Human Immunodeficiency VirusEMVIHNCT05354934
Study of Entry and Continuation in Care for People Living With HIV in French Guiana
An observational study of Human Immunodeficiency Virus, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- quetionnaire
- How many people
- 300 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 23 Mar 2022to 23 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Cayenne
Cayenne, France, 97306
nicolas N Vignier, PhD, 0594395690, nicolas.vignier@ch-cayenne.fr
mathieu M Nacher, PhD, 0594395024, mathieu.nacher@ch-cayenne.fr
About this study
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.
Read more
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
Read the detailed 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- quetionnaire
- Keywords
- Human Immunodeficiency Virus, french guiana, maintain in care, HIV diagnosis
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: quetionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: more than last 12 months
Secondary outcomes (4)
Identifying factors associated with a delay in the introduction of ARVs among PLHIV in French Guyana
Socio-demographic, clinical, biological and therapeutic factors associated with a delay in the introduction of antiretroviral treatment for PLHIV in French Guyana. Delayed initiation of antiretroviral treatment is defined as initiation of antiretroviral drugs more than 30 days after the discovery of HIV infection when it occurred in France or Guyana and after 2013
Measured: baseline
Describe the perceived quality of the HIV diagnostic announcement with a specific questionnaire
perceived quality of the HIV diagnostic announcement with a specific questionnaire
Measured: baseline
describe the difficulties encountered by PLHIV during their hospital follow-up in French Guyana with a specific questionnaire
difficulties encountered by PLHIV during their hospital follow-up in French Guyana with a specific questionnaire
Measured: baseline
Assessing perceived HIV-related stigma and its impact on daily life with a specific questionnaire
perceived HIV-related stigma and its impact on daily life with a specific questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start23 Mar 2022
- Primary completion23 Mar 2024 (estimated)
- Study completion23 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354934
- Sponsor's protocol ID
- EMVIH
- Acronym
- EMVIH
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Entry and Continuation in Care for People Living With HIV in French Guiana
- ClinicalTrials.gov ID
- NCT05354934
- Acronym / sponsor ID
- EMVIH / EMVIH
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, french guiana, maintain in care, HIV diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 23 Mar 2024 (estimated)
- Study completion
- 23 Jun 2024 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People living with HIV | – | Other: quetionnaireThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quetionnaireThe 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 | People living with HIV |
Primary outcome
Identifying factors associated with loss of sight for more than 12 months among people living with HIV in Guyana
Time frame: 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.
4 secondary outcomes
Identifying factors associated with a delay in the introduction of ARVs among PLHIV in French Guyana
Time frame: baseline
Describe the perceived quality of the HIV diagnostic announcement with a specific questionnaire
Time frame: baseline
describe the difficulties encountered by PLHIV during their hospital follow-up in French Guyana with a specific questionnaire
Time frame: baseline
Assessing perceived HIV-related stigma and its impact on daily life with a specific questionnaire
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying factors associated with loss of sight for more than 12 months among people living with HIV in Guyana (time frame: more than last 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.