Steven A. Safren

Professor

Phone:
(305) 284-2818
Locator Code:
0751

 
About

About

I am the Director of the UM Center for HIV and Research in Mental Health (NIMH-funded Developmental AIDS Research Center D-ARC) and the Health Promotion and Care research program (https://hpac.psy.miami.edu/) where we study health behavior change, with a particular emphasis on mental health and substance use components of HIV prevention and treatment domestically and internationally. For example, I have developed and tested adherence and combined depression/adherence interventions that are being used globally. Within HIV prevention, many of my projects investigate social, contextual, and behavioral health issues related to sexual and gender minority populations. I joined the Department of Psychology at the University in of Miami in 2015 after 18 years working in the Harvard Medical School system at Massachusetts General Hospital where I was a Professor and Director of the Behavioral Medicine Service, and led behavioral science studies at Fenway Health. I have been PI or protocol chair of 18 federally funded studies (via NIMH, NIDA, and NIAID), and, in addition to studies where I am PI, I have regularly served as co-PI, co-investigator, or mentor on studies related to HIV prevention and treatment. Finally, I developed and tested one of the only evidenced-based psychosocial treatments for ADHD in adults, and extended that to adolescents. I am also the Co-Director of the Behavioral/Social Sciences and Community Outreach Core for the UM Center for AIDS Research (CFAR).

Google scholar:
https://scholar.google.com/citations?user=mveeHvwAAAAJ&hl=en&oi=ao

Career

Education

1998Ph.D. Psychology (Clinical) SUNY at Albany
1995 Psychology (Clinical) SUNY at Albany
1991B.A. Psychology Brandeis University

Professional Experience

2015 - Professor, University of Miami, Psychology
2012 - 2015Professor, Harvard Medical School
2006 - 2015Director, Behavioral Medicine Service, Massachusetts General Hospital
1998 - 1999Post-Doctoral Fellow, Massachusetts General Hospital, Harvard Medical School
Research

Research

Please see below for 5 topical areas of research that I study, followed by a list of selected current funded projects that I lead or co-lead.

1. Adherence to antiretroviral therapy for HIV treatment, developing the Life-Steps approach.

I developed and tested the first randomized controlled trial (RCT) of an adherence to ART treatment intervention, called “Life-Steps” using a cognitive-behavioral which is now used all over the world, including by MSF treatment clinics in S. Africa.  Shortly thereafter, I completed a second RCT of an adherence intervention, which addressed the frequently identified problem of “forgetting” to take one’s medications.  This was an internet-based pager system.

From these two trials, co-occurring behavioral health problems were prevalent and related to outcomes, so I began working on cognitive behavioral therapy for adherence and depression (CBT-AD) which integrated my approach to adherence counseling with general approaches to treating depression, psychosocially, in individuals with medical illness.  I have conducted several funded trials of this approach examining this approach; and it has been picked up by others being extended to a Spanish version at the U.S. Mexico Border via an R34 lead  by Jane Simoni and a tele-medicine approach for African American women with HIV living in the Deep South lead by Mirjam Kempf.  I recently completed a an R01 of a nurse-delivered effectiveness trial of this intervention in collaboration with the University of Cape Town in S. Africa which showed effects on viral load and depression/adherence outcomes.

  • Safren SA, Otto, MW, Worth J, Salomon E. Johnson W, Mayer K, Boswell S. (2001).Two strategies to increase adherence to HIV antiretroviral medication: Life-Steps and medication monitoring. Behavioural Research and Therapy, 39, 1151-1162. 
  • Safren SA, O’Cleirigh CM, Bullis JR, Otto MS, Stein MD, Pollack MH. (2012). Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-infected Injection Drug Users: A Randomized Controlled Trial.  Journal of Consulting and Clinical Psychology, 80, 404-415. PMCID: PMC3365619
  • Safren SA, Bedoya CA, O'Cleirigh C, Biello KB, Pinkston MM, Stein MD, Traeger L, Kojic E, Robbins GK, Lerner JA, Herman DS, Mimiaga MJ, & Mayer KH. Treating Depression and Adherence (CBT-AD) in Patients with HIV in Care: A Three-arm Randomized Controlled Trial. Lancet HIV. 2016; 3(11): 529-538. PMCID: PMC5321546.
  • Safren SA, O’Cleirigh C, Andersen LS, Magidson, JF, Lee JS, Bainter SA, Musinguzi N., Simoni J, Kagee A., Joska JA. Treating depression and improving adherence in HIV care with task-shifted cognitive-behavioral therapy in Khayelitsha, South Africa: A randomized controlled trial. Journal of the International AIDS Society, JIAS. In press.

