Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
PrEP Adherence Monitoring Using Dried Blood Spots
I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Barriers and Facilitators to HIV Pre-Exposure Prophylaxis Uptake, Adherence, and Persistence Among Transgender Populations in the United States: A Systematic Review.AIDS patient care and STDs · 2022Pooled it
- Exploring potential drug-drug interactions between masculinizing hormone therapy and oral pre-exposure prophylaxis (F/TDF and F/TAF) among transgender men (iMACT study): a randomized, open-label pharmacokinetic study in Thailand.Journal of the International AIDS Society · 2025Trial
- Bidirectional pharmacokinetics of doravirine, tenofovir, and feminizing hormones in transgender women (IDentify): A randomized crossover trial.Clinical and translational science · 2024Trial
- Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions.Clinical pharmacokinetics · 2023Trial
- Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate.AIDS research and human retroviruses · 2022Trial
- PrEP at the site of action in cisgender and transgender women: A pharmacology study of blood and rectal CD4British journal of clinical pharmacology · 2026Article
- Special Issue: New Horizons in HIV and Reproductive Health Research: HIV Acquisition and Reproductive Health in Key Populations.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Review
- A Cross-Biomeasure Study to Optimize Antiretroviral Adherence Estimation.Journal of acquired immune deficiency syndromes (1999) · 2025Article
- Using stated preference methods to design gender-affirming long-acting PrEP programs for transgender and nonbinary adults.Scientific reports · 2024Article
- Acceptability of Event-Driven and Long-Acting HIV Pre-Exposure Prophylaxis Formulations Among Transgender Women Engaged in Street-Based Sex Work in Baltimore, Maryland.Transgender health · 2024Article
- Gender Affirming Hormones Do Not Affect the Exposure and Efficacy of F/TDF or F/TAF for HIV Preexposure Prophylaxis: A Subgroup Analysis from the DISCOVER Trial.Transgender health · 2024Article
- Clinical Relevance of Drug Interactions in People Living with Human Immunodeficiency Virus on Antiretroviral Therapy-Update 2022: Systematic Review.Pharmaceutics · 2023Review
- Mapping Community-Engaged Implementation Strategies with Transgender Scientists, Stakeholders, and Trans-Led Community Organizations.Current HIV/AIDS reports · 2023Review
- Providing gender-affirming care to transgender and gender-diverse individuals with and at risk for HIV.Topics in antiviral medicine · 2023Review
- Inclusion of Transgender and Gender Diverse People in Phase III Trials: Examples from HIV Pharmacologic Prevention Studies.Clinical pharmacology and therapeutics · 2023Review
- PrEP Use and Adherence among Transgender Persons in Chicago, IL (SHIPP Study, 2014-2018, USA).AIDS and behavior · 2023Article
- Awareness and utilization of pre-exposure prophylaxis and HIV prevention services among transgender and non-binary adolescent and young adults.Frontiers in reproductive health · 2023Article
- Population pharmacokinetics of tenofovir, emtricitabine and intracellular metabolites in transgender women.British journal of clinical pharmacology · 2022Article
- PrEP Use and Adherence Among Transgender Patients.AIDS and behavior · 2022Article
Corrections and comments
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Authors and funding
11 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundSex hormone and preexposure prophylaxis (PrEP) drug interactions among transgender women (TGW), transgender men (TGM), and cisgender men (CGM) are not fully understood.
methodsTGM and TGW on at least 6 months of stable sex hormone therapy containing testosterone or estradiol (respectively) were enrolled in a 4-week study of directly observed dosing of daily oral coformulated emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). TFV-DP in dried blood spots and sex hormones in serum were measured at weekly intervals. TFV-DP was compared with 2- and 4-week samples from Directly Observed Therapy Dried Blood Spots (DOT-DBS) Study (NCT02022657).
resultsFrom May 2017 to June 2018, 24 TGM and 24 TGW were enrolled. Testosterone (total and free) and estradiol concentrations were comparable before and after 4 weeks of PrEP use in TGM and TGW, respectively. Historical controls included 17 cisgender women (CGW) and 15 CGM. TFV-DP concentrations at week 4 were comparable between TGW and TGM (mean difference, -6%; 95% confidence interval [CI], -21% to 12%; P = .47), comparable between TGW and CGM (mean difference, -12%; 95% CI, -27% to 7%; P = .21) and were lower among TGM compared with CGW (mean difference, -23%; 95% CI, -36% to -7%; P = .007). All persons in all groups were projected to reach the TFV-DP threshold that has been associated with high protection from human immunodeficiency virus.
conclusionsCGM, TGM, and TGW had comparable TFV-DP concentrations in dried blood spots after 4 weeks of directly observed daily FTC/TDF PrEP use. Serum hormone concentrations were not affected by FTC/TDF PrEP use. CLINICAL TRIALS REGISTRATION: NCT04050371.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.