Evidence map›Paper›PMID 27333000›Full record

ArticlePloS one2016

Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting.

Madeline C Montgomery, Catherine E Oldenburg, Amy S Nunn, Leandro Mena, Peter Anderson, Teri Liegler, Kenneth H Mayer, Rupa Patel, Alexi Almonte, Philip A Chan

Registry-linked trialAbstract read
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03442192 (A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men), which is not on this map. Cited by 55 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03442192 naterminatednot on this mapstarted 2018, after this paper: background citation

A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men (PCA)

TypeinterventionalSponsorJohns Hopkins UniversityRan2018 to 2021Enrolled20ConditionsAdherence, PatientArmsPrEP Care Anywhere Services
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  16. Retention of clients in HIV oral pre-exposure prophylaxis care in Engela, Namibia.African journal of primary health care & family medicine · 2025
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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.

Madeline C MontgomeryDivision of Infectious Diseases, Brown University, Providence, Rhode Island, United States of America.
Catherine E OldenburgDepartment of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, United States of America.
Amy S NunnDepartment of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, United States of America.
Leandro MenaDivision of Infectious Diseases, University of Mississippi, Jackson, Mississippi, United States of America.
Peter AndersonSkaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, United States of America.
Teri LieglerDepartment of Medicine, University of California San Francisco, San Francisco, California, United States of America.
Kenneth H MayerThe Fenway Institute, Fenway Health, Boston, MA; Department of Medicine, Beth Israel Deaconess Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
Rupa PatelDivision of Infectious Diseases, Washington University, St Louis, Missouri, United States of America.
Alexi AlmonteDivision of Infectious Diseases, Brown University, Providence, Rhode Island, United States of America.
Philip A ChanDivision of Infectious Diseases, Brown University, Providence, Rhode Island, United States of America.

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Translational ScienceP30AI042853 · NIAID · MIRIAM HOSPITAL · PI LARRY K BROWN · 1998 to 2026
$51.7M
HIV and Other Infectious Consequences of Substance UseT32DA013911 · NIDA · MIRIAM HOSPITAL · PI TRACI C GREEN, JOSIAH D RICH · 2001 to 2026
$9.6M
Washington University Institute of Clinical and Translational SciencesKL2TR000450 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$8.8M
The Brown Initiative in HIV and AIDS Clinical Research for Minority CommunitiesR25MH083620 · NIMH · MIRIAM HOSPITAL · PI NUNN, AMY STEWART · 2008 to 2025
$3.7M
Molecular Epidemiology of HIV Transmission NetworksK23AI096923 · NIAID · MIRIAM HOSPITAL · PI CHAN, PHILIP ANDREW · 2011 to 2015
$650k
NCATS NIH HHS KL2 TR000450NIAID NIH HHS K23 AI096923NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI042853NIDA NIH HHS T32 DA013911NIMH NIH HHS R25 MH083620
6 · The paper itself

Abstract

backgroundThe HIV epidemic in the United States (US) disproportionately affects gay, bisexual, and other men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) using co-formulated tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has demonstrated high efficacy in reducing HIV incidence among MSM. However, low adherence was reported in major efficacy trials and may present a substantial barrier to successful PrEP implementation. Rates of adherence to PrEP in "real-world" clinical settings in the US remain largely unknown.

methodsWe reviewed demographic and clinical data for the first 50 patients to enroll in a clinical PrEP program in Providence, Rhode Island. We analyzed self-reported drug adherence as well as drug concentrations in dried blood spots (DBS) from patients who attended either a three- or six-month follow-up appointment. We further assessed drug concentrations and the resistance profile of a single patient who seroconverted while taking PrEP.

resultsOf the first 50 patients to be prescribed PrEP, 62% attended a follow-up appointment at three months and 38% at six months. Of those who attended an appointment at either time point (70%, n = 35), 92% and 95% reported taking ±4 doses/week at three and six months, respectively. Drug concentrations were performed on a random sample of 20 of the 35 patients who attended a follow-up appointment. TDF levels consistent with ±4 doses/week were found in 90% of these patients. There was a significant correlation between self-reported adherence and drug concentrations (r = 0.49, p = 0.02). One patient who had been prescribed PrEP seroconverted at his three-month follow-up visit. The patient's drug concentrations were consistent with daily dosing. Population sequencing and ultrasensitive allele-specific PCR detected the M184V mutation, but no other TDF- or FTC-associated mutations, including those present as minor variants.

conclusionIn this clinical PrEP program, adherence was high, and self-reported drug adherence accurately reflected drug concentrations as measured by DBS.

Indexed as

Medication AdherencePre-Exposure ProphylaxisAdolescentAdultDose-Response Relationship, DrugDried Blood Spot TestingFemaleHIV InfectionsHumansMaleMiddle AgedSelf ReportTenofovirYoung AdultTenofovir

Identifiers

PMID27333000
PMCPMC4917105

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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.