Clinical Care and Management (CCM)
CTN 331 will use community-based research principles to investigate the pharmacokinetic effects of common feminizing hormone regimens (oral estradiol and an anti-androgen) on the antiretroviral therapy (ART) combination bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and vice versa. The ultimate goal is to determine if there are any drug–drug interactions between these therapeutic regimens. The CTN 331 researchers chose to investigate B/F/TAF specifically, as they believe it represents a safe, convenient, and highly effective strategy for trans women with HIV. Participants will be recruited from sites in Toronto and Montreal.
Transgender (trans) women are disproportionately affected by HIV. A study of trans people living in Ontario estimated that HIV was ten times more prevalent among this population (2.9 per cent) than the overall provincial prevalence (0.23 per cent). Despite this, ART uptake and adherence are lower among trans people compared with cisgender people. A main reason for this is concern about drug–drug interactions between ART and feminizing hormones; a concern not only among trans women, but also some health care providers, who are hesitant to prescribe feminizing hormones to trans women on ART. As such, more research is needed on the concomitant use of ART and feminizing hormones to support an evidence-based approach for the management of trans women living with HIV.
Participants will be assigned to three groups: group one will include 15 trans women living with HIV who are taking feminizing hormones and ART (investigational group); group two will include 15 premenopausal cis women living with HIV taking ART (ART control group); and group three will include 15 trans women without HIV who are taking hormones (hormone control group). Each participant will attend a baseline visit and a follow-up visit at two months, where they will complete questionnaires and provide bloodwork.
Serum estradiol and total testosterone concentrations will be sampled at the baseline and month two visits and compared among trans women living with and without HIV, as well as to cis women. In addition, at the month two visit, plasma ART drug concentrations will be sampled and compared among trans women on feminizing hormones and premenopausal cis women who are not taking hormone therapy. The data gathered will indicate whether there are any drug–drug interactions between the estradiol-based feminizing hormone therapy and B/F/TAF ART regimen.
In addition to the CTN Investigators listed below, other principal investigators of CTN 331 are Dr. Kim Scarsi, Dr. Alice Tseng, and Ms. Yasmeen Persad.
If you would like to take part in this study or want more information, please contact Roberta:
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