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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2024-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Matched-pair cluster-randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integrated care centers

Participants in the active comparator arm have access to integrated care centers (ICCs)

Group Type ACTIVE_COMPARATOR

Integrated Care Centers

Intervention Type BEHAVIORAL

ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services

ICC + incentives

Participants in the experimental arm have access to the ICC intervention and the incentive intervention

Group Type EXPERIMENTAL

Incentives

Intervention Type BEHAVIORAL

Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.

Integrated Care Centers

Intervention Type BEHAVIORAL

ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services

Interventions

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Incentives

Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.

Intervention Type BEHAVIORAL

Integrated Care Centers

ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services

Intervention Type BEHAVIORAL

Other Intervention Names

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ICC+ ICC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No