TelemedicineNCT04513496
Telemedicine in HIV Care in Buenos Aires
An observational study of Telemedicine and HIV-1-infection, run by Fundacion Ibis.
Trial summary
The aim of this investigation is to conduct an implementation research to facilitate and evaluate the implementation of VCT((Videoconsult through telemedicine) among HIV HCP(healthcare providers) and PLWH(people living with HIV) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, HIV-1-infection
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: PLWH(people living with HIV) that receive care in Buenos Aires public hospitals
Who may be able to join
- 18 years-old or older
- Access to internet
- Willing to participate
Who cannot join
- do not understand the purpose and study procedures
About this study
Official title: Delivery of HIV Care Through Telemedicine in Public Hospitals in Buenos Aires, Argentina During COVID-19 Pandemic: Implementation Research
The aim of this investigation is to conduct an implementation research to facilitate and evaluate the implementation of VCT((Videoconsult through telemedicine) among HIV HCP(healthcare providers) and PLWH(people living with HIV)
Read the detailed description
Through prospective observational methodology the investigators are planning to evaluate VCT(Videoconsult through telemedicine) implementation. Both quantitative and qualitative analysis (mixed methods) will take part in the assessment. Quantitative data will be useful to obtain objective data in terms of proportion of subjects using the intervention, adoption by health care workers and measuring effectiveness. Additionally, qualitative methods will help to understand the outcomes focusing on the barriers and facilitators from both the HCW and patients, and their feedback on continuous implementation.
Hence, perceptions of a vast group of patients and HCW will take a critical point in the qualitative analysis. Finally, by evidencing effectiveness, the investigators will be able to generalize and maintain this intervention as a good clinical practice. Due to the scope of the outcomes, the investigators will use RE-AIM framework.
- Conditions
- Telemedicine, HIV-1-infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Telemedicine Reach. RE-AIM framework
Proportion of included patients over all patients eligible
Measured: 18 months
Telemedicine Effectiveness. RE-AIM framework
Proportion of treatment interruptions and undetectable HIV viral load
Measured: 18 months
Telemedicine Adoption. RE-AIM framework
Proportion of physicians adopting VC, barriers and facilitators to adopt telemedicine
Measured: 18 months
Telemedicine Implementation.RE-AIM framework
Time and cost needed to deliver the intervention
Measured: 18 months
Telemedicine Manteinance. RE-AIM framework
Inclusion of VCT into routine activity, Satisfaction of HCP(healthcare proffesionals and patients with videoconsultation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Ibis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513496
- Sponsor's protocol ID
- TM HIV BA
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of HIV Care Through Telemedicine in Public Hospitals in Buenos Aires, Argentina During COVID-19 Pandemic: Implementation Research
- ClinicalTrials.gov ID
- NCT04513496
- Acronym / sponsor ID
- TM HIV BA
- Conditions
- Telemedicine, HIV-1-infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Fundacion IbisUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 14 Aug 2020 (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.
The aim of this investigation is to conduct an implementation research to facilitate and evaluate the implementation of VCT((Videoconsult through telemedicine) among HIV HCP(healthcare providers) and PLWH(people living with HIV)
Detailed description
Through prospective observational methodology the investigators are planning to evaluate VCT(Videoconsult through telemedicine) implementation. Both quantitative and qualitative analysis (mixed methods) will take part in the assessment. Quantitative data will be useful to obtain objective data in terms of proportion of subjects using the intervention, adoption by health care workers and measuring effectiveness. Additionally, qualitative methods will help to understand the outcomes focusing on the barriers and facilitators from both the HCW and patients, and their feedback on continuous implementation.
Hence, perceptions of a vast group of patients and HCW will take a critical point in the qualitative analysis. Finally, by evidencing effectiveness, the investigators will be able to generalize and maintain this intervention as a good clinical practice. Due to the scope of the outcomes, the investigators will use RE-AIM framework.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PLWH(people living with HIV) that receive care in Buenos Aires public hospitals
Key inclusion criteria (3 listed)
- 18 years-old or older
- Access to internet
- Willing to participate
Key exclusion criteria (1 listed)
- do not understand the purpose and study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Telemedicine Reach. RE-AIM framework
Time frame: 18 months
Proportion of included patients over all patients eligible
Telemedicine Effectiveness. RE-AIM framework
Time frame: 18 months
Proportion of treatment interruptions and undetectable HIV viral load
Telemedicine Adoption. RE-AIM framework
Time frame: 18 months
Proportion of physicians adopting VC, barriers and facilitators to adopt telemedicine
Telemedicine Implementation.RE-AIM framework
Time frame: 18 months
Time and cost needed to deliver the intervention
Telemedicine Manteinance. RE-AIM framework
Time frame: 18 months
Inclusion of VCT into routine activity, Satisfaction of HCP(healthcare proffesionals and patients with videoconsultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Telemedicine and HIV-1-infection, run by Fundacion Ibis.
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 3 inclusion and 1 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 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telemedicine Reach. RE-AIM framework (time frame: 18 months). The study lists 5 primary outcomes in all. 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 14 Aug 2020.