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Chronic HIV infection is characterized by persistent inflammation despite antiretroviral therapy (ART). Cannabinoids may help reduce systemic inflammation in people with HIV (PWH). To assess the effects of oral cannabinoids during HIV, ten PWH on ART were randomized (n = 5/group) to increasing doses of oral Δ9-tetrahydrocannabinol (THC): cannabidiol (CBD) combination (2.5:2.5–15:15 mg/day) capsules or CBD-only (200–800 mg/day) capsules for 12 weeks. Blood specimens were collected prospectively 7–21 days prior to treatment initiation and at weeks 0 to 14. Plasma cytokine levels were determined via Luminex and ELISA. Immune cell subsets were characterized by flow cytometry. HIV DNA/RNA were measured in circulating CD4 T-cells and sperm by ultra-sensitive qPCR. Results from both arms were combined for statistical analysis. Plasma levels of IFN-γ, IL-1β, sTNFRII, and REG-3α were significantly reduced at the end of treatment (p ˂ 0.05). A significant decrease in frequencies of PD1+ memory CD4 T-cells, CD73+ regulatory CD4 T-cells, and M-DC8+ intermediate monocytes was also observed (p ˂ 0.05), along with a transient decrease in CD28–CD57+ senescent CD4 and CD8 T-cells. Ki-67+ CD4 T-cells, CCR2+ non-classical monocytes, and myeloid dendritic cells increased over time (p ˂ 0.05). There were no significant changes in other inflammatory markers or HIV DNA/RNA levels. These findings can guide future large clinical trials investigating cannabinoid anti-inflammatory properties.

HIV self-testing (HIVST) offers an alternative to facility-based voluntary counseling and testing (VCT) services, particularly for vulnerable populations such as adolescents. This study aimed to determine the sociodemographic factors associated with adolescents preferring home-based HIVST over facility-based VCT in Kisangani, Democratic Republic of the Congo. A representative cross-sectional study using random sampling in clusters at three levels was conducted among adolescents (aged 15–19 years) to assess their hypothetical preference in home-based HIVST over facility-based VCT by a face-to-face, paper-based, semi-structured questionnaire, and logistic regression for statistical analysis. In 353 households, 754 adolescents were assessed for eligibility, of whom 628 were eligible. A total of 597 adolescents completed the study questionnaire. A majority of participants were aged 18–19 and of female gender. More than two-thirds of participants had never been tested for HIV and had no knowledge about HIVST before this survey. Among 597 adolescents who had completed the study questionnaire, a slight majority of participants (323/597; 54.1% [95% CI: 50.0–58.0]) preferred home-based HIVST over facility-based VCT. In a multivariate analysis, male gender (adjusted OR: 1.5, 95% CI: 1.1–2.1), marriage or partnered civil status (adjusted OR: 1.8, 95% CI: 1.1–3.1), and previous knowledge about HIVST (adjusted OR: 4.2, 95% CI: 2.6–6.8) were associated with preference for home-based HIVST over facility-based VCT. This study demonstrates that more adolescents preferred home-based HIVST over facility-based VCT in Kisangani. These observations suggest the existence of a specific sociodemographic profile associated with the acceptance of HIVST in adolescents living in sub-Saharan Africa.

Background Human papillomavirus (HPV) testing may be feasible for primary cervical cancer screening in low-resource countries. Objective To compare self-sampling by women with clinician-performed sampling for HPV testing in Africa. Search strategy MEDLINE, Google scholar, EMBASE, and several journals were searched from 2000 until 2015 using relevant terms. Selection criteria Selected studies compared self-sampled and clinician-sampled HPV tests. Data collection and analysis Data extraction forms included description of the type of HPV screening, description of any additional intervention components, study design, sample size, follow-up periods, analytic approach, reported numerical outcomes, results, and limitations. Results Twenty-five studies were identified. Women of a wide age range were successful at self-sampling in many African countries. More than 95% of self-samples yielded HPV DNA results. The concordance in test results between self-collected samples and clinician-collected samples was reasonably high in most studies. In all studies, the quality of cytology from self-sampling matched that of clinician-sampling. Women were generally positive about self-collection, but noted some concerns. Conclusion Self-sampling for HPV DNA testing seems to represent a feasible alternative to the Pap test. Further research is needed to provide a solid evidence base to inform using of self-sampling for HPV DNA testing for primary cervical cancer screening.

Background Biological monitoring of antiretroviral treatment (ART) in human immunodeficiency virus (HIV)-infected pediatric population remains challenging. The aim of the present study was to assess the long-term HIV-1 genetic diversity in pol gene in HIV-1-infected children in virological failure under antiretroviral regimen adapted according to the successive World Health Organization (WHO) guidelines for resource-constrained settings. Methods HIV-1 diversity in pol gene was assessed in HIV-1-infected children and adolescents born from HIV-infected mothers (median age at follow-up: 13.8 years) in virological failure (VF+) despite long-term regimen recommended by the WHO. The numbers of nonsynonymous substitutions per potential nonsynonymous site (dN) and of synonymous substitutions at potential synonymous sites (dS) in HIV-1 pol gene and the dN/dS ratios were used to estimate the selective pressure on circulating HIV-1. Results The immunological responses to ART basically corresponded to: 1) Full therapeutic failure with immunological (I-) and virological nonresponses in one-quarter (24.6%) of study children ((I-, VF+) subgroup); 2) Discordant immunovirological responses with paradoxical high CD4 T cell counts (I+) and high HIV-1 RNA load in the remaining cohort patients (75.4%) ((I+, VF+) subgroup). The mean dS was 1.8-fold higher in (I+, VF+) than (I-, VF+) subgroup (25.9 ± 18.4 vs. 14.3 ± 10.8). In the (I+, VF+) subgroup, the mean dS was 1.6-fold higher than the mean dN. Finally, the mean dN/dS ratio was 2.1-fold lower in (I+, VF+) than (I-, VF+) subgroup (0.6 ± 0.3 vs. 1.3 ± 0.7), indicating purifying selection in the immunovirological discordant (I+, VF+) subgroup and positive selection in the immunovirological failure (I-, VF+) subgroup. Conclusions Children and adolescents in immunovirological therapeutic failure harbor positive selection of HIV-1 strains favoring diversifying in pol-encoded amino acids. In contrast, children with persistent discordant immunovirological responses show accumulation of mutations and purifying selection in pol gene sequences, indicating limited genetic evolution and likely suggesting genetic adaptation of viruses to host functional constraints.

Background High-risk human papillomavirus (HR-HPV) anal infection is a major problem among men who have sex with men (MSM) living in sub-Saharan Africa. The prevalence of anal HR-HPV infection and associated risk factors were estimated in a cross-sectional study in MSM living in Bamako, Mali. Methods MSM consulting at sexual health center of the National NGO Soutoura, Bamako, were prospectively included. Sociodemographic and clinical-biological data were collected. HPV detection and genotyping were performed from anal swabs using multiplex real-time PCR. Risk factors associated with anal HPV infection were assessed by logistic regression analysis. Results Fifty MSM (mean age, 24.2 years; range, 18–35) of which 32.0% were infected with HIV-1, were prospectively included. The overall prevalence of anal HPV infection of any genotypes was 70.0% (35/50) with 80.0% (28/35) of swabs positive for HR-HPV. HR-HPV-58 was the most detected genotype [13/35 (37.1%)], followed by HR-HPV-16 and low-risk (LR)-HPV-6 [12/35 (34.2%)], LR-HPV-40 [10/35 (28.6%)], LR-HPV-11 [9/35 (25.7%)], HR-HPV-51 [8/35 (22.8%)], HR-HPV types 18 and 39 [7/35 (20.0%)] and LR-HPV-43 [6/35 (17.1%)]. HR-HPV-52 and LR-HPV-44 were detected in lower proportions [5/35 (14.3%) and 4/35 (11.4%), respectively]. LR-HPV-42, LR-HPV-54, HR-HPV-31 and HR-HPV-35 were detected in very low proportions [3/35 (8.5%)]. Multiple HR-HPV infections were diagnosed in one-third of anal samples [16/50 (32.0%)], including around half of HR-HPV-positive anal swabs [16/35 (45.7%)]. More than half [27/50 (54.0%)] swabs were infected by at least one of HPV genotypes targeted by Gardasil-9® vaccine, including a majority of vaccine HR-HPV [22/50 (44.0%)]. In multivariate analysis, participation to sex in group was associated with anal infection by multiple HPV (aOR: 4.5, 95% CI: 1.1–18.1%; P = 0.032), and HIV-1 infection was associated with anal shedding of multiple HR-HPV (aOR: 5.5, 95% CI: 1.3–24.5%; P = 0.024). Conclusions These observations indicate that the MSM community living in Bamako is at high-risk for HR-HPV anal infections, with a unique epidemiological HPV genotypes profile and high prevalence of anal HPV covered by the Gardasil-9® vaccine. Scaling up prevention strategies against HPV infection and related cancers adapted to this highly vulnerable MSM community should be urgently prioritized with innovative interventions.

Background: We herein report a cross-sectional study which consecutively enrolled adult women from the community living in N'Djamena, Chad. The aim of the study was to estimate the burden of asymptomatic genital carriage of common curable sexually transmitted infections (STIs) (including Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis) and genital Mycoplasma spp., as well as to assess their possible associated risk factors. Methods: A total of 251 women were consecutively included and screened for common curable STIs as well as for genital mycoplasma carriage by multiplex real-time PCR. Results: Only seven (2.8%) women were found to be infected with at least one common STI by multiplex real-time PCR: C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis were recovered from 3 (1.2%), 1 (0.4%), 4 (1.6%) and 1 (0.4%) women, respectively. No sociodemographic and behavioral characteristics could be associated in multivariate analysis with the genital carriage of the four detected common curable STIs. In contrast, the prevalence of genital mycoplasmas was much higher (54.2%) with a predominance of Ureaplasma parvum (42.6% of the total population). Conclusion: Our study shows a low prevalence of common STIs in contrast with a high prevalence of mycoplasmas among asymptomatic adult women recruited on a community basis in Chad. These observations highlight the need for etiologic management of STIs relying on PCR-based techniques rather than a syndromic approach in resource-limited countries.

Objectives The predictive efficacy of integrase (IN) strand transfer inhibitors (INSTIs) was investigated in HIV-infected children born to HIV-infected mothers in Africa. Methods Plasma was collected at the Complexe Pédiatrique of Bangui, Central African Republic, from INSTI-naive children (n = 8) and adolescents (n = 10) in virological failure (viral load >1000 copies/mL) after 5 years of first- and/or second-line combination ART (cART). IN, reverse transcriptase (RT) and protease (P) genes were genotyped and drug resistance mutations (DRMs) to INSTIs, NRTIs, NNRTIs and PIs were interpreted using the Stanford algorithm. Results Successful IN, RT and P genotypes were obtained for 18, 13 and 15 children (median age 11 years, range 5–18; 8 were female), respectively. Two (2/18; 11.1%) viruses from children treated with a first-line regimen had INSTI DRMs at codon 138 (E138K and E138T), which is known to harbour major resistance mutations, and also had the accessory mutations L74I, G140K, G140R and G163R. The majority (16/18; 88.9%) of HIV-1 IN sequences demonstrated full susceptibility to all major INSTIs with a high frequency of natural polymorphic mutations. Most (12/15; 80%) genotyped viruses harboured at least one major DRM conferring resistance to at least one of the WHO-recommended antiretroviral drugs (NNRTIs, NRTIs and PIs) prescribed in first- and second-line regimens. Conclusions INSTIs could be proposed in first-line regimens in the majority of African children or adolescents and may constitute relevant therapeutic alternatives as second- and third-line cART regimens in HIV-infected children and adolescents living in sub-Saharan Africa.

Although patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) show comparable or very similar manifestations, the therapeutic approaches of these respiratory viral infections are different, which requires an accurate diagnosis. Recently, the novel multiplex real-time reverse transcription-polymerase chain reaction assay AMPLIQUICK® Respiratory Triplex (BioSynex SA, Illkirch-Graffenstaden, France) allows simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV in respiratory tract samples. We herein evaluated the performance of the AMPLIQUICK® Respiratory Triplex for the detection of the four viruses in respiratory specimens, using Allplex™ Respiratory Panel 1 and 2019-nCoV assays (Seegene, Seoul, Korea) as reference comparator assays. A total of 359 archived predetermined respiratory samples, including 83, 145, 19 and 95 positive specimens for SARS-CoV-2, influenza A, influenza B and RSV respectively, were included. The AMPLIQUICK® Respiratory Triplex showed high concordance with the reference assays, with an overall agreement for SARS-CoV-2, influenza A, influenza B, and RSV at 97.6%, 98.8%, 98.3% and 100.0%, respectively, and high κ values ranging from 0.93 to 1.00, indicating an almost perfect agreement between assays. Furthermore, high correlations of cycle threshold (Ct) values were observed for positive samples of the four viruses between the AMPLIQUICK® Respiratory Triplex and comparator assays, with an overall high agreement between Ct values assessed by Bland-Altman analyses. In conclusion, these observations demonstrate that the multiplex AMPLIQUICK® Respiratory Triplex is a reliable assay for the qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV in respiratory specimens, which may prove useful for streamlining diagnostics during the winter influenza-seasons.

Facing the ongoing pandemic caused by SARS-CoV-2, there is an urgent need for serological assays identifying individuals previously infected by coronavirus disease 2019 (COVID-19), including rapid diagnostic tests (RDTs). We herein compared five new CE-IVD-labeled commercially available SARS-CoV-2 whole-blood finger-stick IgG/IgM combined RDTs, in parallel according to the manufacturers' instructions, with two serum panels obtained from 48 patients with confirmed COVID-19 (panel I) and from a group of 52 patients randomly selected, for whom serum samples collected before the COVID-19 epidemic (from October 1 to November 30, 2019) were negative for SARS-CoV-2 IgG (panel II). We found a sensitivity of 95.8 %, 91.6 %, 92.3 %, 97.9 % and 91.4 %, and a specificity of 98.1 %, 86.5 %, 100 %, 98.1 % and 84.6 %, for BIOSYNEX COVID-19 BSS (IgG/IgM) (Biosynex Swiss SA, Freiburg, Switzerland), Humasis COVID-19 IgG/IgM Test (Humasis Co., Ltd., Gyneonggi, Republic of Korea), LYHER COVID-19 IgM/IgG Rapid Test (Medakit Ltd, Hong Kong, China), SIENNA™ COVID-19 (IgG/IgM) Rapid Test Cassette (Salofa Oy, Salo, Finland) and NG-BIOTECH COVID-19 (IgG/IgM) (NG-Biotech, Guipry, France), respectively. Commercially available SARS-CoV-2 IgG/IgM combined RDTs have a sufficient sensitivity for identifying individuals with past SARS-CoV-2 infection, but some RDTs may lack of specificity, with risk of false positivity mainly for the IgM band.

We aimed to evaluate the rates of false-positive test results of three rapid diagnostic tests (RDTs) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific immunoglobulin G (IgG) and IgM detection. Two serum panels from patients hospitalized in Paris, France, and from patients living in Bangui, Central African Republic, acquired before the 2019 COVID-19 outbreak, were tested by 3 CE IVD-labeled RDTs for SARS-CoV-2 serology (BIOSYNEX® COVID-19 BSS [IgG/IgM]; SIENNA™ COVID-19 IgG/IgM Rapid Test Cassette; NG-Test® IgG-IgM COVID-19). Detectable IgG or IgM reactivities could be observed in 31 (3.43%) of the 902 IgG and IgM bands of the 3 RDTs used with all pre-epidemic sera. The frequencies of IgG/IgM reactivities were similar for European (3.20%) and African (3.55%) sera. IgM reactivities were observed in 9 European and 14 African sera, while IgG reactivity was observed in only 1 African serum (15.1% vs. 0.66%). The test NG-Test® IgG-IgM COVID-19 showed the highest rates of IgG or IgM reactivities (6.12% [18/294]), while the test BIOSYNEX® COVID-19 BSS (IgG/IgM) showed the lowest rate (1.36% [4/294]). Some combinations of 2 RDTs in series allowed decreasing significantly the risk of false-positive test results. Our observations point to the risk of false-positive reactivities when using currently available RDT for SARS-CoV-2 serological screening, especially for the IgM band, even if the test is CE IVD-labeled and approved by national health authorities, and provide the rational basis for confirmatory testing by another RDT in case of positive initial screening.

