title: 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.
authors.affiliation: a INSERM, UMR912 (SESSTIM) , Marseille , France.|b Aix Marseille Université, UMR_S912, IRD , Marseille , France.|c ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur , Marseille , France.
authors.forename: Luis
authors.initials: L
authors.lastname: Sagaon-Teyssier
authors.affiliation: a INSERM, UMR912 (SESSTIM) , Marseille , France.|b Aix Marseille Université, UMR_S912, IRD , Marseille , France.|c ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur , Marseille , France.
authors.forename: Marie
authors.initials: M
authors.lastname: Suzan-Monti
authors.affiliation: a INSERM, UMR912 (SESSTIM) , Marseille , France.|b Aix Marseille Université, UMR_S912, IRD , Marseille , France.|c ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur , Marseille , France.
authors.forename: Baptiste
authors.initials: B
authors.lastname: Demoulin
authors.affiliation: d Inserm SC10 , Villejuif , France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Capitant
authors.affiliation: a INSERM, UMR912 (SESSTIM) , Marseille , France.|e Centre for Epidemiological Studies on HIV/STI in Catalonia (CEEISCAT), Agència de Salut Pública de Catalunya (ASPC) , Badalona , Spain.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Lorente
authors.affiliation: a INSERM, UMR912 (SESSTIM) , Marseille , France.|f GRePS Lyon 2 Université , Bron , France.
authors.forename: Marie
authors.initials: M
authors.lastname: Préau
authors.affiliation: a INSERM, UMR912 (SESSTIM) , Marseille , France.|b Aix Marseille Université, UMR_S912, IRD , Marseille , France.|c ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur , Marseille , France.
authors.forename: Marion
authors.initials: M
authors.lastname: Mora
authors.affiliation: f GRePS Lyon 2 Université , Bron , France.|g AIDES (Mission Innovation Recherche Expérimentation) , Pantin , France.
authors.forename: Daniela
authors.initials: D
authors.lastname: Rojas Castro
authors.affiliation: h Department of Infectious Diseases , Hôpital de la Croix Rousse, INSERM U1052 , Lyon , France.
authors.forename: Christian
authors.initials: C
authors.lastname: Chidiac
authors.affiliation: i Department of Infectious Diseases , Hôpital Tenon , Paris , France.
authors.forename: Julie
authors.initials: J
authors.lastname: Chas
authors.affiliation: d Inserm SC10 , Villejuif , France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Meyer
authors.affiliation: j Department of Infectious Disease , Assistance Publique Hôpitaux de Paris, University of Paris Diderot Paris 7, INSERM U941 , Paris , France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
authors.affiliation: a INSERM, UMR912 (SESSTIM) , Marseille , France.|b Aix Marseille Université, UMR_S912, IRD , Marseille , France.|c ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur , Marseille , France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Spire
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D002170:Canada; D017280:Condoms / Q000706:statistics & numerical data*; D003841:Deoxycytidine / Q000008:administration & dosage; D004311:Double-Blind Method; D000068679:Emtricitabine; D005500:Follow-Up Studies; D005602:France; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control*; D018451:Homosexuality, Male / Q000523:psychology* / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage; D017063:Outcome Assessment, Health Care; D065129:Pre-Exposure Prophylaxis; D012309:Risk-Taking; D021841:Safe Sex; D012725:Sexual Behavior / Q000706:statistics & numerical data; D012747:Sexual Partners; D011795:Surveys and Questionnaires; D000068698:Tenofovir; D016903:Drug Monitoring
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine
keywords: MSM; On-demand HIV pre-exposure prophylaxis; adherence; sexual behavior