Testing and Linkage to Care for Injecting Drug Users in Kenya (TLCIDU 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.
|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|
- 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 ]
- 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.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
Behavioral: Point of Care CD4 count and peer case management
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01557998
|Contact: Ann Kurth, PhD, CNMfirstname.lastname@example.org|
|Contact: John Lizcano, MPHemail@example.com|
|National AIDS/STD Control Programme (NASCOP)||Recruiting|
|Principal Investigator: Peter Cherutich, MBChB, MPH|
|Principal Investigator:||Ann Kurth, PhD, CNM||New York University College of Nursing|
|Principal Investigator:||Peter Cherutich, MBchB, MPH||NASCOP, MoH Kenya|