Use of Unmanned Air Vehichles (Medical Drones) to Overcome Geographical Barriers to Delivery of Antiretrovial Therapy and Biological Samples.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,450
- 试验地点
- 1
- 主要终点
- Acceptability for ART delivery as reported using qualitative methods with key stakeholders including health care workers, district officials, people living with HIV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Acceptability for ART delivery as reported using qualitative methods with key stakeholders including health care workers, district officials, people living with HIV
时间窗: 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
次要结局
- Feasibility of medical drones for ART delivery to peer support workers using number of successful flights delivering ART(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)
- 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)
- Acceptability for use of medical drone to move COVID samples as reported using qualitative methods(24 months)
- Cost of samples transport by medical drone as compared to by land using cost of fuel and staff time(24 months)
- Cost of ART transport by boat as compared to drone based on actual costs of fuel and staff time(24 months)