Cohort Study on People Who Inject Drugs in Senegal (CoDISEN)

June 7, 2021 updated by: French National Agency for Research on AIDS and Viral Hepatitis
The main purpose of the CoDISEN cohort study is to propose a model of prevention and care for HIV and viral hepatitis adapted to the needs of people who inject drugs (PWID) in Dakar, Senegal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

THE UNODC estimated the number of consumers of injectable drugs at 1,02 millions in 2012 in Africa among which 12,1 % lived with HIV. Prevalences of HIV, chronic hepatitis C and B among people who inject drugs remain little documented in Sub-Saharan Africa. The transmission of HCV in Africa is mainly hospital-borne, bound to a precarious transfusional and therapeutic safety. However, the transmission by intravenous drug use emerges as a new stake in public health in urban areas. The report of a strong HIV prevalence in the population of PWID in the sub-region ( for example, In 2007, in the Cape Verde, prevalence of the HIV was 14 % in emprisoned PWID against 0,8 % in the general population) contributed to assert the reality of the use of intravenous drugs in the region and the vulnerability of this population. Senegal, a country with an concentrated HIV epidemic [0,5 % prevalence in 2012, WHO source] is the first country of western Africa to have measured prevalence of HIV (5,2 %), HBV (7,9 %) and HCV (23,3 %) in PWID (Study ANRS 12243). In view of these results, the Senegalese authorities introduced from October, 2011 in Dakar, activities of harm reduction by means of a mobile team of social workers and mediators allowing individual and collective activities of prevention, needle exchange program, references for care and follow-up, as well as a opioid substitution program in a methadone center (CEPIAD) located in Dakar, first of its kind in Western Africa. The objective of the present research project thus is to estimate the impact of a strategy of " test and treat " of HIV and harm reduction initiatives on the prevalence and incidence of HIV, HBV and HCV infections in an population of injectable drug consumers followed in the methadone center ( CEPIAD) of Dakar, Senegal

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population of active injecting drug users who are seeking care at the CEPIAD, Dakar, Senegal.

Description

Inclusion Criteria:

  • being aged greater than or equal to 18 years or emancipated minor,
  • Being or have been an injecting drug user and followed at the CEPIAD (methadone program)
  • Living in the Dakar region for at least three months,
  • Consenting to the study after individual information.

Exclusion Criteria:

  • Mental impairment making it difficult or impossible to consent to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of HIV
Time Frame: 24 months
number of participants infected with HIV at inclusion and acquiring HIV during follow-up
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
incidence of hepatitis C infection (HCV)
Time Frame: 24 months
number of participants infected with HCV at inclusion and acquiring HCV during follow-up
24 months
incidence of hepatitis B infection (HBV)
Time Frame: 24 months
number of participants infected with HBV at inclusion and acquiring HBV during follow-up
24 months
incidence of relevant coinfections and comorbidities
Time Frame: 24 months

number of patients developping sexually transmitted infections, tuberculosis and other conditions

-% Test realized / test planned
24 months
Retention rate and its determinants
Time Frame: 24 months
Number of participants retained in the cohort follow-up + analysis of determinants of retention
24 months
mortality rate and determinants
Time Frame: 24 months

Number of participants dead during follow-up + analysis of determinants of death

  • evolution of CD4 and HIV viral load in participants with HIV and treated with ARVs, HBV viral load , and HCV viral load in participants with viral hepatitis B and C
  • Incidence of clinical events and biological of interest
24 months
Access to treatment of HCV, HBV infections and other coditions requiring specific therapeutical management
Time Frame: 24 months
Number of patients treated for HIV, HBV, HCV and other medical conditions according to national or international guidelines recommendations
24 months
Effectiveness of tuberculosis regimens
Time Frame: 24 months
Number of cured patients / number of patients initiating treatment
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre-Marie Girard, M.D., PhD, Inserm - Sorbonne Université
  • Principal Investigator: Moussa Seydi, M.D., CRCF - CHNU Fann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANRS 12334 CoDISEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that can be shared include study protocol, statistical analysis plan, inform consent form and anonymized database

IPD Sharing Time Frame

Duration of the study and 2 years after study closure

IPD Sharing Access Criteria

Any sharing of information related to the study must be approved by the Scientific committee and the sponsor.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexually Transmitted Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings