An interventional study of No Drone delivery and Fixed Wing drones in HIV and Viral Load, sponsored by Makerere University. Recruiting at 2 sites in Uganda. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Makerere University · Not applicable, Interventional, and Treatment
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
The Investigators will undertake a cluster randomised trial of the efficacy of medical drone use by randomization of health facilities and their associated landing sites in Kalangala District. There are 64 landing sites and 18 health facilities. The unit of radomisation will be the landing site, so that all persons at one landing site will receive the drone delivery or boat delivery, facility pick-up. This will avoid contamination of drone delivery by sharing of ART between people getting drone and boat or other modes of deliveries. Bias in this situation will be managed by stratifying the landing sites by distance from drone operations base (a proxy of delivery cost), and number of differentiated service delivery (DSD) groups. Bias in gender and age will be managed at selection of members in DSD groups. We will also undertake a cost effectiveness analysis, carbon analysis and process evaluation. A qualitative study will assess acceptability and additional use cases
Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Delivery of ART by fixed wing drones to landing sites
Device: Fixed Wing drones
Usual ART delivery to landing sites
Device: No Drone delivery
Usual ART delivery to landing sites
Last 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
Time frame: 12 months
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
Time frame: 12 months
proportion of viral load > 200 copies/mL at 24
Proportions be summarised by the treatment arms and compared used Pearson Chi-square test.
Time frame: 24 months
Plan to share: Yes — De-identified individual participant data collected during the trial will be shared at the end of the project after manuscript have been completed.
Supporting information: Statistical analysis plan, Clinical study report, Analytic code
Time frame: Start dates 2027 No limit/end
Access criteria: All interested researchers, policy makers, participants. Can access the data sets, clinical reports, monitoring reports, DSMB reports
Data sharing details ↗ · theacademy.co.ug
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