ACTG 5403
Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study
Transgender women (TW) are the fastest-growing group of people with HIV (PWH). Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed help providers when it comes to choosing HIV medications in TW on Feminizing Hormone Therapy (FHT).
Purpose of this Investigational Study:
The purpose of this study is to determine the best combination of antiretroviral therapy for transgender women living with HIV who take feminization hormonal therapy. All participants will receive FHT. The study will determine if TW remain undetectable while receiving FHT for 48 weeks. Additionally, it will assess if hormone levels change based on the type of HIV medication taken.
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Eligibility Factors for this Study:
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People living with HIV
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Ages 18 and older
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Identify as a transwoman or as a transfeminine person (AMAB)
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Desire to initiate or restart FHT
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On ART for at least 24 weeks prior to study entry
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On certain ART for at least 28 days prior to study entry​
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HIV viral load of 400 copies or less
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Currently not on oral estrogen therapy within 14 days prior to study entry
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Currently not on any injectable estrogen therapy within 30 days prior to study entry
Length of Study:
Approximately 48 weeks
Schedule of Study Appointments:
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In-person and remote visits
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Four fasting visits (*)
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Pre-Entry (conditional on ART), Entry (*), week 4, week 8, week 12 (*), week 24 (*), week 36, and week 48 (*)
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Study Treatment:
Oral 17-β-estradiol 2mg once daily. Dose may change based on desired goals and hormone levels. Oral 17-β-estradiol is provided by the study.
Study Procedures:
Medical histories, Physical exams, Blood draws
Reimbursement:
$20 per visit starting with the screening visit
Contact:
UW Positive Research at 206-773-7129 (call or text)
