Adam W. Carrico, Ph.D. - US grants

DESCRIPTION (provided by applicant): It is well established that HIV-positive persons who use stimulants such as methamphetamine are at increased risk for transmitting medication-resistant strains HIV. Mental health co-morbidities such as symptoms of post- traumatic stress disorder and HIV-specific traumatic stress may substantially contribute to increased stimulant use among HIV-positive persons. Consequently, adjuvant mental health interventions designed to address traumatic stress could ultimately improve substance abuse treatment outcomes and reduce transmission risk behavior among HIV-positive methamphetamine-using men. In particular, expressive writing is a self- administered, exposure-based intervention to address trauma that could be easily disseminated to substance abuse treatment programs without placing significant additional burden on staff for training or intervention delivery. Over the past 20 years, numerous randomized controlled trials (RCTs) have examined the efficacy of self-administered expressive writing interventions where participants are asked write about traumatic events for 15 - 30 minutes over 1 - 5 days. Findings from meta-analyses observed that expressive writing interventions improve psychological adjustment, physiological functioning, and self-reported physical health in various populations. However, to our knowledge no published research has examined the efficacy of expressive writing with active drug users. The proposed formative clinical research will examine the safety, feasibility, and potential clinical utility of delivering a self-administered, expressive writing intervention to HIV-positive methamphetamine-using men. In order to evaluate expressive writing, we will conduct a pilot RCT with 90 HIV-positive methamphetamine-using men. In addition to providing data on safety and feasibility, this RCT will provide an opportunity to examine the potential clinical utility of expressive writing with respect to measures of psychological adjustment (primary outcome) as well as substance use and HIV transmission risk behavior (secondary outcomes). Establishing that expressive writing is safe, feasible, and potentially efficacious with this population represents a crucial first step to inform a planned clinical research program. Subsequent clinical research will examine whether expressive writing can serve as an efficacious adjuvant to substance abuse treatment with HIV-positive methamphetamine-using men. Improving the effectiveness of substance abuse treatment for HIV-positive methamphetamine-using men would alleviate human suffering and could ultimately reduce HIV transmission rates. PUBLIC HEALTH RELEVANCE: The proposed pilot randomized controlled trial addresses a critical public health issue facing HIV-positive methamphetamine-using men who have sex with men (MSM). By examining the safety, feasibility, and potential clinical utility of a self-administered expressive writing intervention with HIV-positive methamphetamine-using MSM, this study has the potential to inform efforts to develop integrative approaches that boost the effectiveness of formal substance abuse treatment with this population. Improving substance abuse treatment outcomes among HIV-positive methamphetamine-using MSM could ultimately alleviate human suffering associated with substance abuse and reduce the transmission of medication-resistant strains of HIV.

DESCRIPTION (provided by applicant): There is increasing recognition that the elevated prevalence rates of cocaine and methamphetamine use among men who have sex with men (MSM) are key drivers of the HIV/AIDS epidemic in this population. Because stimulant use and HIV/AIDS are intertwined epidemics, investigations that examine the psychological correlates of stimulant use among MSM can inform the development of innovative HIV/AIDS prevention interventions. In the limited number of studies conducted to date, psychological correlates of stimulant use have been examined almost exclusively in convenience samples of active methamphetamine users. Further research with more representative samples of MSM is needed to determine whether psychological vulnerabilities differentiate between active stimulant users and non-users. The proposed study will utilize extant data from the Urban Men's Health Study III, a probability-based survey of 879 MSM in San Francisco. These data provide a unique, cost-effective opportunity to examine psychological correlates of stimulant use among MSM who were recruited through probability-based sampling methods. Informed by Stress and Coping Theory, the proposed study will utilize structural equation modeling to examine psychological correlates of engaging in any stimulant use during the past 6 months with 711 MSM who completed a mail-in questionnaire that assessed psychological factors and substance use. By advancing our basic understanding of stress and coping processes that may promote engagement in stimulant use, the proposed study will inform the development of innovative interventions to prevent stimulant use or decrease the frequency of stimulant use among MSM. PUBLIC HEALTH RELEVANCE: The proposed study addresses a critical public health issue facing men who have sex with men (MSM). By identifying psychological factors that differentiate between active stimulant users and non-users, the proposed study will inform the development of innovative stress and coping interventions designed to prevent stimulant use or reduce the frequency of stimulant use among MSM. Reducing stimulant use in this population could ultimately alleviate human suffering related to substance abuse as well as decrease HIV transmission rates.

