Estimating the Effect of PrEP in Black Men Who Have Sex with Men: A Framework to Utilize Data from Multiple Non-Randomized Studies to Estimate Causal Effects.

Black men who have sex with men (MSM) are disproportionately burdened by the HIV epidemic in the US. The effectiveness of pre-exposure prophylaxis (PrEP) in preventing HIV infection has been demonstrated through randomized placebo-controlled clinical trials in several populations. Importantly, no such trial has been conducted exclusively among Black MSM in the US, and it would be unethical and infeasible to do so now. To estimate the causal effects of PrEP access, initiation, and adherence on HIV risk, we utilized causal inference methods to combine data from two non-randomized studies that exclusively enrolled Black MSM. The estimated relative risks of HIV were: (i) 0.52 (95% confidence interval: 0.21, 1.22) for individuals with versus without PrEP access, (ii) 0.48 (0.12, 0.89) for individuals who initiated PrEP but were not adherent versus those who did not initiate, and (iii) 0.23 (0.02, 0.80) for individuals who were adherent to PrEP versus those who did not initiate. Beyond addressing the knowledge gap around the effect of PrEP in Black MSM in the US, which may have ramifications for public health, we have provided a framework to combine data from multiple non-randomized studies to estimate causal effects, which has broad utility.