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

February 12, 2026 updated by: Makerere University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

1086

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rosalind Principal Investigator, MBBS, MA Hons, MRCP, Ph.D
  • Phone Number: +256312211422
  • Email: rratanshi@idi.co.ug

Study Contact Backup

  • Name: Agnes Bwanika Naggirinya, MBChB, MSC, MMed
  • Phone Number: +256 312211422
  • Email: anaggirinya@idi.co.ug

Study Locations

  • Uganda
    • Ssese
      • Kalangala, Ssese, Uganda
        • Recruiting
        • Bwendero Health Centre
        • Contact:
        • Principal Investigator:
          • Rosalind Parkes-Ratanshi, PhD
        • Sub-Investigator:
          • Agnes Bwanika Naggirinya, MMED
      • Kalangala, Ssese, Uganda
        • Recruiting
        • Mugoye health Centre III
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Delivery of ART by fixed wing drones to landing sites
Device: Fixed Wing drones
Last Mile fixed wing drone delivery
Active Comparator: Control arm
Usual ART delivery to landing sites
Device: No Drone delivery
Usual ART delivery to landing sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary endpoint is the proportion of participants with HIV RNA viral load < 200 copies/mL at 12 months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermediate and final 12-month retention in care in those receiving ART via drone compared to control population
Time Frame: 12 months
Retention in care defined as participant with a facility or ART encounter for > 90 days after the last missed scheduled ART collection
12 months
proportion of viral load > 200 copies/mL at 24
Time Frame: 24 months
Proportions be summarised by the treatment arms and compared used Pearson Chi-square test.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Collaborators

Medical Research Council
Infectious Diseases Institute, Uganda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MAKSPHREC 007/2020
  • MRC AGHRB - MR/Y019717/1 (Other Grant/Funding Number: MRC-UKRI (MRC and the International Science Partnerships Fund (ISPF)))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data collected during the trial will be shared at the end of the project after manuscript have been completed.

IPD Sharing Time Frame

Start dates 2027 No limit/end

IPD Sharing Access Criteria

All interested researchers, policy makers, participants. Can access the data sets, clinical reports, monitoring reports, DSMB reports

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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