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
Amy Nunn, ScD
Timothy Flanigan, MD (The Miriam Hospital)

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

Grant Number: 5R25MH083620-08

Our goal is to train the next generation of minority researchers to address the challenges of prevention, diagnosis and treatment of HIV, particularly in minority communities. Nearly 50% of new infections are among African-Americans, and African-Americans have poorer health outcomes at every point along the HIV/AIDS continuum of diagnosis and care. In particular, African American communities, particularly the inner-city Eastern seaboard and the rural and urban South, are most heavily impacted by HIV/AIDS.

President Obama's National AIDS Strategy calls for reduction in HIV incidence, reductions in racial disparities in HIV infection, and allocating resources to the most heavily impacted communities. In order to address racial disparities in HIV infection and the impact of HIV/AIDS in minority communities, we must train minority investigators from the most heavily impacted communities, particularly from inner city communities and the American South. This requires interdisciplinary, culturally competent research training of the next generation of HIV/AIDS researchers; this training must address the social, structural and behavioral factors contributing to the epidemic.

The Brown Initiative in HIV and AIDS Clinical Research for Disadvantaged Communities is an educational and mentoring program for new investigators from underrepresented racial and ethnic groups, with a particular focus on African Americans conducting research on HIV/AIDS health disparities and the co-occurring epidemics of incarceration, hepatitis C co-infection, substance use, and mental illness. During our first five years, we trained 28 minority postdoctoral and junior faculty members in HIV related clinical research, and developed collaborative relationships with five universities, with an emphasis on Mississippi and the South. Scholars from diverse disciplines represent 14 institutions; 79% of scholars are African- American, 11% are Asian Pacific Islander, 7% are Hispanic, and 3% are Native American.

Principal Investigator: Bess Marcus, PhD

Sponsor: National Institutes of Nursing Research (NINR)

Grant Number: 7R01NR011295-08

In the U.S., Latinas report high rates of inactivity and related conditions (obesity, diabetes). Effective interventions that leverage state-of-the-art theory and methods are needed to address such health disparities. We recently conducted a randomized controlled trial of a culturally/linguistically adapted, print-based, mail- delivered physical activity (PA) intervention for Latinas (Seamos Saludables, R01 NR011295), in which participants (N=266) received either individually tailored PA intervention materials based on the Transtheoretical Model and Social Cognitive Theory, or printed wellness materials. Changes in moderate to vigorous PA (MVPA) were significantly greater in the intervention arm from baseline to six months (1.87 min/week to 73.37 min/week) than the control arm (3.02 min/week to 32.98 min/week). These increases were maintained at 12 months and mediated by changes in psychosocial constructs targeted by the intervention.

A renewal of R01NR011295 is proposed to replicate these findings in Mexican Americans (who comprised only 5% of the original sample but most of US Latino population), explore its clinical potential in preventing and managing chronic disease, and to improve the intervention's effectiveness by incorporating participant feedback (desire for increased interactivity and accountability), further targeting SCT constructs that were overall not influenced by the original intervention yet improved amongst the most successful participants (social support and outcome expectancies), and responding to changing trends and technology use in the Latino population (adding text messaging).

In the proposed study, 250 Mexican American women will be randomized to either 1) the original, empirically supported Seamos Saludables tailored print intervention or 2) the technology and theory-enhanced version of the Seamos Saludables intervention. Data will be collected at baseline, 6 months (post-treatment), and 12 months (maintenance) using well-established objective (accelerometers) and subjective (7 Day PAR) PA measures, as well as a comprehensive set of psychosocial questionnaires.

We hypothesize that at the end of treatment (month six) the Enhanced Tailored Intervention participants will report significantly more minutes/week of MVPA than the Original Tailored Intervention participants. We will also examine changes in cardiovascular and metabolic biomarkers (fasting blood glucose, HbA1c, triglycerides, LDL, HDL, HS-CRP), maintenance of treatment effects at 12 months, costs of delivering the enhanced vs. original intervention programs, potential mediators and moderators of the intervention- physical activity relationship, and will also compare the efficacy of the original Seamos Saludables program in Mexican American women to results in the original population (who were mostly Dominican, Colombian, and Puerto Rican). Such high-reach, low-cost strategies for promoting physical activity have great potential for adoption on a larger scale and could have a large impact on reducing health disparities.

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: David M. Williams, PhD

Sponsor: National Cancer Institute

Grant Number: R21CA224609

Engaging in regular physical activity (PA) is consistently inversely associated with risk of breast and colon cancers, with additional evidence for suggesting PA helps prevent endometrial, pancreatic, and lung cancers. Despite these benefits, less than 5% of overweight and obese adults meet national guidelines for PA. Moreover, overweight adults spend less time in PA than normal weight adults, and are more likely to discontinue PA programs. Affect (feeling good/bad) is important for promoting regular PA, as those who respond with less positive affect during moderate intensity PA are less likely to adopt a program of regular PA.

Additionally, those experiencing lower positive affect and higher negative affect outside the context of PA are less likely to engage in PA. Given the importance of positive affect for adoption and maintenance of regular PA, intervention componenents that focus on enhancing positive affect may be a valuable addition to standard PA promotion interventions. Specifically, interventions derived from positive psychology have shown promise in reducing depressive symptoms and increasing positive affect and are beginning to be applied to other areas of behavioral health.

Consistent with the ORBIT model for developing behavioral interventions, the aims of this project are to, first, translate positive psychology theory into a 6-week, group-based positive psychology for PA promotion (PPPA) intervention for low-active overweight or obese adults (>18 years; BMI 25-40), delivered at local YMCAs, and supplemented with text messaging. We will deliver the intervention prototype among a cohort of 10 participants. Participants and investigators will provide ongoing feedback regarding their experiences with the intervention in an iterative development process to refine the protocol. Our second aim is to test proof-of-concept and feasibility of PPPA in the context of a randomized pilot study among 60 low-active overweight or obese adults at local YMCAs. In an additive design, participants will be randomized in a 2:1 ratio to PPPA versus a control intervention including only the standard PA promotion components of the PPPA intervention (i.e., PA education, self- monitoring, and goal-setting), with equal frequency of staff contact and text message delivery. All participants will be followed for 6 months, and will receive a 6-month YMCA membership to equate access to PA facilities.

We hypothesize that participants in PPPA, relative to the standard PA intervention will: demonstrate equal or greater session treatment retention and satisfaction (H1); and more min per week of PA as measured by accelerometry at immediate post-treatment (week 7) and weeks 13 and week 26 (H2). As a secondary aim we will examine effect sizes for PPPA versus the standard PA intervention on putative mediators that may underlie the efficacy of PPPA in improving PA outcomes, including positive and negative affect, optimism, happiness, life satisfaction, social support for PA, and PA enjoyment. The proposed research will set the stage for an RCT to test a novel PA promotion intervention that can be readily disseminated.

Multiple Principal Investigators
Amy Nunn, ScD
Philip Chan, MD (The Miriam Hospital)
Leandro Mena, MD (University of Mississippi Medical Center) 

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

Grant Number: 1 R34MH1 0937 1-01A1

Young, African American men who have sex with men (YMSM) in the Deep South are disproportionately impacted by the HIV/AIDS epidemic. A once daily medication (emtricitabine/tenofovir) known as pre-exposure prophylaxis (PrEP) can dramatically reduce HIV acquisition among MSM but behavioral and social challenges undermine its optimal uptake, use and efficacy. This proposal by early stage investigators develops and tests a pilot intervention designed to enhance PrEP adherence and retention in care for AA YMSM in Mississippi. The findings of this research will be used to help define the essential elements of a prevention intervention to overcome barriers to PrEP adherence and retention in care among AA YMSM, and will be uniquely tailored to the social and health policy contexts relevant for African American men in the Deep South.

Principal Investigator: Bess Marcus, PhD

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

Grant Number: 2R01CA159954-05

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: David M. Williams, PhD

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

Grant Number: R01AG069349

The current USDHHS guidelines recommend that adults expend at least 1000 kcal per week in PA,12 which can be obtained through 150 minutes per week of moderate intensity PA, 75 minutes of vigorous intensity PA, or some combination. However, current estimates suggest that only 3.5% to 43.5% of US adults, and 28% of overweight or obese adults adhere to these recommendations. Moreover, people across all World Health Organization regions become less active as they age. A more progressive decline in PA is seen after age 45- 50. In essence, PA rates tend to decrease as people age and gain weight while the health benefits of PA become more pronounced. A growing body of research suggests that a shift in national guidelines to emphasize PA of a self-selected intensity (i.e., self-paced) instead of prescribed moderate intensity PA may result in better adherence to PA programs, particularly among overweight and obese midlife adults.

In the proposed RCT we will conduct a field-based experimental test of the hypothesis that, among overweight and obese midlife (ages 50-64) adults, adherence to PA programs will be improved when PA is explicitly recommended to be self-paced rather than prescribed at moderate intensity. This approach represents an important shift in mindset for those beginning a new program of PA: That is, PA need not be of a certain intensity in order to "count." If a self-paced recommendation is found to lead to better PA adherence among overweight and obese midlife adults, this could have implications for PA recommendations for that population.

Aim 1: We will conduct an RCT comparing the effects of self-paced versus prescribed moderate intensity PA on PA behavior among low-active overweight and obese midlife (ages 50-64) adults (N=240). Based on procedures developed in our pilot, all participants will receive a 12-month intervention designed to help them overcome barriers to regular PA. The independent variable will be random assignment to either self-paced or prescribed moderate intensity PA. The primary outcome will be total volume of PA (frequency x duration x intensity) as measured by accelerometry at months 3, 6, 9, and 12. H1: A recommendation for self-paced PA will result in more PA (primary outcome) relative to prescribing moderate intensity PA based on current public health guidelines. Secondary outcomes include: (a) self-reported min/week of PA over the 12-month program, (b) fitness changes, and (c) weight changes at months 6 and 12.

Aim 2: Using EMA, we will examine putative mediators of treatment effects based on our conceptual model (see Figure 1). H2: Self-paced PA will lead to a more positive affective response (primary mediator) and thus greater increases in PA behavior.37 Secondary mediators (analogous to secondary outcomes) will include: (a) perceived autonomy, and (b) perceived exertion (RPE).37 Other predictors of PA behavior will also be explored.

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