DESCRIPTION (provided by applicant): In the era of HIV treatment as prevention (TasP), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases HIV viral load among populations that are more likely to engage in HIV transmission risk behavior. Because methamphetamine-using men who have sex with men (MSM) are at greater risk for acquiring and transmitting medication-resistant strains of HIV, interventions targeting stimulant use in this population of high-risk men could boost the effectiveness of TasP. At present, only conditional cash transfer approaches such as contingency management (CM) have demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who are not actively seeking formal treatment. The proposed RCT will examine the efficacy of a positive affect intervention that is designed to optimize the effectiveness of CM to achieve long-term reductions in stimulant use and HIV viral load in this population. Our team will examine the efficacy of this integrative intervention in a randomized controlled trial (RCT) with 230 HIV-positive, methamphetamine-using MSM. After enrolling in CM, participants will be randomized to receive either: 1) the positive affect intervention; or 2) a attention-matched control condition. Follow-up data will be collected at 2, 3, 6, and 12 months post-randomization. This RCT will provide an opportunity to examine the efficacy of an integrative intervention designed to promote long-term reductions in HIV viral load as the primary outcome. Secondary outcomes that will be examined include: increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+) count, and decreases HIV transmission risk behavior. Identifying an efficacious intervention approach to decrease HIV viral load among methamphetamine-using MSM would substantially support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate HIV-related health disparities.

ABSTRACT Among men who have sex with men (MSM), there is an urgent need to optimize the unprecedented clinical and public health benefits of pre-exposure prophylaxis (PrEP) with those who use stimulants (i.e., methamphetamine, cocaine, and crack-cocaine). Stimulant-using MSM experience substantial difficulties with navigating HIV prevention services such that this population currently accounts for one-in-ten undiagnosed HIV infections. The overarching goal of Positive Reinforcement Intervention and Sustained Motivation (PRISM) is to adapt and pilot test scalable, evidence-based motivational enhancement interventions to optimize PrEP clinical evaluation and PrEP uptake in stimulant-using MSM. PRISM will target PrEP clinical evaluation (including HIV testing) as the primary outcome, which will have a dual benefit of facilitating entry of those who are HIV- negative into the PrEP care continuum and promoting regular HIV testing in this high priority population. In Phase 1, we will collect qualitative data from members of PrEP healthcare teams (N = 10) and stimulant-using MSM who are not on PrEP (N = 30) to inform enhancements to PRISM, which includes evidence-based contingency management (CM) and motivational interviewing (MI) interventions that we have previously shown to reduce substance use and condomless anal sex in MSM. We will focus on augmenting these motivational enhancement interventions to simultaneously facilitate entry of into the PrEP care continuum. In Phase 2, we will conduct a pilot sequential multiple assignment randomized trial (SMART) with 60 HIV-negative, stimulant- using MSM with no history of PrEP use. After completing 1-week waiting period, participants will be randomized to receive: 1) a 3-month CM intervention; or 2) four sessions of MI. All participants will be assessed at three months post-randomization for non-response, defined as not having completed PrEP clinical evaluation. Using SMART methods, in a second randomization non-responders will be assigned to: 1) Switch by adding the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments (i.e., CM-Only or MI-Only). Findings from the pilot SMART regarding the feasibility and acceptability of the interventions, the estimated non-response rate, and cost of delivering the interventions will be reviewed with community-based providers of HIV prevention services to lay the foundation for a full-scale SMART. Consistent with the NIH OAR high priority area of ?reducing the incidence of HIV/AIDS,? this clinical research will meaningfully inform the targeted deployment of limited public health resources to optimize the unprecedented clinical and public health benefits of PrEP in stimulant-using MSM, one of highest priority populations for decreasing HIV incidence.

