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Aims: Trans/transfeminine women are disproportionally affected by HIV. Concerns regarding negative drug–drug interactions (DDIs) between ART drugs and gender‐affirming hormone therapy (GAHT), specifically feminizing hormone therapy (FHT), may contribute to the lower ART uptake by trans women with HIV compared with their cis counterparts. The aim of this study is to investigate the bidirectional pharmacokinetic effects of components of FHT regimens (oral oestradiol and androgen‐suppressing medications) with the ART regimen (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF)]. Methods: We present a protocol for a three‐armed, parallel‐group, longitudinal (6‐month), DDI study. Group 1 includes 15 3trans women with HIV taking FHT and ART; group 2 includes 15 premenopausal cis women with HIV taking ART; group 3 includes 15 trans women without HIV taking FHT. Women with HIV must be on or switch to B/F/TAF at baseline and be virally suppressed for ≥3 months. Trans women must be taking a stable regimen of ≥2 mg daily oral oestradiol and an anti‐androgen (pharmaceutical, and/or surgical, and/or medical) for ≥3 months. Plasma ART drug concentrations will be sampled at Month 2 and compared between groups 1 and 2. Serum oestradiol concentrations will be sampled at baseline and Month 2 visits and compared between groups 1 and 3. The primary outcomes are B/F/TAF pharmacokinetic parameters (Cmin, Cmax and AUC) and oestradiol concentrations (Cmin, C4h,Cmax and AUC) at month 2. Discussion: This study is of global importance as it provides critical information regarding safe coadministration of B/F/TAF and FHT, both of which are life‐saving therapies for trans women with HIV. [ABSTRACT FROM AUTHOR]

Objectives: Knowledge gaps exist regarding the effects of experiencing child protective services (CPS) out‐of‐home care (e.g. foster homes) among women with HIV. We examined whether CPS out‐of‐home care was associated with HIV clinical outcome trajectories among women with HIV in a longitudinal cohort study in Ontario, British Columbia, and Quebec, Canada. Methods: At three timepoints across 5 years (2013–2018), we examined self‐reported current antiretroviral therapy (ART) use and viral load (VL) detectability (>50 copies/mL). We used latent class growth analysis (LCGA) to identify trajectories of ART use and VL outcomes across study waves. LCGA identifies subgroups (classes) with similar trajectories within the sample. We assessed whether HIV outcome trajectories could be predicted by CPS history. We then conducted a mediation analysis to test whether a mental health latent construct mediated the association between CPS history and detectable VL. Results: Nearly one‐fifth (n = 272; 19%) of participants (n = 1422; mean age 42.8 years) reported CPS out‐of‐home care. Most participants (89%) were in classes that consistently used ART and had an undetectable VL. Individuals with CPS out‐of‐home care histories were twice as likely to have a consistently detectable VL (β = 0.72, p = 0.02); there were no differences in ART use trajectories. In mediation analyses, we found an indirect path from CPS history to a consistently detectable VL via baseline mental health status (β = 0.02, 95% confidence interval 0.005–0.04, p = 0.02), with a significant odds ratio (1.12, z = 2.43, p = 0.02). Conclusion: Among women with HIV in Canada, experiencing childhood CPS out‐of‐home care was associated with a reduced likelihood of achieving viral suppression, via poorer mental health. [ABSTRACT FROM AUTHOR]

Background: Using data from a national cohort study and focus groups, the Women-Centred HIV Care (WCHC) Model was developed to inform care delivery for women living with HIV. Methods: Through an evidence-based, integrated knowledge translation approach, we developed 2 toolkits based on the WCHC Model for service providers and women living with HIV in English and French (Canada's national languages). To disseminate, we distributed printed advertising materials, hosted 3 national webinars and conducted 2 virtual capacity-building training series. Results: A total of 315 individuals attended the webinars, and the average WCHC knowledge increased by 29% (SD 4.3%). In total, 131 service providers engaged in 22 virtual capacity-building training sessions with 21 clinical cases discussed. Learners self-reported increased confidence in 15/15 abilities, including the ability to provide WCHC. As of December 2023, the toolkits were downloaded 7766 times. Conclusions: We successfully developed WCHC toolkits and shared them with diverse clinical and community audiences through various dissemination methods. Plain Language Summary: A study on creating and sharing a toolkit for healthcare providers and women living with HIV Why was the study done?: The research team created the Women-Centred HIV Care (WCHC) model to help healthcare providers deliver personalised and thorough care to women living with HIV in Canada. This study aimed to develop a practical toolkit based on the model. The goal was to share this toolkit with women and their providers in various ways to get feedback on its usefulness and to understand the best methods for sharing tools in the future. What did the researchers do?: Through an in-depth, collaborative process, English and French WCHC toolkits were developed by a large and diverse team of women and providers. Various methods including printed materials, national webinars and virtual trainings were used to share the toolkits across Canada. The team assessed the toolkit's reception by using surveys, focus groups and tracking toolkit downloads and webpage views. What did the researchers find?: The study found positive results, including a 29% increase in WCHC knowledge for 315 webinar participants and enhanced confidence in 15 abilities for 131 service providers during virtual training. The toolkits were downloaded 7766 times, indicating broad interest. Usability testing showed that the toolkits were easy to use and helpful. Attendees of the webinars and virtual trainings indicated they were likely to use the toolkit and recommend it to others. What do the findings mean?: Overall, the WCHC toolkits offer valuable guidance to women living with HIV and their providers. The study improved providers' knowledge and confidence in delivering WCHC, especially during the virtual training sessions that focused on applying this knowledge to real clinical cases. During months when the toolkit was shared through printed materials, webinars and virtual training, more people visited the toolkit webpage. The study highlighted the importance of involving those who will use healthcare tools from the beginning and using many ways to share these tools to reach more people. [ABSTRACT FROM AUTHOR]

Background: Breastfeeding is not recommended for women living with HIV (WLWH) in Canada. We described the prevalence of breastfeeding and explored experiences of care, support, and stigma related to infant feeding. Setting: Quebec, Ontario, and British Columbia (Canada). Methods: Data were obtained from the HIV Women's Sexual and Reproductive Health Cohort Study (CHIWOS) surveys, conducted between 2013 and 2018. Results: Breastfeeding was reported by 73.5% of the 786 women who delivered before HIV diagnosis and 7.3% of the 289 women who delivered after HIV diagnosis. Among them, earlier year of delivery, delivery outside of Canada, and African, Caribbean, Black ethnicity were independently associated with increased odds of breastfeeding. Among WLWH who had a live birth during the last year, 77% (40/52) felt that they had received support regarding infant feeding practices, and 77% (23/30) were concerned that not breastfeeding could lead to them being identified as WLWH. Among 71 women within one year postpartum at any one of the study waves, 89% reported having an undetectable viral load. Conclusion: Breastfeeding experiences were common among WLWH, most often prior to HIV diagnosis. Fear of unintentional HIV status disclosure when not breastfeeding and challenges to maintain an undetectable HIV viral load are important issues to address during postpartum care. [ABSTRACT FROM AUTHOR]

Background Feminizing hormone therapy (FHT) is essential to many trans women. Concern about negative drug interactions between FHT and ART can be an ART adherence barrier among trans women with HIV. Objectives In this single-centre, parallel group, cross-sectional pilot study, we measured serum oestradiol concentrations in trans women with HIV taking FHT and unboosted integrase strand transfer inhibitor (INSTI)-based ART versus trans women without HIV taking FHT. Methods We included trans women with and without HIV, aged ≥18 years, taking ≥2 mg/day of oral oestradiol for at least 3 months plus an anti-androgen. Trans women with HIV were on suppressive ART ≥3 months. Serum oestradiol concentrations were measured prior to medication dosing and 2, 4, 6 and 8 h post-dose. Median oestradiol concentrations were compared between groups using Wilcoxon rank-sum tests. Results Participants (n  = 8 with HIV, n  = 7 without) had a median age of 32 (IQR: 28, 39) years. Among participants, the median oral oestradiol dose was 4 mg (range 2–6 mg). Participants had been taking FHT for a median of 4 years (IQR: 2, 8). Six trans women with HIV were taking bictegravir/emtricitabine/tenofovir alafenamide and two were taking dolutegravir/abacavir/lamivudine. All oestradiol concentrations were not significantly different between groups. Eleven (73%) participants had target oestradiol concentrations in the range 200–735 pmol/L at C 4h (75% among women with HIV, 71% among those without HIV). Conclusions Oestradiol concentrations were not statistically different in trans women with HIV compared with those without HIV, suggesting a low probability of clinically relevant drug–drug interactions between FHT and unboosted INSTI-based ART. [ABSTRACT FROM AUTHOR]

