No Evidence of Sexual Risk Compensation in the iPrEx Trial of Daily Oral HIV Preexposure Prophylaxis

Abstract

ObjectivePreexposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) reduced HIV acquisition in the iPrEx trial among men who have sex with men and transgender women. Self-reported sexual risk behavior decreased overall, but may be affected by reporting bias. We evaluated potential risk compensation using biomarkers of sexual risk behavior.Design and methodsSexual practices were assessed at baseline and quarterly thereafter; perceived treatment assignment and PrEP efficacy beliefs were assessed at 12 weeks. Among participants with ≥1 follow-up behavioral assessment, sexual behavior, syphilis, and HIV infection were compared by perceived treatment assignment, actual treatment assignment, and perceived PrEP efficacy.ResultsOverall, acute HIV infection and syphilis decreased during follow-up. Compared with participants believing they were receiving placebo, participants believing they were receiving FTC/TDF reported more receptive anal intercourse partners prior to initiating drug (12.8 vs. 7.7, P = 0.04). Belief in receiving FTC/TDF was not associated with an increase in receptive anal intercourse with no condom (ncRAI) from baseline through follow-up (risk ratio [RR] 0.9, 95% confidence interval [CI]: 0.6–1.4; P = 0.75), nor with a decrease after stopping study drug (RR 0.8, 95% CI: 0.5–1.3; P = 0.46). In the placebo arm, there were trends toward lower HIV incidence among participants believing they were receiving FTC/TDF (incidence rate ratio [IRR] 0.8, 95% CI: 0.4–1.8; P = 0.26) and also believing it was highly effective (IRR 0.5, 95% CI: 0.1–1.7; P = 0.12).ConclusionsThere was no evidence of sexual risk compensation in iPrEx. Participants believing they were receiving FTC/TDF had more partners prior to initiating drug, suggesting that risk behavior was not a consequence of PrEP use.

A Cross-Sectional Online Survey of HIV Pre-Exposure Prophylaxis Adoption Among Primary Care Physicians

“…Third, such initiatives will also need to address concerns related to risk compensation and safety. While randomized clinical trials have not observed risk compensation to be normative among participants (measured via self-reported risk behaviors or diagnosed sexually transmitted infections), [36][37][38][39] the perception persists that PrEP will increase risk behaviors, and this was negatively associated with PrEP adoption in our study. Even though increased rates of condomless sex in the context of PrEP use have been reported, this has not been associated with increased risk of HIV acquisition in preliminary accounts of real-world PrEP use.…”

“…13,14,23 Our findings suggest that providers' concerns about the increase in risk behaviors and the safety of PrEP continue to be potential barriers to PrEP adoption. Fears that patient risk compensation (i.e., increase in sexual risk behavior due to a perceived reduction in HIV susceptibility) could offset the protective benefit of PrEP has been a prominent concern among providers in prior studies, 11,13,15,23,28,30,31 despite the lack of evidence of widespread risk compensation in studies investigating the efficacy 36,37 and effectiveness 38,39 of PrEP. In our study, we found that non-adopters were more likely than adopters to perceive PrEP use as leading to risk compensation.…”

Overdose Education and Naloxone for Patients Prescribed Opioids in Primary Care: A Qualitative Study of Primary Care Staff

“…This effect, commonly known as risk compensation, 34 has been raised in response to preventive interventions, such as vaccination against human papilloma virus and pre-exposure prophylaxis for HIV prevention. [35][36][37] However, prescribing naloxone could also represent an opportunity to increase patients' risk perceptions of opioids. Further research is needed to determine whether practice-based naloxone prescribing increases, reduces or has no effect on opioid-related risk behavior.…”

Adolescent Human Immunodeficiency Virus Care Providers’ Attitudes Toward the Use of Oral Pre-Exposure Prophylaxis in Youth

“…Although concerns about risk compensation have been raised by some adult care providers, 12,13,[16][17][18][19][20] studies to date suggest that the majority of people taking PrEP do not practice risky behaviors. [31][32][33] Few participants were concerned about prescribing PrEP for off-label use to a minor-aged patient. Use of medications off-label is a common practice in pediatrics, 23,34,35 and the American Academy of Pediatrics advised that lack of FDA approval for a particular indication ''should not prevent physicians from prescribing an available drug in the best interests of their patients.''…”