Statistical Analysis Plan for Dynamic HIV Choice Prevention delivered with Community Health Workers in Phase A of SEARCH-Sapphire

This document provides the statistical analytic plan (SAP) for a cluster randomized trial evaluating the effect of community-based Dynamic Choice HIV Prevention (DCP) intervention, delivered by community health workers in rural Uganda and Kenya (Clinicaltrials.gov: [NCT04810650][1]). The SAP was locked prior to unblinding and effect estimation. ### Competing Interest Statement DVH reports non-financial support from ViiV Healthcare. All other authors declare no conflicts of interest. ### Clinical Trial NCT04810650 ### Funding Statement This study was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Mental Health (NIMH) and co-funded under award number U01AI150510. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. ### 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 Makerere University School of Medicine Research and Ethics Committee, the Uganda National Council for Science and Technology, the Kenya Scientific and Ethics Review Unit, the National Commission for Science, Technology and Innovation, and the University of California San Francisco Committee on Human Research reviewed and gave ethical approval for the study protocol. All participants provided written informed consent prior to study participation. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the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 A complete de-identified patient dataset sufficient to reproduce the study findings will be made available approximately one year after completion of the ongoing trial ([NCT04810650][1]), following approval of a concept sheet summarizing the analyses to be performed. Further inquiries can be directed to the SEARCH Scientific Committee at douglas.black@ucsf.edu. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04810650&atom=%2Fmedrxiv%2Fearly%2F2023%2F11%2F16%2F2023.11.15.23298580.atom