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Article History

Received: 15 January 2025

Accepted: 14 January 2026

First Online: 5 February 2026

Declarations

:

: The Joint Clinical Research Committee Institutional Review Board/Ethics Committee in Kampala, Uganda, approved this study (Ref JCRC-2023–55) on 14 December 2023. Any modifications to the study protocol that may impact the conduct of the study or patient safety will be sent for IRB approval before implementation. Written informed consent will be obtained by trained study staff fluent in local languages. For minors aged 15–17, assent will be obtained along with caregiver consent unless waived by the IRB. Participants will be asked for optional consent for use of their de-identified data and specimens in future ancillary studies related to HIV prevention. A copy of the consent form will be made available to the journal editor for review upon request. Important protocol amendments will be submitted to the IRB, trial registry (ClinicalTrials.gov), and shared with investigators. Participants will be re-consented if amendments affect participation. Major changes will be communicated via reports and publications. Participants will continue to receive standard HIV care per national guidelines. In the event of study-related injury or harm, participants will be referred for care and compensation as outlined in the Uganda National Guidelines for Research.

: Not applicable.

: All the authors declare that they have no conflicts of interest.