HIVMRC-DRONESNCT06678022
Use of Unmanned Air Vehicles (Medical Drones) to Overcome Geographical Barriers to Delivery of Anti-Retroviral Therapy and Biological Samples
A study testing No Drone delivery and Fixed Wing drones in people with HIV and Viral Load, run by Makerere University at 2 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV, Viral Load
- What is being tested?
- No Drone delivery and Fixed Wing drones
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,086 participants
- Where
- 2 sitesUganda
- Study dates
- 18 Mar 2025to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda2 sites, 2 recruiting
- Recruiting
Bwendero Health Centre
Kalangala, Ssese
Patrick Ssesaazi, MPH, +256756240627, pssesaazi@idi.co.ug
Rosalind Parkes-Ratanshi, PhD
- Recruiting
Mugoye health Centre III
Kalangala, Ssese
Patrick Ssesaazi, MPH, +256756240627, pssesaazi@idi.co.ug
About this study
Official title: 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.
Read more
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
Read the 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
- HIV, Viral Load
- Being tested
- No Drone delivery, Fixed Wing drones
- Keywords
- virological suppression, Fisher Folk, Cluster Randomised Trial, medical drones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Drone deliveryDevice
Usual ART delivery to landing sites
Fixed Wing dronesDevice
Last Mile fixed wing drone delivery
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Delivery of ART by fixed wing drones to landing sites Receives: Device: Fixed Wing drones |
| Control arm | Active comparator | Usual ART delivery to landing sites Receives: Device: No Drone delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Intermediate and final 12-month retention in care in those receiving ART via drone compared to control population
Retention in care defined as participant with a facility or ART encounter for > 90 days after the last missed scheduled ART collection
Measured: 12 months
proportion of viral load > 200 copies/mL at 24
Proportions be summarised by the treatment arms and compared used Pearson Chi-square test.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start18 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised trial using a non-inferiority design
- Masking
- None (open label)
- Enrolment
- 1,086 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Infectious Diseases Institute, Uganda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678022
- Sponsor's protocol ID
- MAKSPHREC 007/2020
- Other IDs
- MRC AGHRB - MR/Y019717/1
- Acronym
- MRC-DRONES
- Status last verified
- Feb 2026
- First submitted
- 5 Nov 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial will be shared at the end of the project after manuscript have been completed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06678022
- Acronym / sponsor ID
- MRC-DRONES / MAKSPHREC 007/2020
- Conditions
- HIV, Viral Load
- Keywords
- virological suppression, Fisher Folk, Cluster Randomised Trial, medical drones
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,086 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Medical Research Council, Infectious Diseases Institute, Uganda
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomised trial using a non-inferiority design
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Fixed Wing dronesDelivery of ART by fixed wing drones to landing sites |
| Control arm | Active comparator | Device: No Drone deliveryUsual ART delivery to landing sites |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Drone deliveryUsual ART delivery to landing sites | Device | Control arm |
| Fixed Wing dronesLast Mile fixed wing drone delivery | Device | Intervention Arm |
Primary outcome
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
2 secondary outcomes
Intermediate and final 12-month retention in care in those receiving ART via drone compared to control population
Time frame: 12 months
proportion of viral load > 200 copies/mL at 24
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial will be shared at the end of the project after manuscript have been completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Drone delivery and Fixed Wing drones in people with HIV and Viral Load, run by Makerere University at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosalind Principal Investigator, MBBS, MA Hons, MRCP, Ph.D (+256312211422, rratanshi@idi.co.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary endpoint is the proportion of participants with HIV RNA viral load < 200 copies/mL at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.