Abstract
Pre-Exposure Prophylaxis (PrEP) is changing the landscape of HIV prevention, and may bring changes in sexual behaviors. The double-blind phase (DBP) and open-label extension (OLE) study of the ANRS-IPERGAY trial allowed us to assess changes in sexual behavior of men who have sex with men (MSM) taking sexual activity-based (i.e., on-demand) PrEP. Generalized Estimating Equation (GEE) models found a significant decrease in the number of sexual partners (Coefficient [CI95%], p value; − 0.37[− 0.70 to − 0.04], p = 0.03) between the DBP and OLE as well as in the number of sexual relations (− 0.25 [− 0.49 to 0.00], 0.04). GEE estimates also showed that respondents’ most recent sexual relation was less likely to have been with an unknown casual partner during the OLE than during the DBP (Odds Ratio [CI95%], p value: 0.75[0.62–0.92], 0.005). Furthermore, they showed an increase in the proportion of condomless anal sex in the OLE (1.32[1.04–1.67], 0.02), a decrease in the proportion of ‘suboptimal PrEP adherence’ over time (0.75[0.58–0.97], p = 0.03), a decrease in PrEP only use (0.73[0.55–0.96], 0.03) and in both PrEP and condom use over time (0.70[0.51–0.95], 0.02) and finally, a decrease in alcohol consumption between the DBP and OLE (0.74[0.61–0.90], 0.002). We observed both protective and risky behaviors in terms of HIV and STI risk after on-demand PrEP uptake in the OLE phase. Our findings are consistent with results from previous PrEP trials.
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Acknowledgements
We would like to thank all the study’s participants who dedicated their time to this research for the benefit of their community. We also thank the AIDES community advocacy group and their community peer counsellors who made the study possible, through their availability and continuous interaction with the participants and study staff at study sites and, most importantly, outside the hours of scheduled visits. Our thanks also to Jude Sweeney for the English revision and editing, and to Bakridine Mmadi Mrenda for his contribution to the statistical analyses. This work was sponsored by the ANRS (France Recherche Nord & Sud Sida-HIV Hépatites) and funded by the ANRS, the Canadian HIV Trials Network, the Fonds de dotation Pierre Bergé pour la Prévention – SIDACTION, and the Bill and Melinda Gates Foundation. MDC is the recipient of a doctoral fellowship from the ANRS.
The ANRS IPERGAY study group: J.-M. Molina (coordinator), C. Capitant, B. Spire, G. Pialoux, L. Cotte, I. Charreau, C. Tremblay, J.-M. Le Gall, E. Cua, A. Pasquet, F. Raffi, C. Pintado, C. Chidiac, J. Chas, P. Charbonneau, C. Delaugerre, M. Suzan-Monti, B. Loze, J. Fonsart, G. Peytavin, A. Cheret, J. Timsit, G. Girard, N. Lorente, M. Préau, J.F. Rooney, M.A. Wainberg, D. Thompson, W. Rozenbaum, V. Doré, L. Marchand, M.-C. Simon, N. Etien, J.-P. Aboulker, L. Meyer, and J.-F. Delfraissy.
Participating hospitals and investigators: Paris St-Louis: C. Pintado, B. Loze, C. Delaugerre, P. Charbonneau, C. Gatey, D. Ponscarme, P. Penot, L. Niedbalski, R. Veron, J. Delgado, E. Dalle, S. Parlier, I. Madelaine, J. Fonsart, M. Danet, N. Mahjoub, N. Mezreb, K. Moudachirou, S. Morel, G. Conort, F. Lorho, M. Meunier, W. Rozenbaum, J.M. Molina; Paris Tenon: J. Chas, C. Monfort, J. Foucoin, B. Boissavy, S. Cousseau, S. Huon, M. Danet, A. Djessima, V. Berrebi, A. Adda, S. le Nagat, L. Zarka, J. Berdougo, G. Pialoux; Lyon: C. Chidiac, N. Mzoughi, F. Clement, A. Decouty, C. Chapolard, M. Godinot, C. Adouard-groslafeige, J. Koffi, A. Pansu, A. Becker, S. Pailhes, F. Bonnet, F. Jeanblanc, C. Brochier, X. Teruin, S. Rouby, L. Gilly, L. Cotte; Montréal: C. Beauvais, P. Arlotto, C. Fortin, A. Talbot, A. Chamberland, A. McKenzie, M. Blanchette, R; Rousseau, K. Montheuth, D. Thompson, M. Morin, M. Wainberg, C. Tremblay; Nice: C. Etienne, F. Tolonin, S. Breaud, V. Péchenot, S. Bagge, T. Cepitelli, PM. Roger, E. Rosenthal, E. Cua; Tourcoing: A. Cheret, P. Cornavin, S. Vandamme, J. Lambec, N. Dumon, O. Leclanche, T. Huleux, R. Biekre, O. Robineau, H. Melliez, H. Bazus, A. Pasquet; Nantes: C. Bernaud, M. Besnier, B. Bonnet, N. Hall, M. Cavellec, H. Hue, L. Larmet, M. Colas, R. Choquet, F. Raffi.
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MDC implemented this work under the supervision of LST and BS. MDC, MM and LST led the analysis. The manuscript was written collaboratively between MDC, LST, MSM, CP and BS, with input from DRC, LM, MP and JMM. CT, CCh and CC provided ongoing support to design and perform data collection throughout the cohort study. All authors approved the final manuscript.
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JMM reports receiving support as an adviser for Gilead Sciences, Merck, Janssen, Bristol–Myers Squib (BMS), and ViiV Healthcare, as well as research grants from Gilead Sciences and Merck. BS reports receiving support as an adviser for Gilead Sciences, Merck, Janssen, and BMS, as well as research grants from Gilead Sciences and Merck. CCh reports receiving support as an adviser for Gilead, Pfizer, Janssen, and Astellas. CT reports receiving support from Gilead Sciences and Pfizer. All other authors declare no competing interests.
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Di Ciaccio, M., Sagaon-Teyssier, L., Mimi, M. et al. Changes in Sexual Behaviors in Men Who Have Sex with Men: A Comparison Between the Double-Blind and Open-Label Extension Phases of the ANRS-IPERGAY Trial. AIDS Behav 24, 3093–3106 (2020). https://doi.org/10.1007/s10461-020-02864-8
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DOI: https://doi.org/10.1007/s10461-020-02864-8