Evidence map›Paper›PMID 21767103›Full record

Trial reportThe New England journal of medicine2011

Prevention of HIV-1 infection with early antiretroviral therapy.

Myron S Cohen, Ying Q Chen, Marybeth McCauley, Theresa Gamble, Mina C Hosseinipour, Nagalingeswaran Kumarasamy, James G Hakim, Johnstone Kumwenda, Beatriz Grinsztejn, Jose H S Pilotto and 26 more

10 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 3,780 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3,780citing papers in PubMed, 4 pooled it
344.1field-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.

NCT00074581 phase3completednot on this map

A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2005 to 2015Enrolled3,526ConditionsHIV InfectionsArmsAtazanavir, Didanosine, Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate, Lamivudine
NCT02356185 unknown statusnot on this mapstarted 2015, after this paper: background citation

Prevalence, Socio-demographic Correlates of Substance Use Disorders Among HIV-infected Adults in Cameroon, and Their Influence on Adherence to Antiretroviral Therapy and Immunological Feature: Study Protocol for a Retrospective Cohort Study

TypeobservationalSponsorGoulfey Health District UnitRan2015 to 2015Enrolled1,000ConditionsHIV
NCT02692027 phase3completednot on this mapstarted 2016, after this paper: background citation

Same Day Community-based ART Initiation Versus Clinic-based Pre-ART Assessment and Counselling for Individuals Newly Tested HIV-positive During Community-based HIV Testing in Rural Lesotho - a Randomized Controlled Trial

TypeinterventionalSponsorSwiss Tropical & Public Health InstituteRan2016 to 2018Enrolled276ConditionsHIV InfectionArmsSame-day ART initiation, Standard of care
NCT02693145 nacompletednot on this mapstarted 2016, after this paper: background citation

Cooperative Re-Engagement Controlled Trial (CoRECT)

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2016 to 2020Enrolled1,893ConditionsHuman Immunodeficiency VirusArmsAnti-Retroviral Treatment and Access to Services (ARTAS)
NCT03394391 nacompletednot on this mapstarted 2018, after this paper: background citation

A Single-blind, Randomized, Parallel Design Study to Assess the Effectiveness of SMS Reminders in Improving ART Adherence Among Adolescents Living With HIV in Nigeria (STARTA Trial-Adolescents)

TypeinterventionalSponsorDr. Olumide ABIODUNRan2018 to 2019Enrolled212ConditionsHIV InfectionsArmsDaily ART-adherence SMS reminder, Standard Adherence Counselling/Patient experience group chat
NCT03429842 completednot on this mapstarted 2015, after this paper: background citation

HIV Awal (Early) Testing & Treatment Indonesia Project Implementing 'Test and Treat' Strategies for HIV Treatment and Prevention in Key Populations in Indonesia: a Prospective Implementation Research Study (Phase 1 - Observational Phase)

TypeobservationalSponsorGadjah Mada UniversityRan2015 to 2017Enrolled2,071ConditionsHIV/AIDS
NCT04102540 nacompletednot on this mapstarted 2019, after this paper: background citation

Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)

TypeinterventionalSponsorColumbia UniversityRan2019 to 2020Enrolled32ConditionsHealth CommunicationArmsInfographic intervention
NCT04388904 phase4completednot on this mapstarted 2021, after this paper: background citation

A Phase 4, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Antiretroviral Treatment-experienced Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Not Currently Receiving Any Antiretroviral Therapy.

TypeinterventionalSponsorThe Crofoot Research Center, Inc.Ran2021 to 2024Enrolled75ConditionsHIV-1-infectionArmsDarunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)
NCT05333679 nacompletednot on this mapstarted 2022, after this paper: background citation

Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2022 to 2025Enrolled200ConditionsRisk ReductionArmsUTRA, UTRA feedback
NCT05783297 nacompletednot on this mapstarted 2023, after this paper: background citation

Midwest TXTXT Scale up of an Evidence-Based Intervention to Promote HIV Medication Adherence

TypeinterventionalSponsorAmy K. Johnson, PhD, MSWRan2023 to 2025Enrolled210ConditionsHIV InfectionsArmsTreatment Text (TXTXT), Standard of Care
3 · Its place in the literature

Who cites it

3,780 citing papers in PubMed, 4 syntheses or guidelines pooled it, 6,930 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. The effect of a combined mHealth and community health worker intervention on HIV self-management.Journal of the American Medical Informatics Association : JAMIA · 2025
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Article
  20. Article

3,720 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

36 authors at 20 institutions in 8 countries.

