Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telemedicine in HIV Care in Buenos Aires

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04513496
Recruitment Status : Not yet recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacion Ibis

Brief 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)

Condition or disease
Telemedicine HIV-1-infection

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delivery of HIV Care Through Telemedicine in Public Hospitals in Buenos Aires, Argentina During COVID-19 Pandemic: Implementation Research
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Telehealth




Primary Outcome Measures :
  1. Telemedicine Reach. RE-AIM framework [ Time Frame: 18 months ]
    Proportion of included patients over all patients eligible

  2. Telemedicine Effectiveness. RE-AIM framework [ Time Frame: 18 months ]
    Proportion of treatment interruptions and undetectable HIV viral load

  3. Telemedicine Adoption. RE-AIM framework [ Time Frame: 18 months ]
    Proportion of physicians adopting VC, barriers and facilitators to adopt telemedicine

  4. Telemedicine Implementation.RE-AIM framework [ Time Frame: 18 months ]
    Time and cost needed to deliver the intervention

  5. Telemedicine Manteinance. RE-AIM framework [ Time Frame: 18 months ]
    Inclusion of VCT into routine activity, Satisfaction of HCP(healthcare proffesionals and patients with videoconsultation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PLWH(people living with HIV) that receive care in Buenos Aires public hospitals
Criteria

Inclusion Criteria:

  • 18 years-old or older
  • Access to internet
  • Willing to participate

Exclusion Criteria:

  • do not understand the purpose and study procedures
Layout table for additonal information
Responsible Party: Fundacion Ibis
ClinicalTrials.gov Identifier: NCT04513496    
Other Study ID Numbers: TM HIV BA
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No