2. Primary and secondary behavioral HIV prevention interventions for in men who have sex with men (MSM): domestic and global work, including stepped care interventions

This work has included behavioral interventions to reduce sexual acquisition and transmission risk among men who have sex with men. I have led and co-lead trials both domestically and internationally, with studies that address syndemic indicators that lay the context for poor health behaviors.

  • Safren SA, O’Cleirigh C, Skeer M, Driskell J, Goshe BM, Covahey C, Mayer KH. (2011). Demonstration and evaluation of a peer-delivered, individually-tailored, HIV prevention intervention for HIV-infected MSM in their primary care setting. AIDS and Behavior, 15, 949-958.
  • Safren SA, O’Cleirigh CM, Skeer MR, Elsesser SA, Mayer KH. (2013). Project Enhance: A randomized controlled trial of an individualized HIV prevention intervention for HIV-infected men who have sex with men conducted in a primary care setting. Health Psychology, 32(2), 171-179. PMCID: PMC3651590
  • Thomas B., Mimiaga MJ, Menon S, Chandrasekaran V, Murugesan P, Swaminathan S, Mayer KH, Safren SA. Unseen and unheard: Predictors of sexual risk behaviour and HIV infection among men who have sex with men (MSM) in Chennai, India.  AIDS Education and Prevention. 2009; 21(4): 372-383. PMCID: PMC3623672
  • Safren SA, Blashill AJ, Lee JS, O’Cleiriigh CO, Tomassili J, Biello KB, Mimiaga MJ, Mayer KH. Condom-use self-efficacy as a mediator between syndemics and condomless sex in men who have sex with men (MSM). Health Psychology. 2018; 37(9):820-827.
  • Poteat TC, Celentano DD, Mayer KH, Beyrer C, Mimiaga MJ, Friedman RK, Srithanaviboonchai K, Safren SA. Depression, Sexual Behavior, and HIV Treatment Outcomes Among Transgender Women, Cisgender Women and Men who have Sex with Men Living with HIV in Brazil and Thailand. AIDS Care. 2020; 32(3), 310-315. https://doi.org/10.1080/09540121.2019.1668526
  • Safren SA, Thomas BE, Biello KB, Mayer KH, Rawat S, Dange A, Bedoya CA, Menon S, Anand V., Balu, V., O’Cleirigh C, Klasko-Foster L, Baruah D., Swaminathan S., Mimiaga MJ. Strengthening resilience to reduce HIV risk in Indian MSM: A multicity randomized clinical efficacy trial. Lancet Global Health, 2021; 9(4), e446-e455.). Doi: 1016/S2214-109X(20)30547-7 (PMCID pending)

3. Antiretroviral therapy for prevention: Treatment as Prevention and Pre-exposure Prophylaxis (PrEP) studies – domestic and international.

I have played behavioral science leading roles in a number of trials that have addressed the issue of ART for HIV prevention, both for treatment as prevention and PrEP. This included HPTN052 (ART for prevention in serodiscordant couples, the first definitive trial demonstrating non-transmission across couples in the context of ART treatment), HPTN083 (long acting injectable PrEP) , protocol chair of HPTN063 (an observational study of high risk MSM, heterosexual women, and heterosexual men in Brazil, Thailand, and Zambia to lay the ground work for treatment as preventions studies linked to care in diverse cultural settings). Along with my mentee, Christina Psaros, we designed, based on Life-Steps, the PrEP adherence counseling for the adherence ancillary study for the Gates funded Partners in PrEP study in Africa. That study found 0 infections in those who were randomized PrEP.  With Dr. Kenneth Mayer, we completed a PrEP adherence intervention for men who have sex with men in Boston, which found high levels of protection using either PrEP or condoms during sex currently being evaluated in an R01.  Also with with my mentee, Dr. Psaros, we are the behavioral scientists on HPTN 083, a study that recently demonstrated the efficacy long acting injectable PrEP in MSM, leading the adherence components of this trial (and has an NIMH supported qualitative component that we lead).   

