Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05354934 |
| Other study ID # |
EMVIH |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2022 |
| Est. completion date |
June 23, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Centre Hospitalier de Cayenne |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
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).
In this context, delays in the introduction of antiretroviral treatment and the risk of loss
of sight (LOS) among PLHIV are major issues in the fight against the epidemic, both in terms
of preventing progression to the AIDS stage, which is still all too common in French Guyana,
and in preventing secondary transmission.
Thus, a better understanding of the quality of the diagnostic announcement will enable work
to be carried out on the points that need to be improved in order to ensure effective
retention in care. In the same way, by identifying the obstacles to the rapid implementation
of ARVs, study team will work to remove these obstacles and provide the necessary responses
to reduce the delay.
The investigators hypothesise that the increase in the rate of people lost to follow-up over
time in French Guyana is associated with an increase in the social difficulties encountered
by PLHIV in a context of demographic and migratory progression and a tension between the
players, the fragility of the specialised care offer over time, and a possible increase in
follow-up in the city, which escapes the hospital surveillance data.
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
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.
The identification of factors associated with a delay in starting antiretrovirals, periods of
loss of sight, as well as obstacles and facilitators to retention in care will enable local
actors to recognise patients requiring particular support for continuity of care and the
COREVIH's loss of sight working group, which is being set up at the same time, to work on
adapted responses that are co-constructed with all the actors. It will also allow for the
adaptation and development of follow-up strategies, for example through better collaboration
between the hospital and the town, or with border countries.
A better understanding of the period between serological diagnosis and the initiation of ARVs
among PLHIV in French Guyana will enable the tools for controlling the epidemic to be
adapted, bringing us closer to the WHO's objectives, and will help to reduce the morbidity
and mortality of patients through individual care adapted to the various reference centres in
French Guyana.
