Testing and Linkage to Care for IDUs in Kenya (TLC-IDU Kenya); HCV Among PWIDs in Kenya: A Supplement to the TLC-IDU Study

Testing and Linkage to Care for Injecting Drug Users in Kenya

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 PWID, 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 PWID in Nairobi, Western region 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 and HCV 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 <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. 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 PWID 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.