Use of Unmanned Air Vehicles (Medical Drones) to Overcome Geographical Barriers to Delivery of Anti-Retroviral Therapy and Biological Samples

NCT06678022 | Recruiting DMC

• 2 other identifiers: MAKSPHREC 007/2020MRC AGHRB - MR/Y019717/1
• Study Type: interventional
• Target: 1,086
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

HIV; Viral Load

Keywords

virological suppression; Fisher Folk; Cluster Randomised Trial; medical drones

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• Intermediate and final 12-month retention in care in those receiving ART via drone compared to control population

  12 months

• proportion of viral load > 200 copies/mL at 24

  24 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Delivery of ART by fixed wing drones to landing sites

Device: Fixed Wing drones

Control arm

ACTIVE COMPARATOR

Usual ART delivery to landing sites

Device: No Drone delivery

Interventions

No Drone delivery DEVICE

Usual ART delivery to landing sites

Control arm

Fixed Wing drones DEVICE

Last Mile fixed wing drone delivery

Intervention Arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Infectious Diseases Institute, Uganda: collaborator
• Makerere University: lead
• Medical Research Council: collaborator

Study Sites (2)

Bwendero Health Centre

Kalangala, Ssese, Uganda

RECRUITING

Mugoye health Centre III

Kalangala, Ssese, Uganda

RECRUITING

Related Links

• Related Info

Central Study Contacts

Rosalind Principal Investigator, MBBS, MA Hons, MRCP, Ph.D

CONTACT

+256312211422; rratanshi@idi.co.ug

Agnes Bwanika Naggirinya, MBChB, MSC, MMed

CONTACT

+256 312211422; anaggirinya@idi.co.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised trial using a non-inferiority design

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, 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

Locations

UG (2)