Case Report: Conducting Clinical Trials during an Outbreak: An Mpox case report

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Background Conducting clinical trials during infectious disease outbreaks presents operational, ethical, and methodological challenges. During the 2024–2025 Mpox outbreak in Uganda, an Mpox case occurred within an HIV-focused clinical trial requiring immediate operational and ethical response. The trial aimed to assess the feasibility of therapeutic drug monitoring and optimize antimicrobial therapy in people living with HIV. Case presentation We report the case of an adult man living with HIV enrolled in the Therapeutic Drug Monitoring for Antimicrobial Agents for People Living with HIV (TAP) trial at a tertiary HIV clinic in Uganda. Following initiation of antimicrobial therapy and study enrolment, at a scheduled study follow up visit, he developed a vesiculopustular rash involving the face and upper limbs. Research staff promptly activated infection prevention and control measures, halted study procedures, and notified the national surveillance team. Mpox infection was confirmed by real-time polymerase chain reaction testing. The participant was transferred to a designated isolation facility for clinical management and withdrawn from the trial. Continuity of HIV care was maintained through remote (phone) adherence counselling and coordination of antiretroviral refills. No secondary cases were identified among study participants or personnel after 21 days of self-monitoring. Conclusions This report highlights the importance of outbreak preparedness, adaptive risk management, and rapid coordination with public health teams to safeguard participants and personnel, protect research integrity, and ensure continuity of essential clinical care during epidemics.

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