Impact of hormonal therapy on HIV-1 immune markers in cis women and gender minorities.

BACKGROUND: Although sex hormones are recognized to induce immune variations, the effect of hormonal therapy use on immunity is only poorly understood. Here, we quantified how hormonal therapy use affects HIV-1 immune markers in cis women (CW) and trans women and non-binary people (TNBP) with HIV. METHODS: We considered CD4, CD8 and lymphocyte measurements from cis men (CM), CW and TNBP in the Swiss HIV Cohort Study. We modelled HIV-1 markers using linear mixed-effects models with an interaction between 'gender' (CW, TNBP) and 'hormonal therapy use' (yes/no). Models were adjusted on age, ethnicity, education level, time since start of antiretroviral therapy and use of intravenous drugs. We assessed the inflammatory effect of hormonal therapy use in 31 TNBP using serum proteomics measurements of 92 inflammation markers. RESULTS: We included 54 083 measurements from 3092 CW and 83 TNBP, and 147 230 measurements from 8611 CM. Hormonal therapy use increased CD4 count and CD4:CD8 ratio in TNBP more than in CW (pinteraction = 0.02 and 0.007, respectively). TNBP with hormonal therapy use had significantly higher CD4 counts [median = 772 cells/µL, interquartile range (IQR): 520-1006] than without (617 cells/µL, 426-892). This was similar to the effect of CW versus CM on CD4 T cells. Hormonal therapy use did not affect serum protein concentrations in TNBP. CONCLUSION: This study highlights the potential role of hormonal therapy use in modulating the immune system among other biological and social factors, especially in TNBP with HIV.

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.

The Impact of the COVID-19 Pandemic on Sexual Health in Cis Women Living in Germany.

BACKGROUND: Preliminary research shows a substantial impact of the COVID-19 pandemic on women's sexual health, whereby empirical work on sexual well-being of minoritized sexual identities is still rare. AIM: The objective of this study was to explore sexual health in heterosexual, lesbian and bisexual cis women during the first wave of COVID-19 pandemic in Germany. METHODS: An anonymous nationwide online survey was conducted among cis women during the first nationwide lockdown in Germany from April 20th to July 20th, 2020. The questionnaire was distributed via e-mail, online chats and social-media platforms. OUTCOMES: Demographic variables and self-report measures from the Sexual Behavior Questionnaire (SBQ-G) "before the pandemic" and "since the pandemic" were collected. RESULTS: A total of 1,368 cis women participants were included: heterosexual women (n = 844), lesbian women (n = 293), bisexual women (n = 231). Results indicate overall decrease in frequency of sexual contacts and masturbation during the COVID-19 pandemic. Regarding differences before and during the pandemic lesbian women showed significant changes in sexual arousal whereas heterosexual women showed significant changes in all dimensions except capability to enjoy sexual intercourse. The data of bisexual women showed significant changes in almost all dimensions except for frequency of sexual intercourse and sexual arousal. Results of the multiple regression analysis revealed that being younger than 36 years-old, and being in a relationship as well as being heterosexual (compared with being lesbian) is positively associated with general satisfaction with sexual life during the pandemic. CLINICAL IMPLICATIONS: The findings suggest that during a pandemic sexual and mental health care for (cis) women should be provided and address the specific needs of sexual minority groups. STRENGTHS & LIMITATIONS: This is the first study to describe sexual behavior in heterosexual, lesbian and bisexual women during the COVID-19 pandemic in Germany. Limitations, however, include the fact that the data described were obtained at only one time point so there is a possibility of recall bias, and that the results cannot be generalized because of the underrepresentation of women over age 46. CONCLUSION: This study examined the impact of the COVID-19 pandemic and resulting social constraints on the sexual health of particular groups of lesbian and bisexual women, which may improve preparedness for future public health and policy crises. Batz F, Lermer E, Hatzler L, et al. The Impact of the COVID-19 Pandemic on Sexual Health in Cis Women Living in Germany. J Sex Med 2022;19:907-922.

Using audience segmentation to identify implementation strategies to improve PrEP uptake among at-risk cisgender women: a mixed-methods study protocol.

BACKGROUND: In the USA, 19% of new HIV infections occur among cisgender women (cis women); however, only 10% of eligible cis women have been prescribed pre-exposure prophylaxis (PrEP) for the prevention of HIV infection (an evidence-based intervention). A fundamental challenge for expanding HIV prevention to cis women is ensuring implementation strategies are tailored to the various healthcare settings in which cis women seek care and the heterogeneous providers nested within these settings. This project's specific aims are to (1) explore clinician-level characteristics and organizational climate factors that are related to variability in adoption of PrEP service delivery as an evidence-based intervention for cis women; (2) identify latent audience segments of women's health providers as the related to PrEP acceptability, adoption, and maintenance and analyze demographic correlates of these segments; and (3) identify audience segment-specific implementation strategies to facilitate the adoption of PrEP as an evidence-based intervention among at-risk cis women. METHODS: Using the i-PARIHS framework, this mixed-methods study examines three domains for guiding audience segmentation to facilitate PrEP implementation for cis women: innovation (degree of fit with existing practices, usability), recipient beliefs and knowledge and context factors (organizational culture, readiness for change), needs to determine appropriate facilitation methods. To achieve aim 1, qualitative interviews will be conducted with PrEP-eligible cis women, women's health providers, and other key stakeholders. Aim 2 will consist of a quantitative survey among 340 women's health providers. Latent class analysis will be used to facilitate audience segmentation. To achieve aim 3, a panel of 5-8 providers for each audience segment will meet and engage in iterative discussions guided by Fernandez's implementation mapping to identify (1) implementation outcomes and performance objectives, determinants, and change objectives and (2) determine and refine of implementation strategies for each audience segment. DISCUSSION: This exploratory mixed methods study will provide an empirical foundation to inform the development implementations strategies aimed at increasing PrEP delivery to cis women among heterogenous groups of providers.