NCT05025891

ISe-santé, a Study Evaluating a Model for Implementing E-health in the Management of HIV Patients

Reducing Inequalities in Access to Care in French Guiana: ISe-santé, a Randomized Study Evaluating a Model for Implementing E-health in the Management of HIV

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Centre Hospitalier de Cayenne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital. The main objective of the study is to evaluate the effectiveness of follow-up of these patients by teleconsultation associated or not with health mediation.

Detailed description

The COVID-19 pandemic crisis has strained health systems, and chronic disease monitoring has often been put on hold, without yet really measuring the resulting health impact. In this context, e-Health has benefited from considerable momentum to overcome the shortcomings that have arisen, to allow remote monitoring of patients infected with COVID 19, to protect patients and caregivers and avoid nosocomial infections. Telemedicine is all the more relevant in Guyana as there are issues of geographic isolation, lack of specialists and critical mass of health professionals. In French Guiana, faced with the arrival of teleconsultation tools, a fear of professionals is their applicability for the most vulnerable populations, not knowing how to read or speak French and having restricted access to digital technology. Moreover HIV infection is an ever stigmatizing infection affecting populations that are often extremely precarious, requiring specialist monitoring and lifelong treatment. The study team propose to carry out a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital : 1/ Control group with classic follow-up at Cayenne hospital. 2/Teleconsultation only group: patients referred to the remote monitoring platform without specific support. 3/Teleconsulation group + mediator: patients referred to the remote monitoring platform with support from a health mediator Patients will be followed every 3 months or 6 months depending on the judgment of the investigating physician for 12 months in the study (primary endpoint evaluated at 1 year). Number of patients to be included: 450 patients.

Conditions

• HIV
• Telemedicine

Interventions

Type	Name	Description
OTHER	Teleconsultation	Patients are randomized into groups in which there are either teleconsultations alone or with the help of a mediator to carry out their follow-up care

Timeline

• Start date: 2021-02-04
• Primary completion: 2022-09-04
• Completion: 2023-03-01
• First posted: 2021-08-27
• Last updated: 2021-08-27

Locations

1 site across 1 country: French Guiana