Tuberculosis Clinical Trial
— CoDISENOfficial title:
Cohort Study on People Who Inject Drugs in Senegal
Verified date | June 2021 |
Source | ANRS, Emerging Infectious Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 208 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Senegal | CEPIAD | Dakar |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis |
Senegal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of HIV | number of participants infected with HIV at inclusion and acquiring HIV during follow-up | 24 months | |
Secondary | incidence of hepatitis C infection (HCV) | number of participants infected with HCV at inclusion and acquiring HCV during follow-up | 24 months | |
Secondary | incidence of hepatitis B infection (HBV) | number of participants infected with HBV at inclusion and acquiring HBV during follow-up | 24 months | |
Secondary | incidence of relevant coinfections and comorbidities | number of patients developping sexually transmitted infections, tuberculosis and other conditions
-% Test realized / test planned |
24 months | |
Secondary | Retention rate and its determinants | Number of participants retained in the cohort follow-up + analysis of determinants of retention | 24 months | |
Secondary | mortality rate and determinants | 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 | |
Secondary | Access to treatment of HCV, HBV infections and other coditions requiring specific therapeutical management | Number of patients treated for HIV, HBV, HCV and other medical conditions according to national or international guidelines recommendations | 24 months | |
Secondary | Effectiveness of tuberculosis regimens | Number of cured patients / number of patients initiating treatment | 24 months |
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