Cohort Study on People Who Inject Drugs in Senegal

NCT03459768 | Unknown

• 1 other identifier: ANRS 12334 CoDISEN
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Addiction; HIV/AIDS; Hepatitis C, Chronic; Hepatitis C, Acute; Hepatitis B, Chronic; Hepatitis B Acute; Tuberculosis; Sexually Transmitted Diseases; Psychiatric Disorder

Outcome Measures

Primary Outcomes (1)

• incidence of HIV

  number of participants infected with HIV at inclusion and acquiring HIV during follow-up

  24 months

Secondary Outcomes (7)

• incidence of hepatitis C infection (HCV)

  24 months

• incidence of hepatitis B infection (HBV)

  24 months

• incidence of relevant coinfections and comorbidities

  24 months

• Retention rate and its determinants

  24 months

• mortality rate and determinants

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

CEPIAD

Dakar, Senegal

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma and serum collected for biobank

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome; Hepatitis C, Chronic; Hepatitis C; Hepatitis B, Chronic; Tuberculosis; Sexually Transmitted Diseases; Mental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepadnaviridae Infections; DNA Virus Infections; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Pierre-Marie Girard, M.D., PhD

  Inserm - Sorbonne Université

  PRINCIPAL INVESTIGATOR

• Moussa Seydi, M.D.

  CRCF - CHNU Fann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: March 9, 2018
• Study Start: August 24, 2016
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Duration of the study and 2 years after study closure
• Access Criteria: Any sharing of information related to the study must be approved by the Scientific committee and the sponsor.

Locations

SE (1)