NCT05025891

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

August 11, 2021

Last Update Submit

August 24, 2021

Conditions

HIVTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • 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)

  • +9 more secondary outcomes

Study Arms (3)

Arm 1: control

NO INTERVENTION

Patients continue consultations as usual in HDJA or at UMIT.

Arm 2: teleconsultation alone

EXPERIMENTAL

Patients are directed to the tele-monitoring platform without specific accompaniment.

Other: Teleconsultation

Arm 3: teleconsultation and mediation

EXPERIMENTAL

Patients are referred to the tele-monitoring platform with specific support with mediation.

Other: Teleconsultation

Interventions

TeleconsultationOTHER

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

Arm 2: teleconsultation aloneArm 3: teleconsultation and mediation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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..

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

RECRUITING

MeSH Terms

Interventions

Remote Consultation

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Central Study Contacts

LUCARELLI Aude, Dr

CONTACT

0594395541aude.lucarelli@ch-cayenne.fr

BOUTROU Mathilde, Dr

CONTACT

mathilde.buotrou@ch-cayenne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 27, 2021

Study Start

February 4, 2021

Primary Completion

September 4, 2022

Study Completion

March 1, 2023

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations

FR(1)