Limitations
The generalizability of study findings are limited in the following ways. There was a significant change in the staff, requiring re-training and interruptions with enrollment. We paused enrollment for 10 months during the COVID-19 pandemic in order to minimize risk to the research staff and the patient population. Injectable PrEP (i.e. cabotegravir) was not yet approved during the enrollment period of the study. It is likely that presentation of PrEP as a daily pill option alongside a bi-monthly injection option may have had a positive influence on readiness and willingness in the intervention. Both options may have also had a positive influence on clinic attendance and PrEP uptake to varying degrees across study arms.During the warm hand-off process, the phone signal in the hospital sometimes prevented real time connections between research staff and hospital partners. This could hinder motivation and engagement to attend the initial PrEP clinic visit. We utilized alternative strategies to make the connection between the PrEP clinic and the patient (i.e. changing location within the hospital) in order to foster a real-time connection, but this approach was met with logistical challenges. Our methodology of relying on the participant to provide the referral code to the PrEP clinic during the initial clinical visit became a significant barrier to confirming a secure link, as the protocol did not allow interagency sharing of protected health information. The referral code could not be verified by the partnering agency in at least one case. It is likely that some of our participants attended initial PrEP clinic visits, but were not accounted for because they were received by clinic staff as patients instead of research participants.