Background: Pre-exposure prophylaxis (PrEP) has been found to be efficacious in preventing HIV, with US national guidelines recommending its use in higher risk populations. Adherence challenges with oral PrEP have stimulated interest in alternate modes of administration.
Methods: We conducted 30 in-depth interviews including 26 trial participants (18 MSM and 8 heterosexual men) and 4 clinical providers in a Phase IIa study (ECLAIR) to evaluate the safety, tolerability and acceptability of LAI CAB in New York and San Francisco. Uninfected adult males at low to moderate risk of HIV acquisition were randomized to 4 weeks of oral PrEP or placebo followed by 3 injections of LAI CAB or LAI placebo every 12 weeks. Interviews explored attitudes and experiences with LAI CAB and perceived advantages/disadvantages in comparison to daily oral PrEP. Interviews were audiotaped, transcribed, coded and analyzed using thematic content analysis.
Results: Almost all participants experienced some level of side effects associated with LAI CAB, mostly temporary injection site soreness. Yet, all reported being satisfied and interested in continuing LAI CAB. Participants described the convenience of LAI CAB and perceived advantage of not having to worry about adhering to a daily oral. Participants described the peace of mind associated with LAI CAB given the possibility for missed oral doses among themselves or their partners who may be on PrEP, particularly in the context of ongoing sexual risk behavior. MSM participants, particularly in San Francisco, described a surrounding culture whereby MSM were expected to be on PrEP to be seen as safe sexual partners. Participants described the dynamic nature of their HIV risk, with periods of lower and higher risk behavior. While several participants felt oral PrEP may be contributing to increased sexual risk behavior in the broader community, only a few reported increased risk behavior during their participation in the trial. Providers expressed the need for guidelines to assist patients in choosing when to start, stop and/or transition between oral PrEP and LAI CAB.
Conclusions: LAI CAB was seen as preferable to oral PrEP among men in this Phase II study. Further research is needed on LAI CAB among women and in other settings.

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