ClinicalTrials.gg
Status unknownNCT03459768CoDISENUpdated Jun 8, 2021

Cohort Study on People Who Inject Drugs in Senegal

An observational study in Drug Addiction, HIV/AIDS and Hepatitis C, Chronic, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Status unknown at 1 site in Senegal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Active, not recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
208
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Drug Addiction
  • HIV/AIDS
  • Hepatitis C, Chronic
  • Hepatitis C, Acute
  • Hepatitis B, Chronic
  • Hepatitis B Acute
  • Tuberculosis
  • Sexually Transmitted Diseases
  • Psychiatric Disorder
03

In context

Substance-Related Disorders

2,241 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's enrollment of 208 is below the median of 251 across 299 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 86 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Mental impairment making it difficult or impossible to consent to the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
208 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. incidence of HIV

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

    Time frame: 24 months

Secondary outcomes

  1. incidence of hepatitis C infection (HCV)

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

    Time frame: 24 months

  2. incidence of hepatitis B infection (HBV)

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

    Time frame: 24 months

  3. incidence of relevant coinfections and comorbidities

    number of patients developping sexually transmitted infections, tuberculosis and other conditions -% Test realized / test planned

    Time frame: 24 months

  4. Retention rate and its determinants

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

    Time frame: 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

    Time frame: 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

    Time frame: 24 months

  7. Effectiveness of tuberculosis regimens

    Number of cured patients / number of patients initiating treatment

    Time frame: 24 months

07

Study locations

1 site
  • CEPIAD
    Dakar, Senegal
08

References and documents

Individual participant data

Plan to share: Yes — IPD that can be shared include study protocol, statistical analysis plan, inform consent form and anonymized database

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Duration of the study and 2 years after study closure

Access criteria: Any sharing of information related to the study must be approved by the Scientific committee and the sponsor.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2016 (actual). Primary completion is estimated for Jun 2021, 58 months after the start.

Of 123 non-industry observational studies under Substance-Related Disorders, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 60. This study's planned 58 months is above that.

Counting every sponsor, half of 134 studies reached it within 36 months; a quarter within 18 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2016
First posted
Mar 9, 2018
StartActual
Aug 24, 2016
Primary completionEst.
Jun 30, 2021
CompletionEst.
Jun 30, 2021
Last update
Jun 8, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03459768
Lead sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Aug 24, 2016
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Jun 8, 2021

Study contacts

Pierre-Marie Girard, M.D., PhD
principal investigator · Inserm - Sorbonne Université
Moussa Seydi, M.D.
principal investigator · CRCF - CHNU Fann

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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