HIV, Viral Load
Conditions
Keywords
virological suppression, Fisher Folk, Cluster Randomised Trial, medical drones
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
Interventions
DEVICENo Drone delivery
Usual ART delivery to landing sites
DEVICEFixed Wing drones
Last Mile fixed wing drone delivery
Sponsors
Makerere University
Medical Research Council
Infectious Diseases Institute, Uganda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster randomised trial using a non-inferiority design
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary endpoint is the proportion of participants with HIV RNA viral load < 200 copies/mL at 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intermediate and final 12-month retention in care in those receiving ART via drone compared to control population | 12 months | Retention in care defined as participant with a facility or ART encounter for \> 90 days after the last missed scheduled ART collection |
| proportion of viral load > 200 copies/mL at 24 | 24 months | Proportions be summarised by the treatment arms and compared used Pearson Chi-square test. |
Countries
Uganda
Contacts
CONTACTRosalind Principal Investigator, MBBS, MA Hons, MRCP, Ph.D
CONTACTAgnes Bwanika Naggirinya, MBChB, MSC, MMed
Outcome results
None listed