Drug-drug interactions between antiretroviral drugs and feminizing hormones among trans women living with HIV in Toronto and Montreal (The Trans DDI) Study
We are researching interactions between Feminizing Hormone Therapy & HIV Treatment.
About the Study
This is a clinical study to look at possible drug-drug interactions (DDIs) between antiretroviral therapy (ART - medication used to treat HIV) and feminizing hormone therapy (FHT - medications some trans women take as part of their transition).
Why are we doing this study?
We’re running this study to see what effects (if any) common feminizing hormone regimens have on ART medications and vice versa. This is an important question for many reasons. Firstly, trans women around the world face a higher risk for HIV than cisgender folks due to biological and sociohistorical factors related to transphobia and intersecting forms of marginalization. Here’s a link to an article with more information!
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The same forces that put trans women at a higher risk for HIV also make it harder for trans women to access safe and consistent treatment and care—trans women living with HIV have also been found to have lower rates of access, usage, and adherence to antiretroviral therapy. An explanation for this is due to concerns about negative interactions between ART drugs and feminizing hormones, especially that ART medications may weaken the effect of feminizing hormones and even cause harm. Feminizing hormones are so vital to trans women’s lives that many will choose them over ART medications if they feel they must make a choice. And it’s not just trans women who have these concerns, but healthcare providers too—studies have shown that many healthcare providers withhold feminizing hormones from trans women living with HIV. This can result in folks finding the medications outside of healthcare contexts, risking dangerous side effects and taking medications without medical supervision.
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Now onto some good news – our study is trying to address the concerns mentioned above. We have good reason to believe that there aren’t drug-drug interactions between common ART medications and oral estradiol (a feminizing hormone regimen that a lot of trans women in Canada take). Our study will be comparing estradiol levels between trans women living with HIV, trans women living without HIV, and cisgender (cis) women living with HIV. We expect that estradiol concentrations will be consistent across all three groups.
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With this study, we want to make sense of the science behind drug-drug interactions and, depending on our findings, reassure both healthcare providers and trans women living with HIV that their medications are safe to take and all their healthcare needs can be met. This is a critical step towards our overall goal and ideal healthcare scenario. We’re working towards a model of shared decision-making where all parties have access to information about ART medications and feminizing hormones, allowing both critical treatment regimens to be prescribed safely and equitably.
Participants of the Study
GROUP 1: TRANS WOMEN LIVING WITH HIV
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Taking Biktarvy ® (medication to treat HIV) OR willing to switch for the study.
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Currently taking 2mg or more of oral estradiol.
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Currently taking an anti-androgen (or have a medical or surgical reason to not need it).
GROUP 3: TRANS WOMEN LIVING WITHOUT HIV
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Not taking PrEP or PEP (medication to prevent HIV).
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Currently taking 2mg or more of oral estradiol.
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Currently taking an anti-androgen (or have a medical or surgical reason to not need it).
GROUP 2: CIS WOMEN LIVING WITH HIV
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Taking Biktarvy ® (medication to treat HIV), or willing to switch for the duration of study.
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Not taking hormonal birth control (non-hormonal copper IUD birth control allowed).
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Have a regular period (regular = a period every 24-35 days) or if uterus was removed, ovarie(s) remain functional.
Participation in this study includes attending a screening appointment to learn more about the study, ask questions, give consent, and determine eligibility.
After eligibility is confirmed, participants will also engage in 3-5 follow-up visits over the course of 2-6 months, which may include bloodwork (such as HIV testing, HIV viral load testing, pregnancy tests, and measures of estradiol and testosterone levels). Additionally, participants will complete questionnaires to evaluate their medication adherence, satisfaction with treatment regimens, and take part in interviews discussing their opinions on healthcare.
Study Updates:
Recruitment is now closed and study follow-up is underway!
Publications
Contact
For more information or questions about this study, contact our Research Team:​