PrEP for women in Europe: a systematic literature review.

BACKGROUND: Prevention of HIV transmission is fundamental to ending the HIV epidemic. Pre-exposure prophylaxis (PrEP) with oral tenofovir-emtricitabine (TDF-FTC) is an established HIV-prevention method; however, most PrEP services in Europe have been targeted at men who have sex with men (MSM). A survey in 2021 by Women Against Viruses in Europe (WAVE) showed considerable variation in PrEP access and guidance for women throughout Europe. WAVE therefore commissioned this systematic review to provide insight into PrEP provision and barriers to uptake for women in Europe. METHODS: PubMed, Embase, and Scopus were searched for studies (January 2013-May 2021) that reported on actual (e.g., efficacy and safety) or hypothetical (e.g., awareness, barriers, PrEP impact models) use of oral PrEP involving women (including cis, transgender, pregnant, migrant, and breastfeeding women). Search terms included HIV, pre-exposure prophylaxis (specifically TDF-FTC), and women. Studies performed outside of the World Health Organization European region were excluded. RESULTS: The search identified 4716 unique citations, and 45 peer-reviewed articles (44 studies) were included. The majority of these studies (34/44 [77%]) included recipients or potential recipients of PrEP, representing 4699 women (243 transgender women). However, few studies were women focused (4/34 [12%]) or took place outside of Western Europe (3/34 [9%]). Across the three clinical studies that reported women-specific outcomes (60 transgender women, 13 pregnant, and 19 cis women), no breakthrough infections were recorded during the use of PrEP. Lack of awareness of PrEP, low self-estimation of HIV acquisition risk, concerns about stigma, lack of protection against other sexually transmitted infections, and PrEP interaction with hormones (for transgender women) were identified as barriers to use. The remaining studies examined healthcare professionals' perceptions of PrEP (9/44 [20%]), asked for public opinion (2/44 [5%]), or modelled the potential of PrEP for HIV prevention (1/44 [2%]). CONCLUSIONS: This review revealed a notable lack of literature on PrEP for cis and transgender women in Europe. This is synonymous with a lack of PrEP provision for women in this region. Barriers to PrEP uptake are complex and rooted in institutional and societal stigma, which must be addressed at policy level. HIV prevention with PrEP is not 'one size fits all' and requires a nuanced gender-responsive approach. Further research into the use of PrEP in cis, pregnant, breastfeeding, and transgender women is essential if we are to stop HIV transmission by 2030.

Clinical outcomes of patients with and without HIV hospitalized with COVID-19 in England during the early stages of the pandemic: a matched retrospective multi-centre analysis (RECEDE-C19 study).

BACKGROUND: The contribution of HIV to COVID-19 outcomes in hospitalized inpatients remains unclear. We conducted a multi-centre, retrospective matched cohort study of SARS-CoV-2 PCR-positive hospital inpatients analysed by HIV status. METHODS: HIV-negative patients were matched to people living with HIV (PLWH) admitted from 1 February 2020 to 31 May 2020 up to a 3:1 ratio by the following: hospital site, SARS-CoV-2 test date ± 7 days, age ± 5 years, gender, and index of multiple deprivation decile ± 1. The primary objective was clinical improvement (two-point improvement or better on a seven-point ordinal scale) or hospital discharge by day 28, whichever was earlier. RESULTS: A total of 68 PLWH and 181 HIV-negative comparators were included. In unadjusted analyses, PLWH had a reduced hazard of achieving clinical improvement or discharge [adjusted hazard ratio (aHR) = 0.57, 95% confidence interval (CI): 0.39-0.85, p = 0.005], but this association was ameliorated (aHR = 0.70, 95% CI: 0.43-1.17, p = 0.18) after additional adjustment for ethnicity, frailty, baseline hypoxaemia, duration of symptoms prior to baseline, body mass index (BMI) categories and comorbidities. Baseline frailty (aHR = 0.79, 95% CI: 0.65-0.95, p = 0.011), malignancy (aHR = 0.37, 95% CI 0.17, 0.82, p = 0.014) remained associated with poorer outcomes. The PLWH were more likely to be of black, Asian and minority ethnic background (75.0% vs 48.6%, p = 0.0002), higher median clinical frailty score [3 × interquartile range (IQR): 2-5 vs, 2 × IQR: 1-4, p = 0.0069), and to have a non-significantly higher proportion of active malignancy (14.4% vs 9.9%, p = 0.29). CONCLUSIONS: Adjusting for confounding comorbidities and demographics in a matched cohort ameliorated differences in outcomes of PLWH hospitalized with COVID-19, highlighting the importance of an appropriate comparison group when assessing outcomes of PLWH hospitalized with COVID-19.

