CoMBAT Opioid Use Disorder: A Pilot RCT of a Combined Medication assisted and Behavioral Activation Treatment for People Living with Opioid Use Disorder
Research Project Leader
5/1/2019 – Present
Jaclyn White Hughto, PhD, MPH
Assistant Professor of Behavioral and Social Sciences; Assistant Professor of Epidemiology, Brown School of Public Health
Tel: 401-863-6580
Email: Jaclyn_Hughto@brown.edu
Jaclyn White Hughto, PhD, MPH is a social epidemiologist with expertise in qualitative and quantitative research methods and analysis. Her research aims to 1) document the structural-, interpersonal-, and individual-level factors that contribute to health inequities for sexual and gender minorities, individuals living with substance use disorder, and other marginalized populations; and 2) develop and test community-based interventions to improve the health of at-risk communities.
Dr. Hughto has authored more than 50 publications and her research has been cited in testimony before state and federal courts to advance the health of gender minorities.
Background: 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 (treatment-as-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.
Complete List of Published Work in My Bibliography:
http://www.ncbi.nlm.nih.gov/sites/myncbi/1xITqqsBVUlAk/bibliography/46862971/public/?sort=date&direction=ascending
Hughto, J.M.W. & Clark, K.A. (2019) Designing a transgender health training for correctional healthcare providers: A feasibility study. The Prison Journal. Ahead of print.
Mimiaga, M.J. Hughto, J.M.W., Biello, K.B., Santostefano, C., Kuhns, K., Reisner, S.L., Garofalo, R. (2019) Longitudinal analysis of syndemic psychosocial problems predicting HIV risk behavior among a multicity prospective cohort of sexually active young transgender women in the United States. JAIDS. Ahead of Print.
Mimiaga, M.J., Pantalone, D.W., Biello, K.B., Hughto, J.M.W., Frank, J., O’Cleirigh, C., Reisner, S.L., Restar, A., Mayer, K.H., Safren, S.A. (2019) An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. Ahead of Print
Mimiaga, M.J., Hughto, J.M. & Reisner, S. (2019) A randomized pilot study of a group-delivered HIV risk reduction intervention for at-risk urban men who have sex with men who regularly attend private sex events. Archives of Sexual Behavior. Ahead of print.
Peitzmeier, S., Hughto, J.M.W., Potter, J., Deutsch, M. & Reisner, S.L. (2019). Development of a novel tool to assess intimate partner violence against transgender individuals. Journal of Interpersonal Violence. Ahead of Print.
McDowell, M., White Hughto, J.M., & Reisner, S.L. (2019). Risk and protective factors for mental health morbidity in a community sample of female-to-male trans-masculine adults. BMC Psychiatry, 19(1) 16-28
Cai, X., Hughto, J.M.W., Reisner, S.L., Pachankis, J.E., & Levy, B. (2018) Benefit of gender-affirming medical treatment for transgender elders: Later-life alignment of mind and body. LGBT Health, 6(1), 34-39.
Fu, E., White, M., Hughto, J.M.W., Steiner, B., & Willis, E. (2019) Development and reliability of the physical activity tracking preference questionnaire. International Journal of Exercise Science, 12(5) 297-309.
Hughto, J.M., Pachankis, J.E., & Reisner, S.L. (2018) Healthcare mistreatment and avoidance in trans masculine adults: The mediating role of rejection sensitivity. Psychology of Sexual Orientation and Gender Identity. Ahead of print.
White Hughto, J.M., Clark, K.A., Reisner, S.L., Kershaw, T.S., Altice, F.L., & Pachankis, J.E. (2018) Creating, reinforcing, and resisting the gender binary: A qualitative study of transgender women’s healthcare experiences in sex-segregated jails and prisons. International Journal of Prisoner Health, 14(2), 1-20.
White Hughto, J.M., Reisner, S.L., Kershaw, T.S., Altice, F.L., Biello, K., Mimiaga, M.J., Garofalo, R., Kuhns, L.M., & Pachankis, J.E. (2018) A multisite, longitudinal study of risk factors for incarceration and impact on mental health and substance use among young transgender women in the USA. Journal of Public Health, Ahead of print, 1-10.
