Strategies to Improve the HIV Care Continuum Among Key Populations in India

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Behavioral: Integrated Care Centers
Behavioral: Incentives

Registration Number: NCT02969915

Lead Sponsor: Johns Hopkins University

Brief Summary: This clinical trial will compare the effectiveness of integrated care centers vs. integrated care centers plus HIV patient treatment incentives for achieving HIV treatment targets among people who inject drugs and men who have sex with men in India. The investigators will also assess cost-effectiveness and barriers and facilitators to implementation through targeted mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key populations in low to middle-income countries.

Detailed Description: The trajectory of the HIV epidemic in coming decades will be determined by the degree to which we can identify infected persons and engage them in care - a point implicit in the ambitious UNAIDS "90-90-90" target, which sets 90% goals for HIV diagnosis, linkage of infected persons to sustained antiretroviral therapy (ART), and viral suppression in those treated. Meeting this target requires successful engagement of difficult to reach populations, such as people who inject drugs (PWID) and men who have sex with men (MSM), who bear a disproportionate share of the epidemic, particularly in low to middle income countries. Our team is nearing completion of a multi-site cluster-randomized trial in India to assess the effectiveness of integrated care centers (ICCs) for PWID and MSM compared to usual care. ICC process measures from the first year show robust uptake of HIV counseling and testing, the primary outcome for that trial, but slower than anticipated ART uptake. Demand-side interventions in public health (such as treatment incentives) can be particularly effective when paired with optimized treatment accessibility (i.e., supply). Consequently, the investigators propose to examine whether provision of HIV care and treatment incentives to ICC clients will improve overall utilization of the clinics and downstream HIV care continuum outcomes.

The investigators propose a hybrid effectiveness-implementation design. This will include a 16-site, pair-matched cluster randomized trial to compare the effectiveness of adding of HIV care incentives to ICCs (ICC+) versus standard ICCs on HIV care continuum outcomes, including ART initiation, adherence and viral suppression. Effectiveness will be compared at the ICC level (from a cohort of HIV-infected ART-eligible clients followed in each ICC and process measures deriving from all ICC clients) and at the community-level through a cross-sectional sample accrued via respondent-driven sampling (RDS) 2 years after initiation of the intervention. Because PWID and MSM will be sampled independently from the ICCs in the RDS, it provides an opportunity to characterize outcomes like community viral load and HIV incidence, reflecting impact within the broader PWID/MSM communities. As an exploratory sub-aim, we will use a rigorous scientific design to assess the effects of withdrawing (vs. continuing) incentives beyond the initial intervention phase. Additionally, the investigators will determine the cost-effectiveness of the ICC+ intervention.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2314

Inclusion Criteria

Speaks Hindi, English, or local language
HIV-positive
Antiretroviral therapy (ART) naive or has used ART less than 12 months
Registered client at the local integrated care center (ICC), which serves either people who inject drugs (PWID) or men who have sex with men (MSM).

Exclusion Criteria

Not competent to provide informed consent or participate in the study.
Receives HIV care in the private sector
Plans to migrate in next 12 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated care centers	Integrated Care Centers	Participants in the active comparator arm have access to integrated care centers (ICCs)
ICC + incentives	Integrated Care Centers	Participants in the experimental arm have access to the ICC intervention and the incentive intervention
ICC + incentives	Incentives	Participants in the experimental arm have access to the ICC intervention and the incentive intervention

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Surviving With Viral Suppression	12 months	Viral suppression defined as HIV RNA \<150 copies/mL

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Surviving With Viral Suppression	24 months	Viral suppression defined as HIV RNA \<150 copies/mL
Proportion of Participants With Viral Suppression at One or More Follow-up Visits	24 months	Proportion with viral suppression (HIV RNA \<150 copies/mL) at one or more follow-up visits
Antiretroviral Therapy (ART) Initiation	12 months	Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART.
ART Adherence	12 months	Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART
Mortality	12 months	All-cause mortality
Retention to HIV Care	12 months	Proportion of participants who attended one or more visits to a government ART clinic in both the 0 to 6 month period and the 6 to 12 month period.