RecruitingNot ApplicableNCT06678022

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

Use of Unmanned Air Vehicles (Medical Drones) to Overcome Geographical Barriers to Delivery of Anti-Retrovical Samples: A Cluster Randomised Trial in Kalangala District, Uganda


Sponsor

Makerere University

Enrollment

1,086 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using medical drones to deliver HIV medications and pick up blood samples can overcome the challenge of reaching people living with HIV in remote island communities in Uganda's Kalangala District, where geography makes regular clinic visits very difficult. **You may be eligible if...** - You are an adult (18+) or emancipated minor (15–17) living with HIV - You are currently on antiretroviral therapy (HIV medication) in Kalangala District - You have lived in Kalangala for at least 6–12 months and plan to stay for 2 more years - You are willing to use the drone delivery service **You may NOT be eligible if...** - You are not currently on HIV treatment - You are not a resident of Kalangala District - You plan to leave the area within 2 years - You are not willing to participate in the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENo Drone delivery

Usual ART delivery to landing sites

DEVICEFixed Wing drones

Last Mile fixed wing drone delivery


Locations(2)

Bwendero Health Centre

Kalangala, Ssese, Uganda

Mugoye health Centre III

Kalangala, Ssese, Uganda

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NCT06678022


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