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Clinical Trials/NCT02969915
NCT02969915
Completed
Not Applicable

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

Johns Hopkins University1 site in 1 country2,314 target enrollmentOctober 30, 2017
ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Johns Hopkins University
Enrollment
2314
Locations
1
Primary Endpoint
Proportion of Participants Surviving With Viral Suppression
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 30, 2017
End Date
May 30, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Proportion of Participants Surviving With Viral Suppression

Time Frame: 12 months

Viral Suppression defined as HIV RNA \<150 copies/mL

Secondary Outcomes

  • Proportion of Participants Surviving With Viral Suppression(24 months)
  • Proportion of Participants With Viral Suppression at One or More Follow-up Visits(24 months)
  • Antiretroviral Therapy (ART) Initiation(12 months)
  • ART Adherence(12 months)
  • Mortality(12 months)
  • Retention to HIV Care(12 months)

Study Sites (1)

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