Testing and Linkage to Care for Injecting Drug Users in Kenya

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.

Conditions

• HIV Infection
• HCV Coinfection

Interventions

BEHAVIORAL

POC 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.

DRUG

HCV+PWID

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.

BEHAVIORAL

Control - No intervention

Sponsors & Collaborators

• NYU Langone Health

  collaborator OTHER

• Kenya National AIDS & STI Control Programme

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Ann Kurth, PhD, CNM · Yale University School of Nursing

• Peter Cherutich, MD, PhD, MPH · NASCOP, MoH Kenya

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2016-04-30

Completion

2018-04-30

Countries

• Kenya

Study Locations