Evidence map›Paper›PMID 26614965›Full record

Trial reportThe lancet. HIV2015

HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial.

Madeline B Deutsch, David V Glidden, Jae Sevelius, Joanne Keatley, Vanessa McMahan, Juan Guanira, Esper G Kallas, Suwat Chariyalertsak, Robert M Grant, iPrEx investigators

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. HIV, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04050371 (I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones), which is not on this map. Cited by 174 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
174citing papers in PubMed, 3 pooled it
13.4field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04050371 phase4completednot on this mapstarted 2017, after this paper: background citation

I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones

TypeinterventionalSponsorUniversity of California, San FranciscoRan2017 to 2018Enrolled48ConditionsHIV Prevention, Transgender HealthArms200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
3 · Its place in the literature

Who cites it

174 citing papers in PubMed, 3 syntheses or guidelines pooled it, 271 citations in OpenAlex.

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  3. Global Epidemiology of HIV Infection and Related Syndemics Affecting Transgender People.Journal of acquired immune deficiency syndromes (1999) · 2016
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114 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 3 countries.

Madeline B DeutschUniversity of California, San Francisco, CA, USA. Electronic address: Madeline.Deutsch@ucsf.edu.
David V GliddenUniversity of California, San Francisco, CA, USA.
Jae SeveliusUniversity of California, San Francisco, CA, USA.
Joanne KeatleyUniversity of California, San Francisco, CA, USA.
Vanessa McMahanGladstone Institutes, San Francisco, CA, USA.
Juan GuaniraINMENSA, Lima, Peru.
Esper G KallasUniversity of São Paulo, São Paulo, Brazil.
Suwat ChariyalertsakRIHES, University of Chiang Mai, Chiang Mai, Thailand.
Robert M GrantUniversity of California, San Francisco, CA, USA; Gladstone Institutes, San Francisco, CA, USA; San Francisco AIDS Foundation, San Francisco, CA, USA. Electronic address: Robert.Grant@ucsf.edu.
iPrEx investigators
University of California, San Francisco · USChiang Mai University · THGladstone Institutes · USUniversidade de São Paulo · BR

Funding

Chemoprophylaxis for HIV Prevention in Men SupplementU01AI064002 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2005 to 2011
$41.3M
Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU)UM1AI069399 · NIAID · CHIANG MAI UNIVERSITY · PI Kiat Ruxrungtham, Khuanchai Supparatpinyo · 2012 to 2026
$25.0M
Chemoprophylaxis and HIV-Host InteractionsR01AI062333 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2004 to 2011
$6.2M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
NIAID NIH HHS R01 AI062333NIAID NIH HHS R01 AI118575NIAID NIH HHS U01 AI064002NIAID NIH HHS UM1 AI069399
6 · The paper itself

Abstract

backgroundPre-exposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate is used to prevent the sexual acquisition of HIV in groups at high risk such as transgender women. We used data from the iPrEx study to assess PrEP efficacy, effectiveness, and adherence in transgender women.

methodsThe iPrEx trial was a randomised controlled trial of PrEP with oral emtricitabine plus tenofovir disoproxil fumarate compared with placebo in men who have sex with men (MSM) and transgender women, followed by an open-label extension. Drug concentrations were measured in blood by liquid chromatography and tandem mass spectroscopy. We did unplanned exploratory analyses to investigate differences in PrEP outcomes among transgender women and between transgender women and MSM.

findingsOf the 2499 participants enrolled in the randomised controlled trial, 29 (1%) identified as women, 296 (12%) identified as trans, 14 (1%) identified as men but reported use of feminising hormones, such that 339 (14%) reported one or more characteristics and are classified as transgender women for the purpose of this study. Compared with MSM, transgender women more frequently reported transactional sex, receptive anal intercourse without a condom, or more than five partners in the past 3 months. Among transgender women, there were 11 HIV infections in the PrEP group and ten in the placebo group (hazard ratio 1·1, 95% CI 0·5-2·7). In the PrEP group, drug was detected in none of the transgender women at the seroconversion visit, six (18%) of 33 seronegative transgender women (p=0·31), and 58 (52%) of 111 seronegative MSM (p<0·0001). PrEP use was not linked to behavioural indicators of HIV risk among transgender women, whereas MSM at highest risk were more adherent.

interpretationPrEP seems to be effective in preventing HIV acquisition in transgender women when taken, but there seem to be barriers to adherence, particularly among those at the most risk. Studies of PrEP use in transgender women populations should be designed and tailored specifically for this population, rather than adapted from or subsumed into studies of MSM.

fundingUS National Institutes of Health and the Bill & Melinda Gates Foundation.

Indexed as

Pre-Exposure ProphylaxisTransgender PersonsAdultAnti-HIV AgentsBrazilClinical Trials, Phase III as TopicCondomsDelivery of Health Care, IntegratedDirective CounselingDrug MonitoringEcuadorEmtricitabineFemaleHIV InfectionsHomosexuality, MaleHumansAnti-HIV AgentsEmtricitabineTenofovir

Identifiers

PMID26614965
PMCPMC5111857
OpenAlexW2145754461

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.