Testing and Linkage to Care for Injecting Drug Users in Kenya (TLCIDU Kenya)

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2016 by Yale University

Sponsor:

Collaborators:

New York University School of Medicine

Kenya National AIDS & STI Control Programme

Information provided by (Responsible Party):

Ann Kurth, Yale University

ClinicalTrials.gov Identifier:

NCT01557998

First received: February 20, 2012

Last updated: July 11, 2016

Last verified: July 2016

History of Changes

Purpose

Interventions for injecting drug users (IDUs) 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 IDUs, 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.

Condition	Intervention
HIV Infection	Behavioral: Point of Care CD4 count and peer case management


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Testing and Linkage to Care for IDUs in Kenya

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Linkage to care and time to ART [ Time Frame: Data collection done in 5 waves separated by 6 months ] [ Designated as safety issue: No ]
Use of rapid CD4 assays to reduce time from HIV diagnosis to ART initiation
Community viral load before and after the TLC-IDU initiation [ Time Frame: Data collection done in 5 waves separated by 6 months ] [ Designated as safety issue: No ]
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).
Retention in Care [ Time Frame: Data collection done in 5 waves separated by 6 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Modeling HIV transmission dynamics [ Time Frame: End of study (will occur in year 5 of the study) ] [ Designated as safety issue: No ]
Conduct mathematical modeling to estimate community viral load in IDU 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.
Assess the incremental cost-effectiveness ratio of the TLC-IDU model [ Time Frame: End of study (will occur in year 5 of the study) ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	10000
Study Start Date:	March 2012
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control IDUs 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 test, and the point of care CD4 test but will not be assigned a peer case manager.
Experimental: 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.	Behavioral: Point of Care CD4 count 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.

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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) 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 viral load testing, individuals must have tested HIV+

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557998

Contacts


Contact: Ann Kurth, PhD, CNM	2037852393	ann.kurth@yale.edu
Contact: John Lizcano, MPH		john.lizcano@yale.edu

Locations


Kenya
National AIDS/STD Control Programme (NASCOP)	Recruiting
Nairobi, Kenya
Principal Investigator: Peter Cherutich, MBChB, MPH

Sponsors and Collaborators

Yale University

New York University School of Medicine

Kenya National AIDS & STI Control Programme

Investigators


Principal Investigator:	Ann Kurth, PhD, CNM	Yale University School of Nursing
Principal Investigator:	Peter Cherutich, PhD, MBchB, MPH	NASCOP, MoH Kenya

More Information


Responsible Party:	Ann Kurth, Professor, Yale University
ClinicalTrials.gov Identifier:	NCT01557998 History of Changes
Other Study ID Numbers:	1R01DA032080
Study First Received:	February 20, 2012
Last Updated:	July 11, 2016
Health Authority:	United States: Institutional Review Board Kenya: Ethical Review Committee Kenya: Data Safety and Management Board

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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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