  • Safren SA, Hughes JP, Mimiaga MJ, Moore AT, Friedman RK, Srithanaviboonchai, K, Limbada M, Williamson B, Elharrar V, Cummings V, Magidson JF, Gaydos CA, Celentano D, Mayer KH for the HPTN063 Study Team. Frequency and predictors of estimated HIV transmissions and bacterial STI acquisition among HIV-infected patients in HIV care across three continents. Journal of the International AIDS Society (JIAS). 2016; 19(1): 21096.
  • Safren SA, Mayer KH, Ou S, McCauley M, Grinsztejn B, Hosseinipour M, Kumarasamy N, Gamble T, Hoffman I, Celentano D, Chen YQ, Cohen M for the HPTN 052 study team. Adherence to Early Antiretroviral Therapy: Results from HPTN 052, A Phase III, Multinational Randomized Trial of ART to Prevent HIV-1 Sexual Transmission in Serodiscordant Couples.  69(2), 234-40. PMCID: PMC4445420
  • Psaros C, Haberer JE, Katabira E, Ronald A, Tumwesigye E, Campbell JD, Wangisi J, Mugwanya K, Kintu A, Enyakoit M, Thomas K, Donnell D, Krows M, Kidoguchi L, Ware N, Baeten JM, Celum C, Bangsberg DR, Safren SA. (2014). An intervention to support HIV pre-exposure prophylaxis (PrEP) adherence in HIV serodiscordant couples in Uganda. Journal of Acquired Immune Deficiency Syndrome, 66(5), 522-529. PMCID: PMC4191829
  • Mayer KH, Safren SA, Elsesser SA, Psaros C, Tinsley J, Marzinke M, Clarke W, Hendrix C, Taylor SW, Haberer J, & Mimiaga MJ. Optimizing pre-exposure antiretroviral prophylaxis adherence in men who have sex with men: Results of a pilot randomized controlled trial of “Life-Steps for PrEP.” AIDS and Behavior. 2017; 21(5): 1350-1360.PMCID: PMC5380582
  • Landovitz RJ, Donnell D, Clement M, Hanscom B, Cottle L, Coelho L, Cabello R, Chariyalestak S, Dunne E, Frank I, Gallardo J, Gaur A, Gonzalez P, Ha V, Hinojosa J, Kallas E, Kelley C, Losso M, Valdez Madruga J, Middelkoop K, Phanuphak N, Santos B, Sued O, Valencia Huanami J, Overton ET, Swaminathan S, del Rio C, Gulick R, Richardson P, Sullivan P, Piwowar-Manning E, Marzinke M, Marrazzo J, Daar E, Asmelash A, Anderson P, Eshleman S, Bryan M, Blanchette C, Lucas J, Psaros C, Safren SA, Sugarman J, Scott H, Eron JJ, Fields SD, Sista ND, Gomez-Feliciano K, Jennings A, Shin K, Rooney J, Spreen W, Margolis D, Rinehart A, Adeyeye A, Cohen M, McCauley M, Grinsztejn B. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. New England Journal of Medicine. (2011: 385:595-608). 1056/NEJMoa2101016

4. Work with other illnesses and selected mentee work. In the area of HIV, I have a variety of additional mentee work that I supervise, including studies of global substance use / mental health in individuals living with HIV (primary mentor on Magidson K award), medication adherence among Black women living with HIV and histories of trauma (primary mentor on Dale K award), body image in HIV-positive men who have sex with men (primary mentor on Blashill K award), HIV prevention and treatment in women in S. Africa (primary mentor on Psaros K award), and retention in care in U.S. Hispanic immigrants (primary mentor on Levison K award). I mentor and work closely with my mentee Joseph Greer on his funded work treating anxiety in advanced cancer (NCI R03 and ACS grant) as well as a PCORI funded study to develop and test an app for adherence to oral chemotherapy.

  • Magidson JF, Joska JA, Belus JM, Andersen LA, Regenauer KS, Rose AL, Myers B, Majokweni S, O’Cleirigh C, Safren SA. Project Khanya: Results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in HIV care in South Africa. Journal of the International AIDS Society (JIAS). 2021; 24, S2. https://doi.org/10.1002/jia2.25720
  • Dale SK, Pierre-Louis C, Bogart LM, O’Cleirigh C, Safren SA. Still I Rise: The need for self-validation and self-care in the midst of adversities faced by Black women with Cultural Diversity and Ethnic Minority Psychology. 2017. PMCID: PMC5726949.
  • Greer JA, Traeger L, Bemis H, Solis J, Hendriksen ES, Park ER, Pirl WF, Temel JS, Prigerson HG, Safren SA. A pilot randomized controlled trial of brief cognitive-behavioral therapy for anxiety in patients with terminal cancer. The Oncologist. 2012; 17(10): 1337-1345. PMCID: 
  • Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty L, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes.  Diabetes Care. 2014: 37(3):625-33. 
  • Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty L, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes.  Diabetes Care. 2014: 37(3):625-33. PMCID: PMC3931377

5. Adult and adolescent ADHD. I developed and tested the first U.S. based psychosocial (cognitive behavioral) treatment for ADHD in adults.  This work was funded first by an R01 for our pilot study, and R01 for our efficacy study, and then an R34 for an adaptation for adolescents.

  • Safren SA, Otto MW, Sprich S, Perlman CL, Wilens TE, Biederman, J. Cognitive behavioral therapy for ADHD in medication-treated adults with continued symptoms.  Behaviour Research and Therapy. 2005; 43(7): 831-842. DOI: 10.1016/j.brat.2004.07.001
  • Sprich SE, Knouse LE, Cooper-Vince C, Burbridge J, Safren SA. Description and demonstration of CBT for ADHD in adults.  Cognitive and Behavioral Practice. 2010; 17(1): 9-15. PMCID: PMC3874265
  • Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy versus relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: A randomized controlled trial.  Journal of the American Medical Association. 2010; 304(8) 875-880. PMCID: PMC3641654
  • Sprich SE, Safren SA, Finkelstein D, Remmert JE, Hammerness P. A randomized controlled trial of cognitive behavioral therapy for ADHD in medication-treated adolescents. Journal of Child Psychology and Psychiatry. 2016; 57(11): 1218-1226. PMCID: PMC5026858

Complete List of Published Work in MyBibliography (>380 at time of writing):
http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/40810297/?sort=date&direction=descending


 

Selected Ongoing Funded Research

P30 MH116867 (NIMH)
Safren (PI)
4/1/2019-3/31/2023

University of Miami Developmental Mental Health HIV/AIDS Research Center (ARC)

This project enhances the infrastructure at the University of Miami to conduct high-impact HIV/AIDS research in mental health via an administrative core, a developmental core, and two research cores: one that focuses on HIV/AIDS Disparities and the other that focuses on mental health/psychiatric comorbidities.

Role: Director (PI). 


 

R01DA042805 (NIDA)
Safren, Mimiaga (MPIs) 4/1/2017-1/31/2022

Integrated behavioral activation and HIV risk reduction counseling for MSM with stimulant abuse.

This study is testing the efficacy, in a three-armed randomized controlled trial, a behavioral intervention to reduce high-risk sex in MSM with stimulant use disorder, who are at risk for HIV acquisition

Role: MPI. 


 

R01MH118043 (NIMH)
Safren/Mayer (MPIs) 9/6/2018-8/31/2024

Evaluation of Life-Steps to enhance adherence and engagement in PrEP care

This is an RCT of a stepped care (text messaging and adherence counseling) to improve adherence and engagement in PrEP care for men who have sex with men, with a particular focus on syndemics.