Project Summary/Abstract Electronic adherence monitoring (EAM) technologies are widely used to support antiretroviral adherence. Unfortunately, EAMs such as Wisepill assume, but cannot verify, actual ingestion of oral medication. In contrast, My/Treatment/Pill (MyTPill), an innovative technology that directly measures ingestion, comprises a digital pill containing a medication and tiny radio emitter in a gelatin capsule. When the digital pill is ingested, gastric contents dissolve the capsule to activate the emitter. The digital pill ?syncs? real-time ingestion data to a smartphone application to provide vivid, indisputable measures of medication ingestion. Head-to-head comparisons of EAMs, however, have yet to be performed. Identifying the superior EAM would improve virologic suppression by enabling real-time interventions to support ART adherence. In this randomized controlled trial, we will compare MyTPill to WisePill among N=80 HIV+ men/women taking prescription opioids and once-daily ART regimens containing tenofovir and emtricitabine with a viral load >200/mL. HIV+ patients on prescription opioids have difficulty adhering to ART regimens, although the reasons are not fully known. Given the high prevalence of prescription opioid misuse among HIV+ individuals?triple that of HIV-negative persons?and striking rates of suboptimal ART adherence (46% worse than those who do not misuse), strategies to improve ART adherence in this population are critically needed. Participants will be randomly assigned in a crossover trial to (1) MyTPill x 3 mos, then WisePill x 3 mos; or (2) Wisepill x 3 mos, then MyTPill x 3 mos. Adherence measured via MyTPill and WisePill will be compared to dried blood spot (DBS) concentrations of tenofovir diphosphate (for cumulative adherence) and emtricitabine triphosphate (for recent adherence). Participants will provide DBS samples on multiple random times according to a schedule that prevents anticipation of sampling but which assesses cumulative/recent ART adherence. We will also examine which aspects of prescription opioid use, pain, withdrawal, and demographic, social, structural, and other environmental contexts (measured by timeline follow back and quantitative interviews) are most closely linked to ART adherence. Furthermore, we will examine how these aspects affect MyTPill and WisePill measures of ART adherence. Primary Aim: Determine if MyTPill, as compared to Wisepill, exhibits: (1) better measures recent and cumulative ART adherence when using DBS as the ?gold standard?; and (2) better participant experience as assessed by observed and self-reported measures (e.g., study retention, fidelity to study, protocol relative subjective index, qualitative interviews). Secondary Aim: Examine which aspect(s) of prescription opioid use (e.g., prescribed use/misuse of opioids as measured by MyTPill, technology subversion, pain, demographic, social, other structural factors) are most closely linked to ART nonadherence (per DBS), and how they affect measuring ART adherence using MyTPill and Wisepill. Public health significance: If MyTPill, a non-invasive, self-contained, and nearly automated ART EAM, is superior to other strategies, it will serve as a platform for subsequent research testing real-time ART adherence interventions; 2) specific factors associated with suboptimal ART adherence can be addressed with interventions directed towards HIV+ persons receiving prescription opioids; and 3) MyTPill can directly address the crisis of opioid misuse arising from treatment of chronic pain.

Project Summary Developmental Core B The overarching objective of the Developmental (Dev) Core for the University of Miami (UM) D-ARC is to build and sustain the pipeline of investigators pursuing mental health (MH) HIV research that can mitigate the disparities experienced by racial/ethnic, sexual, and gender minority populations in South Florida, a US HIV/AIDS epicenter. Consistent with the theme of the D-ARC, our efforts will be focused on promoting community-engaged research to reduce MH and minority health disparities across the HIV prevention and care continua. The work of the Dev Core will be crucial to capitalizing on our success over the past three years in recruiting six new faculty members at the University of Miami with expertise in MH HIV research. The pilot awards program will support the efforts of UM D-ARC investigators to pursue community- engaged, MH HIV research focused on mitigating health disparities in South Florida. The Core will guide investigators, especially Early Stage Investigators (ESIs), in pre-submission consultations with the Methods Core on research design and analysis and the MH Disparities Core on community-engaged approaches. The Dev Core will coordinate competitive review of each pilot award that includes a community reviewer in addition to two scientific reviewers. We will systematically track the progress of pilot awardees in pursuing extramural funding and support those who are not selected to receive pilot award funds to revise their proposals. A comprehensive mentoring program will anchor our efforts to support ESI career development in MH HIV research. The Dev Core?s Mentoring Advisory Committee will oversee comprehensive mentoring of ESIs, guiding them in assembling a multi-disciplinary mentoring team and developing individualized development plans (IDPs). The Dev Core also will contribute to and facilitate access of ESIs to ongoing career development and grant writing workshops conducted by the Miami Center for AIDS Research (CFAR), the UM Clinical and Translational Sciences Institute (CTSI), and Center for Latino Health Research Opportunities (CLaRO). The Dev Core will implement activities to maximize success of all D-ARC scientists in conducting rigorous research. Pre-submission peer reviews of works in progress (e.g., grants, manuscripts) will accelerate the pace of cutting-edge MH HIV research in our D-ARC. An annual writing retreat will create opportunities for iterative peer reviews of scientific works in progress. Targeted Action Groups will cultivate synergies with CFAR scientists to build interdisciplinary collaborations relevant to MH HIV research. The interdisciplinary Dev Core leadership is crucial to the success of the overall mission and scientific aims of the first D-ARC in the Southeastern US in supporting community-engaged MH HIV research that builds upon the 25 year legacy of bio-behavioral MH HIV research and training at UM. Through careful coordination with other D-ARC cores, the Dev Core will provide crucial resources to reinvigorate MH HIV research in a region that is among the most heavily affected by the epidemic.

ABSTRACT The agrarian political regime of the Khmer Rouge in Cambodia led to the death of nearly 2 million civilians and residual symptoms of distress among many survivors. Recent estimates indicate that nearly 50% of the general population exhibits clinically significant symptoms of trauma-related anxiety and/or depression. Targeting of academic leaders during the genocide further undermined an already vulnerable academic health system needed to support innovations in mental health research and care. 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 on the heels of 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. The proposed application will enrich outcomes from the first phase through completion of three layered and integrated aims. Specific Aim 1 will strengthen the mental health research capacity across performance sites utilizing a combination of standardized content for global mental health and professional development programs tailored for research in Cambodia. Measurable outcomes will support the conceptualization, implementation, and evaluation of externally funded research projects resulting in high impact scientific publications. Specific Aim 2 will examine the acceptability and feasibility of trauma-informed care as a culturally relevant response to trauma exposure. Newly trained and certified research teams led by Cambodian investigators will employ a mixed methods design to evaluate the Missouri Model of trauma-informed care. Specific Aim 3 will determine the effectiveness of a culturally-informed, EBT to reduce symptoms of trauma- related anxiety, depression, and problematic substance use. Preliminary work suggests that the Common Elements Treatment Approach (CETA), a task-sharing EBT has high potential to improve affective disorders and substance use disorders in resource restricted environments. However, studies have only examined CETA administered with ongoing supervision by US-based clinicians. Scale-up and sustainability of CETA in resource restricted environments requires empirical evidence that CETA is effective when administered by providers working in the local health system without ongoing case supervision by international partners. Specific Aim 3 will address this critical issue by comparing CETA modified for independent implementation (mCETA) to standard CETA (sCETA) and waitlist controls. Professional gains obtained from the structured training opportunities will be engaged to complete the clinical trial. Collectively, the structured implementation of this Phase II application will establish a formidable culture of research innovation to address current and future mental health needs of the Cambodian population. Outcomes will inform treatment strategies in other trauma-intense, resource restricted regions of the world.

