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Background: Men who have sex with men (MSM) are increasingly using the internet to meet casual sexual partners. Those who do are at higher risk of sexually transmitted diseases. However, little is known about the rates and associations of frequent HIV testing and self-testing among such MSM., Objective: We aimed to examine HIV serostatus communication and perceptions regarding the HIV infection risk of internet-based partners, along with their associations with frequent HIV testing and self-testing., Methods: A cross-sectional study was conducted between May 2018 and April 2019 in Zhejiang Province, China. The study participants were assigned male at birth, were aged 18 years or older, had had casual sex with another male found through the internet in the last 6 months, and were HIV-negative. Information was obtained on HIV-testing behavior, along with demographic characteristics, HIV-related knowledge, internet-based behaviors, sexual behaviors with male partners, HIV serostatus communication, and perceptions regarding the HIV infection risk of internet-based partners. Uni- and multivariate logistic regression models were used to measure the associations of HIV testing and self-testing., Results: The study recruited 281 individuals who had sought casual sexual partners through the internet during the previous 6 months. Of the participants, 61.9% (174/281) reported frequent HIV testing (twice or more frequently) and 50.9% (119/234; 47 with missing values) reported frequent HIV self-testing. MSM who always or usually communicated about the HIV serostatus of internet-based partners in the previous 6 months had 3.12 (95% CI 1.76-5.52) and 2.45 (95% CI 1.42-4.22) times higher odds of being frequently tested or self-tested for HIV, respectively, compared with those who communicated about this issue minimally or not at all., Conclusions: There remains a need to improve the frequency of HIV testing and self-testing among internet-based MSM. HIV serostatus communication should be improved within the context of social networking applications to promote frequent HIV testing among internet-based MSM, especially for those who communicated about this issue minimally or not at all., (©Wanjun Chen, Lin Chen, Zhikan Ni, Lin He, Xiaohong Pan. Originally published in JMIR Formative Research (https://formative.jmir.org), 14.11.2024.)

Background: The frequency of new HIV infections among female sex workers in sub-Saharan Africa is poorly understood. We used routinely collected data that enable unique identification of repeat HIV testers to assess temporal trends in seroconversion and identify associated risk factors for female sex workers accessing Sisters with a Voice, Zimbabwe's national sex worker programme., Methods: We pooled HIV testing data gathered between Sept 15, 2009, and Dec 31, 2019, from 36 Sisters programme sites in Zimbabwe. We included female sex workers aged 16 years or older with an HIV-negative test and at least one subsequent programme test. We calculated HIV seroconversion rates (using the midpoint between the HIV-positive test and the last negative test as the seroconversion date) and estimated rate ratios to compare 2-year periods by using Poisson regression, with robust SEs to account for clustering by site and adjusting for age and testing frequency to assess temporal trends. We did sensitivity analyses to explore assumptions about seroconversion dates and the effects of variation in follow-up time on our conclusions., Findings: Our analysis included data for 6665 female sex workers, 441 (7%) of whom seroconverted. The overall seroconversion rate was 3·8 (95% CI 3·4-4·2) per 100 person-years at risk. Seroconversion rates fell with time since first negative HIV test. After adjustment, there was evidence of a decrease in seroconversion rates from 2009 to 2019 (p=0·0053). In adjusted analyses, being younger than 25 years, and having a sexually transmitted infection diagnosis at a previous visit, were significantly associated with increased seroconversion rates. Our findings were mostly robust to sensitivity analyses, but when 1 month before an HIV-positive test was used as the seroconversion date, seroconversion rates no longer fell with time., Interpretation: We identified high rates of seroconversion shortly after linkage to programme services, which emphasises the need to strengthen HIV prevention programmes from first contact with female sex workers in Zimbabwe. New infections among female sex workers remain challenging to measure, but longitudinal analysis of routine testing data can provide valuable insights into seroconversion rates and associated risk factors., Funding: UN Population Fund, Deutsche Gesellschaft für Internationale Zusammenarbeit, the Bill & Melinda Gates Foundation, The Global Fund to Fight AIDS, Tuberculosis and Malaria, US President's Emergency Plan for AIDS Relief, US Agency for International Development, and the Elton John AIDS Foundation., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objectives: Low-capital-layout sequencing options from Oxford Nanopore Technologies (ONT) could assist in expanding HIV drug resistance testing to resource-limited settings. HIV drug resistance mutations often occur as mixtures, but current ONT pipelines provide a consensus sequence only. Moreover, there is no integrated pipeline that provides a drug resistance report from an ONT sequence file without intervention from skilled bioinformaticists. We therefore investigated Nano-RECall, which provides seamless drug resistance interpretation while requiring low-read coverage ONT sequence data from affordable Flongle or MinION flow cells and which provides mutation mixtures similar to Sanger Sequencing., Methods: We compared Sanger sequencing to ONT sequencing of the same HIV-1 subtype C polymerase chain reaction (PCR) amplicons, respectively using RECall and the novel Nano-RECall bioinformatics pipelines. Amplicons were from separate assays: (a) Applied Biosystems HIV-1 Genotyping Kit (ThermoFisher) spanning protease (PR) to reverse transcriptase (RT) (PR-RT) (n = 46) and (b) homebrew integrase (IN) (n = 21). The agreement between Sanger sequences and ONT sequences was assessed at nucleotide level, and at codon level for Stanford HIV drug resistance database mutations at an optimal ONT read depth of 400 reads only., Results: The average sequence similarity between ONT and Sanger sequences was 99.3% (95% CI: 99.1%-99.4%) for PR-RT and 99.6% (95% CI: 99.4%-99.7%) for INT. Drug resistance mutations did not differ for 21 IN specimens; 8 mutations were detected by both ONT- and Sanger sequencing. For the 46 PR and RT specimens, 245 mutations were detected by either ONT or Sanger, of these 238 (97.1%) were detected by both., Conclusions: The Nano-RECall pipeline, freely available as a downloadable application on a Windows computer, provides Sanger-equivalent HIV drug resistance interpretation. This novel pipeline combined with a simple workflow and multiplexing samples on ONT flow-cells would contribute to making HIV drug resistance sequencing feasible for resource-limited settings., (© 2023 John Wiley & Sons Ltd.)

Introduction: In Botswana, where almost all pregnant women known to have HIV receive antiretroviral therapy, a large proportion of vertical HIV transmission may occur among women with incident undiagnosed HIV infection during pregnancy. Botswana guidelines recommend repeat HIV testing every 3 months in pregnancy, with at least one test in the third trimester. We evaluated the rate of repeat HIV testing, calculated HIV incidence during pregnancy and estimated missed seroconversions., Methods: In the Botswana Tsepamo Study, we abstracted HIV test dates and results from obstetric records of all women who delivered at maternity wards in 18 communities between 7th May 2017 and 20th August 2021. We defined seroconversion as an initial negative/indeterminate HIV test in pregnancy followed by a positive test during pregnancy/at delivery. The incidence rate (IR) of seroconversion was calculated among women with > = 2 known test dates. Missed seroconversions were estimated among women without a test in the third trimester by applying the IR to the time after the last HIV test until delivery., Results: Among 103,529 women delivering in the study period testing negative at the first test and with known conception and HIV test dates, 29,085 (28%) were tested in one trimester of pregnancy, 73,156 (71%) were tested in ≥ 2 trimesters of pregnancy and 9628 (9%) had a test in all trimesters. A total of 78,162 (75%) women had a third-trimester test. There were 223 seroconversions (2.58/1000 pregnancies, 0.26%) among those with ≥ 2 known HIV test dates, yielding an IR of 0.69/100 person-years. Among 25,289 women who did not have a test in the third trimester, we estimate approximately 58 seroconversions may have been missed during pregnancy due to a lack of repeat testing. Factors associated with seroconversion during pregnancy included younger age, less education and not being married., Conclusions: More than two-thirds of women had repeat HIV testing in pregnancy and HIV incidence was low. However, an estimated 21% of seroconversions in pregnancy were likely missed due to a lack of re-testing. To reach the goal of zero new paediatric HIV infections, Botswana will need to intensify repeat HIV testing in the third trimester of pregnancy., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Objective: HIV-positive men who have sex with men (MSM) are a vulnerable group for anal cancer (AC), a cancer with a well-described precursor lesion, which can be detected early in screening programs using anal liquid-based cytology (aLBC). We aim to compare two aLBC sample collection devices: cytology brush (CB) and Dacron swab (DS)., Methods: Retrospective analysis of two consecutive study periods, the first using CB and the second DS. Participants underwent an aLBC, a human papillomavirus (HPV) DNA test and a high-resolution anoscopy (HRA), and a biopsy was performed for suspicious lesions. The sensitivity and specificity of aLBC, area under the receiver operating characteristic (ROC) curve (AUC), and concordance between cytology and HRA were assessed using Cohen's kappa coefficient., Results: A total of 239 participants were enrolled (CB group, 120; DS group, 119). aLBC was benign in 46% of samples, and high-grade squamous intraepithelial lesion (HSIL) was detected in 11.7%. Prevalence of biopsy-proven HSIL was 15.3%. No differences in cytological and histological results were observed between the groups. aLBC-HRA concordance was weak for benign results (CB group, k = 0.309; DS group, k = 0.350) as well as for HSIL (k = 0.321 and 0.387, respectively). Sensitivity and specificity were 100% and 51.4%, respectively, in the CB group and 88% and 54.3% in the DS group (AUC = 0.711 and 0.759, respectively, P-value = .514). Representation of the transformation zone (TZ) was adequate in 83.3% of samples in the CB group and 50.4% in the DS group (P-value <.001)., Conclusion: Our data suggest that both devices had similar accuracy to detect anal HSIL, although samples collected with CB are more likely to have an adequate TZ representation, the presence of which could be an indicator of sample quality., (© 2021 John Wiley & Sons Ltd.)

Introduction: HIV incidence estimates are important to characterize the status of an epidemic, identify locations and populations at high risk and to guide and evaluate HIV prevention interventions. We used the limiting antigen avidity assay (LAg) as part of a recent infection testing algorithm to estimate HIV incidence in the Akwa Ibom AIDS Indicator Survey (AKAIS), Nigeria., Methods: In 2017, AKAIS, a cross-sectional population-based study was conducted at the household (HH) level in 31 local government areas (LGAs) of Akwa Ibom state. Of the 8963 participants aged ≥15 years who were administered questionnaires for demographic and behavioural data, 8306 consented to HIV rapid testing. Whole-blood specimens were collected from 394 preliminary HIV-seropositive individuals for CD4+ cell count determination and plasma storage. Samples were shipped to a central quality laboratory for HIV confirmatory testing and viral load determination. A total of 370 HIV-positive specimens were tested for the recent HIV infection using the LAg assay., Results: Of the 8306 consenting adults, the HIV prevalence was 4.8%. Of the 370 HIV-positive samples tested for HIV recency, the median age was 35 years, 48.8% had CD4+ cell count >500/mm 3 and 81.3% was not virally suppressed. Viral suppression was greater among females (21%) than for males (13%). A total of 11 specimens were classified as recent based on the LAg assay and HIV viral load ≥1000 copies/mL. The weighted, adjusted HIV-1 incidence was 0.41/100 person-years (95% CI 0.16 to 0.66); translating to 13,000 new cases of HIV infections annually in Akwa Ibom, a state with a population of 5.5 million. The HIV incidence rate was similar in females and males (0.41% and 0.42% respectively). The incidence rate was the highest among participants aged 15 to 49 years (0.44%, 95% CI 0.15 to 0.74) translating to 11,000 new infections annually, about 85% of all new infections in the state., Conclusions: The finding of the high HIV incidence among the 15 to 49-year age group calls for renewed and innovative efforts to prevent HIV infection among young adults in Akwa Ibom state., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Acquired immunodeficiency syndrome (AIDS) caused by human immunodeficiency virus (HIV) is a major global public health problem. The aim of this study is to determine the prevalence of HIV-1 infection in four municipalities of Pará State (Marabá, Parauapebas, Curionópolis, and Canaã dos Carajás), in northern, Brazil. The municipalities are located in the Carajás Complex iron mining area. The employment opportunities result in extensive migratory flow of people. A total of 4771 serum samples were obtained from 2005 to 2014 and were sent to Evandro Chagas Institute, Belém-Pará, where they were tested by enzyme-linked immunosorbent assay, with reactive samples confirmed by Western blot analysis. The samples were from individuals from 23 Brazilian states and the Federal District, mainly Maranhão (39.53%) and other municipalities of Pará (34.25%). The total positivity rate was 0.48% (23/4771). The rate was 0.47% (14/2975) in males and 0.50% (9/1796) in females. Of these, 0.33% (14/4275) were from asymptomatic individuals whose serum were collected during the serological survey, 1.81% (9/497) were from cases featuring clinical symptoms including fever/diarrhea/jaundice, which were included in febrile, diarrheal, and icteric syndromes analyzed during the study. The findings indicated the presence of HIV-1 infection in the general population studied. The majority of cases (60.9%, 14 of 23 positive cases) were asymptomatic.

Alcohol abuse has been identified as a risk factor for contracting human immunodeficiency virus (HIV) and accelerating disease progression. Our study aims to determine alcohol consumption rates among Ecuadorian HIV positive (HIV+) patients prior to diagnosis to evaluate its impact as an independent risk factor for contracting HIV. Additionally, we will examine post-diagnosis consumption rates among the HIV+ population.We provided anonymous questionnaires to 300 HIV+ patients and 600 internal medicine patients at 3 hospitals in Quito, Ecuador. Questionnaires quantified alcohol usage prior to HIV diagnosis, at time of diagnosis, and post-diagnosis while accounting for other potential HIV risk factors. We then determined frequencies of alcohol consumption and confounding variables. Finally, we performed a multivariable logistic regression controlling for confounders to determine the statistical significance of alcohol consumption as an independent risk factor for HIV.Our results showed increased odds for contracting HIV among those who drank daily (OR 5.3, CI 2.0-14.0) and those who consumed 6 or more alcoholic beverages on days they drank (OR 5.0, CI 3.1-8.2). Through multivariable analysis, we found that abstaining from binge drinking was a protective factor with an OR 0.5 (0.3-0.96). The percentage of HIV+ patients abstaining from alcohol increased from 30% twelve months prior to diagnosis to 57% after diagnosis.Our results show that alcohol abuse significantly increases the risk of contracting HIV. We found that prior to diagnosis, HIV patients consistently drank more frequently and a greater amount than the control group. Alcohol use significantly decreased among HIV+ patients after diagnosis.

Background and Objective: In the WHO Universal test and treat strategy, false-positive HIV blood donors and patients may be unnecessarily put under antiretroviral treatment and false-negative subjects may be lost to follow-up. This study assessed the false positivity rate of the Cameroonian national HIV screening testing algorithm and the benefit of a confirmation test in the enrolment of patients and donors in the HIV care programme., Methods: We included initial HIV reactive blood donors and patients in a cross-sectional study conducted in two Cameroonian hospitals. Samples were retested according to the Cameroon national algorithm for HIV diagnosis. A positive or discordant sample was retested with the Geenius Bio-Rad HIV 1&2 (Bio-Rad, Marnes-la-Coquette, France) for confirmation. The Geenius HIV-1-positive results with 'poor' profiles were retested for RNA as well as the Geenius indeterminate results., Results: Of the 356 participants, 190/225 (84·4%) patients and 76/131 (58%) blood donors were declared positive with the national algorithm; 257 participants (96·6%) were confirmed HIV-1-positive. The study revealed that about 34/1000 blood donors and patients are false-positive and unnecessarily put on treatment; 89/1000 blood donors and patients declared discordant could have been included immediately in the HIV care programme if confirmatory testing was performed. The second test of the algorithm had a false-negative rate of 3%. Eleven samples (3·1%) were Geenius poor positive and NAT negative., Conclusion: The universal test and treat strategy may identify and refer more individuals to HIV care if a third rapid confirmatory test is performed for discordant cases., (© 2020 International Society of Blood Transfusion.)

Background: Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa., Methods and Findings: We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention., Conclusions: We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success., Trial Registration: This trial is registered at ClinicalTrials.gov under registration number NCT02626351., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Incident HIV infections persist in the United States (U.S.) among marginalized populations. Targeted and cost-efficient testing strategies can help in reaching HIV elimination. This analysis compares the effectiveness and cost of three HIV testing strategies in a high HIV burden area in the U.S. in identifying new HIV infections., Methods: We performed a cost analysis comparing three HIV testing strategies in Chicago: (1) routine screening (RS) in an inpatient and outpatient setting, (2) modified partner services (MPS) among networks of the recently HIV infected and diagnosed, and (3) a respondent drive sampling (RDS)-based social network (SN) approach targeting young African-American men who have sex with men. All occurred at the same academic medical centre during the following times: routine testing, 2011 to 2016; MPS, 2013 to 2016; SN: 2013 to 2014. Costs were in 2016 dollars and included personnel, HIV testing, training, materials, overhead. Outcomes included cost per test, HIV-positive test and new diagnosis. Sensitivity analyses were performed to assess the impact of population demographics., Results: The RS programme completed 57,308 HIV tests resulting in 360 (0.6%) HIV-positive tests and 165 new HIV diagnoses (0.28%). The MPS completed 146 HIV tests, resulting in 79 (54%) HIV-positive tests and eight new HIV diagnoses (5%). The SN strategy completed 508 HIV tests, resulting in 210 (41%) HIV-positive tests and 37 new HIV diagnoses (7.2%). Labour accounted for the majority of costs in all strategies. The estimated cost per new HIV diagnosis was $16,773 for the RS programme, $61,418 for the MPS programme and $15,683 for the SN testing programme. These costs were reduced for the RS and MPS strategies in sensitivity analyses limiting testing efficacy to the highest prevalence patient populations ($2,841 and $33,233 respectively)., Conclusions: The SN strategy yielded the highest proportion of new diagnoses, followed closely by the MPS programme. Both the SN strategy and RS programme were comparable in the cost per new diagnosis. A simultaneous approach that consists of RS in combination with SN testing may be most effective for identifying new HIV infections in settings with heterogeneous epidemics with both high rates of HIV prevalence and HIV testing., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Tuberculosis (TB) is a major public health problem worldwide. Contamination rate and poor recovery of Mycobacterium tuberculosis complex (MTBC) in MGIT960 culture may affect the early diagnosis of TB. Evidence is needed to determine the factors associated with contamination rates and MTBC recovery in MGIT960. Hence, we undertook this study to compare the factors influencing MTBC culture positivity and contamination rates in MGIT960 in patients with Pulmonary tuberculosis (PTB)., Methods: A total of 849 sputum samples from newly diagnosed smear-positive TB cases enrolled into the Regional Prospective Observational Research for Tuberculosis India cohort between May 2014 to March 2017 were analyzed. Samples were inoculated into MGIT960 and positive cultures were examined for the presence of MTBC by immunochromatographic test for detection of MPT64 antigen., Results: Of the 849 cases, 811 (95.5%) were culture positive for MTBC, 23 (2.7%) were culture negative and 15 (1.8%) were contaminated. Salivary sputum showed significantly less culture yield compared to mucopurulent/blood stained samples (p = 0.021). Sputum from individuals <20 or ≥60 years showed lower culture yield of 93.9%, compared to those aged 20-59years (98.2%) (p = 0.002). Based on smear grading, culture isolation of MTBC by MGIT960 was 86.1%, 93.6% and 99.5% for negative, scanty and positive (1+/2+/3+) samples, respectively (p ≤ 0.0001). Sputum from HIV negative patients showed higher culture yield, compared to HIV positive patients (p ≤ 0.0001). Chest X-Ray revealed that patient with cavity showed higher culture isolation of MTBC compared to patients without cavity (p = 0.035). Contamination rates were higher in smear negatives (6.0%), compared to scanty (2.1%) and smear positives (1.1%) (p = 0.007). However, delay in transport of the specimen to the laboratory was the only independent factor significantly associated with increase in culture contamination., Conclusion: Our results highlight that extremes of age, smear negativity, HIV infection, sputum quality and cavitation significantly influence the culture yield of MTBC, whereas transport duration and smear grading affected the contamination rates in MGIT960. Hence, addressing these factors may improve the diagnostic performance of MGIT960., Competing Interests: Declaration of competing interest All authors have none to declare., (Copyright © 2020 Tuberculosis Association of India. All rights reserved.)

Secondary distribution of HIV self-tests to sexual partners is acceptable but concerns remain about reactions if a partner tests HIV-positive. We report on 14 participants whose sexual partners tested HIV-positive during the "I'll Show You Mine" Study, a randomized controlled trial (N = 272) of HIV self- and partner-testing among men who have sex with men (MSM) and transgender women (TGW). All 14 were MSM and racial/ethnic minorities, mean age was 36.6 years; 86% were gay-identified. Twenty-four partners tested positive; about half were new partners. Six participants had multiple partners test positive. During in-depth interviews with 10 of these participants, they reported their partners' reactions ranged from tearful and worried among those whose result was unexpected, to resignation among those who suspected a positive result, to nonchalance among partners who participants concluded knew of their HIV infection. After testing, some HIV-positive partners disclosed prior knowledge of their status. No partner reacted violently. Participants typically comforted their partners and encouraged confirmatory testing. Four participants had anal intercourse with partners who tested positive. Participants and partners were able to effectively handle situations in which the partner tested HIV-positive.

There is currently an absence of products which are cleared by the FDA to provide supplemental testing for oral fluid for HIV antibody. We created a procedure for the use of the BioRad Geenius HIV-1/2 as a supplemental antibody test for oral fluid specimens. The modified procedure was evaluated for its ability to detect HIV-1 antibody in oral fluid in specimens that were found to be repeatedly reactive for HIV-1 antibody by way of the Avioq HIV-1 enzyme immunoassay (EIA). Evaluated were oral fluid specimens analyzed at a local public health laboratory which were stored frozen and oral fluid specimens collected prospectively. Prospectively collected specimens were from patients whose HIV status was subsequently assessed through blood-based testing. For retrospective specimens found repeatedly EIA reactive, and positive by Western blot, the modified Geenius was found positive in 37/38 instances (97.4 %). Those specimens with a mean EIA signal-to-cutoff (S/CO) greater than 3.00 were found to be positive by Geenius in 34/34 (100 %) of instances. For specimens found repeated reactive by EIA and positive by Western blot with mean S/CO less than or equal to 3.00, the Geenius was positive in 4/5 instances (80 %) of instances. For prospectively collected specimens, the Geenius accurately confirmed infection in 22/24 cases (92 %) while prospective specimens found repeatedly reactive by EIA without supplemental Geenius testing were confirmed positive in 29/37 instances (78 %). A modified usage of the Geenius HIV-1/2 Supplemental Assay antibody test may provide utility in the supplementation of testing of oral fluid for the presence of HIV-1 antibody., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: The Reveal G4 antibody rapid test is FDA-approved for HIV-1 detection using the versions LAB S/P and POC in CLIA-moderate complexity settings with serum/plasma and whole blood, respectively. The same Reveal tests are CE-marked for HIV-1 and HIV-2 detection in laboratory and point-of-care (POC) settings., Objective: We compared the performance of G4 LAB S/P with plasma and POC with whole blood (blood) for detecting early and established HIV-1/HIV-2 infections., Study Design: Matched well-characterized plasma and simulated blood were used to evaluate: sensitivity in 104 HIV-1 and 55 HIV-2 established infections, specificity in 49 HIV-negative, and reactivity in early HIV-1 infection in a performance panel (n=38) and 18 plasma panels from seroconverters (SCs, n=183). Median number of days after first RNA-positive was calculated for 13 SCs. Impact of viral suppression (VS) was evaluated in 3 SCs receiving early antiretroviral therapy (ART)., Results: Sensitivity was 100 % for HIV-1 and 98.18 % for HIV-2, while specificity was 100 %. All 38 plasma and blood become reactive by Fiebig stage V. Of 18 SCs, 10 had similar reactivity in plasma/blood, 7 showed delayed reactivity in blood, and 1 was nonreactive in plasma/blood. The median days for a G4-reactive after first RNApositive was 13 for plasma and 14 for blood. Long-term VS had no impact on G4 reactivity., Conclusions: Overall reactivity in early HIV-1 infections is delayed by one day in blood compared to plasma. If FDA-approved for POC settings, the G4 POC is a fast sensitive screening tool for HIV-1/HIV-2-specific IgG even during VS., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Published by Elsevier B.V.)

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., Competing Interests: The authors have declared that no competing interests exist.

Medical advances in the treatment of HIV over the last 35 years mean that people living with HIV (PLHIV) now have a life expectancy close to that of the general population. Further, when successfully treated, PLHIV cannot transmit the virus. Despite this, HIV-related stigma remains widespread, including within healthcare settings. Stigma is not a vague sociological notion but represents a real threat to public health, with repercussions for both PLHIV and HIV-negative individuals. Stigma has been shown to have a negative impact on HIV prevention, testing, access to health services, and on the healthcare management of PLHIV. Taking stigma into consideration is essential, both in meeting the medical and psycho-social needs of PLHIV and in order to effectively combat HIV/AIDS., Competing Interests: Isabel Cobos Manuel, David Jackson-Perry, Cristina Bluntschli, Sybille Carel, Edith Muggli et Vreneli Waelti da Costa n’ont déclaré aucun conflit d’intérêts en relation avec cet article. L’institution de Mme Corine Courvoisier a reçu un soutien pour sponsoring de prestations éducatives de Gilead, MSD et ViiV. L’institution du Dr Eleftheria Kampouri a reçu un soutien de Gilead afin d’assister aux congrès. L’institution du Pr Matthias Cavassini a reçu un financement en lien avec des subsides de recherche de Gilead et Viiv, et suite à son avis d’expert à AbbVie, Gilead, MSD, Sandoz et ViiV. L’institution du Dr Katharine Darling a reçu un financement en lien avec des subsides de recherche de Gilead et un soutien de MSD afin d’assister aux congrès.

HIV self-testing reduces barriers associated with other HIV testing services, such as concerns about confidentiality and inconvenience. This article demonstrates who might benefit from this approach to HIV testing by describing the characteristics of men who have sex with men (MSM) who took interest in a Norwegian pilot project on HIV self-testing. Of the MSM users, 27% reported that they had never been tested for HIV. Not disclosing one's same-sex sexuality, particularly among non-gay-identified MSM, was associated with a higher probability of never having been tested for HIV and choosing to test with an HIV self-test because of its anonymity. Never having been tested for HIV was also associated with a higher probability of choosing to test with an HIV self-test due to anonymity. The results suggest that the HIV self-tests' ability to reach MSM who otherwise would not be tested is partly because it is an anonymous HIV testing alternative.

Introduction: High levels of HIV seroconcordance at the population level reduce the potential for effective HIV transmission. However, the level of HIV seroconcordance is largely unknown among heterosexual couples in sub-Saharan Africa. We aimed to quantify the population level HIV seroconcordance in stable heterosexual couples in rural South Africa., Methods: We followed adults (≥15 years old) using a population-based, longitudinal and open surveillance system in KwaZulu-Natal, South Africa, from 2003 to 2016. Sexual partnerships and HIV status were confirmed via household surveys and annual HIV surveillance. We calculated the proportions of HIV seroconcordance and serodiscordance in stable sexual partnerships and compared them to the expected proportions under the assumption of random mixing using individual-based microsimulation models. Among unpartnered individuals, we estimated the incidence rates and hazard of sexual partnership formation with HIV-positive or HIV-negative partners by participants' own time-varying HIV status. Competing risks survival regressions were fitted adjusting for sociodemographic and clinical factors. We also calculated Newman's assortativity coefficients., Results: A total of 18,341 HIV-negative and 11,361 HIV-positive individuals contributed 154,469 person-years (PY) of follow-up. Overall, 28% of the participants were in stable sexual partnerships. Of the 677 newly formed stable sexual partnerships, 7.7% (95% CI: 5.8 to 10.0) were HIV-positive seroconcordant (i.e. both individuals in the partnership were HIV-positive), which was three times higher than the expected proportion (2.3%) in microsimulation models based on random mixing. The incidence rates of sexual partnership formation were 0.54/1000PY with HIV-positive, 1.12/1000PY with HIV-negative and 2.65/1000PY with unknown serostatus partners. HIV-positive individuals had 2.39 (95% CI: 1.43 to 3.99) times higher hazard of forming a sexual partnership with an HIV-positive partner than did HIV-negative individuals after adjusting for age, opposite-sex HIV prevalence (by 5-years age groups), HIV prevalence in the surrounding community, ART coverage and other sociodemographic factors. Similarly, forming a sexual partnership with an HIV-negative partner was 1.47 (95% CI: 1.01 to 2.14) times higher in HIV-negative individuals in the adjusted model. Newman's coefficient also showed that assortativity by participant and partner HIV status was moderate (r = 0.35)., Conclusions: A high degree of population level HIV seroconcordance (both positive and negative) was observed at the time of forming new sexual partnerships. Understanding factors driving these patterns may help the development of strategies to bring the HIV epidemic under control., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Previous studies have reported the association between Mycoplasma fermentans (M. fermentans) and the risk of human immunodeficiency virus 1 (HIV-1) infection, but the results were inconsistent. The present study aims to systematically review reported studies on M. fermentans and its association with HIV-1 infection, as well as to summarize the findings using a meta-analysis., Methods: Studies meeting the inclusion criteria in the PubMed, Embase, China National Knowledge Infrastructure, WanFang Data, and Chongqing VIP databases up to March 2019 were identified. Cochran Q and I statistics were used to assess heterogeneity. Additionally, pooled odds ratio (OR) with 95% confidence intervals (CI) were calculated and displayed by Forest plots. Also, the funnel plot, Begg test, and Egger test were used to evaluate potential publication bias. In addition, the source of heterogeneity was investigated by subgroup and sensitivity analyses., Results: A total of 11 studies comprising 1028 HIV-1-positive patients and 1298 controls were ultimately included in this meta-analysis. Our results indicated that M. fermentans could increase the risk of HIV-1 infection among humans (OR = 3.66, 95%CI 1.26-10.64). Subgroup analysis showed that the risk of HIV-1 infection associated with M. fermentans was, based on the geographical distribution, 1.19 (95%CI 0.33-4.33) in Europe, 2.83 (95%CI 0.94-8.52) in United States, 11.92 (95%CI 3.93-36.15) in Asia; based on the source of the sample, 2.97 (95%CI 0.89-9.95) in blood samples, 4.36 (95%CI 1.63-11.68) in urine samples; based on the detection method, 2.80 (95%CI 0.72-10.96) with the polymerase chain reaction method, 5.54 (95%CI 1.21-25.28) with other detection methods; based on the source of controls, 1.91 (95%CI 0.53-6.89) in sexually transmitted diseases individuals, and 8.25 (95%CI 2.16-31.60) in health individuals., Conclusion: Our study revealed evidence of the association between M. fermentans and HIV-1 infection. Considering the heterogeneity, further studies are warranted to understand the relationship between M. fermentans and HIV-1 infection.

Rapid test (RT) is the principal screening method in the HIV control practice. However, this method may lead to inaccurate detection, primarily due to the more than 4 weeks of window phase. In the present study, we performed a HIV DNA screening method to show its application prospects in men who have sex with men (MSM). From July 2017 to April 2018, we recruited 1,301 MSM from Beijing who were not previously diagnosed as HIV positive. Both HIV DNA detection and RT were performed. In total, 141 and 135 HIV-positive results were detected by DNA detection and RT, respectively. By repetitive and confirmative tests (Western blot), we verified that DNA detection detected 10 more true positives than RT and 4 false positives were corrected from RT. This represents 14 inaccurate RT results that were corrected by DNA measurement. Therefore, DNA measurement should be fully considered as a screening method in the detection of HIV among MSM in the future.

Background and Objective: Disclosure of human immuno-deficiency virus (HIV) sero-status is a difficult process that involves communication of information about a potentially stigmatizing and transmissible illness. Despite this, it is important for preventing HIV infection and mitigating its impacts. This study aimed to assess the rate and determinants of self-disclosure of HIV sero-status among people living with HIV/AIDS (PLHIV) attending an Antiretroviral Therapy (ART) Clinic in North Central Nigeria with a view to promoting self- disclosure as an intervention for secondary prevention of HIV/AIDS., Methods: It was a cross-sectional study involving 325 consenting adults aged 18 to 65 years PLHIV attending ART clinic who were recruited using systematic random sampling method. Data collected from the participants include socio-demographic data and medical history. The rate and factors affecting self-disclosure of HIV sero-status were obtained by using a structured interviewer-administered questionnaire. Data was analysed using Statistical Package for Social Sciences (SPSS) version 20.0 Results: Most of the participants (66.2%) were females. 96% of the participants had disclosed their HIV sero-status. Self-disclosure of HIV sero-status had statistically significant association with age (c2 = 12.614; p = 0.027) and gender (c2 = 4.638; p = 0.031)., Conclusion: Self-disclosure of HIV sero-status was high among the participants. Being female and within 15-44 year age group were statistically significant factors associated with disclosure of HIV sero-status. Multiple counselling sessions are needed to improve disclosure particularly in males and older PLHIV as self-disclosure of HIV sero-status is a process that requires ongoing support and encouragement.

Individuals living with HIV/AIDS face several stressors and use varying strategies to cope. Disclosure (or nondisclosure) of HIV serostatus is an important consideration among individuals living with HIV. However, studies examining the association between coping and HIV disclosure are lacking, and more research examining potential mediators and moderators is needed. The transactional model of stress and coping and the theory of planned behavior may help in understanding the mediating relationship between coping, decision self-efficacy, and HIV disclosure. Therefore, the aims of this study were to examine the association between coping and HIV disclosure to sexual partners, assess the mediating role of decision self-efficacy, and examine moderation by sex. Baseline data from 262 individuals living with HIV who participated in a disclosure intervention were used for analysis. Descriptive statistics were used to assess sociodemographic characteristics. Principal component analysis was used to operationalize coping. Path analysis was then used to determine the mediating role of decision self-efficacy in the association between overall, adaptive, distancing, and attack/escape avoidance coping and HIV disclosure to sexual partners. After adjusting for age and time since diagnosis, direct associations between coping and decision self-efficacy, and decision self-efficacy and disclosure behavior varied by sex. Among the overall study population, decision self-efficacy mediated the associations between adaptive coping ( β  = 0.064, p  = 0.003), attack/escape avoidance coping ( β  = -0.052, p  = 0.009) and disclosure behavior. Disclosure intervention programs geared towards populations living with HIV should include decision self-efficacy and adaptive coping, and attenuate attack/escape avoidance coping.

Background: The instructions of manufacturers of methodologies for anti-HIV-1/2 antibodies screening tests re-commend avoiding analyzing blood samples with hemolysis or lipemia, but they do not mention references about scientific studies evaluating their interference. The increased need for an opportune detection of HIV infection to avoid its spread has led to public health institutions including routine HIV screening even in internal medicine and emergency rooms. Nevertheless, these blood samples are usually associated with the presence of lipemia and/ or hemolysis, leaving doubt for probable misinterpretations. This fact highlights the need for applying verification techniques, established under the internal methodological conditions of each laboratory, in order to increase the coverage of HIV screening and to ensure the reliability of their results., Methods: Following the ethics committee approval and patient's informed consent, a confirmed anti-HIV-1 positive human serum (undetectable viral load and p24 antigen, and stable total lymphocytes > 30%) was obtained. This work describes techniques for the semiquantitative analysis of anti-HIV antibodies of three commercial HIV-screening methodologies (immunochromatography, enzyme-immunoassay and chemiluminescence) and to deter-mine the detection limit of these screening tests, as well as evaluating the maximum concentration of total lipids and of free hemoglobin that do not interfere in the detection limits., Results: The highest analyzed concentration of total lipid (870 mg/dL) did not interfere with the detection limits of anti-HIV-1 antibodies in any of the evaluated methodologies. Free hemoglobin presented interference at different concentrations depending on the methodology: immunochromatography (0.57 g/dL)), enzyme-immunoassay (8.6 g/dL), and chemiluminescence (11.5 g/dL))., Conclusions: Concentrations of lipemia above postprandial levels or hemolysis induced by experimental manipulation might not interfere with HIV-serological screening. Determining the maximum permissible limits of lipemia and hemolysis by each manufacturer or laboratory based on an internal evaluation of their serological methodology would increase the reliability of HIV-diagnosis in internal medicine and emergency rooms and in patients with dyslipidemia or physiological hemolysis.

Background: There is an imperative need for innovative interventions to identify people living with HIV and initiate them on antiretroviral therapy. The objective of this study was to determine the feasibility of providing index partner/child testing of people living with HIV., Methods: We trained 86 nurses and counsellors in 56 public health facilities in 6 high HIV burden Districts in South Africa 2017 to provide index partner/child testing (tracing and testing of partners/children of people living with HIV). We collected programmatic data including index partner/child HIV positivity by age, gender, and location of testing. In subanalyses, we evaluated factors associated with identifying HIV-positive partners and children in separate models using multivariable logistic regression., Results: We tested 16,033 partners and children of index patients between October 2017 and June 2018. Most of those tested were women (61%) and 20-39 years old (39%). Overall, 6.4% were 10-14 years old, 9.5% were 15-19 years, and 8% were ≥50 years. HIV positivity was 38% [95% confidence interval (CI) = 36% to 40%]. In children ages 10-14 years, 13% were HIV-infected (95% CI = 11% to 14%). In subanalyses, HIV positivity in partners was associated with their increased age [adjusted odds ratio (aOR) for increase in 5-year age category = 1.21; 95% CI = 1.04 to 1.42], female gender (aOR = 1.38; 95% CI = 1.04 to 1.82), and index partner bringing the partner in for HIV testing vs. referring the partner through the provider or recommending testing to the partner (aOR = 1.94, 95% CI = 1.43 to 2.63), adjusting for location of testing. Almost all patients diagnosed (97%) were referred to antiretroviral therapy., Conclusions: Providing index partner/child testing was feasible and we identified a very high yield when testing partners and children of index patients. Index partner and children testing should be offered to all patients living with HIV to improve case finding.

Biomarkers for detecting early HIV infection and estimating HIV incidence should minimize false-recent rates (FRRs) while maximizing mean duration of recent infection (MDRI). We compared HIV subtypes B, E and D (BED) capture enzyme immunoassay (BED), Sedia limiting antigen (LAg) avidity enzyme immunoassay, and Bio-Rad avidity incidence (BRAI) assays using samples from Zimbabwean postpartum women infected with clade C HIV. We calculated MDRIs using 590 samples from 351 seroconverting postpartum women, and FRRs using samples from 2,825 women known to be HIV positive for >12 months. Antibody kinetics were more predictable with LAg and had higher precision compared with BED or BRAI. BRAI also exhibited more variability, and avidity reversal in some cases. For BED, LAg, and BRAI, used alone or with viral load, MDRI values in days were: BED-188 and 170 at normalized optical density (ODn) 0.8; LAg-104 and 100 at ODn cutoff 1.5; BRAI-135 and 134 at avidity index cutoff 30%. Corresponding FRRs were: BRAI 1.1% and 1.0% and LAg 0.57% and 0.35%: these were 3.8-10.9 times lower than BED values of 4.8% and 3.8%. BRAI and LAg have significantly lower FRRs and MDRIs than in published studies, and much lower than BED and could be used to estimate incidence in perinatal women and to measure population-level HIV incidence in HIV control operations in Africa.

Introduction: The ability to achieve an accurate test result and interpret it correctly is critical to the impact and effectiveness of HIV self-testing (HIVST). Simple and easy-to-use devices, instructions for use (IFU) and other support tools have been shown to be key to good performance in sub-Saharan Africa and may be highly contextual. The objective of this study was to explore the utility of cognitive interviewing in optimizing the local understanding of manufacturers' IFUs to achieve an accurate HIVST result., Methods: Functionally literate and antiretroviral therapy-naive participants were purposefully selected between May 2016 and June 2017 to represent intended users of HIV self-tests from urban and rural areas in Malawi and Zambia. Participants were asked to follow IFUs for HIVST. We then conducted cognitive interviews and observed participants while they attempted to complete the HIVST steps using a structured guide, which mirrored the steps in the IFU. Qualitative data were analysed using a thematic approach., Results: Of a total of 61 participants, many successfully performed most steps in the IFU. Some had difficulties in understanding these and made errors, which could have led to incorrect test results, such as incorrect use of buffer and reading the results prematurely. Participants with lower levels of literacy and inexperience with standard pictorial images were more likely to struggle with IFUs. Difficulties tended to be more pronounced among those in rural settings. Ambiguous terms and translations in the IFU, unfamiliar images and symbols, and unclear order of the steps to be followed were most commonly linked to errors and lower comprehension among participants. Feedback was provided to the manufacturer on the findings, which resulted in further optimization of IFUs., Conclusions: Cognitive interviewing identifies local difficulties in conducting HIVST from manufacturer-translated IFUs. It is a useful and practical methodology to optimize IFUs and make them more understandable., (© 2019 World Health Organization; licensed by IAS.)

Background: Fourth generation HIV assays, which detect both HIV p24 antigen and HIV antibodies are widely used in HIV screening. The combination of markers enables the fourth generation assays to shorten the window of detection, which is important in real-world testing scenarios. The Elecsys ® HIV Duo assay is a fourth generation assay, which provides an overall result based on both the detection of the p24 antigen and HIV antibodies, and lists the sub-results for the antibody and antigen units., Objectives and Study Design: The performance of the Elecsys ® HIV Duo assay was assessed at five international centres and compared with other available fourth generation assays., Results: The specificity of the Elecsys ® HIV Duo assay in 13,328 blood donor samples was 99.87% (95% confidence interval [CI] 99.80-99.93) and was 100% (95% CI 99.63-100) in 1000 routine diagnostic samples. Sensitivity was assessed in 139 seroconversion panels; the Elecsys ® HIV Duo assay detected a greater number of positive samples/number of bleeds compared with other assays investigated. An individual analysis of those seroconversion panels also shows that the Elecsys ® HIV Duo assay compared to other fourth generation assays detected HIV up to 2 days earlier than other assays. The Elecsys ® HIV Duo assay also detected 125/130 'early seroconversion' samples assessed, which was greater than the number detected with comparator fourth generation assays., Conclusion: These results indicate that the Elecsys ® HIV Duo assay is appropriate for use in the diagnosis of HIV and for screening of blood donations and is sensitive for the early detection of HIV., (Copyright © 2018. Published by Elsevier B.V.)

Introduction: HIV self-testing (HIVST) provides couples and individuals with a discreet, convenient and empowering testing option. As with all HIV testing, potential harms must be anticipated and mitigated to optimize individual and public health benefits. Here, we describe social harms (SHs) reported during HIVST implementation in Malawi, and propose a framework for grading and responding to harms, according to their severity., Methods: We report findings from six HIVST implementation studies in Malawi (2011 to 2017) that included substudies investigating SH reports. Qualitative methods included focus group discussions, in-depth interviews and critical incident interviews. Earlier studies used intensive quantitative methods (post-test questionnaires for intimate partner violence, household surveys, investigation of all deaths in HIVST communities). Later studies used post-marketing reporting with/without community engagement. Pharmacovigilance methodology (whereby potentially life-threatening/changing events are defined as "serious") was used to grade SH severity, assuming more complete passive reporting for serious events., Results: During distribution of 175,683 HIVST kits, predominantly under passive SH reporting, 25 serious SHs were reported from 19 (0.011%) self-testers, including 15 partners in eight couples with newly identified HIV discordancy, and one perinatally infected adolescent. There were no deaths or suicides. Marriage break-up was the most commonly reported serious SH (sixteen individuals; eight couples), particularly among serodiscordant couples. Among new concordant HIV-positive couples, blame and frustration was common but rarely (one episode) led to serious SHs. Among concordant HIV-negative couples, increased trust and stronger relationships were reported. Coercion to test or disclose was generally considered "well-intentioned" within established couples. Women felt empowered and were assertive when offering HIVST test kits to their partners. Some women who persuaded their partner to test, however, did report SHs, including verbal or physical abuse and economic hardship., Conclusions: After more than six years of large-scale HIVST implementation and in-depth investigation of SHs in Malawi, we identified approximately one serious reported SH per 10,000 HIVST kits distributed, predominantly break-up of married serodiscordant couples. Both "active" and "passive" reporting systems identified serious SH events, although with more complete capture by "active" systems. As HIVST is scaled-up, efforts to support and further optimize community-led SH monitoring should be prioritized alongside HIVST distribution., (© 2019 World Health Organization; licensed by IAS.)

Background: HIV-1 viral load testing is now recommended by the World Health Organization for every patient receiving antiretroviral therapy (ART)., Objectives: The objective of this study is to evaluate the performance of commercial assays for their ability to quantify HIV-1 strains currently circulating in France., Study Design: The performances of the Generic HIV-RNA assay from Biocentric were compared to those of the Roche CAP/CTM v1.5, Roche CAP/CTM v2.0 and Abbott m2000 RealTime HIV-1 assays. A total of 1885 HIV-1 plasma samples were tested, including 684 samples from patients included in the ANRS-Primo Cohort., Results: We found a good concordance of quantification between the Roche v2.0 and the Biocentric assays, both of which were superior to the Roche v1.5 assay. We show moderate agreement between techniques; however, CRF02&#95;AG strains and undetermined viruses were underestimated when quantified with the Roche CAP/CTM v2.0. In contrast, a comparison of the Biocentric and Abbott assay results showed strong agreement between assays, indicating that both are well suited for quantification of CRF02&#95;AG strains. Moreover, a 2% underestimation of the B subtypes was observed with the Biocentric assay., Conclusions: These results have implications for viral load monitoring in Western Africa, where CRF02&#95;AG strains are highly prevalent. Closer epidemiological surveillance and evaluation of commercial assays are still necessary to better evaluate the impact of the genetic evolution of circulating viruses on HIV-RNA quantification in the regions most affected by the HIV-1 epidemic., (Copyright © 2018. Published by Elsevier B.V.)

Objectives: Despite HIV testing recommendations published by the Federal Office of Public Health (FOPH) since 2007, many individuals living with HIV are diagnosed late in Switzerland. The aim of this study is to examine the effect of the 2013 FOPH HIV testing recommendations on HIV testing rates., Setting: Ten clinical services at Lausanne University Hospital, Lausanne, Switzerland., Participants: Patients attending between 1 January 2012 and 31 December 2015., Design: Retrospective analysis using two existing hospital databases. HIV testing rates calculated as the percentage of tests performed (from the Immunology Service database) per number of patients seen (from the central hospital database)., Primary and Secondary Outcome Measures: The primary outcome was testing rate change following the 2013 FOPH testing recommendations, comparing testing rates 2 years before and 2 years after their publication. Secondary outcomes were demographic factors of patients tested or not tested for HIV., Results: 147 884 patients were seen during the study period of whom 9653 (6.5%) were tested for HIV, with 34 new HIV diagnoses. Mean testing rate increased from 5.6% to 7.8% after the recommendations (p=0.001). Testing rate increases were most marked in services involved in clinical trials on HIV testing, whose staff had attended training seminars on testing indications and practice. Testing rates were lower among older (aged >50 years), female and Swiss patients compared with younger, male and non-Swiss patients, both globally (p=0.001) and in specific clinical services., Conclusions: This simple two-database tool demonstrates clinical services in which HIV testing practice can be optimised. Improved testing rates in services involved in clinical trials on testing suggest that local engagement complements the effect of national recommendations. While, overall, HIV testing rates increased significantly over time, testing rates were lower among patients with similar demographic profiles to individuals diagnosed late in Switzerland., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Given the great efforts put into the strategic objective of reducing the proportion of HIV-infected patients that are undiagnosed, the aim of the present study was to review the temporal trends between 1997 and 2016 for median estimates of infection duration and median CD4 count at diagnosis for the main patient origins in French Guiana., Methods: CD4 cell count at HIV sero-conversion and square root of CD4 cell decline were obtained using the CD4 decline in a cohort of HIV-infected persons in the UK, fitting random effect (slope and intercept) multilevel linear regression models. Multivariate analysis used robust regression for modeling the delay between estimated HIV seroconversion and diagnosis and quantile regression for CD4 at HIV diagnosis., Results: The median interval between the estimated HIV seroconversion and HIV diagnosis was 8 years for patients fromBrazil, 4.5 years for those from Haiti, 6.6 years for those from Suriname, 3.3 years for patients from Guyana, and 3.1 years for French patients. A simple robust regression model with French patients as reference group adjusting for sex and age at the time of diagnosis showed that the interval was significantly longer for Brazilian (β = +3.7 years, P = 0.001), Surinamese (β = +4.2 years, P<0.0001), Haitian origins (β = +1.5 years, P = 0.049) but not for those originating from Guyana (β = -0.03 years, P = 0.9); Men independently had a longer interval than women (β = +3.5 years, P<0.0001)., Conclusions: Despite great efforts in French Guiana regarding HIV testing both in terms of diversification and intensification we still need to tailor the offer to better reach the communities in need. These results should help authorities scale up and optimize initiatives to reduce the proportion of patients who are unaware of their infection. They also raise the question of the role of stigma and discrimination as a barrier to HIV testing in small communities, and further emphasize the importance of reducing it., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Here we present the case of a 56-year-old human immunodeficiency virus (HIV)-infected man with multiple anal condylomas and positivity for human papilloma virus (HPV) 18 on anal brushing. Biopsies of the anal mucosa led to the diagnosis of Bowen's disease and a subsequent pelvic magnetic resonance imaging (MRI) scan evidenced multiple reactive lymphoadenopathies and large intra-anal condylomas. The patient was treated with a complete excision of Bowen's lesion and with a 4 months course of supplementation with a high concentration multistrain probiotic formulation administered orally and by rectal instillation with the purpose to reduce local inflammation and to enhance local mucosal immunity., Conclusion: An MRI performed at the end of the supplementation period evidenced the clearance of the anal condylomas previously described and no evidence of residual lymphadenopathies. Trials are therefore required to confirm this therapeutic possibility and for a better understanding of the mechanisms by which this specific probiotic formulation interacts with local epithelium when administered by the anal route.

