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NCT06678022Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1086 (estimated)
First submitted
5 Nov 2024
Start date
18 Mar 2025
Primary completion date
Feb 2027
Lead sponsor
Makerere University
Diseases
HIV
NCT number
NCT06678022

What you commit to

  • Study type: Interventional
  • Planned participants: 1086
  • From 18 Mar 2025 to the primary completion date, Feb 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Potential participants below 15 years with care providers not receiving care from DSD.

Other illness

  • 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.

Other

  • For stage three, participants residing in areas that took part in stage 2 drone delivery eg Bufumira island

Who the study is looking for

  • 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

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mugoye health Centre III
Coordinator of this site? Confirm its status
KalangalaUgandaRecruiting
Bwendero Health Centre
Coordinator of this site? Confirm its status
KalangalaUgandaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.