People who inject drugs (PWID) are at high risk for HIV infection and experience worse treatment outcomes than other key populations, particularly in low to middle income countries (LMIC). Opioid use is common in India and new injection drug epidemics have emerged in the North and Central regions of the country in the last 5-10 years. In these regions, we have documented high rates of needle sharing, high HIV prevalence and incidence, and low access to HIV testing and treatment. Our team demonstrated the potential of respondent- driven sampling (RDS) to leverage social networks and identify unaware and out-of-care HIV-positive PWID. In response to RFA-DA-18-017, we propose to build on our experience with RDS as the foundation of ?seek and test?, by rigorously assessing three scalable strategies aimed at improving the ?treat and retain? steps of the HIV care continuum among PWID in a LMIC setting.
Aim 1 is to conduct a factorial randomized controlled trial to evaluate the individual and combined effects of a policy intervention (same-day ART), a structural intervention (community-based care) and an individual-level intervention (psychosocial/ navigation) to improve treatment outcomes among HIV-positive PWID. A factorial design can assess both the main effects of multiple interventions and interactions between the interventions, offering the potential for trial efficiency (effectively getting 3 trials for the price of one) and novel insights on how interventions with different mechanisms may influence the effectiveness of one another. We will test 3 hypotheses: Hypothesis 1A - Same-day ART initiation will increase 12-month survival with viral suppression among HIV-positive PWID, compared with standard ART initiation. Same-day ART has been found effective in Africa, but has never been evaluated in PWID. Hypothesis 1B - Community-based care will increase 12-month survival with viral suppression among HIV-positive PWID, compared with government-based care. In prior work, we found that PWID-centric integrated care centers (ICCs) were highly effective at engaging the population, providing opioid treatment and increasing HIV testing uptake. Here we propose to scale-up the ICC model to provide community-based HIV care in an accessible and non-discriminatory setting. Hypothesis 1C - A psychosocial/navigation intervention (enhanced support) will increase 12-month survival with viral suppression among HIV-positive PWID, compared with standard support. Patient navigators will provide PWID-focused motivational interviewing, skills building, and field-based systems navigation and retention. We propose to adapt and build upon evidence-based interventions for PWID. Durability of intervention effects will be assessed at 18 months.
Aim 2 is to characterize the barriers and facilitators to implementation of the proposed interventions, and determine the intervention costs and potential cost-effectiveness. We will characterize implementation pathways with a dedicated implementation science evaluation following the Curran type-1 model of an effectiveness-implementation hybrid study and will conduct formal cost-effectiveness analyses.
People who inject drugs (PWID) are at high risk for HIV infection and experience poorer HIV treatment outcomes than other groups, particularly in low and middle income countries. We propose to rigorously assess three interventions that have the potential to improve HIV treatment outcomes among PWID in India.