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Testing and Linkage to Care for Injecting Drug Users in Kenya

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ClinicalTrials.gov Identifier: NCT01557998
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : October 5, 2018
Sponsor:
Collaborators:
New York University School of Medicine
Kenya National AIDS & STI Control Programme
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:

Testing and Linkage to Care for Injecting Drug Users in Kenya:

Interventions for people who inject drugs (PWID) in sub-Saharan African have been almost entirely absent, despite the fact that in countries like Kenya they contribute a growing proportion of incident HIV infections. This study will leverage a historic decision in Kenya to launch needle exchange program (NSP) and related services for this most-at-risk population (MARP). The investigators will use this NSP/MARP platform to seek out PWID, deliver rapid HIV testing, point of care CD4 count and link to ART using peer case managers, and evaluate community viral load impact using a stepped wedge cluster-randomized design. Lessons learned will have important applicability throughout sub-Saharan African.

HCV Among PWID in Kenya: A Supplement to the TLC-IDU study:

The prevalence of HCV in Kenya, where an increasing number of people who inject drugs (PWID) live and are becoming HIV- as well as HCV-infected, has not been defined. We will establish HCV prevalence among PWID in Nairobi, Western, and Coastal region by adding HCV rapid and confirmatory tests in our parent PWID study (TLC-IDU Kenya); deliver appropriate counseling and treatment options to those eligible; collect HCV treatment adherence data; and disseminate study findings. These data will provide novel and relevant information about HCV and HIV co-infection in Kenya among PWID that will be immediately applicable in terms of public health impact to national and regional HCV testing, counseling, and clinical management policy.


Condition or disease Intervention/treatment Phase
HIV Infection HCV Coinfection Behavioral: POC CD4 and Peer Case Management Drug: HCV+PWID Behavioral: Control - No intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing and Linkage to Care for IDUs in Kenya (TLC-IDU Kenya); HCV Among PWIDs in Kenya: A Supplement to the TLC-IDU Study
Actual Study Start Date : May 2012
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Control - No intervention
PWID in the control arm will receive the behavioral survey, follow-up interviews, health education and training sessions on how to recruit peers, the rapid HIV and HCV test, and the point of care CD4 test but will not be assigned a peer case manager. Confirmed HCV viremic will receive HCV treatment.
Drug: HCV+PWID
Deliver direct acting antiviral (DAA) regimens for HCV+PWID. We will treat both active and inactive confirmed HCV viremic PWID from either Medication Assisted Treatment (MAT) clinics in Nairobi, Mombasa, and Malindi, Kenya or Collaborating partners' sites/Drop-in Centers (DICs) in Mombasa and Mtwapa, Kenya with direct acting antiviral (DAA) regimens. The mode of treatment delivery will be Directly Observed Therapy (DOT) for 84 consecutive doses (one dose per day). All participants will receive pre, post and ongoing counseling as per study protocol.
Other Name: Deliver ongoing counseling

Behavioral: Control - No intervention
Experimental: POC CD4 and Peer Case Management
HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <500/μL will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention. Confirmed HCV viremic will receive HCV treatment.
Behavioral: POC CD4 and Peer Case Management
HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <500/μL will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention.

Drug: HCV+PWID
Deliver direct acting antiviral (DAA) regimens for HCV+PWID. We will treat both active and inactive confirmed HCV viremic PWID from either Medication Assisted Treatment (MAT) clinics in Nairobi, Mombasa, and Malindi, Kenya or Collaborating partners' sites/Drop-in Centers (DICs) in Mombasa and Mtwapa, Kenya with direct acting antiviral (DAA) regimens. The mode of treatment delivery will be Directly Observed Therapy (DOT) for 84 consecutive doses (one dose per day). All participants will receive pre, post and ongoing counseling as per study protocol.
Other Name: Deliver ongoing counseling

HCV+PWID
Control and Experimental Confirmed HCV viremic study subject will receive HCV treatment
Drug: HCV+PWID
Deliver direct acting antiviral (DAA) regimens for HCV+PWID. We will treat both active and inactive confirmed HCV viremic PWID from either Medication Assisted Treatment (MAT) clinics in Nairobi, Mombasa, and Malindi, Kenya or Collaborating partners' sites/Drop-in Centers (DICs) in Mombasa and Mtwapa, Kenya with direct acting antiviral (DAA) regimens. The mode of treatment delivery will be Directly Observed Therapy (DOT) for 84 consecutive doses (one dose per day). All participants will receive pre, post and ongoing counseling as per study protocol.
Other Name: Deliver ongoing counseling




Primary Outcome Measures :
  1. Linkage to care and time to ART [ Time Frame: Data collection done in 5 waves separated by 6 months ]
    Use of rapid CD4 assays to reduce time from HIV diagnosis to ART initiation

  2. Community viral load before and after the TLC-IDU initiation [ Time Frame: Data collection done in 5 waves separated by 6 months ]
    Community viral load will be ascertained by collecting specimens from randomly-selected HIV-positives at each of the NASCOP NSP-IDU service sites. This sampling will be done in waves over time, to document changes in infectivity (median viral load).

  3. Retention in Care [ Time Frame: Data collection done in 5 waves separated by 6 months ]
    HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <500/μL will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention.

  4. HCV prevalence determination [ Time Frame: Data collection done in wave 6 - 6-month-period ]
    Establish HCV prevalence in PWIDs in Nairobi, Western and Coastal region, by adding a rapid HCV assay to the study panel among all participants (both HIV infected and uninfected) recruited during the last TLC-IDU study waves

  5. HCV testing and counseling feasibility and acceptability measures [ Time Frame: Done in wave 6 - 6-month-period ]
    Offering HCV testing and counseling to all study participants. Offering treatment referral for those with HCV monoinfection and HIV-HCV infection


Secondary Outcome Measures :
  1. Modeling HIV transmission dynamics [ Time Frame: End of study (will occur in year 5 of the study) ]
    Conduct mathematical modeling to estimate community viral load in PWID injecting and sexual networks, and to assess potential population-level impact of the TLC-IDU intervention on Ro, numbers of infections averted, and quality-adjusted life expectancy.

  2. Assess the incremental cost-effectiveness ratio of the TLC-IDU model [ Time Frame: End of study (will occur in year 5 of the study) ]
    The expectation is that utilizing MARP/NSP services will result in a reduction in median community viral load and in forward HIV transmission. Cost per quality adjusted life year saved and HIV infection averted will be favorable as compared with the alternative of no specific seek, test, treat and retain program directed to IDUs.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

The intervention phase with stepped wedge rollout of TLC-IDU-MARP sites Inclusion Criteria:

  • subjects will be adults (≥18 year olds)
  • attend NSP/MARP service sites
  • live in Nairobi (Central Province), Western region, or coastal Mombasa (Coast Province including Malindi), Kenya
  • are IDUs that ever injected any non-prescribed drugs
  • are IDUs that have used any non-prescribed drugs within the past 12 months
  • for HIV viral load testing, individuals must have tested HIV+
  • for HCV viral load testing, individuals must have been confirmed HCV viremic

Exclusion Criteria:

  • subjects are not adults (<18 years old)
  • do not attend NSP/MRP sites
  • do not live in Nairobi (Central Province), Western region, or coastal Mombasa (Coast Province including Malindi), Kenya
  • are not IDUs
  • for viral load testing, individuals who tested HIV-
  • for HCV viral load testing, individuals who were confirmed HCV NOT viremic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557998


Locations
Kenya
National AIDS/STD Control Programme (NASCOP)
Nairobi, Kenya
Sponsors and Collaborators
Yale University
New York University School of Medicine
Kenya National AIDS & STI Control Programme
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ann Kurth, PhD, CNM Yale University School of Nursing
Principal Investigator: Peter Cherutich, MD, PhD, MPH NASCOP, MoH Kenya

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01557998     History of Changes
Other Study ID Numbers: 1512016965
R01DA032080 ( U.S. NIH Grant/Contract )
R01DA032080-05S1 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Yale University:
Test and linkage to care
Injecting drug user (IDU)
Prevention with positives
ART adherence
point of care CD4 counts
Peer case management
Conditional cash transfer

Additional relevant MeSH terms:
HIV Infections
Coinfection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Infection
Parasitic Diseases