Role: Contact MPI (MPI with Mayer)  


 

1R01MH128868 (NIMH)
Carrico/Paul/Safren (MPIs) 9/15/2021-8/31/2026

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

This mechanistic randomized controlled trial will advance our understanding of the causal pathways whereby cognitive-behavioral treatment for depression alters the microbiome-gut-bran axis in people living with HIV.

Role: PI (PI/MPI with Adam Carrico and Robert Paul)


 

K24DA040489 (NIDA)
K24 MH094214-01 (NIMH)

Safren (PI) 8/01/2011-7/31/2022 (NCE)

Addressing Psychosocial Comorbidities in HIV treatment and Prevention

This K24 is to mentor junior investigators in behavioral interventions related to HIV treatment and prevention, with a specific focus on psychosocial syndemics relevant to HIV prevention and care.

Role: PI


 

5P30A1073961-09 (NIAID)

Pahwa (PI) 6/1/2012-5/31/2022

The Miami Center for AIDS Research                                                            

The Miami CFAR is geared towards the prevention, treatment and ultimately, the cure of HIV/AIDS.

Role: Co-Director of the Behavioral/Social Sciences Community Outreach Core


 

R01MH103770 (NIMH)

Safren/O’Cleirigh, MPI’s 07/01/2015-12/30/2021 (NCE)

Nurse-Delivered CBT for Depression-Adherence in HIV Primary Care South Africa

This project is an effectiveness trial of cognitive behavioral therapy for adherence and depression, to be delivered by nurse interventionists in South Africa.

Role: PI (MPI with O’Cleirigh, site PI: John Joska )


 

Books and treatment manuals by Dr. Safren

  1. Martell C, Safren SA, Prince S.  Cognitive behavioral therapy with gay, lesbian, and bisexual clients.  New York: Guilford Press, 2003.
  2. Safren SA, Perlman CA, Sprich S, Otto MW. Mastery of your adult ADHD.  Client Workbook.  Oxford University Press, 2005.
    -- Translated by various publishers to Dutch, German, Portuguese, Turkish, Swedish, Korean, and Japanese and Polish.
  1. Safren SA, Sprich S, Perlman CA, Otto MW.  Mastery of your adult ADHD, Therapist Manual.  Oxford University Press, 2005.
    -- Also translated to Dutch, German, Portuguese, Turkish, Swedish, Korean, and Japanese and Polish.
  1. Safren SA, Gonzalez JS, Soroudi N. Coping with Chronic Illness: Cognitive behavioral therapy for adherence and depression in individuals with chronic illness, Client Workbook.  2007, Oxford University Press.
  2. Safren SA, Gonzalez JS, Soroudi N. Coping with Chronic Illness: Cognitive behavioral therapy for adherence and depression in individuals with chronic illness, Therapist Guide.  2007, Oxford University Press.
  3. Vranceanu AM, Greer JA, Safren SA (editors).  The MGH Handbook of Behavioral Medicine.  NY: Humana Press (Springer).  2017. 
  4. Safren SA, Sprich S, Perlman CA, Otto MW.  Mastery of your adult ADHD, Client Workbook, 2nd Edition.  Oxford University Press, 2017.
  5. Safren SA, Sprich S, Perlman CA, Otto MW.  Mastery of your adult ADHD, Therapist Manual, 2nd Edition.  Oxford University Press, 2017.
  6. Naar S & Safren SA.  Motivational interviewing and CBT: Combining strategies for maximum effectiveness.  NY: Guilford Press.  2017.
    -- Translated by various publishers to Korean, Swedish, and Polish
  1. Pachankis, J, Safren SA. (Editors).  Handbook of Evidenced Based Mental Health Practice with Sexual and Gender Minority Clients.  NY: Oxford University Press, in press.
  2. Sprich SE & Safren SA. Mastery of your adolescent ADHD.  Therapist Manual.  Book submitted to Oxford University Press.  Under agreement.  Anticipated published in 2019 or 2020.
  3. Sprich SE & Safren SA. Mastery of your adolescent ADHD.  Client Guide.  Book submitted to Oxford University Press.  Under agreement.  Anticipated published in 2019 or 2020.