Is Risk Compensation Real? The Effect Of Perceived Level Of Hiv Acquisition On Risk Behavior In A Pilot Pre-Exposure Prophylaxis Demonstration Project In Men Who Have Sex With Men In Malaysia

Pre-exposure prophylaxis (PrEP) is highly effective in human immunodeficiency virus (HIV) prevention for key populations, including men who have sex with men (MSM). In Malaysia, human immunodeficiency virus (HIV) prevalence among MSM is 22%, and is even higher in key urban areas, including Kuala Lumpur. Despite nationwide campaigns committed to address HIV, scale-up of PrEP for MSM in Malaysia has been suboptimal. This limitation can be attributed partially to concerns that PrEP will lead to increased sexual risk behaviors, based on the controversial theory of risk compensation. A 2018 PrEP demonstration study of MSM in Malaysia (n=150) was used to assess changes in sexual risk behaviors after PrEP initiation, exploring risk compensation. Changes in sexual risk behaviors between baseline and follow-up (months 3, 6, 9, and 12) were tested using Wilcoxon signed-rank and McNemer’s tests for nonparametric continuous and paired binary variables, respectively. Generalized estimating equations were used to model risk outcome behaviors. Significance was set at p<0.05 for all analyses. Participants were mostly single (62.0%), gay (92.0%), young (mean age: 31.33 + 7.36), and employed full-time (81.3%). Participants reported a small but statistically significant increase in sexual partners compared to baseline at all timepoints (all p<0.001), peaking at month 6, and then decreasing significantly thereafter (9 months: p=0.002; 12 months: p=0.001). There was no change in the risk behaviors of condomless anal sex (CAS) or CAS with an HIV+ partner at any timepoint. Baseline HIV risk perception could not predict any change in any risk behavior. Increased number of missed pills was significantly associated with decreased CAS (p=0.003). Lack of associations between baseline HIV risk perception and changes in any sexual risk behavior, as well as lack of changes in CAS and CAS with an HIV+ partner, undermines the notion of risk compensation in MSM while using PrEP. We advocate for the Malaysian government’s endorsement, subsidization, and increased utilization of PrEP in the MSM community. Acknowledgments The development and execution of this project included the work of many collaborators including Mohd Akbar Ab Halim, Meng Li, PhD, Ying-Ru Lo, MD, Nishaan Raman, Frits Van Griensven, MPH, PhD, Roman Shrestha, MPH, PhD, Iskandar Azwa, MD, and Jeffrey A. Wickersham, PhD. This work in its final form was supported by the Department of Internal Medicine at Yale and by the Office of Student Research. In particular, Erica Herzog, MD, PhD for her work in mentoring, editing, and logistics. This work was also supported by many research coordinators at the University of Malaya, Malaysia, as well as the University of California, San Francisco. This work was financially supported by several funding sources including Yale School of Medicine Office of Student Research, National Institute on Drug Abuse (K01 DA038529 for JAW; K01 DA051346 for RS), and UNAIDS. Table of contents Page number v Introduction 1-6 v Statement of purpose 7 v Methods 8-18 Ø Student contributions 8 Ø Ethics statement 8-9 Ø Human subjects research 9-10 Ø Methods description 10-16 Ø Statistical methods 16-17 v Results 18-28 Ø Demographics 18-21 Ø Time-series comparisons of risk behaviors 22-28 Ø Modeling risk behavior 28-29 v Discussion 30-36 v Challenges and limitations 37-39 v Dissemination 40 v References 41-43