Evidence map›Paper›PMID 30530721›Full record

ArticleCMAJ open

Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study.

Darrell H S Tan, Alexandre Schnubb, James Lawless, Leah Szadkowski, Troy Grennan, James Wilton, Shawn Fowler, Trevor A Hart, John Maxwell, Janet M Raboud

Registry-linked trialOpen access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in CMAJ open. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02149888 (A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 36% 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.

NCT02149888 phase4completednot on this map

A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study

TypeinterventionalSponsorUnity Health TorontoRan2014 to 2016Enrolled52ConditionsHIV, Human Immunodeficiency VirusArmsTenofovir/emtricitabine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 3 countries.

Darrell H S TanDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont. darrell.tan@gmail.com.
Alexandre SchnubbDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
James LawlessDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
Leah SzadkowskiDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
Troy GrennanDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
James WiltonDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
Shawn FowlerDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
Trevor A HartDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
John MaxwellDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
Janet M RaboudDivision of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.
3M (United States) · USUniversity of British Columbia · CABC Centre for Disease Control · CAHassle Free Clinic · CASt Michael’s Hospital · IEUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreexposure prophylaxis is efficacious at preventing HIV infection, but concerns persist about adherence and sexually transmitted infections (STIs). We assessed preexposure prophylaxis acceptability, adherence and clinical outcomes in a pilot demonstration project.

methodsHIV-uninfected adult gay and bisexual men who scored 10 or higher on a validated HIV risk score (HIV Incidence Risk Index for MSM) and reported condomless receptive anal sex were sequentially enrolled into a 1-year open-label single-arm pilot study of daily oral therapy with tenofovir disoproxil fumarate/emtricitabine in Toronto. The primary outcome was acceptability of preexposure prophylaxis. Secondary outcomes were preexposure prophylaxis adherence (4-d recall, pill count and dried blood spot analysis), HIV seroconversion, STIs and adverse events.

resultsOf the 86 men screened, 52 were enrolled. Participants were mostly young (median age 33 yr [interquartile range (IQR) 28-37 yr) white (38 [73%]) gay (49 [94%]) men. Preexposure prophylaxis acceptability was high: all participants reported their experience as "good" or "very good." The median adherence rate was high, at 100% (IQR 95%-100%) by self-report and 96.9% (IQR 93.4%-98.4%) by pill count. Dried blood spot analysis suggested that doses were taken 4-7 days/week at 88.7% (173/195) of month 3-12 visits. No cases of HIV seroconversion occurred, but 25 participants (48%) experienced at least 1 bacterial STI, with incidence rates per 100 person-years of 32.8, 32.8, 8.2 and 8.2 for chlamydia, gonorrhea, syphilis and lymphogranuloma venereum, respectively. No adverse events led to discontinuation of prophylaxis, but the estimated glomerular filtration rate declined by 0.22 mL/min per month.

interpretationPreexposure prophylaxis was associated with high adherence and acceptability and no HIV infections in this study. Frequent STIs and clinically unapparent toxic renal effects reinforce the need for ongoing vigilance.

trial registrationClinicalTrials. gov, no. NCT02149888.

Identifiers

PMID30530721
PMCPMC6287974
OpenAlexW2903802977

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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.