NCT05259761

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

December 14, 2021

Last Update Submit

February 15, 2022

Conditions

Keywords

sample transportanti-retroviral therapysupply chainunmanned ariel vehicles

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months

Secondary Outcomes (6)

  • Feasibility of medical drones for ART delivery to peer support workers using number of successful flights delivering ART

    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)

    12 months

  • Cost of ART transport by boat as compared to drone based on actual costs of fuel and staff time

    24 months

  • Acceptability for use of medical drone to move COVID samples as reported using qualitative methods

    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

    24 months

  • +1 more secondary outcomes

Study Arms (3)

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

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

COVID Suspects Moyo District

1200 people attending for COVID tests at Moyo Hospital

Other: Unmanned ariel vehicle

Interventions

Use of an Unmanned ariel vehicle for medical delivery (drugs and samples)

COVID Suspects Moyo DistrictNonPHLIV Kalangala DistrictPLHIV Kalangala District

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Institute

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted DiseasesHepatitisHIV InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rosalind Parkes-Ratanshi, PhD

    Infectious Diseases Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

March 2, 2022

Study Start

September 22, 2021

Primary Completion

March 22, 2022

Study Completion

June 30, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations