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Article History

Received: 9 January 2026

Accepted: 26 May 2026

First Online: 29 May 2026

Declarations

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: Ethical approval for the ULACNet-201 trial was obtained by the Human Subjects Committees of the University of Puerto Rico, School of Medicine in Puerto Rico (IRB00000378, IRB00004408, IRB00004409; 02/05/2020), the University of Saõ Paulo in Brazil (IRB00001650; 07/11/2020), Instituto Nacional de Salud Pública in Mexico (IRB00001022; 09/25/2020), Weill Cornell Medicine (IRB00009417-IRB00009421; 03/17/2020), and H. Lee Moffitt Cancer Center & Research Institute (IRB00000362, IRB00001786; 01/07/2020) before the start of participant enrollment. The study adheres to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from all participants after providing comprehensive information about the trial procedures and potential risks, prior to collecting study data or biospecimens. Oversight is provided by the Data and Safety Monitoring Board (DSMB) at Weill Cornell Medicine, which conducted pre-initiation protocol reviews, and conducts annual assessments, and ad hoc reviews as needed. The DSMB evaluates safety, trial conduct and the overall risk-benefit profile of participants, and provide recommendations on study continuation, modification, or termination; DSMB personnel are not directly related to the study team. A monitoring team reviews the documentation of informed consent, verification of key eligibility criteria, assessment of critical endpoints, and reporting of significant adverse events for a subset of participants. The trial is also audited by external personnel, in collaboration with the NCI.

: The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: Luisa L. Villa reports that financial support was provided by the National Cancer Institute. Luisa L. Villa reports a relationship with Merck & Co Inc. that includes fees for travel and talks. Michael J. Schell reports financial support was provided by National Cancer Institute. Betania Allen-Leigh reports financial support was provided by National Cancer Institute. Julie Rathwell reports a relationship with Merck Sharp & Dohme, LLC that includes: consulting or advisory. Moffitt Cancer Center reports financial support was provided by National Cancer Institute. Anna R Giuliano reports financial support was provided by National Cancer Institute. Anna R Giuliano, reports a relationship with Merck & Co Inc. that includes: consulting or advisory, funding grants, and speaking and lecture fees. Anna R Giuliano holds an American Cancer Society Clinical Research Professorship. Anna Beltrame reports financial support was provided by this award. Grant B Ellsworth reports financial support was provided by National Institutes of Health National Cancer Institute. Grant Ellsworth reports financial support was provided by Merck & Co Inc. Grant B Ellsworth reports a relationship with Northeast Caribbean AIDS Clinical Training Center that includes: speaking and lecture fees. Grant B Ellsworth reports a relationship with International AIDS Society USA that includes: speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.