In Canada, women make up 25% of the prevalent HIV cases and represent an important population of those living with HIV, as a high proportion are racialized and systemically marginalized; furthermore, many have unmet healthcare needs. Using the knowledge-to-action framework as an implementation science methodology, we developed the "Women-Centred HIV Care" (WCHC) Model to address the needs of women living with HIV. The WCHC Model is depicted in the shape of a house with trauma- and violence-aware care as the "foundation". Person-centred care with attention with attention to social determinants of health and family make up the "first" floor. Women's health (including sexual and reproductive health and rights) and mental and addiction health care are integrated with HIV care, forming the "second" floor. Peer support, leadership, and capacity building make up the "roof". To address the priorities of women living with HIV in all their diversity and across their life course, the WCHC Model should be flexible in its delivery (e.g., single provider, interdisciplinary clinic or multiple providers) and implementation settings (e.g., urban, rural). [ABSTRACT FROM AUTHOR]

There is limited research exploring the experiences of people living with HIV (PLWH) who have pursued/successfully adopted children. We aimed to gain a deeper understanding of such experiences by analyzing six interviews with PLWH using thematic analysis. In this paper, we highlight three themes: Understanding the Adoption Process, Desire for Caseworker-Client Transparency, and Framing Health and Wellbeing. While most of the findings are relevant for all people navigating the adoption system, there are clear complexities in the process due to HIV stigma. We consider the key takeaways and offer recommendations for adoption service providers, governing bodies, and future research. [ABSTRACT FROM AUTHOR]

Planning families is an important issue within the HIV community. The primary objective of this study was to explore the fertility desires and intentions of men living with HIV (MLWH). A cross-sectional survey containing 77 questions in 10 domains was developed, validated and administered to MLWH. The sample was stratified by sexual orientation, ethnicity, and city of residence. Logistic regression analyses were conducted to determine sociodemographic correlates of intention to have children. 276 men were recruited, of whom 118 (43%) identified as heterosexual and 158 (57%) as gay, bisexual, two-spirit or queer (GBTQ). 133 (45%) men wished and 120 (44%) actually intended to become a parent. Significantly more heterosexual men desired fatherhood (63% vs 37%, p <.0001) and intended to have children in the future (57% vs. 34%, p <.0001). Among all men, significant predictors of intention to have children were age ≤40, heterosexual orientation, African/Caribbean/Black ethnicity, living in Toronto, higher household income, and being partnered with an HIV-negative individual. When stratified by sexual orientation, younger age remained a significant correlate for both groups. A significant proportion of heterosexual and GBTQ MLWH desire and intend to become a parent. Health care providers and policy makers must support these individuals in their reproductive parenting needs. [ABSTRACT FROM AUTHOR]

Decision-making related to pregnancy planning is complex and human immunodeficiency virus (HIV) may further complicate the process. With increasing rates of pregnancy among individuals affected by HIV, the need to understand decision-making is imperative. The primary objectives of this pilot study were to confirm the feasibility of using discrete choice experimentation (DCE) to elicit an understanding of this process and to determine the acceptability of the choice factors that were included in two novel DCEs, while gathering a preliminary understanding of preference. The choice attributes were risk of vertical HIV transmission, risk of horizontal HIV transmission, cost, probability of conception, method of conception, and travel time. Thirteen respondents completed a DCE for serodiscordant couples in which the female partner was HIV-positive, and 12 respondents completed a DCE for seroconcordant couples. All respondents' utility for an increased chance of a successful pregnancy was positive and statistically significant. In the serodiscordant dyads, the attributes of risk of horizontal transmission, risk of vertical transmission, a 5-h travel time to clinic, and cost were significantly associated with decreased utility. In the seroconcordant dyads, only the attributes of chance of risk of vertical transmission and cost were significantly associated with decreased utility. The serodiscordant dyads preferred home insemination with a syringe and the seroconcordant couples preferred conception methods within fertility clinics, over condomless sex with timed ovulation. On average, participants were willing to pay more for greater chance of conception and less willing to pay for increased risk of transmission. Couples affected by HIV are willing to participate in a DCE and the attributes that were included all seem relevant except risk of vertical transmission. There are various real-life trade-offs that are made during pregnancy planning with HIV and better understanding of these can be useful for clinicians during preconception counseling. [ABSTRACT FROM AUTHOR]

Attrition along the cascade of HIV care poses significant barriers to attaining the UNAIDS targets of 90-90-90 and achieving optimal treatment outcomes for people living with HIV. Understanding the correlates of attrition is critical and particularly for women living with HIV (WLWH) as gender disparities along the cascade have been found. We measured the proportion of the 1425 WLWH enrolled in the Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS) who had never accessed HIV medical care, who reported delayed linkage into HIV care (>3 months between diagnosis and initial care linkage), and who were not engaged in HIV care at interview (<1 visit in prior year). Correlates of these cascade indicators were determined using univariate and multivariable logistic regression. We found that 2.8% of women had never accessed HIV care. Of women who had accessed HIV care, 28.7% reported delayed linkage and 3.7% were not engaged in HIV care. Indigenous women had higher adjusted odds of both a lack of access and delayed access to HIV care. Also, a younger age, unstable housing, history of recreational drug use, and experiences of everyday racism emerged as important barriers to ever accessing care. Programmatic efforts to support early linkage to and engagement in care for WLWH in Canada must address several social determinants of health, such as housing insecurity and social exclusion, and prioritize engagement of Indigenous women through culturally safe and competent practices. [ABSTRACT FROM PUBLISHER]

Attrition along the cascade of HIV care compromises attainment of the UNAIDS 90-90-90 goals and achievement of desirable treatment outcomes for people living with HIV. Given known gender disparities in HIV care and outcomes, understanding the correlates of attrition at stages of the care cascade for women living with HIV (WLWH) is essential. Among the 1425 WLWH enrolled in the Canadian HIV Women's Sexual and Reproductive Health Cohort Study (CHIWOS), we measured the proportion who reported not being currently on combination antiretroviral therapy (cART) and the proportion who reported a detectable viral load (VL; ≥40 copies/mL) despite cART use. Correlates of these cascade indicators were examined using univariate and multivariable logistic regression. Overall, 14.8% of women were not currently on cART. Of women who were on cART, 9.0% were not virally suppressed. In multivariable analyses, age between 26 and 34, unstable housing, food insecurity, current injection drug use, higher HIV-related stigma, and racial discrimination were associated with increased odds of not being on cART. Factors associated with increased odds of reporting a detectable VL among women on cART included age ≤34 years, less than a secondary education, unstable housing, and incarceration in the previous year. Programmatic efforts to support cART use and viral suppression for WLWH in Canada should focus on social determinants of health, including housing and food insecurity, social exclusion, and education. [ABSTRACT FROM AUTHOR]

Globally, women are at increased vulnerability to HIV due to biological, social, structural, and political reasons. Women living with HIV also experience unique issues related to their medical and social healthcare, which makes a clinical care model specific to their needs worthy of exploration. Furthermore, there is a dearth of research specific to women living with HIV. Research for this population has often been narrowly focused on pregnancy-related issues without considering their complex structural inequalities, social roles, and healthcare and biological needs. For these reasons, we have come together, as researchers, clinicians and community members in Canada, to develop the Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS) to investigate the concept of women-centred HIV care (WCHC) and its impact on the overall, HIV, women’s, mental, sexual, and reproductive health outcomes of women living with HIV. Here, we present the CHIWOS cohort profile, which describes the cohort and presents preliminary findings related to perceived WCHC. CHIWOS is a prospective, observational cohort study of women living with HIV in British Columbia (BC), Ontario, and Quebec. Two additional Canadian provinces, Saskatchewan and Manitoba, will join the cohort in 2018. Using community-based research principles, CHIWOS engages women living with HIV throughout the entire research process meeting the requirements of the ‘Greater Involvement of People living with HIV/AIDS’. Study data are collected through an interviewer-administered questionnaire that uses a web-based platform. From August 2013 to May 2015, a total of 1422 women living with HIV in BC, Ontario, and Quebec were enrolled and completed the baseline visit. Follow-up interviews are being conducted at 18-month intervals. Of the 1422 participants at baseline, 356 were from BC (25%), 713 from Ontario (50%), 353 from Quebec (25%). The median age of the participants at baseline was 43 years (range, 16–74). 22% identified as Indigenous, 30% as African, Caribbean or Black, 41% as Caucasian/White, and 7% as other ethnicities. Overall, 83% of women were taking antiretroviral therapy at the time of the baseline interview and of them, 87% reported an undetectable viral load. Of the 1326 women who received HIV medical care in the previous year and responded to corresponding questions, 57% (95% CI: 54%-60%) perceived that the care they received from their primary HIV doctor had been women-centred. There were provincial and age differences among women who indicated that they received WCHC versus not; women from BC or Ontario were more likely to report WCHC compared to participants in Quebec. They were also more likely to be younger. CHIWOS will be an important tool to develop care models specific for women living with HIV. Moreover, CHIWOS is collecting extensive information on socio-demographics, social determinants of health, psychological factors, and sexual and reproductive health and offers an important platform to answer many relevant research questions for and with women living with HIV. Information on the cohort can be found on the study website (). [ABSTRACT FROM AUTHOR]

Data are lacking on factors that may impact conception-related decision-making among individuals living with HIV. This study's aim was to shed light on these considerations. Participants were invited to complete a survey on preconception considerations. A rank-ordered logit model was fit to estimate the relative importance of listed consideration factors; the interaction of HIV status and the factors was assessed. Fifty-nine participants living with HIV and 18 partners (11 HIV-negative participants and 7 living with HIV) were included. Risk of vertical and horizontal HIV transmission and the effect of antiretroviral therapy on the fetus were the top considerations. However, individuals living with HIV prioritized vertical transmission, whereas HIV-negative participants prioritized horizontal transmission. Other factors of importance were probability of conception, stress of trying to conceive, cost associated with fertility clinics, and stigma associated with certain conception methods. This study builds our understanding of the preconception considerations for people living with HIV. [ABSTRACT FROM AUTHOR]

Background: Community-based research has gained increasing recognition in health research over the last two decades. Such participatory research approaches are lauded for their ability to anchor research in lived experiences, ensuring cultural appropriateness, accessing local knowledge, reaching marginalized communities, building capacity, and facilitating research-to-action. While having these positive attributes, the community-based health research literature is predominantly composed of small projects, using qualitative methods, and set within geographically limited communities. Its use in larger health studies, including clinical trials and cohorts, is limited. We present the Canadian HIV Women's Sexual and Reproductive Health Cohort Study (CHIWOS), a large-scale, multi-site, national, longitudinal quantitative study that has operationalized community-based research in all steps of the research process. Successes, challenges and further considerations are offered.Discussion: Through the integration of community-based research principles, we have been successful in: facilitating a two-year long formative phase for this study; developing a novel survey instrument with national involvement; training 39 Peer Research Associates (PRAs); offering ongoing comprehensive support to PRAs; and engaging in an ongoing iterative community-based research process. Our community-based research approach within CHIWOS demanded that we be cognizant of challenges managing a large national team, inherent power imbalances and challenges with communication, compensation and volunteering considerations, and extensive delays in institutional processes. It is important to consider the iterative nature of community-based research and to work through tensions that emerge given the diverse perspectives of numerous team members.Conclusions: Community-based research, as an approach to large-scale quantitative health research projects, is an increasingly viable methodological option. Community-based research has several advantages that go hand-in-hand with its obstacles. We offer guidance on implementing this approach, such that the process can be better planned and result in success. [ABSTRACT FROM AUTHOR]