Agenor, M., White Hughto, J.M., Peitzmeier, S.M., Potter, J., Deutsch, M., Pardee, D.J. & Reisner, S.L. (2018) Gender identity disparities in Pap test use in a sample of binary and non-binary transmasculine adults. Journal of General Internal Medicine. Ahead of print, 1-3.
Diemer, E., White Hughto, J.M. Gordon, A., Guss, C., Austin, S.B., & Reisner, S.L. (2018) Beyond the binary: Differences in eating disorder prevalence by gender identity in a transgender sample. Transgender Health, 3(1), 17-24.
Reisner, S.L., Deutsch, M.B., Peitzmeier, S., White Hughto, J.M., Cavanaugh, T., Pardee, D.J., McLean, S., Panther, L.A., Gelman, M., Mimiaga, M.J., & Potter, J., (2018) Test performance and acceptability of self- versus provider-collected swabs for high-risk HPV DNA testing in female-to-male trans masculine patients. PloS One. 13(3): e0190172.
Mimiaga, M.J., Kuhns, L.M., Biello, K.B., Olson, J., Hoehnle, S., Santostefano, C.M., Hughto, J.M.W., & Garofalo, R. (2018) Positive STEPS – a randomized controlled efficacy trial of an adaptive intervention for strengthening adherence to antiretroviral HIV treatment among youth: study protocol. BMC Public Health. 18(1), 867-896.
Mimiaga, M.J., Pantalone, D.W., Biello, K.B., Glynn, T.R., Santostefano, C.M., Olson, J., Pardee, D.J., Hughto, J.M.W., Valles, J.G., Carrico, A.W., Mayer, K.H., & Safren, S.A. (2018) A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: Project IMPACT study protocol. BMC Public Health. 18(1) 914-925.
White Hughto, J.M., Clark, K.A., Altice, F.L., Reisner, S.L., Kershaw, T.S., & Pachankis, J.E. (2017) Improving correctional healthcare providers’ ability to care for transgender patients: Evaluation of a theory-driven cultural and clinical competence intervention. Social Science & Medicine, 195, 159-169.
White Hughto, J.M., Pachankis, J.E., Willie, T.C., & Reisner, S.L. (2017) Victimization and depressive symptomology in transgender adults: The mediating role of avoidant coping. Journal of Counseling Psychology, 64(1), 41-51.
White Hughto, J.M., Rose, A.J., Pachankis, J.E., & Reisner, S.L. (2017). Barriers to gender transition-related healthcare: Identifying underserved transgender adults in Massachusetts. Transgender Health, 2(1), 107-118.
Clark, K.A., White Hughto, J.M., & Pachankis, J.E. (2017) “What’s the right thing to do?”: Correctional healthcare providers’ knowledge, attitudes, and experiences caring for transgender inmates. Social Science & Medicine, 193(Supplement C), 80-89.
Wang, K., White Hughto, J.M., Biello, K., O’Cleirigh, C., Mayer, K., Rosenberg, J., Novak, D., & Mimiaga, M.J. (2017) The role of distress intolerance in the relationship between childhood sexual abuse and problematic alcohol use among Latin American MSM. Submitting to Drug & Alcohol Dependence, 175, 151-156.
Reisner, S.L., Jadwin-Cakmak, L., White Hughto, J.M., Martinez, M., Salomon, L., & Harper, G.W. (2017) Characterizing the HIV prevention and care continua in a sample of transgender youth in the U.S. AIDS & Behavior, Ahead of print.
Reisner, S.L., Randazzo, R. White Hughto, J.M. Peitzmeizer, S., DuBois, Z., Pardee, D., Marrow, E., & Potter, J. (2017) Sensitive health topics with underserved patient populations: Methodological considerations for online focus group discussions. Qualitative Health Research, Ahead of print.
Willie, T.C., Chakrapani, V., White Hughto, J.M., & Kershaw, T.S. (2017) Victimization and human immunodeficiency virus-related risk among transgender women in India: A latent profile analysis. Violence & Gender, Ahead of print.
