Overcoming Geography With Technology: Medical Drones Project

February 15, 2022 updated by: Makerere University

Use of Unmanned Air Vehichles (Medical Drones) to Overcome Geographical Barriers to Delivery of Antiretrovial Therapy and Biological Samples.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Infectious Diseases Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Timothy Amukele, PhD
        • Sub-Investigator:
          • Dathan Byonanebye, MMED
        • Sub-Investigator:
          • Agnes Kirraga, PhD
        • Sub-Investigator:
          • Rachel King, PhD
        • Sub-Investigator:
          • Joseph Kayagi, MBBS
        • Sub-Investigator:
          • Hillary Bitakaramire, MMED
        • Sub-Investigator:
          • Luke Wijnberg, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PLHIV Kalangala District
250 People living with HIV registered for care at Bufumira Health Centre and Mazinga Health Centre, Kalangala District
Other: Unmanned ariel vehicle
Use of an Unmanned ariel vehicle for medical delivery (drugs and samples)
NonPHLIV Kalangala District
100 People not living with HIV attending for medical services at Bufumira Health Centre and Mazinga Health Centre, Kalangala District
Other: Unmanned ariel vehicle
Use of an Unmanned ariel vehicle for medical delivery (drugs and samples)
COVID Suspects Moyo District
1200 people attending for COVID tests at Moyo Hospital
Other: Unmanned ariel vehicle
Use of an Unmanned ariel vehicle for medical delivery (drugs and samples)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability for ART delivery as reported using qualitative methods with key stakeholders including health care workers, district officials, people living with HIV
Time Frame: 24 months
To assess acceptability of medical drone use for ART in Kalangala as compared to boat delivery through qualitative assessment including focus group discussions and in depth interviews with key stakeholders including district officials, health care workers, people living with HIV
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of medical drones for ART delivery to peer support workers using number of successful flights delivering ART
Time Frame: 24 months
To undertake a process evaluation for feasibility of medical drones for ART and sample transport
24 months
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)
Time Frame: 12 months
To gather information on retention in care in PLHIV receiving ART by medical drone at 6 and 12 months in patients accessing ART compared with other ART service delivery models in Bufumira Sub County and Mazinga sub county, Kalangala District
12 months
Cost of ART transport by boat as compared to drone based on actual costs of fuel and staff time
Time Frame: 24 months
To compare the cost of drone delivery compared to other ART service delivery models (e.g. individual care at health centre, outreach from health centre to landing sites, community drug distribution by boat, community drug distribution by drone) in Bufumira Sub County, Kalangala District.
24 months
Acceptability for use of medical drone to move COVID samples as reported using qualitative methods
Time Frame: 24 months
To assess acceptability of medical drone use for COVID samples as compared to ground delivery through qualitative assessment including focus group discussions and in depth interviews with key stakeholders including district officials, health care workers, people who have been tested for COVID-19
24 months
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
Time Frame: 24 months
To compare turnaround times for samples delivered by drones as compared to delivered by land transport (standard of care) in Moyo and Adjumani districts
24 months
Cost of samples transport by medical drone as compared to by land using cost of fuel and staff time
Time Frame: 24 months
To compare the cost of drone delivery compared to other sample delivery models bike or car in Moyo and Adjumani districts.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Collaborators

Johnson & Johnson
Rakai Health Sciences Program

Investigators

  • Principal Investigator: Rosalind Parkes-Ratanshi, PhD, Infectious Diseases Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 22, 2021

Primary Completion (ANTICIPATED)

March 22, 2022

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

February 15, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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