Sexually Transmitted Infections (Not HIV or Hepatitis)NCT05259761
Overcoming Geography With Technology: Medical Drones Project
An observational study of Sexually Transmitted Infections (Not HIV or Hepatitis) and HIV Infections, run by Makerere University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections (Not HIV or Hepatitis), HIV Infections, COVID-19
- How many people
- 1,450 participants
- Where
- 1 siteUganda
- Study dates
- 22 Sep 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Infectious Diseases Institute
Kampala
Joan Akullo, MSc, 0312307000, jakullo@idi.co.ug
Agnes Naggirinya, MBBS, 0312307000, anaggirinya@idi.co.ug
About this study
Official title: 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.
Read the 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.
- Being tested
- Unmanned ariel vehicle
- Keywords
- sample transport, anti-retroviral therapy, supply chain, unmanned ariel vehicles
- Medical subject headings
- Sexually Transmitted Diseases, Hepatitis, HIV Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unmanned ariel vehicleOther
Use of an Unmanned ariel vehicle for medical delivery (drugs and samples)
| Study group | Role | What they receive |
|---|---|---|
| PLHIV Kalangala District | 250 People living with HIV registered for care at Bufumira Health Centre and Mazinga Health Centre, Kalangala District Receives: Other: Unmanned ariel vehicle | |
| NonPHLIV Kalangala District | 100 People not living with HIV attending for medical services at Bufumira Health Centre and Mazinga Health Centre, Kalangala District Receives: Other: Unmanned ariel vehicle | |
| COVID Suspects Moyo District | 1200 people attending for COVID tests at Moyo Hospital Receives: Other: Unmanned ariel vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability for ART delivery as reported using qualitative methods with key stakeholders including health care workers, district officials, people living with HIV
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
Measured: 24 months
Secondary outcomes (6)
Feasibility of medical drones for ART delivery to peer support workers using number of successful flights delivering ART
To undertake a process evaluation for feasibility of medical drones for ART and sample transport
Measured: 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)
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
Measured: 12 months
Cost of ART transport by boat as compared to drone based on actual costs of fuel and staff time
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.
Measured: 24 months
Acceptability for use of medical drone to move COVID samples as reported using qualitative methods
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
Measured: 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
To compare turnaround times for samples delivered by drones as compared to delivered by land transport (standard of care) in Moyo and Adjumani districts
Measured: 24 months
Cost of samples transport by medical drone as compared to by land using cost of fuel and staff time
To compare the cost of drone delivery compared to other sample delivery models bike or car in Moyo and Adjumani districts.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start22 Sep 2021
- Primary completion22 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted Infections (Not HIV or Hepatitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, Rakai Health Sciences Program
- Responsible party
- Sponsor
- Investigators
- Rosalind Parkes-Ratanshi, PhD, Principal investigator, Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259761
- Sponsor's protocol ID
- HREC801
- Status last verified
- Feb 2022
- First submitted
- 14 Dec 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Unmanned Air Vehichles (Medical Drones) to Overcome Geographical Barriers to Delivery of Antiretrovial Therapy and Biological Samples.
- ClinicalTrials.gov ID
- NCT05259761
- Acronym / sponsor ID
- HREC801
- Keywords
- sample transport, anti-retroviral therapy, supply chain, unmanned ariel vehicles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,450 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson, Rakai Health Sciences Program
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 22 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLHIV Kalangala District | – | Other: Unmanned ariel vehicle250 People living with HIV registered for care at Bufumira Health Centre and Mazinga Health Centre, Kalangala District |
| NonPHLIV Kalangala District | – | Other: Unmanned ariel vehicle100 People not living with HIV attending for medical services at Bufumira Health Centre and Mazinga Health Centre, Kalangala District |
| COVID Suspects Moyo District | – | Other: Unmanned ariel vehicle1200 people attending for COVID tests at Moyo Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unmanned ariel vehicleUse of an Unmanned ariel vehicle for medical delivery (drugs and samples) | Other | COVID Suspects Moyo District, NonPHLIV Kalangala District, PLHIV Kalangala District |
Primary outcome
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
6 secondary outcomes
Feasibility of medical drones for ART delivery to peer support workers using number of successful flights delivering ART
Time frame: 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
Cost of ART transport by boat as compared to drone based on actual costs of fuel and staff time
Time frame: 24 months
Acceptability for use of medical drone to move COVID samples as reported using qualitative methods
Time frame: 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
Cost of samples transport by medical drone as compared to by land using cost of fuel and staff time
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalind Parkes-Ratanshi, PhD principal investigator
Infectious Diseases Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Infections (Not HIV or Hepatitis) and HIV Infections, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Gonza (0312307000, pgonza@idi.co.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.