Importance: Home-based HIV testing is a frequently used strategy to increase awareness of HIV status in sub-Saharan Africa. However, with referral to health facilities, less than half of those who test HIV positive link to care and initiate antiretroviral therapy (ART)., Objective: To determine whether offering same-day home-based ART to patients with HIV improves linkage to care and viral suppression in a rural, high-prevalence setting in sub-Saharan Africa., Design, Setting, and Participants: Open-label, 2-group, randomized clinical trial (February 22, 2016-September 17, 2017), involving 6 health care facilities in northern Lesotho. During home-based HIV testing in 6655 households from 60 rural villages and 17 urban areas, 278 individuals aged 18 years or older who tested HIV positive and were ART naive from 268 households consented and enrolled. Individuals from the same household were randomized into the same group., Interventions: Participants were randomly assigned to be offered same-day home-based ART initiation (n = 138) and subsequent follow-up intervals of 1.5, 3, 6, 9, and 12 months after treatment initiation at the health facility or to receive usual care (n = 140) with referral to the nearest health facility for preparatory counseling followed by ART initiation and monthly follow-up visits thereafter., Main Outcomes and Measures: Primary end points were rates of linkage to care within 3 months (presenting at the health facility within 90 days after the home visit) and viral suppression at 12 months, defined as a viral load of less than 100 copies/mL from 11 through 14 months after enrollment., Results: Among 278 randomized individuals (median age, 39 years [interquartile range, 28.0-52.0]; 180 women [65.7%]), 274 (98.6%) were included in the analysis (137 in the same-day group and 137 in the usual care group). In the same-day group, 134 (97.8%) indicated readiness to start ART that day and 2 (1.5%) within the next few days and were given a 1-month supply of ART. At 3 months, 68.6% (94) in same-day group vs 43.1% (59) in usual care group had linked to care (absolute difference, 25.6%; 95% CI, 13.8% to 36.3%; P < .001). At 12 months, 50.4% (69) in the same-day group vs 34.3% (47) in usual care group achieved viral suppression (absolute difference, 16.0%; 4.4%-27.2%; P = .007). Two deaths (1.5%) were reported in the same-day group, none in usual care group., Conclusions and Relevance: Among adults in rural Lesotho, a setting of high HIV prevalence, offering same-day home-based ART initiation to individuals who tested positive during home-based HIV testing, compared with usual care and standard clinic referral, significantly increased linkage to care at 3 months and HIV viral suppression at 12 months. These findings support the practice of offering same-day ART initiation during home-based HIV testing., Trial Registration: clinicaltrials.gov Identifier: NCT02692027.

Background: Universal antiretroviral therapy (ART), as per the 2015 WHO recommendations, might reduce population HIV incidence. We investigated the effect of universal test and treat on HIV acquisition at population level in a high prevalence rural region of South Africa., Methods: We did a phase 4, open-label, cluster randomised trial of 22 communities in rural KwaZulu-Natal, South Africa. We included individuals residing in the communities who were aged 16 years or older. The clusters were composed of aggregated local areas (neighbourhoods) that had been identified in a previous study in the Hlabisa subdistrict. The study statisticians randomly assigned clusters (1:1) with MapInfo Pro (version 11.0) to either the control or intervention communities, stratified on the basis of antenatal HIV prevalence. We offered residents repeated rapid HIV testing during home-based visits every 6 months for about 4 years in four clusters, 3 years in six clusters, and 2 years in 12 clusters (58 cluster-years) and referred HIV-positive participants to trial clinics for ART (fixed-dose combination of tenofovir, emtricitabine, and efavirenz) regardless of CD4 cell count (intervention) or according to national guidelines (initially ≤350 cells per μL and <500 cells per μL from January, 2015; control). Participants and investigators were not masked to treatment allocation. We used dried blood spots once every 6 months provided by participants who were HIV negative at baseline to estimate the primary outcome of HIV incidence with cluster-adjusted Poisson generalised estimated equations in the intention-to-treat population after 58 cluster-years of follow-up. This study is registered with ClinicalTrials.gov, number NCT01509508, and the South African National Clinical Trials Register, number DOH-27-0512-3974., Findings: Between March 9, 2012, and June 30, 2016, we contacted 26 518 (93%) of 28 419 eligible individuals. Of 17 808 (67%) individuals with a first negative dried blood spot test, 14 223 (80%) had subsequent dried blood spot tests, of whom 503 seroconverted after follow-up of 22 891 person-years. Estimated HIV incidence was 2·11 per 100 person-years (95% CI 1·84-2·39) in the intervention group and 2·27 per 100 person-years (2·00-2·54) in the control group (adjusted hazard ratio 1·01, 95% CI 0·87-1·17; p=0·89). We documented one case of suicidal attempt in a woman following HIV seroconversion. 128 patients on ART had 189 life-threatening or grade 4 clinical events: 69 (4%) of 1652 in the control group and 59 (4%) of 1367 in the intervention group (p=0·83)., Interpretation: The absence of a lowering of HIV incidence in universal test and treat clusters most likely resulted from poor linkage to care. Policy change to HIV universal test and treat without innovation to improve health access is unlikely to reduce HIV incidence., Funding: ANRS, GiZ, and 3ie., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Introduction: In India, to increase human immunodeficiency virus (HIV) case detection, the National Technical Working Group on TB /HIV had made it mandatory to screen for HIV infection among presumptive tuberculosis (TB) cases., Material and Methods: Our study was a cross-sectional study, conducted between June 2015 and December 2016 in a tertiary care institute (JIPMER), in South India, to estimate the prevalence of HIV among presumptive TB cases., Results: Among the 964 presumptive TB cases who attended pulmonary medicine OPD, 189 patients were sputum acid-fast bacilli (AFB) positive. Among the 189 sputum positive cases, 9 were HIV positive. Of the 964 presumptive TB cases, 879 gave consent for HIV testing and 33 (3.7%) turned out to be HIV positive. If only sputum positive cases had been screened for HIV, we would have missed 24 new HIV positive cases. The number needed to screen was 27 among presumptive TB cases and 18 among TB patients., Conclusions: The uptake of HIV testing (91%) and the diagnostic yield of 3.7% of HIV positive cases among the presumptive TB patients is quite high compared to that of the Revised National Tuberculosis Control Programme (RNTCP) mechanism of Puducherry. This reinforces the need to screen all the presumptive cases for HIV infection, to increase HIV case detection so that anti-retroviral therapy (ART) can be initiated early.

New strategies for HIV testing services (HTS) are needed to achieve UN 90-90-90 targets, including diagnosis of 90% of people living with HIV. Task-sharing HTS to trained lay providers may alleviate health worker shortages and better reach target groups. We conducted a systematic review of studies evaluating HTS by lay providers using rapid diagnostic tests (RDTs). Peer-reviewed articles were included if they compared HTS using RDTs performed by trained lay providers to HTS by health professionals, or to no intervention. We also reviewed data on end-users' values and preferences around lay providers preforming HTS. Searching was conducted through 10 online databases, reviewing reference lists, and contacting experts. Screening and data abstraction were conducted in duplicate using systematic methods. Of 6113 unique citations identified, 5 studies were included in the effectiveness review and 6 in the values and preferences review. One US-based randomized trial found patients' uptake of HTS doubled with lay providers (57% vs. 27%, percent difference: 30, 95% confidence interval: 27-32, p < 0.001). In Malawi, a pre/post study showed increases in HTS sites and tests after delegation to lay providers. Studies from Cambodia, Malawi, and South Africa comparing testing quality between lay providers and laboratory staff found little discordance and high sensitivity and specificity (≥98%). Values and preferences studies generally found support for lay providers conducting HTS, particularly in non-hypothetical scenarios. Based on evidence supporting using trained lay providers, a WHO expert panel recommended lay providers be allowed to conduct HTS using HIV RDTs. Uptake of this recommendation could expand HIV testing to more people globally.

Introduction: Knowledge of a person's HIV status during pregnancy is critical for prevention of mother to child transmission of HIV., Objectives: To determine the prevalence and factors associated with unknown HIV status among women delivering in Mulago Hospital., Methods: This was a cross-sectional study of women that had just delivered. The women's demographic characteristics, health seeking behaviour, health system-related factors and knowledge on PMTCT were collected. Fisher's exact test, Wilcoxon rank sum test and logistic regression were used to test associations., Results: The prevalence of unknown HIV status was 2.6% (10/382). Attending ANC at higher level facilities (OR =0.1 95% CI 0.0 - 0.4) and having been counselled for HIV testing during ANC (OR=0.1, 95% CI 0.0 - 0.4) were associated with likelihood of having a known HIV status. Out of the ten women with unknown HIV status, 4/6 who attended ANC in public/government accredited health facilities "opted out" of HIV testing due to personal reasons. Among the four who attended ANC in private clinics, two were not offered HIV testing and one "opted out"., Conclusion: Most participants had a known HIV status at labour (97%). Private clinics need to be supported to provide free quality HCT services in ANC.

Background: There is today no gold standard method to accurately define the time passed since infection at HIV diagnosis. Infection timing and incidence measurement is however essential to better monitor the dynamics of local epidemics and the effect of prevention initiatives., Methods: Three methods for infection timing were evaluated using 237 serial samples from documented seroconversions and 566 cross sectional samples from newly diagnosed patients: identification of antibodies against the HIV p31 protein in INNO-LIA, SediaTM BED CEIA and SediaTM LAg-Avidity EIA. A multi-assay decision tree for infection timing was developed., Results: Clear differences in recency window between BED CEIA, LAg-Avidity EIA and p31 antibody presence were observed with a switch from recent to long term infection a median of 169.5, 108.0 and 64.5 days after collection of the pre-seroconversion sample respectively. BED showed high reliability for identification of long term infections while LAg-Avidity is highly accurate for identification of recent infections. Using BED as initial assay to identify the long term infections and LAg-Avidity as a confirmatory assay for those classified as recent infection by BED, explores the strengths of both while reduces the workload. The short recency window of p31 antibodies allows to discriminate very early from early infections based on this marker. BED recent infection results not confirmed by LAg-Avidity are considered to reflect a period more distant from the infection time. False recency predictions in this group can be minimized by elimination of patients with a CD4 count of less than 100 cells/mm3 or without no p31 antibodies. For 566 cross sectional sample the outcome of the decision tree confirmed the infection timing based on the results of all 3 markers but reduced the overall cost from 13.2 USD to 5.2 USD per sample., Conclusions: A step-wise multi assay decision tree allows accurate timing of the HIV infection at diagnosis at affordable effort and cost and can be an important new tool in studies analyzing the dynamics of local epidemics or the effects of prevention strategies.

We studied posttraumatic stress disorder (PTSD) among a community sample of 500 persons seeking an HIV test. The majority of participants (62.2%) indicated that they had experienced at least one index event that qualified for PTSD, even though a small proportion (5%) actually met the diagnostic criteria for the disorder. Of those who reported an index event, 25 (8.04%) met the diagnostic criteria for PTSD while 286 (91.96%) did not. On average about one-third of participants who did not meet the criteria for PTSD endorsed PTSD symptoms whereas more than three quarters of those who met the full criteria did so. No demographic factors were associated with PTSD caseness, except number of traumatic events. These results are discussed in the context of the need to address traumatic events and PTSD among persons who undergo HIV testing.

Background: Pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate is highly effective against acquisition of HIV infection, and only two cases of infection with a multidrug-resistant virus have been reported under adequate long-term adherence, as evidenced by tenofovir diphosphate concentrations in dried blood spots. We report a case of wild-type HIV-1 infection despite consistent use of emtricitabine and tenofovir disoproxil fumarate., Methods: The patient participated in the Amsterdam PrEP project, a demonstration project of daily and event-driven PrEP. We did extensive testing for HIV, including plasma HIV RNA and nested PCR on bulk peripheral blood mononuclear cells (PBMCs) and sigmoid biopsies after seroconversion., Findings: A 50-year-old man who has sex with men and had been on daily emtricitabine and tenofovir disoproxil fumarate for 8 months presented with fever, urinary tract infection caused by Escherichia coli, anal lymphogranuloma venereum infection, and a positive fourth-generation HIV test. We found an atypical seroconversion pattern, with initially only gp160 antibodies detected in the western blot. HIV RNA could not be detected in plasma, and nested PCR for HIV RNA and DNA on bulk PBMCs and sigmoid biopsies were negative. PrEP was discontinued; 3 weeks later HIV RNA was detected in plasma. No drug-resistant mutations were detected. Tenofovir diphosphate concentrations in dried blood spots were stable and high., Interpretation: To our knowledge, this is the first detailed case report suggesting wild-type HIV-1 infection despite good adherence, evidenced by repeatedly high concentrations of tenofovir diphosphate in dried blood spots. PrEP providers need to be aware that infection can occur despite good adherence. Regular HIV testing and awareness of atypical patterns of seroconversion is highly recommended., Funding: ZonMw, National Institute for Public Health and the Environment, Internal GGD research funds, Aidsfonds, Stichting AmsterdamDiner Foundation, Gilead Sciences, Janssen Pharmaceutica, M A C AIDS Fund, and ViiV Healthcare., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

To report long-term outcomes and toxicity rates after chemotherapy (CHT) followed by radiotherapy (RT) in the highly active antiretroviral therapy (HAART) era in human immunodeficiency virus (HIV) positive patients with head and neck diffuse large B cell lymphomas (HN-DLBCL). Clinical data concerning consecutive HIV patients treated for DLBCL located in head and neck region with CHT and RT were retrospectively reviewed. Systemic treatment consisted of combination CHT agents given with concomitant HAART and regimen was left to oncologists' discretion. Involved field RT was delivered at a total dose of 30-36 Gy (2 Gy per fraction). Survival rates were estimated using the Kaplan-Meier method. Toxicity was evaluated using National Cancer Institute's Common Terminology Criteria for Adverse Events. Overall, 13 patients were included. There were no missing data. Eight patients had advanced disease (stage III-IV = 8; 61.5%). The most common primary tumor location was oral cavity (n = 7) with large mass at presentation. All patients completed the programmed treatment. Severe acute toxicity was observed in one patient, only. Overall, three patients had died and no treatment-related deaths occurred. After a median follow-up of 152 months, the 20-year overall survival and disease-free survival rates were 65.9 and 41.5%, respectively. Globally, there were no RT-related late complications. This data analysis suggested that CHT followed by RT can be safety proposed in the management of patients with HIV-related HN-DLBCL in the HAART era. Further investigations are necessary to validate our results.