Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT03459768
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2016-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study on People Who Inject Drugs in Senegal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma and serum collected for biobank'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2016-08-10', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of HIV', 'timeFrame': '24 months', 'description': 'number of participants infected with HIV at inclusion and acquiring HIV during follow-up'}], 'secondaryOutcomes': [{'measure': 'incidence of hepatitis C infection (HCV)', 'timeFrame': '24 months', 'description': 'number of participants infected with HCV at inclusion and acquiring HCV during follow-up'}, {'measure': 'incidence of hepatitis B infection (HBV)', 'timeFrame': '24 months', 'description': 'number of participants infected with HBV at inclusion and acquiring HBV during follow-up'}, {'measure': 'incidence of relevant coinfections and comorbidities', 'timeFrame': '24 months', 'description': 'number of patients developping sexually transmitted infections, tuberculosis and other conditions\n\n-% Test realized / test planned'}, {'measure': 'Retention rate and its determinants', 'timeFrame': '24 months', 'description': 'Number of participants retained in the cohort follow-up + analysis of determinants of retention'}, {'measure': 'mortality rate and determinants', 'timeFrame': '24 months', 'description': 'Number of participants dead during follow-up + analysis of determinants of death\n\n* 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\n* Incidence of clinical events and biological of interest'}, {'measure': 'Access to treatment of HCV, HBV infections and other coditions requiring specific therapeutical management', 'timeFrame': '24 months', 'description': 'Number of patients treated for HIV, HBV, HCV and other medical conditions according to national or international guidelines recommendations'}, {'measure': 'Effectiveness of tuberculosis regimens', 'timeFrame': '24 months', 'description': 'Number of cured patients / number of patients initiating treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Drug Addiction', 'HIV/AIDS', 'Hepatitis C, Chronic', 'Hepatitis C, Acute', 'Hepatitis B, Chronic', 'Hepatitis B Acute', 'Tuberculosis', 'Sexually Transmitted Diseases', 'Psychiatric Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population of active injecting drug users who are seeking care at the CEPIAD, Dakar, Senegal.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being aged greater than or equal to 18 years or emancipated minor,\n* Being or have been an injecting drug user and followed at the CEPIAD (methadone program)\n* Living in the Dakar region for at least three months,\n* Consenting to the study after individual information.\n\nExclusion Criteria:\n\n* Mental impairment making it difficult or impossible to consent to the study.'}, 'identificationModule': {'nctId': 'NCT03459768', 'acronym': 'CoDISEN', 'briefTitle': 'Cohort Study on People Who Inject Drugs in Senegal', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Cohort Study on People Who Inject Drugs in Senegal', 'orgStudyIdInfo': {'id': 'ANRS 12334 CoDISEN'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dakar', 'country': 'Senegal', 'facility': 'CEPIAD', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}], 'overallOfficials': [{'name': 'Pierre-Marie Girard, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inserm - Sorbonne Université'}, {'name': 'Moussa Seydi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRCF - CHNU Fann'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Duration of the study and 2 years after study closure', 'ipdSharing': 'YES', 'description': 'IPD that can be shared include study protocol, statistical analysis plan, inform consent form and anonymized database', 'accessCriteria': 'Any sharing of information related to the study must be approved by the Scientific committee and the sponsor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}