CoDISEN: Cohort Study on People Who Inject Drugs in Senegal

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03459768

Collaborator

(none)

208

Enrollment

Location

58.2

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Addiction HIV/AIDS Hepatitis C, Chronic Hepatitis C, Acute Hepatitis B, Chronic Hepatitis B Acute Tuberculosis Sexually Transmitted Diseases Psychiatric Disorder

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

Actual Enrollment :

208 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cohort Study on People Who Inject Drugs in Senegal

Actual Study Start Date :

Aug 24, 2016

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Outcome Measures

Primary Outcome Measures

incidence of HIV [24 months]
number of participants infected with HIV at inclusion and acquiring HIV during follow-up

Secondary Outcome Measures

incidence of hepatitis C infection (HCV) [24 months]
number of participants infected with HCV at inclusion and acquiring HCV during follow-up
incidence of hepatitis B infection (HBV) [24 months]
number of participants infected with HBV at inclusion and acquiring HBV during follow-up
incidence of relevant coinfections and comorbidities [24 months]
number of patients developping sexually transmitted infections, tuberculosis and other conditions -% Test realized / test planned
Retention rate and its determinants [24 months]
Number of participants retained in the cohort follow-up + analysis of determinants of retention
mortality rate and determinants [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
Access to treatment of HCV, HBV infections and other coditions requiring specific therapeutical management [24 months]
Number of patients treated for HIV, HBV, HCV and other medical conditions according to national or international guidelines recommendations
Effectiveness of tuberculosis regimens [24 months]
Number of cured patients / number of patients initiating treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.