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

Study Overview
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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.

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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Incentives
* Behavioral: Integrated Care Centers


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Matched-pair cluster-randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integrated care centers<br>Participants in the active comparator arm have access to integrated care centers (ICCs) | Behavioral: Integrated Care Centers<br>* ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services<br>* Other names: ICC;|
| Experimental: ICC + incentives<br>Participants in the experimental arm have access to the ICC intervention and the incentive intervention | Behavioral: Incentives<br>* 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.<br>* Other names: ICC+;Behavioral: Integrated Care Centers<br>* ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services<br>* Other names: ICC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 6 months | 
| Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 18 months | 
| Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 24 months | 
| Proportion of Participants With Viral Suppression at One or More Follow-up Visits | Proportion with viral suppression (HIV RNA <150 copies/mL) at one or more follow-up visits | 24 months | 
| Antiretroviral Therapy (ART) Initiation | Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART. | 12 months | 
| Retention to HIV Care | 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. | 12 months | 
| ART Adherence | Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART | 12 months | 
| Mortality | All-cause mortality | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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people who inject drugs, men who have sex with men, HIV, India