Clinical trial NCT06678022: Use of Unmanned Air Vehicles (Medical Drones) to Overcome Geographical Barriers to Delivery of Anti-Retroviral Therapy and Biological Samples
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Viral Load
Keywords: virological suppression
Fisher Folk
Cluster Randomised Trial
medical drones
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: United Kingdom Research and Innovation
First posted: 2024-11-07
Enrollment: 1086
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised trial using a non-inferiority design
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: primary endpoint is the proportion of participants with HIV RNA viral load < 200 copies/mL at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Intermediate and final 12-month retention in care in those receiving ART via drone compared to control population
timeFrame: 12 months
measure: proportion of viral load > 200 copies/mL at 24
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: