Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: A Protocol for a Randomized Controlled Trial

Background HIV prevention is a public health priority. Despite progress in recent years, PrEP use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention. Objective HOT4PrEP (Home Option Testing for PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement into a sexual health clinic setting, and impacts PrEP retention over time. Methods The RCT will recruit approximately 450 persons currently taking or soon to initiate PrEP at the Sexual Health Clinic in Seattle, WA and randomize them to continue standard of care or have the option to use HB-PrEP for two of three tri-annual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction/acceptability, feasibility, self-reported PrEP adherence, and STI incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation. Results The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed in December 2022. From the first 100 enrollees, median age is 34 years and most are cisgender gay men (89%) with at least some college education (91%). Among those randomized to the HB-PrEP option, 65% have opted at least once to self-collect samples at home and 84% have successfully returned test kits for HIV/STI testing. Primary PrEP retention and qualitative analyses are ongoing. Conclusions Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users. Trial Registration: [ClinicalTrials.gov][1] [NCT05856942][2] ### Competing Interest Statement Blood collection devices were provided in kind by Tasso, Inc. ### Clinical Trial NCT05856942 ### Funding Statement The study did not receive any funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Institutional Review Board of the University of Washington gave ethical approval for this work (STUDY00013871). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All preliminary data produced in the present work are contained in the manuscript. [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05856942&atom=%2Fmedrxiv%2Fearly%2F2023%2F12%2F18%2F2023.12.17.23300112.atom