HIV/AIDS
Conditions
Interventions
Arm A Tasso device
Arm B Collect2know device
Sponsors
Zambart
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - People living with HIV aged = 18 years and on ART and attending the clinic for their routine monitoring visits. - Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: - < 18 years old - Not on ART
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to evaluate the successful collection of the correct blood volume by the intended users using the two devices during an unsupervised visit (i.e. self collection of sample at home). A successful sample collection would be defined as having correctly self-collected a minimal of 0.5mls of blood using either of the two devices during an unsupervised visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the usability and acceptability of the self-sample collection devices. Usability and acceptability will be examined using predefined benchmarks to deem a variable usable or acceptable. Usability refers to the ease with which users can learn to operate, understand, and safely use the device without direct supervision. It encompasses the intuitiveness of the device, clarity of instructions, the simplicity of the process, and the user's overall experience in successfully collecting a blood sample. A highly usable device will typically require minimal training, will have intuitive design features, and will allow users to complete the collection process efficiently and without errors. Usability will be evaluated based on how correctly participants are able to use the device with ease during an unsupervised visit, follow the written instructions of the device and ability to collect the sample at home and bring it to the clinic. Acceptability refers to the extent to which users find the device to be satisfactory, appropriate, and acceptable for its intended purpose. This encompasses user satisfaction, comfort level with the procedure, willingness to use the device again, and preference over other traditional methods of blood collection. Acceptability takes into account not just the functional aspects of the device, but also the psychological and emotional responses of users. A device that users find painful, intimidating, or otherwise unpleasant, even if technically easy to use, may have low acceptability. In this study, we will assess acceptability through a questionnaire, focusing on device acceptance, future self-collection likelihood, and recommendations. We will also gather insights from focus group discussions with users and healthcare workers, covering practical use, facilitators, and barriers. 2. Device preferences – this will evaluated using participants preferences between the two devices and type of device they would prefer to use in the f | — |
Countries
Zambia
Contacts
Public ContactChepela Ngulube
Research Governance Officer
Outcome results
None listed