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Testing and Linkage to Care for Injecting Drug Users in Kenya (TLC-IDU Kenya)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by New York University
Sponsor:
Collaborator:
New York University School of Medicine
Information provided by (Responsible Party):
Ann Kurth, New York University
ClinicalTrials.gov Identifier:
NCT01557998
First received: February 20, 2012
Last updated: March 16, 2012
Last verified: March 2012

February 20, 2012
March 16, 2012
March 2012
April 2015   (final data collection date for primary outcome measure)
  • 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 <350/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.
Same as current
Complete list of historical versions of study NCT01557998 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Testing and Linkage to Care for Injecting Drug Users in Kenya
Testing and Linkage to Care for IDUs in Kenya

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.

The purpose of the study will be to leverage the GoK's first-ever needle and syringe program, to implement the HIV seek, test, treat, and retain paradigm among IDUs, whose parenteral and sexual transmission networks amplify HIV epidemics. Study innovations include: (1) use of a stepped wedge trial design; (2) intent to track community viral load in a low-income country setting; (3) use of rapid CD4 assays to reduce time from HIV diagnosis to ART initiation; and (4) use of conditional cash transfers to support peer case management of participant HIV treatment retention.

Aim 1: Evaluate seek test treat retain using a stepped wedge cluster-randomized design. Clusters will be the planned NSP service sites. The investigators will initiate respondent-driven sampling (RDS) to reach IDUs in Nairobi and coastal Mombasa (including Malindi) for baseline HIV-1 prevalence determination, then collect waves of study data as service sites roll out, including behavioral data. Teams will do rapid HIV testing and refer for addiction/mental health and other services (e.g., OST). HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <350/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. Both peer case managers and subjects will receive small conditional cash transfers for subject's adherence to HIV care visits. Primary study outcomes will include time to successful linkage to care, time to ART, and community viral load before and after 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). With individual viral loads collected per site per time step (for a n= of at least 1800 viral loads in total across all sites and timewaves) the investigators will have good power to detect log10 viral load changes of 0.23 and hazard ratios of ~1.5 when comparing pre- and post-intervention period using linear mixed effects analysis.

Aim 1: Research hypothesis: Staggered rollout of a planned NSP/MARP program can be utilized to collect pre- and post intervention data that will allow assessment of impact on community viral load. Linkage to care will be higher, time to ART initiation will be reduced, and retention in care will be higher during time periods with the TLC-IDU services as compared to time periods with standard of care.

Aim 2: 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.

Aim 2: Research hypothesis: HIV transmission dynamics models can use parameters from Aim 1 data waves, with sensitivity analyses identifying those parameters with largest impact on effect estimation and stability.

Aim 3: Assess the incremental cost-effectiveness ratio of the TLC-IDU model, using a national payer perspective. This study will provide among the world's first data regarding implementation of the seek, test, treat and retain paradigm with IDUs in sub-Saharan Africa. It will demonstrate the degree to which a combination of structural, biomedical and behavioral interventions can reduce infectivity. Partnership with Kenya's national HIV program will allow lessons learned from this study to inform other countries considering how best to address the growing IDU contribution to the HIV epidemic in this high-HIV-burden region.

Aim 3: Research hypothesis: 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
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 <350/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.
  • 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 <350/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.
    Intervention: Behavioral: Point of Care CD4 count and peer case management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
4500
April 2015
April 2015   (final data collection date for primary outcome measure)

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+ at least nine months previously

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+ less than nine months previously
Both
18 Years and older
Yes
Contact: Ann Kurth, PhD, CNM 212-998-5316 akurth@nyu.edu
Contact: John Lizcano, MPH 646-763-2940 john.lizcano@nyu.edu
Kenya
 
NCT01557998
1R01DA032080
Yes
Ann Kurth, New York University
New York University
New York University School of Medicine
Principal Investigator: Ann Kurth, PhD, CNM New York University College of Nursing
Principal Investigator: Peter Cherutich, MBchB, MPH NASCOP, MoH Kenya
New York University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP