Clinical trial NCT02969915: Strategies to Improve the HIV Care Continuum Among Key Populations in India
Official title: Strategies to Improve the HIV Care Continuum Among Key Populations in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: people who inject drugs
men who have sex with men
HIV
India
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: YR Gaitonde Centre for AIDS Research and Education
name: Elton John AIDS Foundation
First posted: 2016-11-21
Enrollment: 2314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matched-pair cluster-randomized trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of Participants Surviving With Viral Suppression
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of Participants Surviving With Viral Suppression
timeFrame: 6 months
measure: Proportion of Participants Surviving With Viral Suppression
timeFrame: 18 months
measure: Proportion of Participants Surviving With Viral Suppression
timeFrame: 24 months
measure: Proportion of Participants With Viral Suppression at One or More Follow-up Visits
timeFrame: 24 months
measure: Antiretroviral Therapy (ART) Initiation
timeFrame: 12 months
measure: Retention to HIV Care
timeFrame: 12 months
measure: ART Adherence
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
Other outcomes:
measure: HIV Testing Rate in Integrated Care Centers (ICCs)
timeFrame: 6, 12, 18, and 24 months
measure: Rate of New HIV Diagnoses at ICCs
timeFrame: 6, 12, 18, and 24 months
measure: Qualitative Evaluation of Incentive Intervention
timeFrame: 24-36 months
measure: Recent HIV Testing, Community-level (Respondent-driven Sampling [RDS] Survey)
timeFrame: 36-48 months
measure: Awareness of HIV-positive Status, Community-level (RDS Survey)
timeFrame: 36-48 months
measure: Recent HIV Care Visit, Community-level (RDS Survey)
timeFrame: 36-48 months
measure: Current ART Use, Community-level (RDS Survey)
timeFrame: 36-48 months
measure: Viral Load Suppression, Community-level (RDS Survey)
timeFrame: 36-48 months
measure: Prevalence of Viremic Persons, Community-level (RDS Survey)
timeFrame: 36-48 months
measure: HIV Incidence, Community-level (RDS Survey)
timeFrame: 36-48 months
measure: Costs Per Quality-adjusted Life Year Gained
timeFrame: 6, 12, 18, and 24 months
Locations:
city: Chennai
country: India
facility: YR Gaitonde Center for AIDS Research and Education
state: Tamil Nadu
Study officials:
affiliation: Johns Hopkins University
name: Shruti H Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Gregory M Lucas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.