Recently, Pang and colleagues reported that thermal inactivation of clinical samples at +56 °C adversely affected the efficiency of RT-PCR for SARS-CoV-2 detection, likely by disrupting the integrity of the SARS-CoV-2 RNA with subsequent risk of false negative results [1]. However, the impact of heat inactivation on nucleic acid amplification-based testing results remains controversial. Thus, Chen and colleagues reported that the inactivation by incubating sample at +56 °C for 30 min had no significant effect on the detection of SARS-CoV-2 by real-time RT-PCR [2]. In April 2020, Abbott Molecular (Des Plaines, IL, USA) received emergency use authorization (EUA) approval from Food and Drug Administration (FAD), USA, for real-time RT-PCR test to detect SARS-CoV-2 RNA in clinical specimens from suspected COVID-19 patients [3]. The RealTime SARS-CoV-2 assay (Abbott Molecular) amplifies target regions of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) and nucleocapsid (N) genes. The assay is run on the automated Abbott m2000 SP/rt platform currently in use internationally by reference laboratories and university hospitals. The RealTime SARS-CoV-2 assay has been validated for clinical use, and with the high-throughput, fully automated Abbott m2000 SP/rt system, this assay will accelerate the pace of SARS-CoV-2 testing [4]. The instructions for use of the RealTime SARS-CoV-2 assay (Abbott Molecular; reference 09N77-095) do not give details on pre-analytical processing of samples, and only claims that all human sourced materials should be considered infectious and be handled using appropriate laboratory biosafety practices [3]. Iorder to provide protection of our laboratory staff, and in the absence of instruction for clinical specimen inactivation from the manufacturer, we investigated herein whether thermal inactivation could affect the results of viral detection using RealTime SARS-CoV-2 assay (Abbott Molecular).

International audience; Introduction: Human papillomavirus (HPV) are the causative agent of mucosal neoplasia. Both cervical, anal and oropharyngeal cancers incidence is constantly increasing, making the HPV infection, a significant worldwide concern. Together, the CD8+ T cytotoxic cell-mediated response and the HPV-specific antibody response control most of the HPV infections before the development of cancers. Areas covered: We searched the MEDLINE and EMBASE databases and identified 228 eligible studies from 1987 to 2019 which examines both naturally acquired and vaccine induced humoral immunity against HPV infection in female and male subjects from worldwide origin. Herein, we synthesize current knowledge on the features of systemic and mucosal humoral immunity against HPV. We discuss the issues of the balance between the viral clearance or the escape to the host immune response, the differences between natural and vaccine-induced HPV-specific antibodies and their neutralizing capability. We also discuss the protection afforded after natural infection or following prophylactic vaccination. Expert opinion: Understanding the antibody response induced by HPV infection has led to the design of first-generation prophylactic vaccines. Now, prophylactic vaccination induces protective and long-lasting antibody response which would also strengthened the natural moderate humoral response in people previously exposed to the virus.

Background Biological monitoring of antiretroviral treatment (ART) in human immunodeficiency virus (HIV)-infected pediatric population remains challenging. The aim of the present study was to assess the long-term HIV-1 genetic diversity in pol gene in HIV-1-infected children in virological failure under antiretroviral regimen adapted according to the successive World Health Organization (WHO) guidelines for resource-constrained settings. Methods HIV-1 diversity in pol gene was assessed in HIV-1-infected children and adolescents born from HIV-infected mothers (median age at follow-up: 13.8 years) in virological failure (VF+) despite long-term regimen recommended by the WHO. The numbers of nonsynonymous substitutions per potential nonsynonymous site (dN) and of synonymous substitutions at potential synonymous sites (dS) in HIV-1 pol gene and the dN/dS ratios were used to estimate the selective pressure on circulating HIV-1. Results The immunological responses to ART basically corresponded to: 1) Full therapeutic failure with immunological (I-) and virological nonresponses in one-quarter (24.6%) of study children ((I-, VF+) subgroup); 2) Discordant immunovirological responses with paradoxical high CD4 T cell counts (I+) and high HIV-1 RNA load in the remaining cohort patients (75.4%) ((I+, VF+) subgroup). The mean dS was 1.8-fold higher in (I+, VF+) than (I-, VF+) subgroup (25.9 ± 18.4 vs. 14.3 ± 10.8). In the (I+, VF+) subgroup, the mean dS was 1.6-fold higher than the mean dN. Finally, the mean dN/dS ratio was 2.1-fold lower in (I+, VF+) than (I-, VF+) subgroup (0.6 ± 0.3 vs. 1.3 ± 0.7), indicating purifying selection in the immunovirological discordant (I+, VF+) subgroup and positive selection in the immunovirological failure (I-, VF+) subgroup. Conclusions Children and adolescents in immunovirological therapeutic failure harbor positive selection of HIV-1 strains favoring diversifying in pol-encoded amino acids. In contrast, children with persistent discordant immunovirological responses show accumulation of mutations and purifying selection in pol gene sequences, indicating limited genetic evolution and likely suggesting genetic adaptation of viruses to host functional constraints.

