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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Integrated Care Centers; Behavioral: Incentives

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.

• Study Type: Interventional
• Enrollment (Actual): 2314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600010
      • YR Gaitonde Center for AIDS Research and Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Testing Rate in Integrated Care Centers (ICCs)	HIV tests done per unit time	6, 12, 18, and 24 months
Rate of New HIV Diagnoses at ICCs	New HIV diagnoses per unit time	6, 12, 18, and 24 months
Qualitative Evaluation of Incentive Intervention	In-depth interviews with study participants and ICC staff	24-36 months
Recent HIV Testing, Community-level (Respondent-driven Sampling [RDS] Survey)	Proportion reporting HIV test in prior 12 months among RDS survey participants	36-48 months
Awareness of HIV-positive Status, Community-level (RDS Survey)	Proportion of HIV-positive participants aware of their status	36-48 months
Recent HIV Care Visit, Community-level (RDS Survey)	Proportion of HIV-positive participants with treatment visit in prior 6 months	36-48 months
Current ART Use, Community-level (RDS Survey)	Proportion of HIV-positive participants with ART use in prior 30 days	36-48 months
Viral Load Suppression, Community-level (RDS Survey)	Proportion of HIV-positive participants with suppressed viral load (HIV RNA <150 c/mL)	36-48 months
Prevalence of Viremic Persons, Community-level (RDS Survey)	Proportion of all participants (HIV-negative and HIV-positive) with a measured HIV RNA ≥150 copies/mL.	36-48 months
HIV Incidence, Community-level (RDS Survey)	Estimated with a validated multi-assay algorithm measured in HIV-positive participants	36-48 months
Costs Per Quality-adjusted Life Year Gained	Evaluation of intervention costs and cost-effectiveness	6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA); YR Gaitonde Centre for AIDS Research and Education; Elton John AIDS Foundation
• Investigators: Principal Investigator: Shruti H Mehta, PhD, Johns Hopkins University; Principal Investigator: Gregory M Lucas, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Solomon SS, McFall AM, Srikrishnan AK, Verma V, Anand S, Khan RT, Kushwaha BS, Vasudevan C, Saravanan S, Paneerselvam N, Kumar MS, Das C, Celentano DD, Mehta SH, Lucas GM. Voucher incentives to improve viral suppression among HIV-positive people who inject drugs and men who have sex with men in India: a cluster randomised trial. Lancet HIV. 2024 May;11(5):e309-e320. doi: 10.1016/S2352-3018(24)00005-5. Epub 2024 Apr 4.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (Estimated): November 21, 2016

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HIV; India; men who have sex with men; people who inject drugs
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Behavior; Sexual Behavior; Sexuality; HIV Infections; Homosexuality; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Fertility
• Other Study ID Numbers: IRB00082575; R01DA041034 (U.S. NIH Grant/Contract); K24DA035684 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will require prospective collaborators to submit concept sheets to the study PIs that include a brief summary of the proposed hypothesis, summary of research methods, specific data or specimens that are being requested, and plans for analysis. Reasonable requests that address relevant scientific questions will be welcomed and supported to the extent possible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No