Trials / Recruiting
RecruitingNCT06678022
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,086 (estimated)
- Sponsor
- Makerere University · Academic / Other
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | No Drone delivery | Usual ART delivery to landing sites |
| DEVICE | Fixed Wing drones | Last Mile fixed wing drone delivery |
Timeline
- Start date
- 2025-03-18
- Primary completion
- 2027-02-01
- Completion
- 2027-12-15
- First posted
- 2024-11-07
- Last updated
- 2026-02-17
Locations
2 sites across 1 country: Uganda
Source: ClinicalTrials.gov record NCT06678022. Inclusion in this directory is not an endorsement.