Adult outpatients attending the main sexually transmitted infection clinic of Bangui, Central African Republic, were prospectively subjected to a multiplex rapid diagnostic test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). In group I (n = 208) of patients already followed for HIV, 6 (2.9%) were unexpectedly negative, thus corresponding to false positive for HIV by the national HIV algorithm; hepatitis B surface antigen and HCV positivities were high (18.7% and 4.3%, respectively). In group II (n = 71) of patients with unknown HIV status, at least 1 chronic viral disease was diagnosed in 26 (36.6%) patients, including 5 (7.1%) HIV, 17 (23.9%) HBV, and 3 (4.2%) HCV infections.

Background The accuracy of CD4 T cell monitoring by the recently developed flow cytometry-based CD4 T cell counting Muse™ Auto CD4/CD4% Assay analyzer (EMD Millipore Corporation, Merck Life Sciences, KGaA, Darmstadt, Germany) was evaluated in trained lay providers against laboratory technicians. Methods After 2 days of training on the Muse™ Auto CD4/CD4% analyzer, EDTA-blood samples from 6 HIV-positive and 4 HIV-negative individuals were used for CD4 T cell counting in triplicate in parallel by 12 trained lay providers as compared to 10 lab technicians. Results Mean number of CD4 T cells in absolute number was 829 ± 380 cells/μl by lay providers and 794 ± 409 cells/μl by technicians (P > 0.05); and in percentage 36.2 ± 14.8%CD4 by lay providers and 36.1 ± 15.0%CD4 by laboratory technician (P > 0.05). The unweighted linear regression and Passing-Bablok regression analyses on CD4 T cell results expressed in absolute count revealed moderate correlation between CD4 T cell counts obtained by lay providers and lab technicians. The mean absolute bias measured by Bland–Altman analysis between CD4 T cell/μl obtained by lay providers and lab technicians was −3.41 cells/μl. Intra-assay coefficient of variance (CV) of Muse™ Auto CD4/CD4% in absolute number was 10.1% by lay providers and 8.5% by lab technicians (P > 0.05), and in percentage 5.5% by lay providers and 4.4% by lab technicians (P > 0.05). The inter-assay CV of Muse™ Auto CD4/CD4% in absolute number was 13.4% by lay providers and 10.3% by lab technicians (P > 0.05), and in percentage 7.8% by lay providers and 6.9% by lab technicians (P > 0.05). Conclusions The study demonstrates the feasibility of CD4 T cell counting using the alternative flow cytometer Muse™ Auto CD4/CD4% analyzer by trained lay providers and therefore the practical possibility of decentralization CD4 T cell counting to health community centers.

BACKGROUND The HIV/HCV/HBsAg Triplex consists in manually performed, visually interpreted, lateral flow, immunochromatographic rapid diagnostic test simultaneously detecting in 15min human immunodeficiency virus (HIV)-1 and HIV-2 and hepatitis C virus (HCV)- specific antibodies (Ab) (IgG and IgM) and hepatitis B virus (HBV) surface antigen (HBsAg) in serum, plasma and whole blood. METHODS A hospital-based cross-sectional study was conducted on a prospective panel of serum samples from adult inpatients included from routine analysis irrespectively of age and sex, including 250 sera positive for HIV-1-specific Ab, 250 for HCV-specific Ab, 250 for HBsAg and 250 sera negative for HIV- and HCV- Ab and HBsAg, and from 110 HIV-2-infected patients living in Ivory Coast, according to the results obtained by the reference chemiluminiscent microparticle immunoassay (CMIA) Abbott Architect i2000SR analyzer (Abbott Diagnostic, Chicago, IL, USA). Among HCV-seropositive sera, 187 were positive for HCV RNA (chronic infection), whereas 63 were negative (resolved infection), respectively. Serum samples were further tested blindly by HIV/HCV/HBsAg Triplex according to manufacturers' recommendations. RESULTS HIV/HCV/HBsAg Triplex showed very high sensitivity and specificity, as well as excellent concordance with CMIA Abbott results, as shown in the Table. Lower sensitivity was observed only in individuals who had cleared their HCV infection (presence of HCV-specific Ab in absence of HCV RNA). The mean lower limit of HBsAg detection was 2.38±0.63 IU/ml. Erythrocytes-spiked serum samples gave similar results than serum samples. CONCLUSIONS Advantages of HIV/HCV/HBsAg Triplex for HIV-1, HIV-2, HCV and HBV include the requirement for less overall specimen volume, fewer finger-sticks if capillary whole blood is used, cost savings through lower cost per virus tested, improved patient flow with results for multiple viruses available at the same time, overall service delivery efficiencies with less time required per infected patient; and patient benefits from fewer visits and lower cost associated with each clinic attendance. The screening of chronic HIV, HCV and HBV by multiplex HIV-1/HIV-2/HCV/HBsAg Triplex may improve the "cascade of screening" and quite possibly linkage-to-care with reduced cost.

To compare the practicability (usability and satisfaction) and analytical performances of VitaPCR™ Flu AB Assay (Credo Diagnostics Biomedical Pte. Ltd., Singapore, Republic of Singapore) and Xpert® Xpress Flu/RSV kit (Cepheid, Sunnyvale, USA), two rapid point-of-care (POC) nucleic acid amplification tests (NAATs) by reference to multiplex RT-PCR for respiratory viruses. Nasopharyngeal swabs (n=117) were collected from patients with influenza-like illness in Paris, France. Thawed specimens were further analyzed with both NAATs. The usability was comparable for both NAATs. Satisfaction questionnaire was better for the VitaPCR™ platform for the short time of test result in 20 minutes. Both NAATs showed comparable sensitivities (VitaPCR

Zinc tetra-ascorbo-camphorate (or drug “C14”) is a synthetic monoterpenoid derivative that has potent anti-HIV-1 activity in vitro. In this study, we evaluated the in vitro antiviral properties of C14 against human papillomavirus (HPV). Inhibition assay of HPV-16-pseudovirus (PsVs) adsorption on COS-7 cells by C14 was used. C14 inhibited HPV-16-PsVs adsorption with IC50 ranging between 2.9 and 8.3 μM and therapeutic indexes between >410 to >3,300. Pretreatment of COS-7 cells with C14 before addition of HPV-16-PsV was associated with more potent anti-HPV activity than simultaneous deposition on COS-7 of HPV-16-PsV and C14, suggesting that C14 is more effective in preventing HPV attachment to target cells than post-HPV adsorption viral events. Overall, these in vitro studies suggest that the monoterpenoid zinc tetra-ascorbo-camphorate molecule may be suitable for further clinical evaluations as potential microbicide or therapeutic drug., Terpenoid; Camphor derivates; L-ascorbic acid conjugate; Zn metal; HPV; HPV-16; Pseudovirus; Inhibition assay.

Background: Opportunities for HIV testing could be enhanced by offering HIV self-testing (HIVST) in populations that fear stigma and discrimination when accessing conventional HIV counselling and testing. Field experience with HIVST was poorly reported in French-speaking African countries. Objective: To investigate the usability of HIVST in Bangui, Central African Republic. Methods: The prototype self-test Exacto® Test HIV (Biosynex, Strasbourg, France) was used to assess the usability of HIVST in 300 adults living in Bangui, according to WHO technical recommendations. Simplified and easy-to-read leaflet was translated in French and Sango. Results: Preliminary survey in 3,484 adult volunteers including students, men who have sex with men and female sex workers living in Bangui showed that previous HIV testing in conventional centres for HIV counselling and testing was relatively infrequent and that acceptability of HIVST was elevated, although high heterogeneity could be observed between groups. The notice in French and Sango of Exacto® Test HIV were chosen in 242/300 (80.6%) and 58/300 (19.4%), respectively. It was correctly understood in 273/300 (91.0%). The majority (275/300; 91.6%) correctly performed the HIV self-test; however, 71/300 (23.0%) asked for oral assistance. Most of the participants (273/300; 91.0%) found that performing of the self-test was very easy or easy, and less than Most of participants (273/300; 91.0%) found that performing of the self-test was very easy or easy and less than 1.0% (2/300) found it difficult. Overall the result were correctly interpreted in 96.9% (3,782/3,900), the reading/interpretion errors concerned the positive (96/1,800;5.3%), invalid (17/600;2.8%) and negative (5/1,500; 0.3%) self-test. The Cohen's coefficient κwas 0.94. The main obstacle for HIVST was the educational level, with interpretation difficulties in poorly educated people. Conclusions: Our observations on profane adults living in Central African Republic, demonstrate: (i) the need to adapt the notice of instruction to African public, including educational pictograms as well as notice in vernacular language(s); (ii) the frequent difficulties in understanding the notice with frequent misinterpretation of test results; (iii) and the generally good usability of the HIV self-test despite these latter pitfalls. More research on exploring the best strategy (i.e. supervised versus unsupervised strategies) for different high- and low- risk populations in resource-constrained settings remains needed.

Background Cervical cancer is caused by HR-HPV infection. Self-collection of genital specimens and HPV DNA testing are methods increasing screening rates. The GYNAUTO-CHAD study compared the acceptability and HPV DNA diagnostic accuracy of clinician-collected endocervical sample with swab (as reference collection) and genital self-collection method with veil (V-Veil-Up Gyn Collection Device, V-Veil-Up Pharma Ltd., Nicosia, Cyprus) in adult women living in N’Djamena, Chad. Methods Five of the 10 districts of N’Djamena were randomly selected for inclusion. Peer educators contacted women to participate to the survey by coming to the clinic for women’s sexual health ‘La Renaissance Plus’. A clinician performed pelvic examination and endocervical sampling using swab. Genital secretions were also obtained by self-collection using veil. Both clinician- and self-collected specimens were tested for HR-HPV DNA using Anyplex™ II HPV28 genotyping test (Seegene, Seoul, South Korea). Acceptability and accuracy of both collection methods were assessed. Results 253 women (mean, 35.0 years) were prospectively enrolled. HPV prevalence was 22.9%, including 68.9% of HR-HPV (total HR-HPV prevalence: 15.8%), with unusual HR-HPV genotypes distribution and preponderance (70%) of HR-HPV targeted by Gardasil-9® vaccine. Veil-based genital self-collection showed high acceptability (96%), feasibility and satisfaction. Self-collection by veil was non-inferior to clinician-based collection for HR-HPV DNA testing, with ‘good’ agreement between both methods, high sensitivity (95.0%; 95%CI: 88.3–100.0%) and specificity (88.2%; 95%CI: 83.9–92.6%). Remarkably, the rates of HPV DNA and HR-HPV DNA positivity were significantly higher (1.67- and 1.57- fold, respectively) when using veil-based collection than clinician-collection. Conclusion These observations highlight the unsuspected high burden of cervical oncogenic HR-HPV infection in Chadian women. Self-collection of genital secretions using the V-Veil-Up Gyn Collection Device constitutes a simple, highly acceptable and powerful tool to collect genital secretions for further molecular testing and screening of oncogenic HR-HPV that could be easily implemented in the national cervical cancer prevention program in Chad. Disclosure No significant relationships.

Background We herein assess the HPV detection and HPV-related cervical lesions in immigrant African women living in France. Methods In 2018, immigrant African adult women attending for sexual health and HIV care a French healthcare facility, were included and subjected to endocervical swabs and Pap smear. HPV DNA was detected by multiplex real-time PCR (AnyplexTM II HPV28, Seegene, Seoul, South Korea). Results 50 African immigrant women (mean age, 41.7) residing in France for an average of 10.7 years (range 1–32), including 74.0% of HIV-positive and 26.0% of HIV-negative, were prospectively included. HPV prevalence was 68.0%, with 56.0% of HR-HPV and 24.0% of multiple HPV. Unexpectedly, the non-vaccine HR-HPV-68 (20.0%) was the predominant genotype, followed by the Gardasil-9® vaccine HR-HPV-58 (14.0%). HPV-16 and HPV-18 were respectively detected in 6.0% and 10.0%. HIV-infected women were more infected with HR-HPV (62.2%) and multiple HR-HPV (16.2%) than HIV-negative women (38.4% and 7.7%, respectively), (P=0.19 and P=0.66, respectively). Most women (84.0%) showed normal cytology, but 16.0% exhibited cervical abnormalities, including 6.0% of Low-grade Squamous Intraepithelial Lesions (LSIL) and Abnormal Squamous Cells with Unknown Significance (ASCUS), and 4.0% of High-grade Squamous Intraepithelial Lesions (HSIL). HPV-16 and HPV-18 were detected in one woman with HSIL. Finally, 87.5% of the study women with cervical abnormalities were HIV-positive, while only one HIV-negative woman showing cervical abnormalities. Conclusion These findings highlight the unsuspected high burden of cervical HR-HPV infections often associated with cervical abnormalities in the first-generation immigrant women originating from sub-Saharan Africa and residing in France. These observations also point out the atypical epidemiological profile of cervical HPV infection with a rare and non-vaccine high-risk genotype being the most detected HPV, raising thus a concern about the low predictive efficacy of the Gardasil-9® vaccine in the prevention of the main genotypes circulating in these specific population residing in France. Disclosure No significant relationships.

Background We assessed the prevalence and risk factors of anal and oral high-risk (HR) human papillomavirus (HPV) infection in human immunodeficiency virus–uninfected men who have sex with men (MSM) and take preexposure prophylaxis (PrEP) in France. Methods Anal and oral samples were screened by multiplex real-time polymerase chain reaction (Anyplex II HPV 28; Seegene) for HPV DNA. Results A total of 61 unvaccinated MSM (mean age, 36.1 years) were enrolled. Anal HPV and HR-HPV prevalences were 93.4% and 81.9%, respectively, and oral HPV and HR-HPV prevalences, 33.9% and 19.6%, respectively. HR-HPV type 33 was the most detected genotype, in both anal and oral samples. Among MSM, 68.8% carried ≥1 anal HPV type targeted by the 9-valent Gardasil-9 vaccine; all oral HPV-positive samples carried ≥1 strain included in the vaccine. Condomless receptive anal intercourse and history of anal gonorrhea were the main factors associated with increased risk for anal HPV infection (adjusted odds ratio, 10.4) and anal infection with multiple HR-HPV genotypes (5.77), respectively. Conversely, having had, French MSM using PrEP are at high risk for both anal and oral carriage of HR-HPV. Although PrEP alone constitutes a promising tool for reducing and preventing HIV in MSM, it remains necessary to associate PrEP with sexual health interventions.

