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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Telemedicine
• Intervention / Treatment: Other: Teleconsultation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LUCARELLI Aude, Dr; Phone Number: 0594395541; Email: aude.lucarelli@ch-cayenne.fr
• Study Contact Backup: Name: BOUTROU Mathilde, Dr; Email: mathilde.buotrou@ch-cayenne.fr

Study Locations

• French Guiana
  • Cayenne, French Guiana, 97306
    • Recruiting
    • General Hospital of Cayenne
    • Contact: Mathieu Nacher, Pr; Phone Number: 0594395385; Email: mathieu.nacher@ch-cayenne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic HIV infection.
• Patient with a regular follow-up for more than three months in the adult day hospital or in the infectious diseases department of the Cayenne Hospital Center.
• Patient of legal age.
• Patient having signed the consent form..

Exclusion Criteria:

• Pregnant patient
• Patient with a severe neurological or psychiatric history (significant cognitive disorders, intellectual disability).
• Patient with a physical disability that prevents communication via the e-Health platform (mute patient, visually and hearing impaired, specific manual motor disability, bedridden patient).
• Patient who does not master one of the languages available at the mediation.
• Patients under guardianship or trusteeship, people under protective measures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1: control; Patients continue consultations as usual in HDJA or at UMIT.
Experimental: Arm 2: teleconsultation alone; Patients are directed to the tele-monitoring platform without specific accompaniment.	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
Experimental: Arm 3: teleconsultation and mediation; Patients are referred to the tele-monitoring platform with specific support with mediation.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of the proportions of patients who followed the schedule proposed by the physician at inclusion (or revised during important events) in the 3 arms.	The inclusion period (1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the best strategy for implementing an e-Health platform in French Guiana in the management of chronic HIV infection		The inclusion period (1 year)
The proportion of patients throughout the inclusion period (1 year) likely to use the platform will be assessed using the number of patients meeting the inclusion criteria (having agreed to participate in the research or not).		The inclusion period (1 year)
The obstacles to the use of an e-health platform will be evaluated using a questionnaire for caregivers and patients and based on the number of failed connections		The inclusion period (1 year)
Patient satisfaction score assessed with study specific questionnaire		The inclusion period (1 year)
Caregiver satisfaction score assessed with study specific questionnaire		The inclusion period (1 year)
Evaluation of the material needs to guarantee accessibility of the consultation places		The inclusion period (1 year)
Evaluation of the material needs for the implementation and maintenance of the e-health platform		The inclusion period (1 year)
Measurement of the average intervention time of the doctors per patient		The inclusion period (1 year)
Measurement of the average intervention time of the mediators per patient		The inclusion period (1 year)
Measurement of the average intervention time of the ETP nurse per patient		The inclusion period (1 year)
Compare the patients followed up with the platform and the patients followed up in classic consultation on: the proportion of check-ups done during the same duration of follow-up, the proportion of patients with an undetectable viral load, the proportion		The inclusion period (1 year)
proportion of check-ups done during the same duration of follow-up between patients followed up with the platform and the patients followed up in classic consultation		The inclusion period (1 year)
proportion of patients with an undetectable viral load between patients followed up with the platform and the patients followed up in classic consultation		The inclusion period (1 year)
Questionnaire for all the care providers assessed with study specific questionnaire	In order to evaluate the number of patients lost to follow-up, service congestion, patient waiting time, knowledge of the patient's pathway, communication with the patient, the number of missed consultations and the viral load of patients followed via the platform.	The inclusion period (1 year)

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Cayenne

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Anticipated): September 4, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ISe-SANTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No