load monitoring strategies are needed to help individuals maintain an undetectable viral load (UVL). In 2018, U.S. MSM living with HIV with a past detectable VL received a dried blood spot (DBS) kit at baseline and 3-month follow-up and returned specimens to a research laboratory. Of 56 consenting participants, 91% returned specimens at baseline and 77% at 3-month follow-up; 74% who returned two specimens had UVL at both time points. At-home DBS collection and longitudinal VL monitoring is feasible among U.S. MSM with fluctuating viral load. This complementary approach to clinical care could improve viral suppression maintenance.

RESUMEN: Se necesitan nuevas estrategias para evaluar los niveles de la carga viral para ayudar a las personas viviendo con VIH a mantener una carga viral indetectable (CVI). En 2018, hombres viviendo con VIH, que reportaron sexo con hombres y una carga viral detectable, recibieron dos paquetes de materiales para colectar muestras de sangre seca después de completar una evaluación basal y después de tres meses de seguimiento. Participantes devolvieron las muestras de sangre seca a un laboratorio. De 56 participantes que dieron su consentimiento a participar en el estudio, el 91% devolvió una muestra de sangre seca al inicio del estudio y el 77% a los 3 meses de seguimiento. Además, el 74% que devolvió dos muestras de sangre seca tenían CVI en ambos puntos de tiempo. La colección de sangre seca en el hogar y el monitoreo longitudinal de la carga viral de VIH es factible entre los hombres viviendo con el VIH y que tienen sexo con hombres. Los resultados de este estudio pueden proporcionar un enfoque complementario a la atención clínica para mejorar la supresión viral del VIH.

Partner Notification Services for Patients with Established and New HIV Infection Leads to Diagnosis and Linkage of HIV-Positive Partners.

Offering people living with HIV the opportunity to refer partners for HIV testing is an efficient way of identifying new HIV diagnoses. This report describes the outcomes of physician-led partner services at an urban academic center. Patients with HIV VL > 1000 copies/mL in both inpatient and outpatient settings were offered partner notification services (PNS). Of referred partners, 8.7% had a new diagnosis of HIV. New HIV+ partners were as likely to be referred by patients with existing HIV diagnoses as new diagnoses (p = 0.61), and as likely to be referred by patients interviewed while hospitalized as those in the clinic (p = 0.61).

Three-year outcome of rapid HIV testing at public health centers in Seoul, Republic of Korea: a short report.

Before 2014, the only test used for anonymous voluntary human immunodeficiency virus (HIV) screening at public health centers (PHCs) in the Republic of Korea was an enzyme-linked immunosorbent assay (ELISA), which takes around 3 days to obtain results. In 2014, to encourage voluntary anonymous HIV screening tests, the Seoul Metropolitan Government adopted a rapid HIV screening test at PHCs. The rapid HIV screening test was introduced at four PHCs in 2014 and all 25 PHCs after 2015. We compared the numbers of HIV screening tests and confirmed positive individuals before and after introduction of the rapid HIV screening test. In 2012-2013, before the introduction of rapid HIV screening test, an average of 330 HIV screening tests were performed monthly (355 in 2012 and 305 in 2013) and 69 individuals were confirmed to have HIV in 2012 and 93 in 2013. After the introduction of the rapid HIV screening test, anonymous voluntary HIV screening increased to a monthly average of 447 tests in 2014, 2099 in 2015, and 2409 in 2016. These identified 38 new cases in 2014, 116 in 2015, and 143 in 2016. Adoption of the rapid HIV screening test has increased the number of HIV screening tests and confirmed cases.

Acceptability of a tablet-based application to support early HIV testing among men in rural KwaZulu-Natal, South Africa: a mixed method study.

Uptake of HIV testing remains low among men in South Africa. As part of a trial, we assessed the acceptability of a theoretically derived and adapted tablet-based-application (EPIC-HIV1) in rural South Africa. We conducted 20 in-depth interviews with men aged ≥18 years and offered a tablet-based survey to all men aged ≥15 years who received EPIC-HIV1 (Sep-Dec 2018). We conducted a descriptive analysis of the survey and used Self-Determination Theory (SDT) to guide our thematic analysis. A total of 232/307 (75%) completed the survey, 55% of whom were aged 15-24 years. 96%[ CI: 92.8-98.2%; n = 223] found EPIC-HIV1 acceptable and 77% [95% CI: 71.8-82.6%; n = 179] found it user-friendly. 222 [96%] reported that EPIC-HIV1 motivated them to test; 83% (192/232) tested for HIV, of which 33% (64/192) were first time testers. Those who did not consent (n = 40) were more likely to have had an HIV-positive test result. Participants reported that the app boosted their confidence to test. However, they were unsure that the app would help them overcome barriers to test in local clinics. Given reach and usability, an adapted SDT male-tailored app was found to be acceptable and could encourage positive health-seeking behavioural change among men.

Acceptability of HIV self-testing is low among men who have sex with men who have not tested for HIV: a study with respondent-driven sampling in Brazil.

BACKGROUND: Brazil has many people living with HIV (PLWH) who are unaware of their serostatus. The public health system has recently added HIV self-testing (HIVST) for key populations such as men who have sex with men (MSM). This study estimates HIVST acceptability among Brazilian MSM and explores factors associated with acceptability among MSM who have never tested for HIV or who had a previous negative result. METHODS: Respondent-driven sampling (RDS) was used to recruit 4176 MSM in 12 Brazilian cities in 2016 to this biological and behavioral surveillance study. We excluded from this analysis all MSM who were aware of their positive HIV serostatus. Descriptive, bivariate and multivariate analyses were conducted. Overall proportions were weighted with Gile's estimator in RDS Analyst software and 95% confidence intervals were calculated. The analyses of HIVST acceptability were stratified by prior HIV testing (never or one or more times). RESULTS: For this analysis, 3605 MSM were included. The acceptability of HIVST was 49.1%, lower among those who had never tested for HIV (42.7%) compared to those who had a previous HIV negative test (50.1%). In the subgroup of MSM who had never tested for HIV, those who reported discrimination or who had a medical appointment in the last 12 months reported higher HIVST acceptability. Among MSM who had a previous negative HIV test, only those reporting condomless receptive anal sex reported higher HIVST acceptability. In addition, we observed that high levels of knowledge of HIV/AIDS, taking part in lesbian, gay, bisexual, and transgender nongovernmental organizations (LGBT-NGO), or complete secondary or incomplete higher undergraduate education reported higher acceptability. CONCLUSIONS: The acceptability of HIVST was low among MSM, especially among those who never tested for HIV. Given access to HIVST in Brazil, we point to the need for programs that enhance promotion of testing addressed to MSM.

Field evaluation of capillary blood and oral-fluid HIV self-tests in the Democratic Republic of the Congo.

BACKGROUND: HIV self-testing (HIVST) is an additional approach to increasing uptake of HIV testing services. The practicability and accuracy of and the preference for the capillary blood self-test (Exacto Test HIV) versus the oral fluid self-test (OraQuick HIV self-test) were compared among untrained individuals in the Democratic Republic of the Congo (DRC). METHODS: This multicenter cross-sectional study (2019) used face-to-face, tablet-based, structured questionnaires in a facility-based HIVST approach. Volunteers from the general public who were at high risk of HIV infection, who were between 18 and 49 years of age, and who had signed an informed consent form were eligible for the study. The successful performance and correct interpretation of the self-test results were the main outcomes of the practicability evaluation. The successful performance of the HIV self-test was conditioned by the presence of the control band. The sensitivity and specificity of the participant-interpreted results compared to the laboratory results were estimated for accuracy. Preference for either type of self-test was assessed. Logistic regression models were used to examine factors associated with participants' preference. RESULTS: A total of 528 participants were included in this survey. The rate of successful performance of the HIV self-tests was high, with the blood test (99.6%) and the oral-fluid test (99.4%) yielding an absolute difference of 0.2% (95% CI: -1.8 to 1.1; P = 0.568). The rate of correct interpretation of the HIV self-test results was 84.4% with the blood test versus 83.8% with the oral-fluid test (difference = 0.6; 95% CI: -0.2 to 1.7; P = 0.425). Misinterpretation (25.4% for the blood test and 25.6% for the oral-fluid test) and inability to interpret (20.4% for the blood test and 21.1% for the oral-fluid test) test results were significantly more prevalent with invalid tests. The Exacto Test HIV self-test and the OraQuick HIV self-test showed 100% and 99.2% sensitivity, and 98.9% and 98.1% specificity, respectively. Preference for oral-fluid-based HIVST was greater than that for blood-based HIVST (85.6% versus 78.6%; P = 0.008). Preference for the blood test was greater among participants with a university education (86.1%; aOR = 2.4 [95% CI: 1.1 to 4.9]; P = 0.016), a higher risk of HIV infection (88.1%; aOR = 2.3 [95% CI: 1.0 to 5.3]; P = 0.047), and knowledge about the existence of HIVST (89.3%; aOR = 2.2 [95% CI: 1.0 to 5.0]; P = 0.05). CONCLUSION: Our field observations demonstrate that blood-based and oral-fluid-based HIVST are both practicable approaches with a high and comparable rate of accuracy in the study setting. Although preference for the oral-fluid test was generally greater, preference for the blood test was greater among participants with a university education, a high risk of HIV infection, and knowledge about the existence of HIVST. Both approaches seem complementary in the sense that users can choose the type of self-test that best suits them for a similar result. Taken together, our observations support the use of the two HIV self-test kits in the DRC.

Promoting routine syphilis screening among men who have sex with men in China: study protocol for a randomised controlled trial of syphilis self-testing and lottery incentive.

BACKGROUND: Men who have sex with men (MSM) bear a high burden of syphilis infection. Expanding syphilis testing to improve timely diagnosis and treatment is critical to improve syphilis control. However, syphilis testing rates remain low among MSM, particularly in low- and middle-income countries. We describe the protocol for a randomised controlled trial (RCT) to assess whether provision of syphilis self-testing services can increase the uptake of syphilis testing among MSM in China. METHODS: Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1) standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control). Self-testing services include a free syphilis self-test kit through the mail at monthly intervals. Participants in the lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB (approximately 15 US Dollars) upon confirmed completion of syphilis testing. Syphilis self-test kits have step-by-step instructions and an instructional video. This is a non-blinded, open-label, parallel RCT. Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger). Confirmation of syphilis self-test use will be determined by requiring participants to submit a photo of the used test kit to study staff via secure data messaging. Both self-testing and facility-based testing will be ascertained by sending a secure photographic image of the completed kit through an existing digital platform. The primary outcome is the proportion of participants who tested for syphilis in the past 3 months. DISCUSSION: Findings from this study will provide much needed insight on the impact of syphilis self-testing on promoting routine syphilis screening among MSM. The findings will also contribute to our understanding of the safety, effectiveness and acceptability of syphilis self-testing. These findings will have important implications for self-testing policy, both in China and internationally. TRIAL REGISTRATION: ChiCTR1900022409 (10 April, 2019).

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.

Optimizing PMTCT efforts by repeat HIV testing during antenatal and perinatal care in resource-limited settings: A longitudinal assessment of HIV seroconversion.

BACKGROUND: Mother to child transmission (MTCT) of HIV remains a challenge in resource-limited settings. Central to elimination of MTCT is effective Provider Initiated HIV Counseling and Testing (PICT). Research has shown that conducting PICT only at the initial antenatal care (ANC) visit fails to benefit pregnant women who seroconvert later in their pregnancy. This study aimed to determine the most cost effective time to perform repeat HIV testing during ANC and perinatal care (PNC). METHODS: We studied the repeat HIV testing results of pregnant women ≥ 18 and adolescent girls aged 15-17 in the Sauri, Kenya Millennium Villages Project (MVP) site. Nurses provided HIV screening to 1,403 expectant women and 256 adolescent girls following the 1st, 2nd, 3rd and 4th ANC visits, at birth and 6 and 14 weeks postpartum. RESULTS: Five women seroconverted during the study period (incidence proportion 0.41%). One woman seroconverted at the 2nd ANC visit, another one at the 3rd, two at the 4th and one at 6 weeks post-partum. Of all the women who seroconverted, four reported an HIV negative primary partner, while one reported an unknown partner status. None of the participants reported condom use during pregnancy. Two of the seroconverters vertically transmitted HIV to their babies. The results did not suggest a clear pattern of seroconversion during ANC and PNC. CONCLUSIONS: The low rates of seroconversion suggest that testing pregnant women multiple times during ANC and PNC may not be cost effective, but a follow-up test during birth may be protective of the newborn.

"It Had a Lot of Cultural Stuff in It": HIV-Serodiscordant African American Couples' Experiences of a Culturally Congruent Sexual Health Intervention.

Objective: The increased life expectancy of people living with HIV has brought about an increase in serodiscordant couples, in which there is risk of HIV transmission. Therefore, interventions that promote sexual health and reduce risk are critical to develop for these couples. Given the disproportionate burden of HIV among populations of color, it is also critical that these interventions are culturally congruent. The EBAN intervention for African American serodiscordant couples recognizes the centrality of culture in shaping sexual behaviors and helps couples develop intimacy and positive prevention behaviors. The analytic objective of our study was to examine the knowledge and awareness gained by participants in the intervention. Participants: Participants (n=17) who completed at least half of the eight intervention sessions. Methods: Brief post-implementation semi-structured interviews were conducted between January 1, 2016 and December 31, 2016. Team-based, targeted content analysis focused on knowledge and awareness gains. Results: Participants described learning about sexual health, expanded sexual options, and sexual communication. The "EBAN café," a component that gives couples a menu of options for safer sex behaviors, was particularly popular. Participants also noted the value of learning how to communicate with one another about their sexual health-related concerns and preferences. They appreciated the "cultural stuff" that was infused throughout the sessions, including the emphasis on learning from one another as couples. Conclusions: Couples at risk for HIV transmission benefit from strengthening skills and knowledge related to healthy sexuality. A behavioral intervention that aligns with cultural values and imparts culturally congruent sexual health information appeals to couples who seek ways to enhance their intimacy and sexual options while also reducing risk.

Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing.

HIV partner-testing (PT) may represent a unique and empowering HIV prevention strategy for groups that face structural and institutional barriers to HIV testing and care, including transgender women. We report on in-depth interviews (IDIs) with N = 10 transgender women who used HIV self-test kits for three months to screen potential sexual partners in a randomized controlled trial (iSUM; "I'll Show You Mine") that took place in New York City and San Juan, Puerto Rico. Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months). We conducted IDIs with the first N = 10 transgender women to enroll in the intervention group after three months in the study (after participants used kits with partners) to understand their experiences. Themes discussed in IDIs included: partners' reaction to HIV testing, participants' reactions to partners' test results or refusal to test, partners' own reaction to their test results, and decision-making around test use. Data were independently analyzed by two coders. Overwhelmingly, participants' experiences with PT was positive. Participants reported kits were convenient and acceptable to most partners. Transgender women felt that PT could pose additional risk for them; one woman experienced violence related to kit use. Furthermore, the availability of kits appeared to encourage participants and their partners to think about their HIV status and, in some cases, modify sexual behavior. Work suggests that HIV PT could be a viable risk-reduction strategy for transgender women.

Five Waves of an Online HIV Self-Test Giveaway in New York City, 2015 to 2018.

BACKGROUND: HIV self-tests increase HIV status awareness by providing convenience and privacy, although cost and access may limit use. Since 2015, the New York City (NYC) Health Department has conducted 5 waves of an online Home Test Giveaway. METHODS: We recruited adult cisgender men who have sex with men (MSM) and transgender and gender-nonconforming (TGNC) individuals who had sex with men, who were living in NYC, not previously HIV diagnosed, and using paid digital advertisements (4-8 weeks per wave). Eligible respondents were e-mailed a code to redeem on the manufacturer's website for a free HIV self-test and an online follow-up survey ~2 months later. For key process and outcome measures, we present means across 5 waves. RESULTS: Across the 5 waves of Home Test Giveaway, there were 28,921 responses to the eligibility questionnaire: 17,383 were eligible, 12,182 redeemed a code for a free HIV self-test, and 7935 responded to the follow-up survey (46% of eligible responses). Among eligible responses, approximately half were Latino/a (mean, 32%) or non-Latino/a, black (mean, 17%). Mean report of never testing before was 16%. Among 5903 follow-up survey responses who reported test use, 32 reported reactive results with no known previous diagnosis (0.54%), of whom 78% reported receiving confirmatory testing. Report of likelihood of recommending the Home Test Giveaway to friends was high (mean, 96%). CONCLUSIONS: We recruited diverse NYC MSM and TGNC and distributed a large number of HIV self-tests to them. Among respondents who reported newly reactive tests, the majority reported confirmatory testing. This seems to be one acceptable way to reach MSM and TGNC for HIV testing, including those who have never tested before.

Determination of HIV status and identification of incident HIV infections in a large, community-randomized trial: HPTN 071 (PopART).

INTRODUCTION: The HPTN 071 (PopART) trial evaluated the impact of an HIV combination prevention package that included "universal testing and treatment" on HIV incidence in 21 communities in Zambia and South Africa during 2013-2018. The primary study endpoint was based on the results of laboratory-based HIV testing for> 48,000 participants who were followed for up to three years. This report evaluated the performance of HIV assays and algorithms used to determine HIV status and identify incident HIV infections in HPTN 071, and assessed the impact of errors on HIV incidence estimates. METHODS: HIV status was determined using a streamlined, algorithmic approach. A single HIV screening test was performed at centralized laboratories in Zambia and South Africa (all participants, all visits). Additional testing was performed at the HPTN Laboratory Center using antigen/antibody screening tests, a discriminatory test and an HIV RNA test. This testing was performed to investigate cases with discordant test results and confirm incident HIV infections. RESULTS: HIV testing identified 978 seroconverter cases. This included 28 cases where the participant had acute HIV infection at the first HIV-positive visit. Investigations of cases with discordant test results identified cases where there was a participant or sample error (mixups). Seroreverter cases (errors where status changed from HIV infected to HIV uninfected, 0.4% of all cases) were excluded from the primary endpoint analysis. Statistical analysis demonstrated that exclusion of those cases improved the accuracy of HIV incidence estimates. CONCLUSIONS: This report demonstrates that the streamlined, algorithmic approach effectively identified HIV infections in this large cluster-randomized trial. Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.