Myron S CohenUniversity of North Carolina at Chapel Hill, Institute for Global Health and Infectious Diseases, Suite 2115, Bioinformatics Bldg., 130 Mason Farm Rd., CB 7030, Chapel Hill, NC 27599, USA. mscohen@med.unc.edu
Ying Q Chen
Marybeth McCauley
Theresa Gamble
Mina C Hosseinipour
Nagalingeswaran Kumarasamy
James G Hakim
Johnstone Kumwenda
Beatriz Grinsztejn
Jose H S Pilotto
Sheela V Godbole
Sanjay Mehendale
Suwat Chariyalertsak
Breno R Santos
Kenneth H Mayer
Irving F Hoffman
Susan H Eshleman
Estelle Piwowar-Manning
Lei Wang
Joseph Makhema
Lisa A Mills
Guy de Bruyn
Ian Sanne
Joseph Eron
Joel Gallant
Diane Havlir
Susan Swindells
Heather Ribaudo
Vanessa Elharrar
David Burns
Taha E Taha
Karin Nielsen-Saines
David Celentano
Max Essex
Thomas R Fleming
HPTN 052 Study Team
Johns Hopkins University · USUniversity of North Carolina at Chapel Hill · USCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZAHarvard University · USNational AIDS Research Institute · INNational Institute of Allergy and Infectious Diseases · USBotswana Harvard AIDS Institute Partnership · BWChiang Mai University · THFamily Health International 360 · USFenway Health · USHospital Geral de Fortaleza · BRHospital Nossa Senhora da Conceição · BRInstituto Evandro Chagas · BRJohns Hopkins University Center for AIDS ResearchKenya Medical Research Institute · KEPerinatal HIV Research Unit · ZAUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Nebraska Medical Center · USUniversity of Washington · US

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI MYRON Scott COHEN, Sinead Delany-Moretlwe · 2011 to 2026
$779.5M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
HIV Prevention trials Network (HPTN) Coordinating and Operations CenterU01AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI VERMUND, STEN H. · 2006 to 2010
$72.7M
Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Colleen F Kelley · 2012 to 2026
$46.0M
Leadership for HIV/AIDS Clinical Trials Networks; HIV Prevention Trials NetworkU01AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DONNELL, DEBORAH J · 2006 to 2010
$28.8M
HIV Prevention Trials Network: Network LaboratoryU01AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ESHLEMAN, SUSAN H · 2006 to 2010
$16.5M
Research Infrastructure for the Hopkins Population CenterR24HD042854 · NICHD · JOHNS HOPKINS UNIVERSITY · PI CHERLIN, ANDREW J · 2003 to 2017
$5.1M
Therapeutic Strategies for HIV DiseaseK24AI051982 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2002 to 2012
$1.3M
NIAID NIH HHS K24 AI051982NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI068613NIAID NIH HHS U01-AI068613NIAID NIH HHS U01 AI068617NIAID NIH HHS U01-AI068617NIAID NIH HHS U01 AI068619NIAID NIH HHS U01-AI068619NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1-AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1-AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1-AI068619NIAID NIH HHS UM1 AI069418NICHD NIH HHS R24 HD042854
6 · The paper itself

Abstract

backgroundAntiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.

methodsIn nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death.

resultsAs of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01).

conclusionsThe early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).

Indexed as

HIV-1AdolescentAdultAnti-Retroviral AgentsDisease ProgressionDisease Transmission, InfectiousDrug Therapy, CombinationFemaleHIV InfectionsHIV SeropositivityHumansKaplan-Meier EstimateMaleProportional Hazards ModelsSexual PartnersSpousesAnti-Retroviral Agents

Identifiers

PMID21767103
PMCPMC3200068
OpenAlexW2152505869

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

and 4 more above

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.