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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04513496
Other study ID # TM HIV BA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date July 1, 2022

Study information

Verified date August 2020
Source Fundacion Ibis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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)


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4000
Est. completion date July 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years-old or older

- Access to internet

- Willing to participate

Exclusion Criteria:

- do not understand the purpose and study procedures

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundacion Ibis

Outcome

Type Measure Description Time frame Safety issue
Primary Telemedicine Reach. RE-AIM framework Proportion of included patients over all patients eligible 18 months
Primary Telemedicine Effectiveness. RE-AIM framework Proportion of treatment interruptions and undetectable HIV viral load 18 months
Primary Telemedicine Adoption. RE-AIM framework Proportion of physicians adopting VC, barriers and facilitators to adopt telemedicine 18 months
Primary Telemedicine Implementation.RE-AIM framework Time and cost needed to deliver the intervention 18 months
Primary Telemedicine Manteinance. RE-AIM framework Inclusion of VCT into routine activity, Satisfaction of HCP(healthcare proffesionals and patients with videoconsultation 18 months
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