Living conditions, HIV and gender affirmation care pathways of transgender people living with HIV in France: a nationwide, comprehensive, cross-sectional, community-based research protocol (ANRS Trans&HIV).

INTRODUCTION: Transgender identity is poorly accepted in France, and data on living conditions and the daily difficulties transgender people encounter are scarce. This lack of data reinforces their invisibility in social life, contributes to their stigmatisation and probably increases the burden of HIV infection, especially for HIV-positive transgender people (TRHIV). The main objective of the community-based research study ANRS Trans&HIV is to identify personal and social situations of vulnerability in TRHIV, the obstacles they encounter in terms of access to and retention in medical care, and their gender affirmation and HIV care needs. METHODS AND ANALYSIS: ANRS Trans&HIV is a national, comprehensive, cross-sectional survey of all TRHIV currently being followed in HIV care units in France. TRHIV women are exclusively included in the quantitative component, and TRHIV men in the qualitative component. Data are collected by community-based interviewers and will be analysed to explore patient care pathways and living conditions in the TRHIV population with regard to gender affirmation and HIV. Data collection began in October 2020 and should be completed in December 2021. The statistical analyses techniques used will be adapted to each of the study's objectives and to the type of data collected (cross-sectional (questionnaires) and retrospective (biographical trajectory)). The study's results will provide a greater understanding of TRHIV health needs in order to suggest possible national recommendations for comprehensive HIV and gender affirmation medical care. ETHICS AND DISSEMINATION: ANRS Trans&HIV was approved by Inserm's Ethical Evaluation Committee (no 20-694 on 12 May 2020) and is registered with the National Commission on Informatics and Liberty under number 2518030720. Potential participants are informed about the study through an information note provided by their attending HIV physician. All results published in peer-reviewed journals will be disseminated to the HIV transgender community, institutional stakeholders and healthcare providers. TRIAL REGISTRATION NUMBER: NCT04849767.

Pre-exposure HIV prophylaxis (PrEP) among transgender women: 3 years of follow-up in a university hospital in Paris.

OBJECTIVES: The principal outcome was to describe clinical characteristics of a transgender male-to-female (TGW) cohort followed for pre-exposure HIV prophylaxis (PrEP). INTRODUCTION: Few efforts and preventive interventions have targeted transgender population, despite them being at great risk of HIV infection. METHODS: This was a retrospective transgender male-to-female (TGW) cohort followed for PrEP at Bichat Hospital Sexual Health Clinic between February 2016 and January 2019.The principal outcome was to describe clinical characteristics of this TGW population: modalities of PrEP uptake, treatment adherence and tolerance, sanitary system retention, hormonal therapy and STIs.Data about age, ethnicity, language, sex work and sanitary healthcare insurance coverage were also collected. RESULTS: Forty-nine TGW were included, with a median age of 33 years; 43/49 (87.7%) were from South America and 43/49 (87.7%) were sex workers. Forty-four 44/49 TGW (89.7%) had no regular healthcare insurance coverage. Nineteen out of 49 (38.7%) had a history of STI in the last 12 months. Hormone intake was reported in 16/49 (32.60%). PrEP with oral TDF/FTC was prescribed on a daily basis for 45/49 TG (91.8%). Two TGW discontinued PrEP for gastrointestinal intolerance. No case of renal toxicity or HIV seroconversion has been reported. Retention rate was high (71.4%), but average follow-up was 9 months. CONCLUSIONS: Our data showed a very vulnerable population, with a high proportion of migrants, sex workers and with a low healthcare insurance coverage. Retention rate was high (71.4%). Further multi-component interventions are needed to improve global sex health approach, PreP follow-up and sanitary system retention among TGW population.

Congenital Leishmaniasis in a Newborn Infant Whose Mother was Coinfected With Leishmaniasis and HIV.

In utero transmission of Leishmania infantum is the putative mechanism of congenital leishmaniasis. However, this hypothesis is based on limited research. In addition, the consequences for infant newborn development remain to be clarified by additional data. We report here the occurrence, specific management, and monitoring of congenital leishmaniasis in a newborn infant whose mother was coinfected with leishmaniasis and human immunodeficiency virus; transplacental transmission, confirmed by overt clinical disease at birth, was documented, which provides, to our knowledge, the first evidence of hepatic and neurologic impairment in an infant with congenital visceral leishmaniasis.

Illicit massive silicone injections always induce chronic and definitive silicone blood diffusion with dermatologic complications.

Male-to-female transgender (MtF TG) individuals often report using illegal subcutaneous silicone injections for body feminisation. It leads to silicone dissemination and various dermatologic complications.We report the long-term complications of these feminisation procedures with blood smear examination and dermatologic examination.Between July 2015 and December 2015, 77 MtF TG consulting at Bichat Hospital (Paris, France) were included in this cross-sectional study. Blood smear examinations were performed by a trained haematologist to quantify the presence of silicone vacuoles in monocytes.All patients reported a history of massive amounts of silicone injections (mean 4 L, range 0.5-15 L). Most patients were South American (75/77, 97%). Fifty-nine (59/75, 79%) were HIV-seropositive, mostly with undetectable HIV RNA plasma levels (46/58, 80%). Clinical examinations reported dermatologic complications for all patients: lymphatic or subcutaneous migration of silicone (59%), inflammation (50%), varicose veins (39%), post-inflammatory pigmentation (20%), infection (14%) and abscesses (4%). Blood smear examination showed intracytoplasmic vacuoles containing silicone in monocytes in all patients.We did not chemically prove the silicone nature of the vacuoles. The design of this study does not allow evaluation of short-term complications that should not be minimized.Illicit massive silicone injections always induced chronic and definitive silicone blood diffusion with dermatologic complications. This study highlights the dangers and the inefficiency of clandestine esthetic surgery. There is a need for targeted information campaigns with transgender populations about silicone injections. Otherwise, these practices may persist.

Metabolic syndrome and endocrine status in HIV-infected transwomen.

BACKGROUND: HIV-infected transwomen face multiple specific issues. Economic and social marginalization, sex work, substance abuse, hormonal consumption and silicone injection may affect the course of HIV infection and lead to metabolic and endocrine complications. METHODS: A matched case-control study was performed between 2013 and 2015 in a University Hospital and compared metabolic syndrome (MetS), thyroid and adrenal functions in HIV-infected transwomen (i.e. cases) and cisgender HIV-infected men (i.e. controls) matched for age and antiretroviral therapy. The interaction between hormonal consumption, the course of HIV infection and antiretroviral therapy was also studied. Clinical and biological data (CD4 cell count, HIV RNA load, antiretroviral plasma drug concentration, HDL, triglycerides, glucose, cortisol, thyroid stimulating hormone, free thyroxine, prolactine) were measured. RESULTS: A total of 292 HIV-infected patients (100 cases and 192 controls) were prospectively included. There was no difference between the two populations in terms of frequency of MetS, but subclinical hypothyroidism and adrenal insufficiency were more frequent in cases than in controls with, respectively, 12 vs. 3% (P < 0.002) for hypothyroidism and 20 vs. 8% (P < 0.001) for adrenal insufficiency. Prolactinemia, only performed in transwomen, was often elevated (21%) but rarely confirmed as true active hyperprolactinemia (monomeric form) (3%). Although hormonal intake was frequent among transwomen (31%), no impact on antiretroviral bioavailability and efficacy was detected. CONCLUSION: In this study, no increase in the prevalence of MetS was detected in HIV-infected transwomen patients. In contrast, adrenal and thyroid functions abnormalities were frequent and should be systematically assessed in this population. No impact of hormonal intake on antiretroviral bioavailability and efficacy was detected.

Foscarnet, zidovudine and dolutegravir combination efficacy and tolerability for late stage HIV salvage therapy: A case-series experience.

Salvage therapy including foscarnet (PFA), zidovudine (ZDV) and an optimized background ART (OBT) has been shown to be effective in patients with advanced HIV infection, and no therapeutic options. Dolutegravir (DTG) may offer a more active combination. Objective was to describe efficacy and tolerability of PFA-ZDV-DTG containing regimen. In our cohort, we identified patients who: (i) had plasma HIV-1 RNA load (pVL) >50 c/ml (>100 for HIV-2) on combination ART (cART); (ii) had at least 1 PI/r, 1 NRTI, 1 NNRTI (for HIV-1), and at least 1 raltegravir resistance mutations; (iii) were naive to DTG; and (iv) initiated on a PFA-ZDV-DTG containing-regimen with 48 weeks (W48) of follow-up. Out of 5 patients, 2 were infected with HIV-2. At PFA-ZDV-DTG initiation, CD4 cell count was (/mm(3) ) of 64, 40, 10, in HIV-1, and 37, 199, in HIV-2 infected patients; and pVL (log10 c/ml) of 4.8, 5.1, 4.4, in HIV-1, and 3.6, 4.2, in HIV-2 infected patients, respectively. Median OBT genotypic sensitivity score was 1.5 [1-2]. PFA was discontinued in one patient, due to an acute renal failure. At W48, one HIV-1 infected patient had a pVL <50 c/ml and two <200 c/ml; the two HIV-2 infected patients had pVL >100 c/ml. No lack of treatment adherence was observed. In treatment experienced HIV-infected patients, failing cART and without other therapeutic options, a PFA-ZDV-DTG combination therapy could be effective. Renal adverse events should be monitored.