Abstract Among men who have sex with men (MSM), there is a resurgent epidemic of methamphetamine (meth) and other stimulant use that fuels new HIV infections and compromises the benefits of HIV treatment as prevention. Although MSM living with HIV who use meth can achieve viral suppression, prior research from our team and others has documented that recent stimulant use amplifies immune dysregulation in treated HIV infection. MSM living with HIV are also more likely to report amplified behavioral risk such as condomless anal intercourse that increases risk for HIV acquisition and onward HIV transmission. The scientific premise of this administrative supplement is that co-occurring meth and HIV will create a double jeopardy for the novel coronavirus (COVID-19) pandemic. In order to examine the potentially synergistic effects of meth and HIV for the COVID-19 pandemic, we will enroll 200 MSM in a seroprevalence study testing for IgM and IgG antibodies to the novel coronavirus (SARS-CoV-2). Using an intact groups design, participants will be enrolled based on meth use (user versus non-user) by HIV status (positive versus negative). Among men living with HIV, only those who report an undetectable viral load will be enrolled. Among men who are HIV-negative, only those who are not currently taking pre-exposure prophylaxis (PrEP) will be enrolled. There will be 50 participants enrolled per group: METH+HIV+, METH+HIV-, METH-HIV+, and METH-HIV-. The primary hypothesis is that those with co-occurring meth use and HIV (METH+HIV+) will display the greatest seroprevalence of SARS-CoV-2 relative to meth or HIV alone (METH+HIV- or METH-HIV+) or controls (METH-HIV-). We will also examine the extent to which co-occurring meth and HIV are indirectly linked to higher SARS-CoV-2 seroprevalence via alterations in gut-immune dysregulation, smoking behaviors, and decreased adherence to social distancing guidelines. This supplement will provide some of the first data regarding whether and how those with co- occurring meth use and HIV are more vulnerable to SARS-CoV-2 infection. This represents a crucial first step to identifying high priority populations that will directly inform the development bio-behavioral interventions to mitigate risk for COVID-19. These findings will also inform targeted public health efforts to ?flatten the curve? of community-level SARS-CoV-2 transmission in this rapidly evolving COVID-19 pandemic.

Abstract Among men who have sex with men (MSM), there is an urgent need to optimize the unprecedented clinical and public health benefits of pre-exposure prophylaxis (PrEP) to prevent HIV with those who use stimulants (i.e., methamphetamine, cocaine, and crack-cocaine). Stimulant-using MSM display 3-6 fold faster rates of HIV seroconversion, and one-in-ten MSM with newly diagnosed HIV infection report recent stimulant use. Findings from our team and others also demonstrate that stimulant use is a key obstacle to PrEP adherence and persistence. Stimulant-using MSM have a 3-fold greater rate of disengagement from PrEP care and 5-fold greater odds of sub-optimal PrEP adherence. The proposed multi-site randomized controlled trial (RCT) will leverage a promising intervention model of delivering a positive affect intervention during contingency management (CM), which we have recently demonstrated achieves durable and clinically meaningful reductions in viral load among HIV+, methamphetamine-using MSM. In the proposed multi-site RCT, we plan to test whether delivering an Affect Regulation Treatment to Enhance Medication Intervention Success (ARTEMIS) positive affect intervention during smartphone-based 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 (TFV-DP) levels <700 fmol per punchand self- reported recent condomless anal sex (CAS). Up to 300 MSM on PrEP who report stimulant use and CAS in the past 3 months as well as any PrEP non-adherence in the past month will be recruited from social networking applications as well as PrEP clinical services in South Florida and San Francisco. Participants who meet the inclusion and exclusion criteria at an in-person baseline assessment will provide a dried blood spot (DBS) specimen that will be stored to measure TFV-DP levels and begin 3-months of smartphone-based CM that includes financial incentives for completing up to four directly observed PrEP doses per week (48 doses total over the 3 months). Participants will complete a run-in period (waiting period) where they will complete 4 directly observed smartphone-based CM PrEP doses prior to randomization. At a separate randomization visit, 240 participants (120 South Florida and 120 San Francisco) will be randomized to receive their first individually delivered ARTEMIS positive affect intervention or attention-control session. All 5 individually delivered intervention sessions will be delivered during the 3-month CM intervention period. Follow-up assessments will be conducted at 3, 6, and 12 months after beginning CM, with DBS collected to measure TFV-DP at 6 and 12 months. Consistent with the NIH OAR high priority area of ?reducing the incidence of HIV/AIDS,? this clinical research will meaningfully inform the targeted deployment of limited public health resources to optimize the unprecedented clinical and public health benefits of PrEP in stimulant-using MSM, one of highest priority populations for decreasing HIV incidence.

There is a strong resurgence of methamphetamine and other stimulant use in the United States (US). HIV- positive stimulant-using men who have sex with men (HIV+ SUMSM) may have greater difficulties navigating the HIV care continuum as well as display substantially elevated viral load (VL), amplified HIV transmission risk, and faster clinical HIV progression. While behavioral interventions show promise for achieving durable reductions in unsuppressed VL over time among HIV+ SUMSM, those residing outside of urban centers experience difficulties accessing services for HIV and substance use. For these reasons we propose a two-arm RCT of a 6-month mHealth intervention for HIV+ SUMSM, called Supporting Treatment Adherence for Resilience and Thriving (START). We will test the efficacy of START to improve VL suppression at 6 months (primary outcome) and determine whether any gains are maintained at month 12 (secondary outcome). START integrates two theoretically-grounded, evidence-based interventions (APP+ and ARTEMIS) with the goal of optimizing the effectiveness of treatment as prevention (TasP). HIV+ SUMSM (n=350) will be recruited and randomized to START or control to assess the following aims: Aim 1a. Test the efficacy of START for achieving a higher proportion of SUMSM who are virally suppressed at 6 months (primary outcome) compared to a website with referrals to HIV treatment information and substance use treatment resources (control condition). Aim 1b. Test the efficacy of START for maintaining viral suppression gains at 12 months, decreasing stimulant use and sexual risk, and increasing theory-based psychological processes (e.g., behavioral skills, positive affect). Aim 2. To assess the cost and cost-effectiveness of START, relative to the control condition, in achieving and/or maintaining viral suppression, including net savings with respect to averted healthcare utilization. During Phase I, we will integrate APP+ and ARTEMIS into a single START intervention platform using an iterative integration process that includes feedback through online focus groups with SUMSM. Phase I will conclude with usability testing among 10 HIV+ SUMSM to ensure a smooth transition to Phase II where we will conduct an RCT to test the efficacy of START. We will use home-based dried blood spot (DBS) collection to assess lab-quantified VL. All men will receive their respective condition for 6 months, with quarterly assessments until month 12. DBS specimens to measure VL will be collected at baseline, 6 and 12 months. The cost analysis will be framed from the provider perspective to estimate ?real world? costs of providing START to give stakeholders a sense of feasibility for broader implementation, given existing resources and reimbursement mechanisms. The proposed project is highly significant since optimizing TasP with HIV+ SUMSM is among the highest NIH and National HIV/AIDS Strategy priorities. START is innovative because it is scalable to reach a broader population of HIV+ SUMSM and may be adapted to clinic- and community-based settings.

There is a strong resurgence of methamphetamine and other stimulant use in the United States (US). HIV- positive stimulant-using men who have sex with men (HIV+ SUMSM) may have greater difficulties navigating the HIV care continuum as well as display substantially elevated viral load (VL), amplified HIV transmission risk, and faster clinical HIV progression. While behavioral interventions show promise for achieving durable reductions in unsuppressed VL over time among HIV+ SUMSM, those residing outside of urban centers experience difficulties accessing services for HIV and substance use. For these reasons we propose a two-arm RCT of a 6-month mHealth intervention for HIV+ SUMSM, called Supporting Treatment Adherence for Resilience and Thriving (START). We will test the efficacy of START to improve VL suppression at 6 months (primary outcome) and determine whether any gains are maintained at month 12 (secondary outcome). START integrates two theoretically-grounded, evidence-based interventions (APP+ and ARTEMIS) with the goal of optimizing the effectiveness of treatment as prevention (TasP). HIV+ SUMSM (n=350) will be recruited and randomized to START or control to assess the following aims: Aim 1a. Test the efficacy of START for achieving a higher proportion of SUMSM who are virally suppressed at 6 months (primary outcome) compared to a website with referrals to HIV treatment information and substance use treatment resources (control condition). Aim 1b. Test the efficacy of START for maintaining viral suppression gains at 12 months, decreasing stimulant use and sexual risk, and increasing theory-based psychological processes (e.g., behavioral skills, positive affect). Aim 2. To assess the cost and cost-effectiveness of START, relative to the control condition, in achieving and/or maintaining viral suppression, including net savings with respect to averted healthcare utilization. During Phase I, we will integrate APP+ and ARTEMIS into a single START intervention platform using an iterative integration process that includes feedback through online focus groups with SUMSM. Phase I will conclude with usability testing among 10 HIV+ SUMSM to ensure a smooth transition to Phase II where we will conduct an RCT to test the efficacy of START. We will use home-based dried blood spot (DBS) collection to assess lab-quantified VL. All men will receive their respective condition for 6 months, with quarterly assessments until month 12. DBS specimens to measure VL will be collected at baseline, 6 and 12 months. The cost analysis will be framed from the provider perspective to estimate ?real world? costs of providing START to give stakeholders a sense of feasibility for broader implementation, given existing resources and reimbursement mechanisms. The proposed project is highly significant since optimizing TasP with HIV+ SUMSM is among the highest NIH and National HIV/AIDS Strategy priorities. START is innovative because it is scalable to reach a broader population of HIV+ SUMSM and may be adapted to clinic- and community-based settings.

ABSTRACT The goal of this diversity supplement is to leverage global positioning systems (GPS) spatial mobility data to guide in-depth qualitative interviews examining the antecedents and consequences of intersectional minority stress in HIV-negative Black and Latinx sexual minority men (SMM) who use stimulants. Black and Latinx SMM experience profound HIV-related health disparities that are amplified by co-occurring use of stimulants. In 2018, 47% of all new US HIV infections were among Black and Latinx SMM. Overlapping structural factors such as racism, heterosexism, incarceration, and urban migration patterns within the built environment are important drivers of these racial disparities. Use of GPS tracking to analyze spatial mobility will allow us to use objective location data paired with narratives from participants explaining how interactions within certain spaces lead to stigmatizing experiences, and how those impact substance use behaviors. We can use this paired, mixed method approaches to place to the exposure before the outcomes, i.e., the environmental movements before the intersectional stigma and consequential substance use. This is a novel application of GPS methods to advance our understanding of intersectional stigma. To our knowledge, no previous studies have used GPS data to understand the impact of spatial mobility on the relationships among intersectional stigma, stimulant use, and HIV risk. We will Enroll 30 HIV-negative Black and Latinx sexual minority men living in South Florida who use stimulants as part of parent R01. Implement a mixed-methods design, first collecting GPS data from participants to plot their geographic mobility within the different areas of interests, including work, home, social and sexual activity spaces over a two-week span. A following qualitative component would leverage the mobility maps to guide an in-depth qualitative interview to understand how their dynamic movements related to experiences of intersectional stigma vary across settings, and what (if any) implications this has for their substance use. Mentoring and Training: The proposed diversity supplement training plan is sponsored by Dr. Adam Carrico and co-sponsored by Drs. Dustin Duncan and Audrey Harkness. Training includes advanced methods in GPS spatial mobility data collection and analysis, geographic information systems (GIS) computation methodology, design and implementation of intersectional stigma qualitative research, psychopathology, social psychology, and cognitive neuroscience relevant to addiction, and HIV prevention, care and treatment science. This diversity supplement will provide an ideal foundation for a planned F32 application where I will build upon this work to integrate ecological momentary assessment (EMA) methods with GPS data collection to understand how the experiences of intersectional stigma that fuel stimulant use and HIV risk vary across environmental contexts.