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Clinical Trials/NCT03459768
NCT03459768UnknownNot Applicable

Cohort Study on People Who Inject Drugs in Senegal

French National Agency for Research on AIDS and Viral Hepatitis1 site in 1 country208 target enrollmentStarted: August 24, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
208
Locations
1
Primary Endpoint
incidence of HIV

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

incidence of HIV

Time Frame: 24 months

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

Secondary Outcomes

  • 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)
  • Access to treatment of HCV, HBV infections and other coditions requiring specific therapeutical management(24 months)
  • Effectiveness of tuberculosis regimens(24 months)

Investigators

Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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