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Drug AddictionCoDISENNCT03459768

Cohort Study on People Who Inject Drugs in Senegal

An observational study of Drug Addiction and HIV/AIDS, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in Senegal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Drug Addiction, HIV/AIDS, Hepatitis C, Chronic
How many people
208 participants
Where
1 siteSenegal
Study dates
24 Aug 2016to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Senegal1 site

  • CEPIAD

    Dakar

Other trials in Senegal

About this study

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.

Read the 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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of HIV

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

    Measured: 24 months

Secondary outcomes (7)

  1. incidence of hepatitis C infection (HCV)

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

    Measured: 24 months

  2. incidence of hepatitis B infection (HBV)

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

    Measured: 24 months

  3. incidence of relevant coinfections and comorbidities

    number of patients developping sexually transmitted infections, tuberculosis and other conditions

    -% Test realized / test planned

    Measured: 24 months

  4. Retention rate and its determinants

    Number of participants retained in the cohort follow-up + analysis of determinants of retention

    Measured: 24 months

  5. 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

    Measured: 24 months

  6. 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

    Measured: 24 months

  7. Effectiveness of tuberculosis regimens

    Number of cured patients / number of patients initiating treatment

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2018
  2. Study start24 Aug 2016
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03459768
Sponsor's protocol ID
ANRS 12334 CoDISEN
Acronym
CoDISEN
Status last verified
Jun 2021
First submitted
10 Aug 2016
Last updated
8 Jun 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: IPD that can be shared include study protocol, statistical analysis plan, inform consent form and anonymized database

Questions about this trial

What is this clinical trial studying?

An observational study of Drug Addiction and HIV/AIDS, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in Senegal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of HIV (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.

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