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AimsTrans/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)].MethodsWe 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.DiscussionThis 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.
AimsTrans/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)].MethodsWe 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.DiscussionThis 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.
Background Recent calls to action have been made for Implementation Science to attend to health inequities at the intersections of race, gender, and social injustice in the United States. Transgender people, particularly Black and Latina transgender women, experience a range of health inequities and social injustices. In this study, we compared two processes of transgender community engagement in Los Angeles and in Chicago as an implementation strategy to address inequitable access to care; we adapted and extended the Exploration Planning Implementation and Sustainment (EPIS) framework for transgender health equity. Methods A comparative case method and the EPIS framework were used to examine parallel implementation strategies of transgender community engagement to expand access to care. To foster conceptual development and adaptation of EPIS for trans health equity, the comparative case method required detailed description, exploration, and analyses of the community-engagement processes that led to different interventions to expand access. In both cities, the unit of analysis was a steering committee made up of local transgender and cisgender stakeholders. Results Both steering committees initiated their exploration processes with World Café-style, transgender community-engaged events in order to assess community needs and structural barriers to healthcare. The steering committees curated activities that amplified the voices of transgender community members among stakeholders, encouraging more effective and collaborative ways to advance transgender health equity. Based on analysis and findings from the Los Angeles town hall, the steering committee worked with a local medical school, extending the transgender medicine curriculum, and incorporating elements of transgender community-engagement. The Chicago steering committee determined from their findings that the most impactful intervention on structural racism and barriers to healthcare access would be to design and pilot an employment program for Black and Latina transgender women. Conclusion In Los Angeles and Chicago, transgender community engagement guided implementation processes and led to critical insights regarding specific, local barriers to healthcare. The steering committee itself represented an important vehicle for individual-, organizational-, and community-level relationship and capacity building. This comparative case study highlights key adaptations of EPIS toward the formation of an implementation science framework for transgender health equity.
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