Diagnosing acute HIV infection at point of care: a retrospective analysis of the sensitivity and specificity of a fourth-generation point-of-care test for detection of HIV core protein p24.

OBJECTIVES: Detection of acute HIV infection is vital in preventing onward transmission. HIV point-of-care testing (POCT) has improved uptake of HIV testing but has been limited to third-generation assays, which only detect chronic HIV infection. Previous evaluation of the fourth-generation Alere Determine HIV-1/2 Ag/Ab Combo POCT showed only 50% sensitivity for HIV core protein p24 (p24 antigen) detection, which is suboptimal for diagnosis of acute HIV infection with limited advantage over third-generation POCT. We aimed to assess the sensitivity of the new Alere HIV Combo POCT to detect acute HIV infection. METHODS: Stored samples in samples already identified as p24-positive using standard-of-care fourth-generation assays were randomly selected alongside groups of antibody-positive samples and HIV-negative samples. Each sample was tested using the new Alere POCT according to manufacturer's instructions. Sensitivity and specificity were then calculated. RESULTS: The Alere HIV Combo POCT test demonstrated 88% sensitivity 95% CI (78% to 98%) and 100% specificity 95% CI (99.7% to 100%) for detection of p24 antigen. CONCLUSIONS: This new POCT shows improved sensitivity for detection of p24 antigen and may be of value for clinical use in detecting acute HIV infection. Further evaluation of its use in a clinical setting is still required.

2019 British Association of Sexual Health and HIV National Clinical Audit of timelines to be seen, test results and treatment for Chlamydia trachomatis.

BACKGROUND: BASHH/MEDFASH (Medical Foundation for HIV and Sexual Health) Standards for the Management of Sexual Health Services 20141 set out a number of recommendations regarding time between contacting a service to being seen, time to receiving results, and time to treatment. This audit investigated if UK practice is compliant with BASHH standards of care in terms of: Time to patient being seen after contacting sexual health services, time to chlamydia (CT) NAAT (nucleic acid amplification test) results and time from positive CT result to treatment. METHODS: All UK level 2 (non-specialist) and level 3 (specialist) sexual health clinics were invited to take part. Data were collected via a survey of sexual health clinics and a retrospective case-note review of the last 40 people aged 16 or over per service seen with chlamydia but not syphilis or gonorrhoea. Cases were identified using the SHHAPT (Sexual Health and HIV Activity Types) National STI Surveillance code for chlamydia (C4). RESULTS: There were responses from 221 sites. 67% of sites reported offering both appointment and walk-in access, 26.2% appointment-only, 6.8% walk-in only. The mean turn-away rate of individuals seeking walk-in access on the last open day was 6.1%. There were variations in local service specification turnaround times for chlamydia nucleic acid amplification test results; 32% of sites reported no specified turnaround time. Case note audit of individuals seen with chlamydia showed 74.1% of individuals were tested for chlamydia at a level 3 clinic, 11.8% at a level 2 sexual health clinic, 7.3% used a self-sampling kit requested online and 3.9% tested at a different setting. 92.1% of individuals who initially tested at a sexual health service had an attempted notification within 10 working days of a positive chlamydia test. 95% of individuals were treated within a sexual health service. Overall, 94.0% of individuals were treated within 15 working days of the test result. CONCLUSION: When missing data were excluded, patient initiated GUM/level 3 attenders seen within 2 working days met the audit standard as did patient access to results within 10-working days for those whose initial CT NAAT sample was taken at a GUM/level 3 clinic and treatment within 3 weeks for GUM/level 3 attenders. Patients offered to be seen/assessed within 2 working days and lab report within 5 working days did not meet the audit standard. Recommendations include ensuring that laboratory turn-around times are included in contracts or service level agreements for clinical services, and local monitoring of these. Dates when individuals first seek to access sexual health services should also be recorded and used to monitor performance in comparison with access standards.