Testing and Linkage to Care for Injecting Drug Users in Kenya
3 other identifiers
interventional
9,449
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedOctober 5, 2018
October 1, 2018
4 years
February 20, 2012
October 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Linkage to care and time to ART
Use of rapid CD4 assays to reduce time from HIV diagnosis to ART initiation
Data collection done in 5 waves separated by 6 months
Community viral load before and after the TLC-IDU initiation
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).
Data collection done in 5 waves separated by 6 months
Retention in Care
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.
Data collection done in 5 waves separated by 6 months
HCV prevalence determination
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
Data collection done in wave 6 - 6-month-period
HCV testing and counseling feasibility and acceptability measures
Offering HCV testing and counseling to all study participants. Offering treatment referral for those with HCV monoinfection and HIV-HCV infection
Done in wave 6 - 6-month-period
Secondary Outcomes (2)
Modeling HIV transmission dynamics
End of study (will occur in year 5 of the study)
Assess the incremental cost-effectiveness ratio of the TLC-IDU model
End of study (will occur in year 5 of the study)
Study Arms (3)
Control - No intervention
OTHERPWID 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.
POC CD4 and Peer Case Management
EXPERIMENTALHIV-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.
HCV+PWID
OTHERControl and Experimental Confirmed HCV viremic study subject will receive HCV treatment
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- NYU Langone Healthcollaborator
- Kenya National AIDS & STI Control Programmecollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
National AIDS/STD Control Programme (NASCOP)
Nairobi, Kenya
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Kurth, PhD, CNM
Yale University School of Nursing
- PRINCIPAL INVESTIGATOR
Peter Cherutich, MD, PhD, MPH
NASCOP, MoH Kenya
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2012
First Posted
March 20, 2012
Study Start
May 1, 2012
Primary Completion
April 30, 2016
Study Completion
April 30, 2018
Last Updated
October 5, 2018
Record last verified: 2018-10