Smoking
Development of an Integrated mHealth App-Based Intervention to Support Smoking Cessation in People Living with HIV
Principal Investigator: Bettina Hoeppner, PhD
Co-Investigator: Conall O’Cleirigh, PhD
Funding Source: NIH
Project Number: 1R21CA261458-01
Description: HIV positive smokers lose more life-years to smoking than to HIV. Public health efforts to reduce the prevalence of smoking have under-served this important population, as demonstrated by the prevalence of smoking among persons living with HIV, which is more than twice as high compared to the general population. We propose to develop an integrated smoking cessation treatment that builds on our expertise and the field's successes in leveraging the HIV clinical care setting and smartphone app technology to provide scalable, tailored, sustained smoking cessation support to HIV-positive smokers.
Effectiveness of a Smoking Cessation Algorithm Integrated into HIV Primary Care
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: National Institute on Drug Abuse
Project Number: R01DA044112
Smoking remains the leading cause of preventable death and disability in the United States. Whereas smoking has declined significantly among individuals such as people living with HIV/AIDS (PLWH) in whom smoking prevalence rates and result comorbidity rates remain high. Medical advances in the treatment of HIV have resulted in substantial increases in life expectancy among PLWH and as a consequence PLWH smokers are now, more than ever, at heightened risk for tobacco-related illness and death. In fact, PLWH smokers engaged in treatment lose more years of life due to smoking now than to HIV disease. Although PLWH smokers engaged in HIV care typically see a medical provider every 4-6 months, smoking cessation treatment and referral is often not part of routine HIV care. While 94% of HIV treatment providers indicated that they would be willing to provide smoking cessation services to their patients, few have received training in how to provide smoking cessation services. With 7 first-line pharmacotherapies available for smoking cessation, development of algorithms to assist providers in selecting the most appropriate pharmacotherapy is an important but untested strategy to increase smoking cessation in PLWH.
The purpose of this study is to:
- Compare the efficacy of Algorithm Treatment to Enhanced Treatment as Usual for smoking cessation among PLWH smokers engaged in HIV clinical care. Algorithm Treatment includes the generation of a pharmacotherapy prescription recommendation sent to the patient’s medical provider through the electronic medical record.
- Characterize provider-, staff-, patient-, and clinic-level facilitators and barriers to integration of Algorithm Treatment.
- Examine the cost effectiveness for the intervention relative to primary smoking outcomes.
This project is being conducted at Fenway Community Health in Boston, MA, University of Alabama at Birmingham, and at University of Washington at Seattle.
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: National Institute on Drug Abuse
Project Number: R01DA047933
Although the prevalence of smoking has declined over the past 50 years, large disparities in tobacco use remain across several subgroups, particularly disadvantaged and health compromised populations. Smokers living with HIV represent a major health disparity population in the United States and the world more generally, and their unique healthcare needs are not being adequately addressed. For people living with HIV, smoking is related to poorer survival and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV. Major contributing factors to maintenance and relapse of smoking among smokers living with HIV include exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression.
The purpose of this study is to:
- Test the efficacy of the QUIT intervention plus Nicotine Replacement Therapy in HIV-infected smokers, using a 3-arm RCT. QUIT is a cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities.
- Examine the degree to which smoking abstinence is mediated by reductions in symptoms of anxiety and depression.
- Estimate the cost-effectiveness of the QUIT intervention for smoking cessation among smokers living with HIV with clinically significant symptoms of anxiety/depression.
Assessing the integration of tobacco cessation treatment into lung cancer screening
Principal Investigator: Elyse R. Park, PhD, MPH; Nancy A. Rigotti, MD; Jennifer S. Haas, MD, MSPH
Funding Source: National Cancer Institute
Project Number: R01CA218123
Description: This project will address the integration of a virtual tobacco cessation treatment into lung cancer screening in a large integrated health care delivery system by integrating into its LDCT-LCS sites a novel, personalized, evidence-based smoking cessation intervention in English and Spanish.
Currently enrolling participants.
Implementing a virtual tobacco treatment in community oncology practices
Principal Investigator: Elyse R. Park, PhD, MPH; Jamie Ostroff, PhD
Funding Source: National Cancer Institute
Project Number: 1R01CA214427-01A1
Description: The aim of this study is to conduct an effectiveness-implementation trial to assess virtual delivery of an evidence-based tobacco treatment intervention in cancer community sites affiliated with the newly established NCI community Oncology Research Program nationally.
Currently enrolling participants.
Integrating tobacco treatment into cancer care
Principal Investigator: Elyse R. Park, PhD, MPH
Funding Source: National Cancer Institute
Project Number: 1K24 CA197381-01
Description: The mentoring and research aims of this proposal involve expanding our knowledge of how to develop and deliver evidence-based tobacco treatment for diverse/variety of cancer patients.
Potential participants: No longer recruiting.
Integrating tobacco treatment into cancer care: Supplement to promote diversity in research
Principal Investigator: Elyse R. Park, PhD, MPH
Co-PI: Giselle K. Perez, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: 3R01CA166147-03S1
Description: Although there is a clear need for tobacco treatment among black and Hispanic smokers, little is known about their smoking behaviors and engagement in tobacco treatment following a cancer diagnosis and initiation of cancer care. Understanding the contribution of racial and ethnic factors on tobacco treatment during cancer care will help inform the development of tobacco programs that target the needs of this group. The proposed supplement aims to understand attitudes and barriers toward tobacco cessation treatment among black and Hispanic cancer patients.
Potential participants: No longer recruiting.
Depression
Be Well at Work-Plus: Engaging low-wage workers in the design and implementation of a depression and physical activity intervention.
Principal Investigator: Jessica McCurley, PhD, MPH
Funding Source: National Heart, Lung, and Blood Institute
Project Number: K23HL157763
Description: Low-wage workers comprise one third of all workers in the U.S. and have a high prevalence of cardiometabolic risk factors, including depression and physical inactivity. This study will develop and test a dynamic workplace-based telehealth depression intervention that is tailored to the specific social and behavioral needs of low-wage workers. In addition to Cognitive Behavioral Therapy to support work productivity, the intervention will include assessment and referrals for social determinants of health, physical activity promotion, and personalized text message support for mood and physical activity. This study will be developed using a planned adaptation approach and will involve low-wage workers in the design of the intervention.
Oncology
A Randomized Controlled Trial of Emotion-Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress
Principal Investigator: Allison Applebaum, PhD and Douglas Mennin, PhD (MGH Site PI: Jamie Jacobs, PhD)
Funding Source: National Cancer Institute
Project Number: R01CA244185
This is a multisite randomized controlled trial comparing Emotion Regulation Therapy to Traditional Cognitive Behavioral Therapy to reduce distress and burden in family and friend caregivers of patients undergoing treatment for varying cancer types and stages. Caregivers caring for patients with any type of cancer or any stage of disease are eligible to participate and will receive 8 free individual therapy sessions via videoconference. Patients are also eligible to complete surveys if their caregiver is enrolled in the trial. Interested patients or caregivers may contact Kate Morgan for more information at caregivingresearch@mgh.harvard.edu.
Randomized trial of a multimodal sexual dysfunction intervention for hematopoietic stem cell transplant survivors
Principal Investigator: Areej El-Jawahri, MD
Co-investigator: Lara Traeger, PhD
Funding Source: American Cancer Society
Description: This project entails conducting a single site randomized clinical trial to test the efficacy of a multimodal sexual dysfunction intervention to enhance sexual function, quality of life, and mood in hematopoietic stem cell transplant survivors.
Psychological Intervention for Caregivers of Patients with Malignant Gliomas
Principal Investigator: Deborah Forst, MD
Co-investigator: Jamie Jacobs, PhD
Funding Source: Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO)
This is a randomized controlled trial to examine the efficacy of a 6-session intervention based in cognitive behavioral therapy to reduce anxiety in caregivers of patients with malignant gliomas, in comparison with usual care. Caregivers of patients with malignant gliomas are eligible and will be randomly assigned to either the intervention (6 sessions with a therapist via videoconference) or a usual care control group. For more information about this study contact Michelle Mesa: mmesa@mgh.harvard.edu.
Intervention for Fear of Cancer Recurrence and Uncertainty in Survivorship (IN FOCUS)
Principal Investigator: Daniel L. Hall, PhD
Funding Source: National Center for Complementary and Integrative Health
Project Number: K23At010157
Description: This is a study to adapt and pilot test a virtual, multimodal mind-body resiliency intervention (SMART-3RP) to help cancer survivors manage fear of recurrence (FOR). FOR is a common, highly distressing difficulty after diagnosis of a chronic and/or life threatening illness that may increase risk for poorer clinical outcomes by influencing healthcare engagement (e.g., frequency of follow-up screening). Among cancer survivors, a population growing in prevalence, clinically-impairing FOR is pervasive and can persist for years. Using qualitative and quantitative methods, this project will assess the feasibility and acceptability of an adapted mind-body intervention targeting FOR among cancer survivors and will inform the science of managing these fears and their clinical consequences among medical populations more broadly. Phase 1 of this study included focus groups and individual interviews with cancer survivors to identify targets for adaptation, including FOR-related coping and healthcare engagement patterns. Phase 2 will test the feasibility of the adapted intervention in a pilot RCT and will explore preliminary effects on FOR and healthcare engagement outcomes.
Potential Participants: We anticipate opening recruitment for our pilot trial early 2021. To learn more about this research study, please contact the study coordinator at hmizrach@mgh.harvard.edu or 617-982-3972.
Survivorship Sleep Program (SSP): An Adapted Telehealth Intervention for Insomnia among Cancer Survivors
Principal Investigator: Daniel L. Hall, PhD
Funding Source: American Cancer Society
Project Number: Institutional Research Grant
Description: This is a study to test the feasibility, acceptability, and preliminary effects of a virtual cognitive behavioral therapy for insomnia (CBT-I) program for cancer survivors. Insomnia is a significant and often unaddressed problem for adults treated for various types of cancer, with a prevalence rate (30-50%) approximately three times as high as in the general population. CBT-I is a safe, highly effective, and affordable treatment for insomnia that may be delivered to patients in as few as four sessions; however, attrition is common, and engaging patients may require a patient-centered approach. Using qualitative and quantitative methods, this project will seek to adapt CBT-I to address survivor late effects and unique sleep related concerns. Phase 1 of this study included 10 individual interviews with cancer survivors with insomnia to identify perceived needs and preferences for virtually-delivered CBT-I. Phase 2 is testing the feasibility and preliminary efficacy of the Survivorship Sleep Program in a pilot RCT and will explore preliminary effects on evening actigraphy measures.
Potential Participants: We are looking for cancer survivors experiencing difficulty sleeping to participate in study testing a 4-week virtual cognitive behavioral program. If you are interested in participating in this research, please contact the study coordinator at hmizrach@mgh.harvard.edu or 617-982-3972.
Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy with a Culturally Informed Intervention
Principal Investigator: Jamie Jacobs, PhD
Funding Source: MGH ESSCO Breast Oncology
The goal of this project is to develop and test a culturally-informed psychosocial intervention to increase initiation of adjuvant endocrine therapy in patients with early-stage, hormone receptor positive breast cancer and to improve equity in breast cancer care. This is a mixed methods study which will entail a qualitative phase with semi-structured interviews of Black, Latina, and
Asian American patients who have not started adjuvant endocrine therapy and are hesitant to begin therapy. The second phase will involve a single arm pilot to test a culturally sensitive intervention to address cultural barriers to starting endocrine therapy. For more information contact Shibani Datta: sdatta12@mgh.harvard.edu.
Promoting adherence to endocrine therapy for breast cancer survivors
Principal Investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute
Project Number: 5K07CA211107-02
Description: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors) to reduce the risk of recurrence and improve survival; however, adherence to these medications among breast cancer survivors is overwhelmingly poor, with half of women being non-adherent within five years. Furthermore, breast cancer survivors with high psychological distress (e.g., related to side effects) are less likely to be adherent to this preventative treatment. There is an absence of efficacious interventions to improve endocrine therapy adherence, help survivors manage symptoms, and reduce distress. To address this gap, this study employs a mixed-methods design to develop and test a stepped-care, telehealth intervention to improve adherence to endocrine therapy and reduce distress in breast cancer survivors at Massachusetts General Hospital Cancer Center and three community affiliates. Step 1 is a 3-session, Brief Adherence Intervention for BCS with poor adherence; Step 2 is an adapted 8-session Cognitive-Behavioral Therapy for BCS with poor adherence and high distress. Phase 1 includes (1) intervention development with psychologists and oncology clinicians and semi-structured interviews with breast cancer survivors, and (2) a pilot study to evaluate acceptability and refine the intervention. Phase 2 will entail a randomized controlled trial to assess the feasibility of comparing the stepped-care, telehealth intervention to a medication monitoring control on adherence outcomes over eight months.
Potential participants: We are currently recruiting female breast cancer survivors who have completed active treatment (e.g., surgery, chemotherapy, radiation) for early-stage, ER+/PR+ breast cancer and are currently taking endocrine therapy (e.g., Tamoxifen, Arimidex, Aromasin, Femara, Faslodex, Zoladex). Participants will complete a 20-30 minute phone interview with research staff.
For more information, please contact: Emily Walsh, 617-724-1414
Principle investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute
Project Number: K07CA211107
Description: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors) to reduce the risk of recurrence and improve survival; however, adherence to these medications among breast cancer survivors is overwhelmingly poor, with half of women being non-adherent within five years. Furthermore, breast cancer survivors with high psychological distress (e.g., related to side effects) are less likely to be adherent to this preventative treatment. There is an absence of efficacious interventions to improve endocrine therapy adherence, help survivors manage symptoms, and reduce distress. To address this gap, this study employs an intervention, STRIDE (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy), versus standard care plus medication monitoring in up to 100 breast cancer survivors taking adjuvant endocrine therapy (run-in period, n=5; RCT, n=100). Patients randomly assigned to the STRIDE intervention will receive six weekly one-hour sessions in small groups of two to three patients delivered via videoconferencing by a mental health professional. Patients assigned to the medication monitoring group will store their medication in the electronic pill bottle and receive oncology follow-up care as usual.
Potential participants: We are currently recruiting female breast cancer survivors who have completed active treatment (e.g., surgery, chemotherapy, radiation) for early-stage, ER+/PR+ breast cancer and are currently taking endocrine therapy (e.g., Tamoxifen, Arimidex, Aromasin, Femara, Faslodex, Zoladex).
For more information, please contact: Jamie Jacobs, 617-724-1414
Understanding and Improving Health Insurance Coverage Among Long-Term Follow-up Study Cohort Participants / HINT I
Principal Investigators: Elyse Park, PhD; Giselle Perez Lougee, PhD
Funding Source: American Cancer Society
Description: Dr. Park and her colleagues published findings in the Journal of Clinical Oncology demonstrating that CCSS survivors, compared to siblings, were significantly more likely to be uninsured and to have difficulties obtaining health insurance. Given the current insurance landscape and the additional insurance burden that childhood cancer survivors face, the present study seeks to develop and pilot a health insurance navigation program targeted at feasibility and acceptability with survivors and improving health insurance literacy and ameliorating financial distress related to medical costs. The proposed health insurance navigation will involve 4 navigator-led health insurance navigation sessions. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
Using a Virtual Health Insurance Navigation Pilot Program to Understand and Improve Health Insurance Coverage Among Survivors of Colorectal Cancer / HINT-C
Principal Investigators: Elyse Park, PhD; Giselle Perez Lougee PhD
Description: This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve 1) health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
Currently enrolling participants.
A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors
Principal Investigator: Perez Lougee, PhD
Funding Source: National Cancer Institute
Project Number: 1K07CA211955-01A1
Description: Survivors of cancers diagnosed during adolescence and young adulthood (AYA) represent a distinct group of survivors who are vulnerable to experiencing chronic stress and adverse health outcomes. Receiving a cancer diagnosis during a developmental period marked by peak socioemotional and physical changes has the potential to exacerbate typical adjustment problems and interfere with important age-specific milestones; despite their vulnerability, there are a lack of targeted programs to help AYAs manage these stressors. Using self-report and objective measures, this study proposes to develop and test the feasibility, acceptability and preliminary effects of an adapted, virtually delivered, evidence-based program, the Relaxation Response Resiliency Program (3RP),9 in promoting stress management and coping among survivors of AYA cancers.
Specific Aims: Using a 2-phase, mixed methods approach, we propose to:
- Adapt a mind-body resiliency group intervention for AYAs (3RP-AYA) that is aimed at reducing stress and promoting stress- management during the post-treatment transitional period
- Conduct an open pilot (n=8) to test and refine the 3RP-AYA
- Examine, in a pilot randomized controlled trial (n=60), the feasibility, acceptability, and preliminary effects of a virtual, group-based, stress-management program for AYAs who are in the early stages of survivorship; and 3b) explore the feasibility and acceptability of collecting hair samples to examine intervention-related changes in stress as measured by cortisol.
Potential participants: No longer recruiting.
Exploring oncology providers’ attitudes toward cancer clinical trials
Principal Investigator: Giselle K. Perez, PhD
Funding Source: Lazarex-Mass General Cancer Care Equity Program
Project Number: NA
Description: Cancer clinical trials represent the “gold standard” of comparing and testing the safety and effectiveness of novel therapies for the treatment of cancer. Adequate participation of eligible populations is critical to ensuring the accuracy and generalizability of trial findings across diverse groups; however, trial enrollment rates remain suboptimal. The proposed study intends to expand this body of research by using mixed methods strategies to describe oncology providers’ perspectives of enrolling eligible patients into cancer clinical trials. Specifically, we aim to describe their attitudes, experiences, and barriers with recommending and enrolling patients into cancer clinical trials, purposely attending to concerns related to the enrollment of minority and underserved groups. In addition, this study aims to identify strategies to improve trial accrual rates. Findings will help guide the development of an educational intervention for cancer care providers to improve clinical trial enrollment among vulnerable and underserved populations.
Potential participants: No longer recruiting.
Promoting stress management and resiliency among lymphoma survivors transitioning off treatment
Principal Investigator: Perez Lougee, PhD
Funding Source: American Cancer Society (ACS)
Project Number: ACS IRG 2016S000828
Description: Lymphoma survivors are faced with a number of psychosocial and physical sequelae related to their cancer type and treatment that makes them susceptible to experiencing higher rates of distress compared to other survivor groups. This study proposes to develop and test a virtual group program to promote stress management and coping among lymphoma survivors transitioning off treatment.
Potential participants: No longer recruiting.
Enhancing quality of life in adults completing lung cancer treatment with curative intent
Innovation Award
Principal Investigator: Lara Traeger, PhD
Funding Source: American Lung Association
Description: The goal of this project is to conduct a multi-site randomized clinical trial to test the efficacy of the Transitions Program, a behavioral intervention to improve quality of life in patients who have completed lung cancer treatment with curative intent. We aim to test the efficacy of the Transitions Program in improving patient-reported quality of life relative to the control group.
To learn more about this study, please contact the study coordinator at: kmassad@mgh.harvard.edu
Principal Investigator: Lara Traeger, PhD
Funding Source: American Cancer Society
Project Number: ACS MRSG PCSM 1410701
Description: This study is a trial of the Transitions Program, a telehealth intervention for up to 45 adults who have been treated for lung cancer or mesothelioma with curative intent. As patients finish cancer treatment and move on (“transition”) to surveillance or follow-up care, they may face a range of unexpected concerns. Some of these concerns may include lingering symptoms, changes in social support, and uncertainty about the future, which can impact important areas of wellbeing. Study participants who are assigned to the Transitions Program will receive up to five sessions with a study clinician to learn and practice strategies for enhancing their quality of life. We aim to test the feasibility and acceptability of the Transitions Program, along with its benefits to quality of life. This study is a critical step toward enhancing quality of life during a critical but often neglected phase of cancer care for patients with thoracic cancers.
Potential Participants: If you are interested in participating in this research, please contact the study coordinator at kmassad@mgh.harvard.edu.
HIV
Harvard University Center for AIDS Research (CFAR) Behavioral and Social Sciences Core
Principal Investigator: Conall O’Cleirigh, PhD, Associate Director
Description: In his role as Associate Director of the Harvard University CFAR Behavioral and Social Sciences (BSS) Core, Dr. O’Cleirigh provides consultation on developing and supporting HIV-related clinical research. The Core provides services to behavioral and biomedical researchers; will leverage ongoing biomedical projects to integrate behavioral/social science and conduct add-on behavioral/social science studies; and will engages community stakeholders to increase buy-in of research and acceptance of new biomedical technologies.
Principal Investigator: Abigail Batchelder, PhD, MPH
Funding Source: National Institute of Drug Abuse (NIDA)
Project Number: K23DA043418-04S1
Description: This administrative supplement supports ongoing community-based data collection and study operations related to the active pilot randomized controlled trial designed to improve engagement in HIV care by addressing internalized stigma and shame among sexual minority men with substance use disorders.
Intersecting stigmatized identities and engagement in HIV treatment (INSIGHT) study
Principal Investigator: Abigail Batchelder, PhD, MPH
Funding Source: Harvard Center for AIDS Research NIH/NIAID 5P30AI060354-13
Description: Men who have sex with men (MSM) continue to be disproportionately affected by HIV in the US and in Massachusetts; they also have higher rates of distress and substance use compared to heterosexual men. Further, the sexual minority stress theory posits that stigma accounts for higher rates of psychological distress and substance use. Emerging evidence indicates that when stigma is internalized, it can be experienced as chronic trauma. The well-supported Stress and Coping Theory suggests that the relationship between internalized stigma and poor engagement in HIV care may be due to avoidant coping, a common outcome of trauma. Internalized stigma is associated with poor engagement in care, including nonadherence to antiretroviral treatment (ART), which may be intensified by, the co-occurrence of intersecting internalized stigmas. However, the mechanisms by which intersecting internalized stigmas (e.g., being MSM, HIV+, or a substance user) lead to worse HIV outcomes are neither well understood nor addressed with existing interventions. Leveraging recent findings on the intersectionality of identities and related-chronic trauma, this study will expand on my previous work by providing critical data to adapt a promising intervention that I originally designed to address substance use and HIV-related shame and associated thoughts (e.g., internalized HIV and substance use-stigma), as barriers to engagement in HIV care. The intervention incorporates components of evidence-based cognitive behavioral therapy (CBT) with an innovative bidirectional text message platform to enhance emotional self-regulation in order to improve engagement in HIV care among HIV+ substance users.
Goals:
- Identify substance using HIV+ MSM’s perceptions of the link between sub-optimal engagement in HIV treatment and intersecting internalized stigmas, including the role of avoidance (n=30, or until saturation).
- Use structural equation modeling (SEM) to assess how engagement in HIV care, using a cascade index score, relates to intersecting internalized stigmas (HIV, substance use, and homonegativity; n=207).
Understanding and addressing internalized stigma and shame as barriers to engagement in HIV care
Principal Investigator: Abigail Batchelder, PhD, MPH
Funding Source: National Institute of Drug Abuse (NIDA)
Project Number: K23DA043418
Description: Internalized stigma and related emotions, such as shame, are under-addressed modifiable barriers to engagement in HIV care across the cascade, which theory indicates may mechanistically occur via avoidance coping behaviors, including substance use. As stigma-related emotions are notoriously under-reported, improved measurement and assessment of these pathways are needed to more strategically intervene on these barriers to HIV care. This K23 aims to elucidate underlying behavioral and social mechanisms associated with substance use and to optimize treatment success among MSM sub-optimally engaged in HIV care. This work involves three aims. 1) The assessment of the interrelationships between HIV care cascade indicators (i.e., linkage and engagement in care), substance use, and stigma-related emotions, informed by three measurements (recently validated nonverbal behavioral coding, narrative coding, and self-report).
This study will also assess whether avoidant coping mediates these relationships. 2) Focus groups with this target population in order to obtain feedback to be integrated with the results from the secondary data analysis to inform the refinement of a previously developed emotion regulation intervention (PI Batchelder: supported by UCSF’s Center for AIDS Prevention Studies Innovative Early Investigator Award) designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in care. 3) A pilot randomized controlled trial (RCT) of the refined intervention with substance using HIV+ MSM sub-optimally engaged in HIV care. Outcome data from this pilot will be used to assess the clinical utility for improving engagement in HIV care and reducing substance use.
Development of a trauma-informed intervention for adaptive engagement in care among MSM with HIV
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: The Fenway Institute
Description: Gay and bisexual men and other men who have sex with men (MSM) experience significant mental health disparities particularly, distress, trauma, depression and substance use compared to heterosexual men. Rates of PTSD and substance use are twice among gay and bisexual men and other MSM compared to heterosexual men. The relative high frequency of mental health problems among MSM may be even higher among MSM living with HIV/AIDS. For example, in a sample of over 500 gay and bisexual men living with HIV in primary care, 47% met diagnostic criteria for an anxiety disorder (inclusive of PTSD). These problems are not only distressing and interfering in and of themselves, but also are associated with health concerns such as higher risk of HIV or STI acquisition and, for MSM living with HIV/AIDS, suboptimal engagement in HIV and STI treatment uptake and care. Accordingly, no matter what new biomedical or behavioral HIV prevention or treatment tools emerge as we approach 2020, those at highest risk for HIV acquisition or worse HIV treatment outcome are likely to be those affected by comorbid mental health problems.
The purpose of this study is to:
- Test the feasibility and acceptability of a psychosocial intervention to improve engagement in HIV care, HIV medication adherence among MSM living with HIV with trauma histories. The intervention integrates most current empirically supported cognitive-behavioral approaches to support engagement in HIV care (i.e., LifeSteps) with cognitive-processing therapy, an empirically validated, cognitive-behavioral intervention for reducing posttraumatic stress.
- Examine, in a pilot randomized controlled trial, the impact of the proposed intervention for MSM with trauma history on improvement in engagement in HIV care, adherence to HIV treatment, (primary outcomes) and reductions of sexual transmission risk taking behaviors (secondary outcome).
- Explore whether intervention related changes in trauma-specific distress, will mediate intervention related changes in increases in engagement in care and ART adherence.
This project is being conducted at Fenway Health in Boston, MA and Ryerson University in Toronto, Canada.
Potential Participants: If you are interested in participating, please call 617-927-6465 (Boston site) or 416-979-5000 (Toronto site)
National HIV Behavioral Surveillance
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: Centers for Disease Control and Prevention
The purpose of National HIV Behavioral Surveillance (NHBS), which was created in 2003 by the Centers of Disease Control and Prevention, is to conduct behavioral surveillance among persons at high risk for HIV in 22 cities across the US. The study is run in 3 annual, rotating cycles, each of which aims to surveille a population at increased risk for HIV:
- Gay, bisexual, and other men who have sex with men (MSM) [2017,2020] Persons who inject drugs (IDU) [2018, 2021] Heterosexuals at increased risk for HIV infection (HET) [2019, 2022]
Since 2017, the Boston project site has been managed through a collaboration between the Massachusetts Department of Public Health and The Fenway Institute at Fenway Health.
The UNC/Emory Care Center for Innovative Technology (iTech) across the prevention and care continuum
(Sub-grant: An evidence-based cognitive behavioral adherence intervention to enhance PrEP uptake and adherence in high risk YMSM (Life Steps for Youth))
Principal Investigator: Christina Psaros, PhD & Kenneth Mayer, PhD (Project PIs); Lisa Hightow-Weidman & Patrick Sullivan (Overall PIs)
Funding Source: NICHD
Project Number: U19 HD089881-02S2
Description: The goal of this study is to refine the LifeSteps Intervention to meet the needs of young men who have sex with men who wish to use PrEP. We will then test the refined intervention in a pilot randomized controlled trial.
PrEP Demonstration Project Among Women at Risk for HIV Infection
Co-Principal Investigators: Christina Psaros and M. Kempf
Funding Source: NCCIH / R34 MH118044
Description: In the proposed pilot implementation study, we will first conduct preliminary work to understand how to best implement PrEP services into FQHC clinics in Alabama. In the next phase, an existing protocol for PrEP delivery will be modified, implemented, and refined using an iterative process; provider and patient level data on adherence to the PrEP care continuum will be collected.
A qualitative ancillary study of HPTN 083
A phase 2b/3 double blind efficacy study of quarterly injectable cabotegravir compared to daily oral tenofovir/emtricitabine (Truvada), for PrEP in HIV uninfected MSM and transgender women
Protocol Chairs: Christina Psaros, PhD & Steve Safren, PhD
Funding Source: NIH/NIAID
Project Number: HPTN 08320725
Description: The objective of this study is to (1) identify potential barriers, facilitators, and potentially modifiable issues related to adherence to clinic visits in the context of injectable PrEP; (2) learn about preferences and decision-making regarding the use of oral versus injectable PrEP, or other biomedical prevention products; and (3) gather explanatory qualitative data regarding participants’ experiences in HPTN 083 to better interpret study results and guide next step prevention strategies.
Evaluation of Trial of Life-Steps to Enhance Adherence and Engagement in PrEP Care
Principal Investigators: S. Safren and K. Mayer
Co-Investigator: Christina Psaros
Funding Source: NIH / R01 MH118043
Description: In the proposed study, the Life Steps intervention will be tested for efficacy in promoting PrEP adherence and maintenance. The primary outcome will be measure of adherence to daily PrEP over 12 months, and secondary outcomes will examine changes in sexual behavior, exploring the effectiveness of the intervention.
Aging
Effect of COVID-19 in caregivers of persons with dementia
Principal Investigator: Christine Ritchie, MD, MSPH
Co-investigator: Lara Traeger, PhD
Funding Source: National Institute on Aging (NIA)|
Project Number: 3R01AG050515-04S1
Description: The purpose of this study is to better understand the experience of caregivers caring for persons with dementia in assisted living facilities, nursing homes and in the community during the COVID-19 pandemic. We aim to: 1) describe the caregiver lived experience during the COVID-19 pandemic, 2) examine how COVID-19 related factors have affected caregiver stress, 3) explore the role of COVID-19 related factors on behavior changes and severity in persons living with dementia, and 4) assess the impact of COVID-19 on caregiver planning and health care decision-making.
Enhancing Resilience in Senior Living Community Residents
Principal Investigator: Lara Traeger, PhD
Funding Source: Erickson Living
Description: Mind-body medicine offers key strategies to help older adults enhance their health, resilience and capacity to flourish. This pilot study is designed to test the feasibility of integrating a mind-body group program into senior living communities. We also will explore participant satisfaction and potential benefits of program participation. This study will be conducted in collaboration with Erickson Living senior living communities across the U.S. We will use study results to guide next steps for larger scale program implementation.
To learn more about this study, please contact the study coordinator at gstyklunas@mgh.harvard.edu
Understanding and improving surgical decision-making for persons living with dementia, their family caregivers role, and their providers: A mixed methods study
Principal Investigator: Joel Weissman, PhD
Co-investigator: Lara Traeger, PhD
Funding Source: National Institute on Aging (NIA)
Project Number: R01AG067507-01
Description: The goal of this study is to understand and improve surgical decision making in persons living with dementia. We aim to: 1) develop the evidence base to understand the case mix and comparative outcomes of surgery provided to people living with dementia, 2) characterize surgical decision-making in clinical settings for people living with dementia, and 3) develop recommendations around surgical decision-making processes.
Weight Management and Physical Activity
Testing the feasibility and preliminary efficacy of a psychological and behavioral interventional to promote physical activity after weight loss
Principal Investigator: Emily Feig, PhD
Funding Source: National Heart Lung and Blood Institute (NHLBI)
Project Number: K23HL148017
Description: Physical activity is critical for maintaining health and preventing weight regain after bariatric surgery; however, most patients do not meet recommended levels of physical activity. The aim of this qualitative study is to better understand the lived experiences of physical activity in patients who have undergone bariatric surgery, in particular the emotions they experience when engaging in physical activity. The results will inform the development of a positive psychology-based intervention to increase physical activity after bariatric surgery.
Testing the feasibility of an intervention to promote physical activity for metabolic syndrome
Principal Investigator: Rachel Millstein, PhD
Funding Source: National Heart Lung and Blood Institute (NHLBI)
Project Number: K23HL135277
Description: Physical activity is critical for patients with metabolic syndrome, as it can prevent the risk of progressing to chronic diseases; however, most patients do not meet recommended levels of physical activity. This study aims to develop and test the feasibility of an 8-week physical activity intervention with targets of change at individual (positive psychology and motivational interviewing), social (group-based), and environmental (neighborhood walkability) levels of influence in patients with metabolic syndrome. If the intervention is successful, it can have the potential to improve health outcomes and prevent chronic diseases in this high-risk population.
Potential participants: We are looking to recruit people with a combination of high blood pressure, high blood sugar, high cholesterol or triglycerides, and high body weight, who speak English, do not do enough physical activity, and may benefit from learning skills to improve physical and emotional well-being. The program is takes place in groups of 4-8 people (total of up to 64 participants) and consists of eight weekly 90-minute sessions at local Mass General outpatient clinics.
For more information, please contact Sonia Kim (617-643-0871).
Sexual Minority Health
The daily effects of trauma and minority stress among sexual minority women with post-traumatic stress symptoms
Principal Investigators: Jillian Scheer
Co-Investigator: Abigail Batchelder, PhD, MPH
Funding Source: Yale Fund for Lesbian and Gay Studies
Description: This study aims to understand the trajectory of minority stress among sexual minority women with posttraumatic stress symptoms using daily diaries.
The Price of Minority Stress on Violence-exposed Sexual Minority Women’s Mental Health and Coping Strategies
Principal Investigators: Jillian Scheer
Co-Investigator: Abigail Batchelder, PhD, MPH
Funding Source: Women Faculty Forum Seed Grant
Description: This study aims to collect qualitative and quantitative data to develop an intervention for sexual minority women who have been exposed to violence.
Children with ASD/Special Needs
Promoting resiliency among SIBLINGS of children with autism spectrum disorder (ASD)
Principal Investigators: Karen Kuhlthau, PhD & Elyse R. Park, PhD, MPH
Funding Source: HRSA
Project Number: N/A
Description: Building on our work with parents of children with ASD, we adapted a program for siblings of children with ASD. To learn more about the experience of being a sibling of a child with ASD. We completed a pilot wait-list controlled trial.
Potential participants: We are recruited siblings, nationally, of children any age with Autism Spectrum Disorder.
Contact information: For more information, please email Lucy Fell (lfell@mgh.harvard.edu).
Promoting resiliency among FATHERS of children with autism spectrum disorder (ASD)
Principal Investigators: Karen Kuhlthau, PhD & Elyse R. Park, PhD, MPH
Funding Source: HRSA
Project Number: N/A – Project under development
Description: Expanding our reach to fathers of children with special needs, we are conducting in-depth interviews and will pilot an adapted version of our resiliency treatment for fathers.
Potential participants: We are recruiting fathers, nationally, of children any age with special needs.
Contact information: For more information, please email Lucy Fell (lfell@mgh.harvard.edu).
Mind-body Resiliency Data Repository
Principal Investigator: Elyse R. Park, Ph.D., MPH
Funding Source: N/A
Project Number: N/A
Description: The purpose of the Resiliency Data Repository is to provide a centralized data warehouse that will make the research and clinical data collected from participants in clinical resiliency programs. Typically, participants in these programs are individuals dealing with an ongoing stressor and/or chronic illness. Participants include adult and young adult cancer survivors, relatives of children with learning and attentional disabilities, and women with HIV. Data collected may relate to, or reflect, participant quality of life, such as data regarding engagement in health behaviors (e.g., healthy eating, physical activity, sleep quality), resiliency, social support, emotional distress, positive affect, and mindfulness. The data repository will standardize and streamline the collection, management and analysis of this data from these clinical and research projects.
Potential participants: Clinical and research participants enrolled in resiliency treatment programs and research.
Contact information: For more information, please email Lucy Fell (awrasmussen@mgh.harvard.edu)