Use of Unmanned Air Vehicles (Medical Drones) to Overcome Geographical Barriers to Delivery of Anti-Retroviral Therapy and Biological Samples
Recruiting · NCT06678022 · Interventional (participants receive a specific treatment) · Lead sponsor: Makerere University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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
- Willing to stay for a minimum next 24 months
- Willing to disclose HIV status to an expert peer or village health team member.
- Willing to join discentralised Service Delivery model groups
Exclusion criteria
- 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.
- For stage three, participants residing in areas that took part in stage 2 drone delivery eg Bufumira island
Where it is running
2 locations listed.
- Bwendero Health Centre - Kalangala, Ssese, Uganda
- Mugoye health Centre III - Kalangala, Ssese, Uganda