New York University College of Nursing (NYUCN) received a five-year, $4,161,665.00 grant from the National Institute of Health's National Institute on Drug Abuse (NIH/NIDA) to research "Test and Linkage to Care Among Injecting Drug Users (TLC_IDU) Kenya." Principal Investigator Ann Kurth notes HIV infections in sub-Saharan Africa increasingly occur among injecting drug users (IDUs), a most-at-risk population (MARP). Evidence-based services for IDUs such as needle and syringe exchange programs (NSPs), opiod substitution therapy (OST), and IDU-specific antiretroviral therapy (ART) adherence support have been non-existent in this region.
"Kenya is conducting size estimations of IDUs and is preparing to launch the first-ever needle syringe program in Africa," said NYUCN Professor Ann Kurth, PhD, CNM, RN. "Our team of Kenyan policy leaders, addiction/behavioral scientists and modelers will leverage Kenya's new program to seek out IDUs, deliver rapid HIV testing, point of care CD4 count and link to antiretroviral therapy (ART), and evaluate community viral load in Nairobi and coastal Mombasa, where most IDUs in Kenya reside," she said.
The grant's co-PI is Dr. Peter Cherutich, of the Kenya National AIDS & STD Control Programme.
The study's goals are as follows:
Aim 1: Evaluate seek test treat retain 'Testing & Linkage to Care for IDUs' (TLC-IDU Kenya) using a stepped wedge cluster-randomized design. Clusters will be at a planned n=25 IDU/MARP service sites. The teams will initiate respondent-driven sampling (RDS) to reach IDUs in Nairobi and Mombasa for baseline HIV-1 prevalence determination, then collect seven waves of study data as service sites roll out, including behavioral data on PDAs.
Teams will do rapid HIV testing and refer for addiction/mental health. HIV-positive persons 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 the TLC-IDU initiation. 'Community viral load' will be ascertained by collecting specimens from around nine randomly-selected HIV-positives at each of the 25 sites. This sampling will be done in eight waves over time, to document changes in infectivity (median viral load). This will give good power to detect HIV viral load changes when comparing pre- and post-intervention periods..
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 numbers of infections averted,and quality-adjusted life expectancy.
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," said Kurth.
|Contact: Christopher James|
New York University