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Use of Unmanned Air Vehicles (Medical Drones) to Overcome Geographical Barriers to Delivery of Anti-Retroviral Therapy and Biological Samples

Study acronym: MRC-DRONES
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Collaborators revised (2)v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Study completion date: Dec 2027 to Dec 15, 2027
    • Start date changed from estimate of Feb 15, 2025 to Mar 18, 2025
    v3
  3. Collaborators: 1 to 2
    • Eligibility criteria shortened, about 5 words
    • Study description expanded, about 1 word
    • Study title expanded, about 3 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if the intervention of delivery of antiretroviral drugs by medical drones can improve virological suppression in a fisherfolk community population living with HIV in the islands of Kalangala District, Uganda. The main question it aims to answer is: Can delivery of anti-retroviral therapy (ART) by unmanned aerial vehicles (medical drones) to people living with HIV (PLHIV) improve virological outcomes compared to the standard of care (SOC) in an underserved population? Primary hypothesis: The investigators hypothesize that using drones will increase viral suppression in those receiving the intervention as compared to the control or outcome measure one-will be the proportion of PLHIV with undetectable HIV viral load in the intervention (drones) versus SOC arm at 12 months. If there is a comparison group: Researchers will compare \[Medical Drones delivery group\] to see total cost of 12 months medication delivery to people living with HIV (PLHIV) in the intervention as compared to standard of care (SOC) arm. Proportion PLHIV with an undetectable viral load at 6, 18 and 24 months in intervention Rates of retention in care of PLHIV at 6,12, 18 and 24 months in intervention as compared to SOC arm * Participants will be seen every 6 months for 24 months * They will have blood draws for viral load tests * They will complete interviewer administered questionnaires * The intervention is last-mile delivery of ART by drones to landing sites
Trial Details
NCT Number NCT06678022
Lead Sponsor Makerere University
Collaborators: Medical Research Council, Infectious Diseases Institute, Uganda
Conditions
(from sponsor)		 HIV, Viral Load
Enrollment 1,086 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov