Study of Entry and Continuation in Care for People Living With HIV in French Guiana

NCT05354934 | Unknown

• 1 other identifier: EMVIH
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Research Involving the Non-Interventional Human Subject (RIPH category 3). Non-interventional, cross-sectional, multicentre, descriptive and analytical epidemiological study. A cross-sectional, pseudo-anonymous questionnaire focusing on entry and retention in care will be administered to a sample of PLHIV presenting for consultation in one of the GHT hospitals over a 12-month period. A sample of 300 PHAs is envisaged to have sufficient power to highlight the main factors associated with periods of loss of sight. Main objective: \- To identify factors associated with loss of sight for more than 12 months among people living with HIV in Guyana Secondary objectives:

• To identify factors associated with a delay in the introduction of ARVs among PLHIV in Guyana
• To describe the perception of the quality of the announcement of the diagnosis of HIV
• To describe the difficulties encountered by PLHIV during their hospital follow-up in French Guyana
• To assess the perceived stigma associated with HIV and its consequences in daily life

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus; french guiana; maintain in care; HIV diagnosis

Outcome Measures

Primary Outcomes (1)

• Identifying factors associated with loss of sight for more than 12 months among people living with HIV in Guyana

  Socio-demographic, clinical, biological and therapeutic factors associated with a period of loss of sight of PLWH in Guyana. Loss of sight is defined as a period of 12 months or more of follow-up since the last specialist hospital consultation in one of the three participating hospitals.

  more than last 12 months

Secondary Outcomes (4)

• Identifying factors associated with a delay in the introduction of ARVs among PLHIV in French Guyana

  baseline

• Describe the perceived quality of the HIV diagnostic announcement with a specific questionnaire

  baseline

• describe the difficulties encountered by PLHIV during their hospital follow-up in French Guyana with a specific questionnaire

  baseline

• Assessing perceived HIV-related stigma and its impact on daily life with a specific questionnaire

  baseline

Study Arms (1)

People living with HIV

The questionnaire includes the following modules * Demography and socio-economic conditions * Screening and modalities of discovery and announcement of HIV infection * Time and modalities of introduction of antiretroviral drugs after diagnosis * Knowledge of HIV infection * The perception of follow-up in the health care service * Experiences of stigma * Barriers to accessing care * Periods of loss of sight and reasons for this * Perceived health status, mental health (PHQ4), chronic illness, functional limitations * Addictions * Social network and support * Clinical data Date of HIV diagnosis Date of introduction of antiretrovirals CD4 count at diagnosis Viral load at diagnosis Period without follow-up for more than 12 months CD4 nadir Last CD4 count Last viral load Antiretroviral treatment at last consultation Comorbidities Initial hospitalisation Recent hospitalization

Other: quetionnaire

Interventions

quetionnaire OTHER

The questionnaire includes the following modules * Demography and socio-economic conditions * Screening and modalities of discovery and announcement of HIV infection * Time and modalities of introduction of antiretroviral drugs after diagnosis * Knowledge of HIV infection * The perception of follow-up in the health care service * Experiences of stigma * Barriers to accessing care * Periods of loss of sight and reasons for this * Perceived health status, mental health (PHQ4), chronic illness, functional limitations * Addictions * Social network and support * Clinical data Date of HIV diagnosis Date of introduction of antiretrovirals CD4 count at diagnosis Viral load at diagnosis Period without follow-up for more than 12 months CD4 nadir Last CD4 count Last viral load Antiretroviral treatment at last consultation Comorbidities Initial hospitalisation Recent hospitalization

People living with HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cross-sectional, pseudo-anonymous questionnaire, focusing on entry and retention in care, will be administered to a sample of PLHIV presenting for consultation in the three GHT hospitals. The questionnaire will be offered once to each eligible PLHIV consulting one of the three study hospitals and not opposed to participation over a 12-month period. Inclusion will be carried out by the consulting physician or intern who will be responsible for presenting the study, collecting non-opposition and administering the questionnaire presented in paper format. The questionnaire may be completed by the qualified persons listed on the study task sheet. The questionnaire will be administered to a sample of the active file based on the availability of qualified persons (doctors and interns) participating in the survey. Depending on the number of subjects required, it is expected that 300 questionnaires can be administered over the study period.

You may qualify if:

• People living with HIV
• Aged 18 years and over
• Followed in one of the 3 GHT Guiana hospitals (Cayenne, Kourou, Saint-Laurent-du-Maroni)
• Not opposed to participating in the study

You may not qualify if:

• Be under 18 years of age
• Not be living with HIV
• Not being followed in one of the GHT Guyana hospitals
• Have a physical or mental disability that prevents them from answering the questionnaire
• Be under guardianship or under legal protection

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, France, 97306, French Guiana

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: May 2, 2022
• Study Start: March 23, 2022
• Primary Completion: March 23, 2024
• Study Completion: June 23, 2024
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)