Impact of early antiretroviral treatment on sexual behaviour in the INSIGHT Strategic Timing of Anti-Retroviral Treatment (START) Trial: A randomised comparison

Fiona C. Lampe, Alison J. Rodger, William Burman, Andrew Grulich, Gerald Friedland, Wafaa El Sadr, James Neaton, Giulio M. Corbelli, Sean Emery, Jean Michel Molina, Chloe Orkin, Jose Gatell, Jan Gerstoft, Kiat Ruxrungtham, Monica Barbosa De Souza, Andrew Phillips

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


BACKGROUND: Antiretroviral treatment (ART) reduces HIV infectiousness, but the effect of early ART on sexual behaviour is unclear.

METHODS: We assessed, within the START randomised trial that enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART < 6 months ago or viral load(VL)>200c/mL or no VL in past 6 months), during two year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.

RESULTS: Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6% versus 13.1%; difference (95% CI): -0.4% (-3.1%, 2.2%), p = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8% versus 8.3%; difference:2.5% (-0.1%, 5.2%), p = 0.062]; the difference was greater at month 24 [9.3% versus 5.6%; difference:3.7%(1.0%, 6.4%), p = 0.007], at which time CLS was higher in the immediate arm [20.7% versus 15.7%, p = 0.013]. CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.

CONCLUSIONS: A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk-sex, to a very low absolute level.

Original languageEnglish (US)
Pages (from-to)2337-2350
Number of pages14
Issue number15
StatePublished - Dec 1 2019

Bibliographical note

Funding Information:
Funding: The START study was primarily funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award numbers: UM1-AI068641 and UM1-AI120197. START was supported by the National Institutes of Health Clinical Center, National Cancer Institute, National Heart, Lung, and Blood Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (France), National Health and Medical Research Council (Australia), National Research Foundation (Denmark), Bundes ministerium für Bildung und Forschung (Germany), European AIDS Treatment Network, Medical Research Council (United Kingdom), National Institute for Health Research, National Health Service (United Kingdom), and University of Minnesota. Antiretroviral drugs were donated to the central drug repository by AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Janssen Scientific Affairs and Merck.

Publisher Copyright:
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.


  • Antiretroviral therapy
  • Condomless sex
  • HIV
  • Heterosexual
  • MSM
  • Transmission

PubMed: MeSH publication types

  • Journal Article


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