Medical drones to deliver HIV medicines and lab samples in the Kalangala islands
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
This trial tests whether delivering antiretroviral medicines by medical drones can help people with HIV in Kalangala islands achieve undetectable viral loads.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1086 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Makerere University Academic / other |
| Locations | 2 sites (Kalangala, Ssese and 1 other locations) |
| Trial ID | NCT06678022 on ClinicalTrials.gov |
What this trial studies
Researchers will run a cluster-randomized trial in Kalangala District, randomizing 64 landing sites to either drone delivery or standard-of-care delivery (boat/facility pick-up) so that everyone at a landing site receives the same delivery method. Adults and emancipated minors on ART who join decentralized service delivery groups will be followed for 12 months to compare the proportion with undetectable HIV viral load between arms. The protocol includes stratification by distance from the drone base and number of DSD groups to reduce bias, and avoids contamination by using landing sites as the unit of randomization. The study also incorporates cost-effectiveness and carbon footprint analyses plus a qualitative process evaluation of acceptability and potential additional use cases.
Who should consider this trial
Good fit: Adults (over 18) and emancipated minors aged 15–17 living with HIV who are on ART, resident in Kalangala District, willing to join decentralized service delivery groups and remain in the district for the study period.
Not a fit: People with active opportunistic infections at enrollment, those with medical or psychiatric conditions that impair decision-making, non-residents, or children under 15 without appropriate caregivers are not eligible and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, drone delivery could increase adherence and viral suppression while reducing travel time and costs for remote fisherfolk and improving timely access to medicines and lab samples.
How similar studies have performed: Pilot drone programs in countries such as Rwanda and Ghana have shown feasibility for delivering medical supplies, but randomized evidence that drone ART delivery improves viral suppression is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kalangala, Ssese and 1 other locations
- Bwendero Health Centre — Kalangala, Ssese, Uganda (Recruiting)
- Mugoye health Centre III — Kalangala, Ssese, Uganda (Recruiting)
Study contacts
- Study coordinator: Rosalind Principal Investigator, MBBS, MA Hons, MRCP, Ph.D
- Email: rratanshi@idi.co.ug
- Phone: +256312211422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.