Innovative Collaboratory for Advancing Research with the Underserved and Stigmatized (ICARUS)

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Research

START

There is a resurgence of methamphetamine and other stimulant use in the United States, which threatens to compromise the benefits of HIV treatment as prevention (TasP) in HIV-positive stimulant using men who have sex with men (HIV+ SUMSM). HIV+ SUMSM have greater difficulties navigating the HIV care continuum as well as display elevated viral loads, amplified HIV transmission risk, and faster clinical HIV progression. This randomized controlled trial will test the efficacy of Supporting Treatment Adherence for Resilience and Thriving (START), a mHealth application that integrates two evidence-based behavioral interventions for HIV+ SUMSM. The primary outcome for the START trial is viral suppression, measured using dried blood spot specimens that participants collect at 6 and 12 months.

Principal Investigators:

Dr. Adam Carrico
(305) 243-6947
a.carrico@miami.edu

Dr. Keith Horvath

Dr. Sabina Hirshfield

ARTEMIS PrEP

Stimulant-using men who have sex with men (MSM) have a 3-fold greater rate of disengagement from PrEP care and 5-fold greater odds of sub-optimal PrEP adherence. This randomized controlled trial is testing whether delivering an Affect Regulation Treatment to Enhance Medication Intervention Success (ARTEMIS) positive affect intervention during smartphone-based contingency management (CM) for directly observed PrEP doses achieves more durable reductions in HIV acquisition risk over 12 months. HIV acquisition risk (the primary outcome) will be operationalized as tenofovir diphosphate levels < 700 fmol per punch and self-reported recent condomless anal sex.

Principal Investigators:

Dr. Adam Carrico
(305) 243-6947
a.carrico@miami.edu

Dr. Mallory Johnson

PRISM 2.0

PRISM Logo

Among men who have sex with men (MSM), there is an urgent need to optimize the exceptional clinical, public health of societal benefits of pre-exposure prophylaxis (PrEP). This is especially true in individuals who also use stimulants (i.e., methamphetamine, cocaine, and crack cocaine), who experience substantial difficulties with navigating HIV prevention services to support PrEP uptake and adherence. The overarching goal of Positive Reinforcement Intervention and Sustained Motivation (PRISM) is the adapt and pilot test evidence-based motivational enhancement interventions to optimize engagement in PrEP healthcare services and PrEP uptake

Principal Investigators:

Dr. Adam Carrico
(305) 243-6947
a.carrico@miami.edu

Dr. Christian Grov

CRUSH

CRUSH Logo


The scientific premise of this 6-month prospective cohort is that co-occurring methamphetamine and HIV will create a double jeopardy for the novel coronavirus (COVID-19) pandemic. COVID-19 Research for Understanding the role of Substance use and HIV (CRUSH) will enroll 200 MSM to test for IgM and IgG antibodies to the novel coronavirus (SARS-CoV-2) at baseline and 6 months. The primary hypothesis is that those with co-occurring methamphetamine use and HIV (METH+HIV+) will display the greatest SARS-CoV-2 prevalence and incidence relative to methamphetamine or HIV alone (METH+HIV- or METH-HIV+) or controls (METH-HIV-). We will also examine the extent to which co-occurring methamphetamine and HIV are indirectly linked to higher SARS-CoV-2 infection via alterations in soluble markers of gut-immune dysregulation, smoking behaviors, and decreased adherence to social distancing guidelines.

Principal Investigators:

Dr. Adam Carrico
(305) 243-6947
a.carrico@miami.edu

Dr. Keith Horvath

Dr. Sabina Hirshfield

MyTPill

Electronic adherence monitoring (EAM) technologies hold great promise for supporting antiretroviral medication adherence. This project will test the potential benefits of My treatment pill (MyTPill), which provides a direct measure of ingestion of antiretroviral medications to an electronic pill box (WisePill) in people living with HIV who are prescribed opioids for pain. This study seeks to compare the accuracy of these EAM technologies with respect to antiretroviral medication levels and viral load.

Principal Investigators:

Dr. Edward Boyer

Dr. Adam Carrico
(305) 243-6947
a.carrico@miami.edu

Trauma Informed Treatment Algorithms for advancing Novel outcomes (TITAN)

This randomized controlled trial is testing the feasibility, acceptability, and preliminary efficacy of a behavioral activation (BA) intervention for optimizing Post-Traumatic Stress Disorder (PTSD) treatment outcomes. In collaboration with the Mekong Project in Phnom Penh, participants are randomized to receive either: 1) six sessions of stabilization techniques (ST-Only); or 2) three sessions of BA with three sessions of stabilization techniques (BA+ST). Participants who screen positive for PTSD are randomized to receive ST-Only or BA+ST during the first two months of PTSD treatment at the Mekong Project. Those with persistent elevations in PTSD symptoms at two months (i.e., non-responders) will receive Eye Movement Desensitization and Reprocessing (EMDR), an exposure-based approach to PTSD treatment that is the standard of care in Phnom Penh, Cambodia. Final outcome assessments are conducted at four months post-randomization.

In conducting this trial, our team is delivering a series of trainings to build the capacity of Cambodian investigators to pursue mental health research studies. Cambodian leadership is committed to resolving the existing mental health gap through strategic partnerships, enhanced capacity building, and adoption of evidence-based treatments (EBT) capable of shifting the trajectory of health and wellness of the population. This application follows a successful Phase I program culminating in a clear vision of capacity building needs and national research priorities with high potential for local adoption, scale-up, and sustainability.

PARTI

parti

Stimulant-using men who have sex with men (MSM) have a 3-fold greater rate of disengagement from PrEP care and 5-fold greater odds of sub-optimal PrEP adherence. This randomized controlled trial is testing whether delivering an Affect Regulation Treatment to Enhance Medication Intervention Success (ARTEMIS) positive affect intervention during smartphone-based contingency management (CM) for directly observed PrEP doses achieves more durable reductions in HIV acquisition risk over 12 months. HIV acquisition risk (the primary outcome) will be operationalized as tenofovir diphosphate levels < 700 fmol per punch and self-reported recent condomless anal sex.

Principal Investigators:

Dr. Adam Carrico (305) 243-6947 a.carrico@miami.edu

Dr. Mallory Johnson University of California, San Francisco

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

The overarching goal of this randomized controlled trial (RCT) is to identify the causal pathways that drive depressive symptoms among people with HIV (PWH). The scientific premise is that evidence-based depression treatment is an innovative, experimental probe to determine the neural substrates of depression and mechanistic relevance of microbiome-gut-brain (MGB) axis changes during and after Cognitive-Behavioral Therapy for Adherence and Depression (CBTAD) on brain and behavioral function.

LITE-2

This LITE-2 (RFA-AI-21-018) proposal responds to a resurgent epidemic of methamphetamine (meth) use in sexual minority men (SMM), which we have shown to be a primary driver of HIV incidence. The overarching goals are two-fold: 1) identify multi-level and bio-behavioral determinants of amplified HIV seroconversion risk in meth-using SMM; and 2) test the effectiveness and scalability of telehealth motivational enhancement interventions for promoting entry or re-entry of SMM who use meth into the PrEP care continuum. Findings from our team and others demonstrate that meth use is disproportionately impacting SMM who are ethnic minorities and accounts for one-in-three new HIV infections in SMM. A critical HIV prevention science gap is the need to identify multi-level (i.e., structural, psychological, and social) and biobehavioral (i.e., rectal cytokines/chemokines) determinants of amplified HIV seroconversion risk for SMM who use meth to guide targeted, combination interventions to reduce HIV incidence. A critical HIV implementation science gap is the need to test the effectiveness and scalability of evidence-based motivational enhancement interventions such as contingency management (CM) and motivational interviewing (MI) adapted for telehealth delivery with meth-using SMM who are not currently using PrEP, despite being at high risk for HIV. Our team pioneered studies examining multi-level and bio-behavioral determinants of amplified HIV risk in meth-using SMM as well as adapted scalable, telehealth CM and MI for promoting PrEP use, which will propel our success in LITE-2.