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临床试验/NCT05354934
NCT05354934招募中不适用

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

Centre Hospitalier de Cayenne1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Identifying factors associated with loss of sight for more than 12 months among people living with HIV in Guyana

研究概览

简要总结

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

详细描述

French Guyana is the French territory most affected by the HIV epidemic, with a prevalence estimated at between 1.13 and 1.18% of the adult population aged 15 to 49, and the incidence remains high at 0.90 per 1,000 people in 2018(1,2). Although French Guyana is a territory where the rate of screening per inhabitant is high, the proportion of infections diagnosed at a very advanced stage remains stable (from 30% in Cayenne to 45% in Saint-Laurent-du-Maroni). HIV/AIDS remains one of the main causes of premature mortality in French Guyana, with serious opportunistic pathologies specific to the territory, such as disseminated histoplasmosis.

The context of the discovery of HIV infection, the quality of the ensuing announcement and the time taken to introduce antiretroviral treatment are important determinants of the care pathway and the subsequent management in the "test and treat" era. Regular medical follow-up, good understanding of one's infection and good adherence to treatment allow the achievement of an undetectable viral load, immune restoration, maintenance of good health and reduction of the risk of secondary transmission (3, 4, 5)(3-5).

In 2018, the cascade of care in Guyana was estimated at 90% of PLHIV diagnosed, 91% of patients screened on treatment, and 94% of patients on antiretroviral treatment for more than 6 months in treatment success(1).

The WHO sets "Test and Treat" targets at 7 days following serological diagnosis in the absence of medical contraindication(6), or even the same day in circumstances where access to consultations is difficult. However, the median time for introducing antiretrovirals (ARVs) in French Guyana was estimated at 22 days in 2019(7), far from the 7-day target. This average delay, which is key to controlling the epidemic, has not been the subject of further analysis of its determinants. Territorial disparities are already apparent, with a longer delay in the west than on Cayenne Island (24 days at the West Guyana Hospital Centre and 20 days at the Cayenne Hospital Centre)(7).

On the other hand, the rate of LOS is high in French Guyana and particularly in Saint Laurent du Maroni where it is estimated that between 2 and 11% of people are lost to follow-up each year (1).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: more than last 12 months

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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