Clinical trial NCT03459768: Cohort Study on People Who Inject Drugs in Senegal
Official title: Cohort Study on People Who Inject Drugs in Senegal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Addiction
HIV/AIDS
Hepatitis C, Chronic
Hepatitis C, Acute
Hepatitis B, Chronic
Hepatitis B Acute
Tuberculosis
Sexually Transmitted Diseases
Psychiatric Disorder
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2018-03-09
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of active injecting drug users who are seeking care at the CEPIAD, Dakar, Senegal.

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

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of HIV
timeFrame: 24 months
Secondary outcomes:
measure: incidence of hepatitis C infection (HCV)
timeFrame: 24 months
measure: incidence of hepatitis B infection (HBV)
timeFrame: 24 months
measure: incidence of relevant coinfections and comorbidities
timeFrame: 24 months
measure: Retention rate and its determinants
timeFrame: 24 months
measure: mortality rate and determinants
timeFrame: 24 months
measure: Access to treatment of HCV, HBV infections and other coditions requiring specific therapeutical management
timeFrame: 24 months
measure: Effectiveness of tuberculosis regimens
timeFrame: 24 months
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: CEPIAD
Study officials:
affiliation: Inserm - Sorbonne Université
name: Pierre-Marie Girard, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CRCF - CHNU Fann
name: Moussa Seydi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: