Uptake of PrEP and condom and sexual risk behavior among MSM during the ANRS IPERGAY trial

ABSTRACT

The double-blind phase of the randomized ANRS IPERGAY trial, evaluating sexual activity-based oral HIV pre-exposure prophylaxis (PrEP), was conducted among high-risk men who have sex with men (MSM). Results showed an 86% (95% CI: 40–98) relative reduction in HIV incidence among participants with tenofovir disoproxil fumarate–emtricitabine vs. placebo. The present pooled analysis aimed to analyze (i) participants’ adherence to the prescribed treatment and/or condom use during sexual intercourse and (ii) sexual behavior during the double-blind phase of the study. Four hundred MSM were enrolled in the trial. Every 2 months they completed online questionnaires collecting sexual behavior and PrEP adherence data regarding their most recent sexual intercourse. A total of 2232 questionnaires (M0–M24) were analyzed. Changes over time were evaluated using a mixed model accounting for multiple measures. Irrespective of sexual partner and practice type, on average, 42.6% (min: 32.1–max: 45.8%) reported PrEP use only during their most recent episode of sexual intercourse; 29% (22.9–35.6%) reported both PrEP and condom use; 11.7% (7.2–18.9%) reported condom-use only, and 16.7% (10.8–29.6%) reported no PrEP or condom use with no significant change during the study. Scheduled (i.e., correct) PrEP use was reported on average by 59.0% (47.2–68.5%) of those reporting PrEP use during their most recent sexual intercourse. Overall, 70.3% (65.3–79.4%) and 69.3% (58.3–75.4%) of participants reported, respectively, condomless anal and condomless receptive anal intercourse during their most recent sexual encounter without significant change during follow-up. Overall, on average 83.3% (min: 70.4–max: 89.2%) of participants protected themselves by PrEP intake or condom use or both during the trial, and no increase in at-risk sexual practices was observed. None of these indicators showed significant trend during the follow-up, although we found a tendency toward decrease (p = .19) of the median number of sexual partners strengthening the absence of behavioral disinhibition. On-demand PrEP within a comprehensive HIV prevention package could improve prevention in MSM.

KEYWORDS:

• On-demand HIV pre-exposure prophylaxis
• MSM
• adherence
• sexual behavior

Acknowledgements

We would like to thank the study's participants for their time and their dedication to this research, for the benefit of their community. We also thank the AIDES community advocacy group and their community peer counselors who made this study possible, through their availability and continuous interaction with the participants and study staff at study sites and, most importantly, between scheduled visits (J.M. Le Gall, S. Morel, V. Pechenot, S. Bagge, A. Djessima Taba, M. Danet, K. Moudachirou, B. Dos Santos, J. Lambec, S. Rouby, X. Teruin, N. Dumon, V. Coquelin, P. Brunet, L. Gilly, T. Cepitelli, R. Porion, D. Rojas Castro, B. Spire). We thank our community advisory board for its continuous support during the study (S. Karon (secretary), D. Villard (Action Santé Alternative), J.M. Astor (Boucle Rouge), D. Ganaye (Federation LGBT), T. Craig (Act-Up), B. Brive (J'y suis j'y reste), R. Orioli (Les Flamands Roses), M. Vanhedde (Solidarite SIDA), H. Baudoin (Sida Info Service), H. Fisher (TRT-5), and the Gay communities in France and Canada (COQSIDA, REZO) who supported this work, Drs S. Becker, P.S. Sow, J. Presley, and M. Aikenhead at the Bill and Melinda Gates foundation for fruitful discussions and funding, Dr J.F. Rooney, A. Cheng, H. Jaffe, C. Rabian, and P. Petour at Gilead Sciences for donating study drugs, and members of the Independent Data and Safety Monitoring Board for their expertise and guidance (Drs D. Costagliola (Chair), Y. Yazdanpanah, V.-K. Nguyen, A.-M. Taburet, and C. Taéron).

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.

Finally, we would like to thank Jude Sweeney for revising and editing the manuscript.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was sponsored by the ANRS (France Recherche Nord & Sud Sida-HIV Hépatites) and funded by ANRS, the Canadian HIV Trials Network, the Fonds de dotation Pierre Bergé pour la Prévention – SIDACTION, and the Bill and Melinda Gates Foundation.