Reisner, S.L., Deutsch, M., Peitzmeizer, S., White Hughto, J.M., Cavanaugh, T., Pardee, D., McClean S., Marrow, E., Mimiaga, M.J., Panther, L., Gelman, M., Green, J., & Potter, J. (2017) Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: A mixed-methods biobehavioral study protocol. BMC Infectious Diseases, 17(1), 444-454.
Vijay, A., Wickersham, J.A., Earnshaw, V.A., Tee, Y.C., Pillai, V., White Hughto, J.M., Clark, K.A., Kamarulzaman, A., & Altice, F.L. (2017) Factors associated with medical doctors’ intention to discriminate against transgender patients in Kuala Lumpur, Malaysia. LGBT Health, Ahead of print.
White Hughto, J.M., Murchison, G., Clark, K.A., Pachankis, J.E., & Reisner, S.L. (2016) Geographic and individual differences in healthcare access for U.S. transgender adults: A multilevel analysis. LGBT Health, 3(6), 424-433.
White Hughto, J.M., Pachankis, J.E., Edlahan, A.I., & Keene, D.E. (2016) “You can’t just walk down the street and meet someone:” The intersection of social-sexual networking technology, stigma, and health among gay and bisexual men in the small city. American Journal of Men’s Health, Ahead of print.
White Hughto, J.M., Robertson, A.M., Hilalgo, A., Reisner, S.L., Rowley, B.R., & Mimiaga, M.J. (2016) Indicators of HIV-risk resilience among men who have sex with men: A content analysis of online profiles. Sexual Health, Ahead of print.
White Hughto, J.M. & Reisner, S.L. (2016) Social context of depressive distress in aging transgender adults. Journal of Applied Gerontology, Ahead of print.
White Hughto, J.M. & Reisner, S.L. (2016) A systematic review of the effects of hormone therapy on psychological functioning and quality of life in transgender individuals. Transgender Health, 1(1), 21-31.
White Hughto, J.M., Biello, K.B., Reisner, S.L., Perez-Brumer, A., Heflin, K.J., & Mimiaga, M.J. (2016) Health risk behaviors in a representative sample of bisexual and heterosexual female high school students in Massachusetts. Journal of School Health, 86(1), 61-71.
Reisner, S.L., White Hughto, J.M., Gamarel, K.E., Mizock, L., Keuroghlian, A.S., & Pachankis, J.E. (2016) Discriminatory experiences associated with posttraumatic stress disorder symptoms among transgender adults. Journal of Counseling Psychology, 63(5), 509-519.
Reisner S.L., White Hughto, J.M., Pardee, D.J., Kuhns, L., Garofalo, R., & Mimiaga, M.J. (2016). LifeSkills for Men (LS4M): Pilot evaluation of a gender-affirmative HIV and STI prevention intervention for young adult transgender men who have sex with men. Journal of Urban Health. 93(1), 189-205.
Reisner, S.L., Biello, K.B., White Hughto, J.M., Kuhns, L., Mayer, K.H., Garofalo, R., & Mimiaga, M.J. (2016) Psychiatric diagnoses and comorbidities in a diverse, multicity cohort of young transgender women: Baseline findings from Project LifeSkills. JAMA Pediatrics, 170(5), 481-486.
Gordon, A., Austin, B., Krieger, N., White Hughto, J.M., & Reisner, S. (2016). “I have to constantly prove to myself, to people, that I fit the bill”: Perspectives on weight and shape control behaviors among low-income, ethnically diverse young transgender women. Social Science & Medicine, 165, 141-149.
Katz-Wise, S.L., Reisner, S.L., White Hughto, J.M., & Budge, S. (2016) Self-reported changes in attractions and social determinants of mental health in transgender adults. Archives of Sexual Behavior, 1-15.
Keene, D.E., Eldahan, A.I., White Hughto, J.M., & Pachankis, J.E. (2016). ‘The big ole gay express’: sexual minority stigma, mobility and health in the small city. Culture, Health & Sexuality, 1-14.
