Cohort Study on People Who Inject Drugs in Senegal

Tuberculosis Clinical Trial

— CoDISEN  

Official title:

Cohort Study on People Who Inject Drugs in Senegal

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03459768
• Other study ID #: ANRS 12334 CoDISEN
• Status: Active, not recruiting
• Start date: August 24, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Drug Addiction
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Acute
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis C, Acute
• Hepatitis C, Chronic
• HIV/AIDS
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Sexually Transmitted Diseases
• Substance-Related Disorders
• Tuberculosis

Locations

Country	Name	City	State
Senegal	CEPIAD	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

Senegal, 

Outcome

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