Background. Sexually transmitted infections (STIs) are highly prevalent in sub-Saharan Africa. Genital self-sampling may facilitate the screening of STIs in hard-to-reach remote populations far from large health care centers and may increase screening rates. The cross-sectionalGYNAUTO-STIstudy was carried out to assess the performance of a novel genital veil (V-Veil-Up Gyn Collection Device, V-Veil-Up Pharma, Ltd., Nicosia, Cyprus) as a genital self-sampling device to collect genital secretions to diagnose STIs by molecular biology as compared to reference clinician-collected genital specimens, in adult African women.Methods. Adult women living in N’Djamena, the capital city of Chad, were recruited from the community and referred to the clinic for women’s sexual health “La Renaissance Plus”. A clinician obtained an endocervical specimen using flocked swab. Genital secretions were also obtained by self-collection using veil. Both clinician- and self-collected specimens were tested for common curable STIs (includingChlamydia trachomatis,Neisseria gonorrhoeae,Mycoplasma genitalium, andTrichomonas vaginalis) and genitalMycoplasmaspp. by multiplex real-time PCR (Allplex™ STI Essential Assay, Seegene, Seoul, South Korea). Test positivities for both collection methods were compared by assessing methods agreement, sensitivity, and specificity.Results. A total of 251 women (mean age, 35.1 years) were prospectively enrolled. Only seven (2.8%) women were found to be infected with at least one common STIs [C. trachomatis: 3 (1.2%),N. gonorrhoeae: 1 (0.4%),M. genitalium: 4 (1.6%) andT. vaginalis: 1 (0.4%)], while the prevalence of genital mycoplasmas was much higher (54.2%) with a predominance ofUreaplasma parvum(42.6%). Self-collection by veil was non-inferior to clinician-based collection for genital microorganisms DNA molecular testing, with “almost perfect” agreement between both methods, high sensitivity (97.0%; 95%CI: 92.5-99.2%), and specificity (88.0%; 95%CI: 80.7-93.3%). Remarkably, the mean total number of genital microorganisms detected per woman was 1.14-fold higher in self-collected specimens compared to that in clinician-collected specimens.Conclusions. Veil-based self-collection of female genital secretions constitutes a convenient tool to collect in gentle way cervicovaginal secretions for accurate molecular detection of genital bacteria. Such sampling procedure could be easily implemented in STIs clinics in sub-Saharan Africa.

BackgroundWe conducted in 2018 a descriptive, quantitative, population-based, cross-sectional survey estimating the prevalence of cervical high-risk human papillomavirus (HR-HPV) infection and associated risk factors among adult women living in N'Djamena, Chad.MethodsFive of the 10 districts of N'Djamena were randomly selected for inclusion. Peer educators contacted adult women in community-churches or women association networks to participate in the survey and come to the clinic for women's sexual health "La Renaissance Plus", N'Djamena. Medical, socio-demographical and behavioral informations were collected. HPV DNA was detected and genotyped in endocervical swab using Anyplex II HPV28 genotyping test (Seegene, Seoul, South Korea).Results253 women (mean age, 35.0 years; range, 25-65) including 3.5% of HIV-positive women were prospectively enrolled. The prevalence of HPV infection was 22.9%, including 68.9% of HR-HPV infection and 27.6% being infected with multiple genotypes, providing a total HR-HPV prevalence of 15.8% (95% CI%: 11.3-20.3). The most prevalent HR-HPV genotypes were HPV-58, HPV-35, HPV-56, HPV-31, HPV-16, HPV-45, HPV-52 and HPV-18. HPV types targeted by the prophylactic Gardasil-9 vaccine were detected in nearly 70% (67.5%) and HPV-58 was the most frequently detected. HIV infection was a risk factor strongly associated with cervical infection with any HPV [adjusted Odds ratio (aOR): 17.4], multiple types of HPV (aOR: 8.9), HR-HPV (aOR: 13.2) and cervical infection with multiple HR-HPV (aOR: 8.4).ConclusionThese observations highlight the unsuspected high burden of cervical HR-HPV infection in Chadian women, and point the potential risk of further development of HPV-associated cervical precancerous and neoplastic lesions in a large proportion of women in Chad. The high rate of preventable Gardasil-9 vaccine genotypes constitutes the rationale for introducing primary vaccine prevention against cervical cancer in young female adolescents living in Chad.

Adult Chadian women from 5 of the 10 districts of N’Djamena, the capital city of Chad, were randomly selected for inclusion. Peer educators contacted adult women in community-churches or women association networks to participate to the survey and come to the clinic for women’s sexual health “La Renaissance Plus”, N'Djamena. Medical, socio-demographical and behavioral informations were collected. HPV DNA was detected and genotyped in endocervical swab using Anyplex™ II HPV28 genotyping test (Seegene, Seoul, South Korea).

Objectives. We evaluated the performances of Amplix real-time PCR platform developed by Biosynex (Strasbourg, France), combining automated station extraction (Amplix station 16 Dx) and real-time PCR (Amplix NG), for quantifying plasma HIV-1 RNA by lyophilized HIV-1 RNA-based Amplix reagents targeting gag and LTR, using samples from HIV-1-infected adults from Central African Republic. Results. Amplix real-time PCR assay showed low limit of detection (28 copies/mL), across wide dynamic range (1.4–10 log copies/mL), 100% sensitivity and 99% specificity, high reproducibility, and accuracy with mean bias < 5%. The assay showed excellent correlations and concordance of 95.3% with the reference HIV-1 RNA load assay (Roche), with mean absolute bias of +0.097 log copies/mL by Bland-Altman analysis. The assay was able to detect and quantify the most prevalent HIV-1 subtype strains and the majority of non-B subtypes, CRFs of HIV-1 group M, and HIV-1 groups N and O circulating in Central Africa. The Amplix assay showed 100% sensitivity and 99.6% specificity to diagnose virological failure in clinical samples from antiretroviral drug-experienced patients. Conclusions. The HIV-1 RNA-based Amplix real-time PCR platform constitutes sensitive and reliable system for clinical monitoring of HIV-1 RNA load in HIV-1-infected children and adults, particularly adapted to intermediate laboratory facilities in sub-Saharan Africa.