Clinical trial NCT05259761: Overcoming Geography With Technology: Medical Drones Project
Official title: Use of Unmanned Air Vehichles (Medical Drones) to Overcome Geographical Barriers to Delivery of Antiretrovial Therapy and Biological Samples.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexually Transmitted Infections (Not HIV or Hepatitis)
HIV Infections
COVID-19
Keywords: sample transport
anti-retroviral therapy
supply chain
unmanned ariel vehicles
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
name: Rakai Health Sciences Program
First posted: 2022-03-02
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People attending health centres in Bufumira and Mazinga sub-county will be approached for inclusion in the study. In Moyo, those with COVID symptoms will be approached.

Brief summary: In this study, the investigators shall evaluate the use unmanned air vehicles (medical drones) to deliver ART to adult patients eligible/enrolled in community DSD models in Bufumira Islands, Kalangala district. The geography of the islands is ideal for this project because of the flat landscape and water coverage. The investigators hypothesize that the use of drones would be acceptable to patients and stakeholders, reduce facility drug stock outs, increase retention in care by 10% in intervention (at 12 months) compared to the control health centres and be cost neutral (to the patients and health sector perspectives). The investigators will also undertake evaluation of an efficient sample delivery system using medical drones especially for expansive rural areas like Moyo and Adjumani.

Detailed description: Stage one will be a cross-sectional observational study with baseline data collection on ART accessibility, adherence, challenges as well as perceptions and attitudes towards possible medical drones. Stage two will be a non-randomized observational pilot of medical drones at 3 landing sites in Kalangala District, comparing to 3 landing sites without drones, and at five health facilities in Moyo and Adjumani districts. The investigators shall use qualitative and quantitative methods and a process evaluation to assess the feasibility of using drones for ART delivery and determine the impact on patient outcomes. The COVID pandemic has taken hold in Uganda since this protocol was first approved in June 2020, and having received approval from the Ministry of Health, the investigators will extend this pilot to Moyo and Adjumani Districts. The investigators shall use qualitative and quantitative methods and a process evaluation to assess the feasibility of using drones for COVID sample delivery and determine the impact on result turnaround times. Stage two includes a sub-study on validity and quality of transport of biological samples including HIV, STI, TB and COVID diagnostic and monitoring samples.

Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years) or emancipated minor (15-17 years) who is HIV-infected and receiving antiretroviral therapy in Bufumira sub-county or non PLHIV adult who has attended a government health facility in Bufumira sub-county
* Resident in Kalangala district for at least the preceding 12 months with an intent to stay for a minimum next 12 months (resident is defined as those who spend more than 9 out of 12 months per year in Kalangala district, even if they move within the district)
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
* Willingness to comply with survey procedures

Exclusion Criteria:

* Patients with mental illness or any other medical condition that compromises decision making process.
* 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 joining a DSD group.

Primary outcomes:
measure: Acceptability for ART delivery as reported using qualitative methods with key stakeholders including health care workers, district officials, people living with HIV
timeFrame: 24 months
Secondary outcomes:
measure: Feasibility of medical drones for ART delivery to peer support workers using number of successful flights delivering ART
timeFrame: 24 months
measure: Retention in care as determined by attendance for ART refils at health facility or peer support group meetings in Bufumira health centre (with drone delivery) as compared to Mazinga health centre (with boat only)
timeFrame: 12 months
measure: Cost of ART transport by boat as compared to drone based on actual costs of fuel and staff time
timeFrame: 24 months
measure: Acceptability for use of medical drone to move COVID samples as reported using qualitative methods
timeFrame: 24 months
measure: Turnaround times of COVID samples from arrival in receiving laboratory to results returned to receiving laboratory delivered by medical drone as compared to by land transport
timeFrame: 24 months
measure: Cost of samples transport by medical drone as compared to by land using cost of fuel and staff time
timeFrame: 24 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
Study officials:
affiliation: Infectious Diseases Institute
name: Rosalind Parkes-Ratanshi, PhD
role: PRINCIPAL_INVESTIGATOR
References: