CHPHE conducts interdisciplinary research and education to create healthier behaviors and environments. Current projects focus on clinical, behavioral and translational research related to HIV/AIDS, hepatitis C and other infectious diseases; improving dietary habits; increasing physical activity; weight control; encouraging smoking cessation; and using culturally sensitive materials to promote better health. Current research studies are listed below.

Multiple Principal Investigators
Matthew Mimiaga, ScD, MPH (University of California Los Angeles)
Robert Garofalo, MD, MPH (Lurie Children's Hospital, Chicago)
Katie Biello, PhD, MPH (Brown University site PI)

Sponsor: National Institutes of Health (NIH)/National Institute of Nursing Research

Grant Number:1R01NR017098-01

Evidence indicates that a significant and growing population of adolescents are acquiring and living with HIV in the U.S. According to the Centers for Disease Control and Prevention, an estimated >12,200 adolescents were diagnosed with HIV infection in 2010, a 22% increase since 2008. In 2010, adolescents made up only 17% of the US population, but accounted for 26% (12,200) of all new HIV infections (47,500) in the U.S. Although HIV can be managed with ongoing ART, exceptionally high levels of adherence are required. The purpose of this study is to test the efficacy of an integrated technology- and counseling-based antiretroviral therapy (ART) stepped care, adherence intervention ("Positive Steps") for HIV infected adolescents, ages 16 to 24. If successful, the stepped care intervention would be ready for translation studies to examine effectiveness testing and dissemination into "real-world" settings.

Multiple Principal Investigators
Matthew Mimiaga, ScD, MPH (University of California Los Angeles)
Steven Safren, PhD (University of Miami)
Katie Biello, PhD, MPH (Brown University site PI)

Sponsor: National Institutes of Health (NIH)/National Institute on Drug Abuse (NIDA)

Grant Number:1R01DA042805-01A1

This application builds off of our successful formative and pilot work and is designed to assess the efficacy, in a three-arm randomized controlled trial (RCT), of Project IMPACT—a behavioral intervention to reduce high-risk sex in MSM with stimulant use disorder who are at risk for HIV acquisition. The intervention incorporates risk reduction counseling with behavioral activation (BA) to help participants re-engage in enjoyable and meaningful life activities not involving drugs. Behavioral activation is an evidence-based, easy to administer, cognitive behavioral approach to treat depression and other problems that focuses on helping individuals reengage in activities that generate feelings of enjoyment (i.e., mastery and pleasure). We chose this strategy for MSM with stimulant use disorder because our formative work revealed that MSM who abuse stimulants report becoming unable to enjoy activities that they previously enjoyed as a result of ongoing stimulant use. This lack of enjoyment (i.e., anhedonia, one of the core symptoms of depression) in activities that do not involve stimulant use or sex contributes to the continued use of stimulants and potentially unsafe sex. We developed and openly field-tested this intervention in a NIDA-funded non- randomized pilot (R03 DA023393), and, subsequently, conducted a NIDA-funded pilot RCT (R34 DA031028) of this intervention.

Principal Investigator: Bess Marcus, PhD

Sponsor: National Institutes of Health (NIH)/National Cancer Institute (NCI)

Grant Number: R01CA159954

In the U.S., Latina women report higher rates of inactivity than their non-Hispanic White and male counterparts, and are disproportionately affected by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). To address this public health crisis, evidence-based interventions that utilize state-of-the-art technology, theory and methods are needed to increase physical activity (PA) among this high-risk population. Recently, our team conducted a randomized controlled trial (N=205) to test the efficacy of a 6-month culturally adapted, individually tailored, Spanish-language Internet-based PA intervention among Latinas (Pasos Hacia La Salud, R01CA159954) vs. a Wellness Contact Control Internet Group. Increases in minutes/week of moderate-to-vigorous physical activity (MVPA) were significantly greater in the Intervention Group compared to the Control Group at 6 and 12 months (p < .01) but still did not reach levels recommended in the national physical activity guidelines.

As improvements in PA in the Intervention Group were significantly associated with website use and increases in self-efficacy, enjoyment, and social support in the parent study, we used these data to inform technology and theory-supported enhancements to the intervention (i.e., text messaging and adaptive goal setting to increase website use and further targeting of the previously mentioned key psychosocial constructs) to achieve even greater increases in PA, and maintain these gains over the long term (24 months) in the renewal of R01CA159954.

For the proposed study, 300 Latina women will be randomized to either 1) the original Pasos Hacia La Salud tailored Internet-based PA intervention (Original Intervention) or 2) the data driven, enhanced version of the Pasos Hacia La Salud PA intervention (Enhanced Intervention). We hypothesize that participants in the Enhanced Intervention arm will report significantly more minutes/week of MVPA than participants in the Original Intervention arm at 6 months. We will also examine the maintenance of treatment effects at 12, 18, and 24 months, as well as the costs of delivering the Enhanced vs. Original Intervention programs, and the potential mediators of the intervention-PA relationship. The proposed high- reach, low-cost intervention holds great promise in promoting and maintaining the positive health benefits of PA in the lives of Latina women in the United States.

Multiple Principal Investigators
Katie Brooks Biello, PhD
Angela Robertson Bazzi, PhD (Boston University)

Sponsor: National Institutes of Health (NIH)/National Institute on Drug Abuse

Grant Number: R01DA051849

A persistent ~10% of new U.S. HIV infections occur among people who inject drugs (PWID). Provision of sterile syringes (via syringe service programs [SSPs] and pharmacies) helps prevent injection- related HIV transmission; however, syringe access is insufficient in many locations, and the majority of PWID experience substantial overlapping sexual and injection-related HIV risks. As in several geographic regions of the United States, in the Northeast, increasing injection of opioids, stimulants, and other drugs is causing renewed concerns about HIV transmission, with CDC declaring HIV outbreaks connected to injection drug use. Despite the proven efficacy of pre-exposure prophylaxis (PrEP) and U.S. Preventive Services Task Force recommendation that PrEP be offered to PWID at risk for HIV acquisition, uptake in this socially marginalized population remains severely limited.

This project is a culmination of extensive preliminary research, including (a) in-depth qualitative research with PWID across Northeastern communities affected by opioid use and HIV that documented high HIV risk and low PrEP knowledge but high interest, (b) key informant interviews with PrEP providers, SSP staff, and other key stakeholders who provided specific suggestions for PrEP intervention content and delivery strategies, and (c) two pilot randomized controlled trials (RCTs) of PrEP Navigator-delivered behavioral interventions with high risk populations including people who use drugs and PWID that demonstrated the feasibility, acceptability, and preliminary efficacy of our proposed approach. This extensive research has led to the development of the "PrEP for Health" intervention.

"PrEP for Health" is a brief, multi-component behavioral intervention delivered to PWID by highly trained PrEP Navigators embedded within SSPs that seeks to improve PrEP uptake (primary outcome) and PrEP adherence and persistence (secondary outcomes) among PWID by increasing HIV and PrEP knowledge, improving HIV risk perceptions and PrEP interest and motivation, cultivating PrEP use self-efficacy and behavioral skills, and reducing structural barriers to PrEP use. We propose testing efficacy of "PrEP for Health" in two SSPs in Lawrence and Boston/Cambridge, Massachusetts, areas heavily affected by injection-related HIV transmission. We will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention, which includes Navigator-delivered, theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing PrEP navigation (n=100), or (b) standard of care (information and referrals; n=100). We will evaluate successful PrEP uptake (via medical/pharmacy records), adherence (via drug levels in hair), and persistence (via medical/ pharmacy records) over 12 months. We will also examine the degree to which intervention efficacy occurs through specific conceptual mediators (e.g., PrEP knowledge, motivation, self-efficacy) and differs according to hypothesized moderators (e.g., age, gender, sexual risk).

Principal Investigator: Jaclyn White Hughto, PhD, MPH

Sponsor: National Institutes of Health (NIH)/National Institute of General Medical Sciences

Grant Number: P20GM125507

Opioid use disorder is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medication Assisted Treatment (MAT) has been shown to reduce opioid use in diverse populations; however, long-term retention in MAT care is often suboptimal. Depression, the stigma of opioid use and addiction, and limited self-efficacy to navigate life challenges have been shown to contribute to MAT disengagement. Behavioral activation (BA) therapy is an evidenced-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder.

Conceptual Model. The conceptual model underlying BA posits that self-defeating behaviors, such as substance use and the behavioral avoidance of health-promoting resources serve the function of coping with negative feelings and make individuals feel better in the short-run, but ultimately exacerbate depression through a process of negative reinforcement. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression, cope with stigma, and build the capacity to navigate life challenges, pairing BA with MAT could help to ensure continued engagement in care and improve treatment outcomes for individuals with opioid use disorder.

Overview of Study. Following the NIH Stage Model of psychosocial treatment development and testing, this study seeks to determine the feasibility of study procedures, enhance participant acceptability, and provide preliminary efficacy data to support the submission of a full-scale, NIH R01 efficacy trial. We will enroll 80 individuals currently being treated with MAT for opioid use disorder in a pilot randomized controlled trial (RCT) of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 6-session CoMBAT intervention; or 2) MAT alone (treatmentas- usual). The primary outcome is retention in MAT care. Secondary outcomes include days of opioid use, opioid positive urinalysis, and potential mediators (e.g., depression, stigma coping, self-efficacy) and moderators (e.g., comorbid mental health, substance use, criminal justice system involvement) of the intervention at baseline, and 3- and 6-months. Intervention feasibility and acceptability will also be assessed. This study will provide the requisite data to inform future efficacy testing of the intervention in a large-scale R01 trial, with the ultimate goal of developing an efficacious intervention to address the opioid epidemic

Principal Investigator: David M. Williams, PhD

Sponsor: National Institutes of Health (NIH)/National Cancer Institute

Grant Number: R01CA262894

Participation in regular physical activity (PA) has numerous health benefits including reduced risk of all-cause mortality, cardiovascular disease, diabetes, and cancers of the breast and colon, as well as energy balance. However, only 54% of U.S. adults meet national guidelines of expending > 1000 kcals/week through PA, and as few as 10% meet guidelines when objective assessments of PA are used. Thus, there is a need to improve adherence to PA programs using innovative approaches. Economic incentives have been shown to be powerful motivators for behavior change and for improving health outcomes. While there is evidence suggesting the general efficacy of incentive programs for increasing PA, research has not yet demonstrated the optimal format for incentive programs. Nonetheless, spurred by organizational incentives (i.e., tax breaks) provided by the Affordable Health Care Act, major insurance companies are now offering economic incentives for regular attendance at fitness facilities in the absence of empirical support. Thus, we propose to conduct an RCT to examine the efficacy of the exercise incentive program currently offered by three major US insurance companies consisting of a $200 rebate on fitness facility membership fees for at least 50 confirmed visits to the fitness facility (maximum 1/day, verified by objective swipe-card data) over 6 months.

In the context of the RCT, we will also compare the insurance-based standard incentive program to a second, loss-frame incentive condition in which the same incentive schedule is used, but with participants told (and reminded during the course of the program) that $200 of their membership fee is being held and will be returned or forfeited depending on whether they use the gym at least 50 times in the next 6 months. The proposed RCT will be conducted in a community setting at the Greater Providence YMCAs.

Aim 1. Conduct an RCT (N=330) comparing (a) the widely used insurance-based Standard incentives program (n=110), (b) a Loss-framed incentive program (n=110), and (c) no-incentive Control (n=110). Each participant will be enrolled for two consecutive 6-month periods for a total of 12 months per participant. The primary outcome will be number of visits to the fitness facility. Secondary outcomes will include total moderate-to-vigorous PA (MVPA) over 7-day periods at 3-month intervals through accelerometers and self-reported MVPA. We hypothesize that the two incentive conditions will result in higher attendance at the YMCA and more PA, with the Loss-framed incentive program outperforming the Standard insurance-based program.

Aim 2. Examine habit formation and anticipated regret as putative mediators and household income and age as moderators of the incentive-based programs. Aim 3. Conduct a within trial cost-utility analysis from a societal perspective to quantify (a) the incremental costs per quality-adjusted life year (QALY) gained, (b) cost per change in YMCA attendance, and (c) cost per incremental change in PA. We will additionally apply a productivity model to estimate the economic impact of the intervention on future household and labor force participation.

Principal Investigator: David M. Williams, PhD

Sponsor: National Institutes of Health (NIH)/National Center for Complementary and Integrative Health

Grant Number: R34AT011302

Up to 25% of U.S. adults have clinically significant depressive symptoms, and people who experience these symptoms are at increased risk of all-cause mortality and chronic disease. Engaging in regular physical activity (PA) can help alleviate depressive symptoms and reduce risk of chronic diseases, such as cardiovascular disease and type 2 diabetes that are associated with depression.

Despite the benefits of PA for those with depressive symptoms, depressive symptoms consistently predict PA nonadherence. Factors such as decreased distress tolerance and low motivation make adherence to regular PA particularly difficult for adults with depressive symptoms. Thus, an important problem that needs to be addressed is how to help adults with depressive symptoms overcome barriers to regular PA. Acceptance and Commitment Therapy (ACT) is a mindfulness-informed intervention that is efficacious for fostering behavior change in various healthy populations and for treating depression. ACT enhances motivation for functional activities in depressed individuals by helping them to clarify personal values consistent with behavioral goals, and foster present-moment, nonjudgmental awareness (i.e., mindfulness) and acceptance of internal experiences to increase distress tolerance. These foci of ACT may be applied to address the intolerance of negative affective response to PA and low motivation for PA that serve as barriers to regular PA among adults with depressive symptoms.

The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based ACTivity to PA+Education among 60 low-active adults (ages 18-65) with elevated depressive symptoms at two Greater Providence YMCA branches. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities.

Aim 1: Develop and demonstrate training and intervention fidelity procedures for bachelor’s-level interventionists to direct the ACTivity and PA+Education interventions.

Aim 2: Demonstrate feasibility of recruitment, randomization, retention, and data collection procedures to conduct an individually randomized group treatment trial (IRGT).

Aim 3: Demonstrate credibility (i.e., how convincing and logical a treatment seems) and acceptability of the ACTivity and PA+Education programs.

Impact: The proposed research is a necessary step to prepare for a future multi-site RCT that has the potential to change clinical practice guidelines if shown to be effective. Specifically, if shown to be effective, ACTivity will provide a community-based treatment that can be delivered at local YMCAs by bachelor’s-level staff to increase moderate to vigorous physical activities among depressed adults and thereby decrease their risk for chronic disease.

Principal Investigator: Tanya Benitez, PhD

Sponsor: National Institutes of Health (NIH)/National Cancer Institute

Grant Number: R03CA252500

Cancer is the leading cause of death among Latinos in the U.S. While engaging in a physically active lifestyle is one of the most important modifiable behaviors for reducing cancer risk; few Latinas achieve health- enhancing levels of physical activity (PA) recommended by the National PA Guidelines, particularly for muscle- strengthening activities (MSA). For instance, 44% of Latinas meet the national guidelines for aerobic PA but only 17% meet the full guidelines for both aerobic and MSA. While the benefits of aerobic MVPA are well established for cancer and chronic disease prevention, participating in regular MSA may be key to further reducing cancer risk, as adherence to MSA guidelines has been associated with a 19% to 31% lower cancer mortality risk, independent of aerobic PA.

There is a need for interventions promoting MSA in Latinas. However, only a select few MSA interventions have included Latinas in their sample, and none to our knowledge, were designed exclusively for this group or addressed socio-cultural factors influencing Latinas' muscle-strengthening behaviors (e.g., perception that MSA is for men; MSA is an avoided topic in their culture and social circles; belief that women should only do certain types of MSA). Moreover, existing interventions often involved in-person exercise programs, which can be inaccessible to many Latinas due to barriers such as lack of transportation or fear of immigration enforcement. Our research team has previously developed and tested aerobic moderate-to-vigorous PA (MVPA) interventions for Latinas that overcome barriers to in-person programs and address PA-related socio-cultural factors. These theory-driven, individually tailored interventions have shown success at increasing aerobic MVPA among Latina women in both print and Internet-based randomized controlled trials. Thus, our web-based intervention (Pasos Hacia la Salud), in particular, provides an ideal platform for promoting muscle-strengthening PA in this at-risk population.

To address the gap in literature on muscle-strengthening PA, we recently conducted qualitative interviews with 19 Latinas to identify theory-based barriers and facilitators of muscle-strengthening PA, then developed MSA intervention materials and are further refining for cultural appropriateness, relevance, and appeal in Latinas. In the proposed research, we will incorporate the newly developed MSA promotion materials into our existing Pasos Hacia la Salud (Pasos) web-based aerobic MVPA intervention and conduct a 12-week fully online randomized pilot trial testing the preliminary efficacy of the newly adapted web-based aerobic plus MSA intervention for Latinas. Fifty Latina adults (i.e., aged 18-65 years) will be randomized to either the: 1) original Pasos aerobic MVPA intervention arm, or 2) a Pasos aerobic MVPA plus MSA intervention arm. Our study aims to 1) Assess the preliminary efficacy of the aerobic and muscle-strengthening intervention for increasing MSA, and 2) Explore potential mediators and moderators of MSA. This interactive and highly disseminable approach can achieve significant health improvements in an at-risk population. 

Multiple Principal Investigators
Amy Nunn, ScD, MS
Leandro Mena, MD, MPH (US Centers for Disease Control and Prevention)

Sponsor: National Institutes of Health (NIH)/National Institute of Mental Health

Grant Number: R25MH083620-11A

The goal of this program is to train the next generation of researchers to end the HIV epidemic and to conduct research related to reducing racial disparities in HIV outcomes in the Southern United States. The project is led by Dr. Amy Nunn and Dr. Leandro Mena, who have worked collaboratively on these topics for over a decade in Mississippi and beyond. This program was initially funded in 2008 and exceeded its key objectives during the last 11 years; we trained 40 investigators during the last funding cycle. During the last five years, our fellows attributed 492 peer-reviewed articles and 53 successfully funded grants to this training program.

This renewal continues our focus on racial disparities and community engaged scholarship, with greater emphasis on ending the epidemic in the South and in jurisdictions most heavily impacted by the HIV epidemic. This initiative and the mentoring curriculum will align with the US Plan to End the HIV Epidemic (EtHE). The program will prioritize training investigators from communities historically underrepresented in the sciences, with emphasis on training investigators from or conducting practice-oriented research in geographic hotspots of HIV infection, with a focus on the South. This structured mentoring program will focus on community-engaged scholarship, geographically circumscribed interventions, reducing racial disparities in HIV infection, partnering with health departments, and delivering proven HIV prevention and care interventions through novel means in the rural South.

The program has the following specific aims:

Specific Aim 1: To train the next generation of researchers in the communities most heavily impacted by the epidemic in HIV/AIDS research to develop, implement, and evaluate interventions to reduce racial disparities in HIV prevention and care, including HIV screening, PrEP, and HIV treatment. This training includes formal coursework, quarterly mentoring workshops, one-on-one mentoring, epidemiological design, and clinical service delivery experiences in real-world clinical and community settings.

Specific Aim 2: To train investigators from communities enumerated in the EtHE plan, particularly African Americans and Hispanic/Latinos in the South. These investigators will lead scientific investigation addressing social, structural and behavioral drivers of the epidemic; lead clinical, epidemiological and implementation research to mitigate HIV/AIDS disparities; and develop, implement, and evaluate culturally appropriate and geographically circumscribed interventions focused on the South.

Multiple Principal Investigators
Katie Biello, PhD, MPH
Matthew Mimiaga, ScD, MPH (University of California Los Angeles)

Sponsor: National Institutes of Health (NIH)/National Institute on Mental Health

Grant Number: R34MH126894

Sexual and gender minority (SGM) youth account for the largest number of incident HIV infections in Brazil. Although HIV can be managed with ongoing antiretroviral therapy (ART), exceptionally high levels of adherence are required. Brazil has implemented a comprehensive HIV treatment program with broad access to ART, but this program does not specifically address barriers to optimal ART adherence, particularly for SGM youth who experience many challenges taking their medication as prescribed.

This project seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among HIV infected SGM youth (ages 15-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence. To inform the content, structure, and format of the proposed intervention, the MPIs recently conducted focus groups with SGM youth (N = 18) and key informant interviews (N = 7) with medical providers and staff at local HIV service organizations working closely with SGM youth in Rio de Janeiro. Across focus groups and key informant interviews there was universal agreement that an intervention should capitalize on and enhance social support structures among SGM youth, and address their specific concerns, especially as related to the individual (e.g., ART side effects, mood, substance use), social (e.g., HIV/SGM stigma), and structural (e.g., clinic hours, transportation challenges) barriers that they regularly face.

The intervention is guided by Social Cognitive and Social Support Theories and is grounded in the social and contextual realities of SGM youth living with HIV in Brazil. Specifically, social support is emphasized and informational, problem-solving and cognitive-behavioral “steps” are addressed over 4-group adherence counseling sessions, which include short video vignettes that seek to normalize adherence challenges. In addition, daily tailored SMS text messages are delivered as part of the intervention to facilitate social-cognitive cues to take medications as prescribed.

Research Plan
Phase 1: Refine and enhance participant acceptability of the intervention and resolve any issues with intervention delivery/implementation; this will be achieved by convening and obtaining feedback from our youth community advisory board throughout this phase and subsequent phases; and by conducting an open-phase pilot with up to 12 SGM youth, with post-intervention exit interviews, as well as obtaining feedback from our youth community advisory board throughout this and subsequent phases.

Phase 2: Examine, in a pilot randomized controlled trial, the feasibility, acceptability and potential impact of the proposed intervention among 72 SGM youth who will be equally randomized to the intervention or a time- and attention-matched control condition with standard of care. The outcomes are improved ART adherence (Wisepill, pharmacy assessment and self-report), retention in care and viral load suppression. Study assessments will be conducted at baseline, 3- and 6-months.

Principal Investigator: Katie Biello, PhD, MPH
Sponsor: National Institutes of Health (NIH)/National Institute of Nursing Research
Grant Number: R01NR020227

Male sex workers (MSWs), or men who exchange sex for money, goods, drugs, or other items of value with other men, are at exceptionally high risk for HIV infection. Pre-exposure prophylaxis (PrEP) is effective at reducing HIV acquisition among HIV uninfected individuals, but its efficacy is highly dependent on uptake and excellent adherence. However, uptake of and adherence to PrEP among those who might benefit the most from using PrEP, such as MSWs, remains suboptimal. A successful PrEP uptake and adherence package must be responsive and tailored to MSWs’ distinct psychosocial and contextual circumstances.

Conceptual Model: The “PrEPare for Work” intervention is based on Social Cognitive Therapy (SCT), which specifies a core set of mechanisms that influence health behavior with a primary emphasis on self-regulation and self-reflection, including self-efficacy.

Overview of Study Design: We now propose to test the efficacy of the “PrEPare for Work” package in the Greater Providence area and in Los Angeles County using a two-stage randomization design.
Stage 1: 500 MSW will be equally randomized to receive either the “PrEPare for Work Stage 1 intervention” (strength-based case management and facilitated PrEP linkage) or standard of care to evaluate successful PrEP uptake (verified by real-time tenofovir urinalysis; prescription data) within 2 months.
Stage 2: Those who initiate PrEP (n~156; ~55% from Stage 1 intervention arm and ~20% from Stage 1 SOC arm) will be equally re-randomized to the “PrEPare for Work Stage 2 intervention” (1-on-1 skills training, problem solving, and motivational interviewing adherence counseling and personalized, daily text messaging reminders) or SOC to assess PrEP adherence (tenofovir concentration in hair sample) and retention in PrEP care (appointments attended) over 12 months. We will also examine the degree to which improvements in PrEP uptake and adherence occur in the context of the conceptual mediators (e.g., PrEP motivation, self-efficacy) and moderators (e.g., race/ethnicity, substance use, perceived HIV risk) of the intervention. Intervention cost-effectiveness will be assessed.

Principal Investigator: Diana Grigsby-Toussaint, PhD

Sponsor: National Institutes of Health (NIH)/National Institute on Minority Health and Health Disparities

Grant Number: R01MD016241

The WHO indicates 10% to 20% of children and adolescents have pediatric mental health disorders, contributing to a projected worldwide economic burden of $6 trillion by 2030. In RI, approximately 19% of children under the age of 17 have mental health challenges that can adversely affect their development, education, peer relationships, and physical health. Sleep is an increasingly recognized contributor to mental health and well-being. In children, inadequate sleep has been linked to diminished mental and physical health.

Exposure to greenspace, broadly defined as various forms of vegetation, has been shown to confer numerous health benefits. In this study, we propose to explore the association between exposure to greenspace and mental health outcomes in elementary school children.

Aim 1. Sleep and greenspace. Determine how green space utilization (GPS-derived measures of daily activity and environmental features) is related to sleep (duration, timing, regularity) in children.
Hypothesis 1.1 Children spending more time in greenspace as derived by GPS (i.e., utilization) will have earlier, longer and more regular sleep than children spending less time in greenspace.
Hypothesis 1.2. Greenspace utilization will influence sleep through increased light exposure, higher levels of physical activity measured using accelerometry, and lower levels of stress measured by IL-1 beta.

Aim 2. Mental health, greenspace and sleep. Determine whether greenspace utilization is associated with mental health and wellbeing via sleep behaviors.
Hypothesis 2.1. Children spending more time in greenspace will have fewer mental health symptoms as measured by validated PROMIS® measures of anxiety, cognitive functioning, psychological stress and wellbeing compared to children spending less time in greenspace.
Hypothesis 2.2. Greenspace utilization will influence mental health and well-being through sleep behavior (duration, timing, regularity) assessed using actigraphy.

Aim 3. Exploratory Aim. Greenspace, epigenetics, sleep and wellbeing. Explore the potential epigenetic contribution of greenspace on sleep and wellbeing in children. Exploratory Hypothesis 1.1. Patterns of differential DNA methylation between high and low greenspace users may differ in genes associated with stress response, inadequate sleep, light exposure, or physical activity. We will work in Rhode Island, which is currently engaged in expanding access to tree-canopy across the entire state – a unique designation in the US. Thus, the health and policy implications of our study is timely, and can have implications for other states interested in exploring the use green space to improve health among children and their families.