White Hughto, J.M., Reisner, S.L., & Mimiaga, M.J. (2015) Characteristics of transgender residents of Massachusetts’ cities with high HIV prevalence. American Journal of Public Health, 105(12), e14–e18.
White Hughto, J.M., Reisner, S.L., & Pachankis, J.E. (2015) Transgender stigma and health: A critical review of stigma determinants, mechanisms, and interventions. Social, Science & Medicine, 147, 222–231.
White, J.M., Dunham, E., Rowley, B.R., Reisner, S.L., & Mimiaga, M.J. (2015) Sexually explicit racialised media targeting men who have sex with men online: A content analysis of high-risk behaviour depicted in online advertisements. Culture, Health & Sexuality, 17(8), 1-14.
Reisner, S.L., White Hughto, J.M., Dunham, E., Heflin, K.H., Begenyi, J.B.G., Coffey- Esquivel, J., & Cahill, S. (2015) Legal protections in public accommodations settings: A critical public health issue for gender minority people. Milbank Quarterly. 93(3), 1–32.
Reisner, S.L., White Hughto, J.M., Pardee, D., & Sevelius, J. (2015) Syndemics and gender affirmation: HIV sexual risk in female-to-male trans masculine adults reporting sexual contact with cisgender males. International Journal of STD & AIDS, 27(11), 955–966.
Katz-Wise, S.L., Reisner, S.L., White Hughto, J.M., & Keo-Meier, S.C. (2015) Differences in sexual orientation diversity and sexual fluidity in attractions among gender minority adults. Journal of Sex Research, 53(1), 74-84.
Keuroghlian, A.S., Reisner, S.L., White, J.M., & Weiss, R. (2015) Substance use and treatment of substance use disorders in a community sample of transgender adults. Drug & Alcohol Dependence, 152, 139-146.
Reisner, S.L., Vetters, R., White, J.M., Cohen, E.L., LeClerc, M., Zaslow, S. Wolfrum, S., & Mimiaga, M.J. (2015) Laboratory-confirmed HIV and sexually transmitted infection seropositivity and risk behavior among sexually active transgender patients at an adolescent and young adult urban community health center. AIDS Care, 27(8), 1031-1036.
Reisner, S.L., Pardo, S.T., Gamarel, K.E., White Hughto, J.M., Pardee, D.J., & Keo-Meier, C.L. (2015). Substance use to cope with stigma in healthcare among US female-to-male trans masculine adults. LGBT Health, 1(3), 177-184.
White, J.M., Gordon, J., & Mimiaga, M.J. (2014) The role of substance use and mental health problems in medication adherence among HIV-infected MSM. LGBT Health, 1(4), 319-322.
White, J.M., Reisner, S.L., Dunham, E., & Mimiaga, M.J. (2014). Race-based sexual preferences in a sample of online profiles of urban men seeking sex with men. Journal of Urban Health, 91(4), 768-775.
Reisner, S.L., White, J.M., Bradford, J.B., & Mimiaga, M.J. (2014) Transgender health disparities: Comparing full cohort and nested matched-pair study designs in a community health center. LGBT Health, 1(3): 177-184.
Mimiaga, M.J., White, J.M., Krakower, D.S., Biello, K.B., & Mayer, K.H. (2014) Suboptimal awareness and comprehension of published pre-exposure prophylaxis efficacy results among Massachusetts physicians. AIDS Care, 26(6), 684-693.
Reisner, S.L., White, J.M., Mayer, K.H., & Mimiaga, M.J. (2014) Sexual risk behaviors and psychosocial health concerns of female-to-male transgender men screening for STDs at an urban community health center. AIDS Care, 26(7), 857-864.
White, J.M., Mimiaga, M.J., Reisner, S.L., & Mayer, K. H. (2013). HIV sexual risk behavior among black men who meet other men on the internet for sex. Journal of Urban Health, 90(3), 464-481.
White, J.M., Mimiaga, M.J., Krakower, D.S., & Mayer, K.H. (2012). Evolution of Massachusetts physician attitudes, knowledge and experience regarding the use of antiretrovirals for HIV prevention. AIDS Patient Care & STDs, 26(7), 395-405.
Krakower, D., Mimiaga, M.J., Rosenberger, J., Novak, D., Mitty, J., White, J.M., & Mayer, K.H. (2012). Limited awareness and low immediate uptake of pre-exposure prophylaxis among men who have sex with men using an internet social networking site. PloS One, 7(3), e33119.
Bland, S.E., Bland, S. E., Mimiaga, M.J., Reisner, S.L., White, J.M., Driscoll, M.A., Isenberg, D., Cranston, K., & Mayer, K.H. (2012). Sentencing risk: History of incarceration and HIV/STD transmission risk behaviours among black men who have sex with men in Massachusetts. Culture, Health & Sexuality, 14(3), 329-345.
Rajasingham, R., Mimiaga, M.J., White, J.M., Pinkston, M.M., Baden, R.P., & Mitty, J.A. (2012). A systematic review of behavioral and treatment outcome studies among HIV-infected men who have sex with men who abuse crystal methamphetamine. AIDS Patient Care & STDs, 26(1), 36-52.
Matthew Mimiaga, ScD, MPH
Professor of Behavioral and Social Sciences, Professor of Epidemiology, Professor of Psychiatry and Human Behavior
Brown University School of Public Health
Matthew_mimiaga@brown.edu
Ongoing Research Support
CDC/MA Dept. Public Health Green (PI) 12/1/2018-11/30/2019
Rapid Assessment of Consumer Knowledge on Cocaine and Opioid-related Overdose in Massachusetts (RACK 2.0). Uses rapid assessment of consumer knowledge (RACK) methodology to examine the context underlying recent epidemiological trends in Massachusetts in the increase in opioid-related overdoses among Hispanics/Latinx, and African-Americans, as well as an increase in the combination of cocaine and opioids (particularly fentanyl) as demonstrated by toxicology reports. Role: Co-I.
CMS: Health Equity Research Award Hughto (PI) 10/01/2018-09/30/2021
Characterizing Disparities in the HIV Prevention and Care Continuum among Transgender and Cisgender Medicaid and Medicare Beneficiaries. Uses Center for Medicare & Medicaid services claims data to explore disparities in HIV prevention and care engagement for transgender and cisgender adults. Role: PI.
Providence/Boston CFAR: Pilot Award Hughto (PI) 09/01/2018-08/31/2019
Examining Multilevel Factors Associated with Entry into and Engagement in the HIV Prevention and Care Continuum for Transgender Adults in Massachusetts and Rhode Island. Utilizes mixed methods to explore factors associated with engagement in HIV prevention and care services for HIV positive and negative transgender adults in Massachusetts and Rhode Island. Role: PI.
AD‐2017C1‐6569 PCORI Reisner (PI) 04/01/2018-03/31/2019
Transgender Cohort Study of Gender Affirmation and HIV-Related Health. Investigates the role of medical gender affirmation in the HIV outcomes of a multisite clinic-based cohort of transgender patients. Role: Co-I
NIMHD 1R21MD012371-01 Jasuja & Rose (MPI) 09/20/2017-04/30/2021
Exploring Quality Measures for the Care of Transgender Persons. Develops an algorithm to identify transgender persons in medical claims data and characterize the type of healthcare delivered to transgender persons in the US. Role: Co-I.
Completed Research Support
NIMHD F31MD011203-01 White Hughto (PI) 09/1/2016-01/15/2018
Intervention to Overcome Mental Health Disparities in Criminally-Justice Involved Transgender Women. Documented the relationship between substance use, mental health and incarceration in transgender women and developed/evaluated a transgender competency training for correctional healthcare providers. Role: PI.
NIMH T32MH020031 Kershaw (PI) 8/1/2014-08/31/2016
Interdisciplinary HIV Training Grant. Received state-of-the-art research, analysis, and paper and grant writing training under this interdisciplinary HIV training for pre and postdoctoral fellows. Role: Pre-Doctoral Fellow.
