Testing and Linkage to Care for Injecting Drug Users in Kenya

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborators: Kenya National AIDS & STI Control Programme; National Institute on Drug Abuse (NIDA); NYU Langone Health

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), Western region, 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 HIV viral load testing, individuals must have tested HIV+

• for HCV viral load testing, individuals must have been confirmed HCV viremic

Exclusion Criteria:

• subjects are not adults (<18 years old)

• do not attend NSP/MRP sites

• do not live in Nairobi (Central Province), Western region, or coastal Mombasa (Coast Province including Malindi), Kenya

• are not IDUs

• for viral load testing, individuals who tested HIV-

• for HCV viral load testing, individuals who were confirmed HCV NOT viremic