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Sexual activity without condoms and risk of HIV transmission in serodifferent couples when the HIV-positive partner is using suppressive antiretroviral therapy.
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IMPORTANCE: A key factor in assessing the effectiveness and cost-effectiveness of antiretroviral therapy (ART) as a prevention strategy is the absolute risk of HIV transmission through condomless sex with suppressed HIV-1 RNA viral load for both anal and vaginal sex. OBJECTIVE: To evaluate the rate of within-couple HIV transmission (heterosexual and men who have sex with men [MSM]) during periods of sex without condoms and when the HIV-positive partner had HIV-1 RNA load less than 200 copies/mL. DESIGN, SETTING, AND PARTICIPANTS: The prospective, observational PARTNER (Partners of People on ART-A New Evaluation of the Risks) study was conducted at 75 clinical sites in 14 European countries and enrolled 1166 HIV serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex (September 2010 to May 2014). Eligibility criteria for inclusion of couple-years of follow-up were condomless sex and HIV-1 RNA load less than 200 copies/mL. Anonymized phylogenetic analysis compared couples' HIV-1 polymerase and envelope sequences if an HIV-negative partner became infected to determine phylogenetically linked transmissions. EXPOSURES: Condomless sexual activity with an HIV-positive partner taking virally suppressive ART. MAIN OUTCOMES AND MEASURES: Risk of within-couple HIV transmission to the HIV-negative partner. RESULTS: Among 1166 enrolled couples, 888 (mean age, 42 years [IQR, 35-48]; 548 heterosexual [61.7%] and 340 MSM [38.3%]) provided 1238 eligible couple-years of follow-up (median follow-up, 1.3 years [IQR, 0.8-2.0]). At baseline, couples reported condomless sex for a median of 2 years (IQR, 0.5-6.3). Condomless sex with other partners was reported by 108 HIV-negative MSM (33%) and 21 heterosexuals (4%). During follow-up, couples reported condomless sex a median of 37 times per year (IQR, 15-71), with MSM couples reporting approximately 22,000 condomless sex acts and heterosexuals approximately 36,000. Although 11 HIV-negative partners became HIV-positive (10 MSM; 1 heterosexual; 8 reported condomless sex with other partners), no phylogenetically linked transmissions occurred over eligible couple-years of follow-up, giving a rate of within-couple HIV transmission of zero, with an upper 95% confidence limit of 0.30/100 couple-years of follow-up. The upper 95% confidence limit for condomless anal sex was 0.71 per 100 couple-years of follow-up. CONCLUSIONS AND RELEVANCE: Among serodifferent heterosexual and MSM couples in which the HIV-positive partner was using suppressive ART and who reported condomless sex, during median follow-up of 1.3 years per couple, there were no documented cases of within-couple HIV transmission (upper 95% confidence limit, 0.30/100 couple-years of follow-up). Additional longer-term follow-up is necessary to provide more precise estimates of risk.
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“Additional studies of HIV mixed-status couples, heterosexual and MSM couples (PARTNER study), and MSM couples (Opposites Attract and PARTNERS2 studies) reported that patients with HIV taking ART who maintain an undetectable viral load demonstrate no risk for transmitting HIV to their HIV-negative sex partners (95–97).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [95]
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“Effective ART that suppresses HIV replication to undetectable levels reduces morbidity, provides a near-normal lifespan, and prevents sexual transmission of HIV to others (95–97,410–412).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [95]
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“Persons with HIV infection who achieve and maintain a viral load suppressed to <200 copies/mL with ART have effectively no risk for sexually transmitting HIV (95–97,421).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [95]
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- [1]1. had no role in design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. PARTNER Study Group: Spain: Hospital Virgen del Rocío, Sevilla: V. Pompeyo, M. Trastoy, R. Palacio. Hospital General de Elche: F. Gutiérrez, M. Masiá, S. Padilla, C. Robledano. Hospital Universitari Germans Trias i Pujol, Badalona: B. Clotet, P. Coll. Hospital La Paz, Madrid: J. Peña. Hospital Universitario San Carlos, Madrid: V. Estrada, M. Rodrigo, E. Santiago. Hospital Universitario Reina Sofia De Cordoba: A. Rivero. Hospital Clínico Universitario de Santiago de Compostela: A. Antela, E. Losada, C. Lires, A. Aguilera. Hospital Clínic de Barcelona, Barcelona: J. Gatell. Centro Sanitario Sandoval, Madrid: J. Guerrero. Hospital Ramon y Cajal, Madrid: F. Dronda. Hospital Carlos III, Madrid: V. Soriano. United Kingdom: Chelsea and Westminster Hospital, London: D. Asboe, N. Nwokolo, J. Sewell. Mortimer Market Clinic, London: R. Gilson, N. Esteban, S. McNamara. Royal Free Hospital: A. Rodger, K. Sturgeon. Southmead Hospital, Bristol: M. Gompels, L. Jennings. Coventry and Warwickshire Hospital: S. Allan. Edinburgh Infectious Diseases, University of Edinburgh: C. Leen, S. Morris. King's College Hospital: M. Brady, L. Campbell. Brighton: M. Fisher. Leicester Royal Infirmary: J. Dhar. Newham: R. O'Connell. Birmingham Heartlands: D. White. St Thomas Hospital, London: J. Fox. St Mary's Hospital, London: S. Fidler. Bradford: P. Stanley. Earnsdale, Redhill: U. Natarajan. Northampton: M. Ghanem. North Middlesex University Hospital, London: J. Ainsworth, A. Waters. North Manchester General Hospital: E. Wilkins. St James's, Leeds: J. Minton, J. Calderwood. Hastings: H. Patel. Whipps Cross Hospital, London: M. Lascar. Germany: University Clinic, Hamburg Eppendorf: J. Lunzen. University Hospital Cologne: T. Kümmerle, G. Fätkenheuer, E. Rund, C. Lehmann. Praxis Driesener Straße, Berlin: I.
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Metadata
- Authors
- Rodger, A. J., Cambiano, V., Bruun, T., Vernazza, P., Collins, S., van Lunzen, J., Corbelli, G. M., Estrada, V., Geretti, A. M., Beloukas, A., Asboe, D., Viciana, P., Gutiérrez, F., Clotet, B., Pradier, C., Gerstoft, J., Weber, R., Westling, K., Wandeler, G., Prins, J. M., Rieger, A., Stoeckle, M., Kümmerle, T., Bini, T., Ammassari, A., Gilson, R., Krznaric, I., Ristola, M., Zangerle, R., Handberg, P., Antela, A., Allan, S., Phillips, A. N., Lundgren, J., & for the PARTNER Study Group
- Affiliations
- University College London (GB)
- University of Copenhagen (DK)
- Kantonsspital St. Gallen (CH)
- HIV i-Base, London, United Kingdom
- University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany
- European AIDS Treatment Group, Bruxelles, Belgium
- Universidad Complutense de Madrid (ES)
- Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom
- University of Liverpool (GB)
- Chelsea and Westminster Hospital NHS Foundation Trust (GB)
- Hospital Universitario Virgen del Rocío (ES)
- Universitat de Miguel Hernández d'Elx (ES)
- Universitat Autònoma de Barcelona (ES)
- Laboratoire Motricité Humaine Éducation Sport Santé (FR)
- Rigshospitalet (DK)
- University of Zurich (CH)
- Karolinska University Hospital (SE)
- University of Bern (CH)
- Amsterdam UMC Location University of Amsterdam (NL)
- Medical University of Vienna (AT)
- University Hospital of Basel (CH)
- University Hospital Cologne (DE)
- Ospedale San Paolo (IT)
- Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani (IT)
- Praxis Driesener Straße, Berlin, Germany
- Helsinki University Hospital (FI)
- Innsbruck Medical University (AT)
- Hvidovre Hospital (DK)
- Complejo Hospitalario Universitario de Santiago (ES)
- Coventry and Warwickshire Hospital, Coventry, United Kingdom
- ORCID
- Rodger, Alison J.
- Cambiano, Valentina
- Vernazza, Pietro
- Collins, Simon
- Corbelli, Giulio Maria
- Estrada, Vicente
- Beloukas, Apostolos
- Asboe, David
- Gutiérrez, Félix
- Clotet, Bonaventura
- Pradier, Christian
- Gerstoft, Jan
- Weber, Rainer
- Westling, Katarina
- Wandeler, Gilles
- Prins, Jan M.
- Rieger, Armin
- Stoeckle, Marcel
- Ammassari, Adriana
- Gilson, Richard
- Krznaric, Ivanka
- Ristola, Matti
- Zangerle, Robert
- Antela, Antonio
- Allan, Sris
- Phillips, Andrew N.
- Lundgren, Jens
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2016-07-12
- Volume
- 316
- Issue
- 2
- Pages
- 171
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2461009619
- Cited by
- 1,431
- References
- 21
- Citations by year
- 2026: 57 · 2025: 85 · 2024: 112 · 2023: 139 · 2022: 146 · 2021: 164 · 2020: 169 · 2019: 226 · 2018: 166 · 2017: 141 · 2016: 24
- FWCI
- 171.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
- Pure Amsterdam UMC (acceptedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
- Bern Open Repository and Information System (University of Bern) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- CINECA IRIS Institutial Research Information System (University of Genoa) (submittedVersion)
- Scopus (Elsevier) (submittedVersion, other-oa)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- National Institute for Health and Care Research (PB-PG-1013-32069, RP-PG-0608-10142)
- National Research Foundation
- Danmarks Grundforskningsfond
- Programme Grants for Applied Research (RP-PG-0608-10142)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Keywords
- unprotected sex, HIV-1 RNA suppression, antiretroviral therapy, men who have sex with men, heterosexual couples, HIV prevention, phylogenetic analysis, viral load, anal sex, vaginal intercourse, HIV-negative men who have sex with men, HIV-negative women, HIV-negative children
- MeSH terms
- Adult, Europe, Family Characteristics, Female, HIV Seropositivity, Humans, Male, Middle Aged, Phylogeny, Prospective Studies, Risk, RNA, Viral, Sexual Behavior, Sexual Partners, HIV-1, HIV Infections, Condoms, HIV Seronegativity, Anti-HIV Agents, Viral Load, Unsafe Sex
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