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
Adult (>18 years) living with HIV
Emancipated minor (15-17 years) who is living with HIV
Receiving antiretroviral therapy in Kalangala District
Be a resident in Kalangala district for at least the preceding 6-12 months
Potential participants below 15 years with care providers not receiving care from DSD.
No active opportunistic infection (including but not limited to TB) in health centre records or self-report or suspected by the study team at enrolment (will be referred back to health facility for investigations and can be enrolled if no infection confirmed).
Patients with mental illness or any other medical condition that compromises decision making process (as determined by medical records at facility and direct questioning to participant)
Any other clinical condition that, in the opinion of the site investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.
Parallel
No Drone delivery
DeviceUsual ART delivery to landing sites
Fixed Wing drones
DeviceLast Mile fixed wing drone delivery
primary endpoint is the proportion of participants with HIV RNA viral load < 200 copies/mL at 12 months
Analysis of the primary endpoint shall be done on modified intention-to-treat population, mITT (i.e. includes all participants randomized, and received at-least one dose of treatment). We shall use log-binomial/Poisson mixed effects regression model to compare proportion of PLHIV with an undetectable HIV viral load (i.e. \<200 copies/mL) at month 12 between the two arms
Intermediate and final 12-month retention in care in those receiving ART via drone compared to control population
Retention in care defined as participant with a facility or ART encounter for \> 90 days after the last missed scheduled ART collection
proportion of viral load > 200 copies/mL at 24
Proportions be summarised by the treatment arms and compared used Pearson Chi-square test.
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Makerere University
Lead sponsor
Medical Research Council
Collaborator
Infectious Diseases Institute, Uganda
Collaborator
