Professor of Psychology, Health Division
University at Albany, 1998,
Specific Research Areas of Interest
- 1. Adherence to antiretroviral therapy (ART) for HIV treatment.
- 2. Primary and secondary behavioral HIV prevention interventions for in men who have sex with men (MSM): domestic and global work.
- 3. Antiretroviral therapy for prevention: Treatment as Prevention and Pre-exposure Prophylaxis (PrEP) studies – domestic and international.
- 4. Work with other illnesses and selected mentee work.
- 5. Adult and adolescent ADHD.
Overview of Dr. Safren's research program
I will be taking doctoral students starting in the fall 2017 academic year. I am joining the Department of Psychology at the University in of Miami in the Fall of 2015 after 18 years working in the Harvard Medical School system at Massachusetts General Hospital where I was the founding Director of the current Behavioral Medicine Service and track Director of the Behavioral Medicine Internship track. During this time I was also an Affiliated Investigator at Fenway Health where I lead studies related to HIV prevention for men who have sex with men (MSM). I am a clinical health psychologist with expertise in health-related behavior change and a particular focus on psychosocial (mental health and substance use) comorbidities related to HIV prevention and treatment in both domestic and international settings. I have been PI or protocol chair of 12 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, I work with other medical illnesses, and I work on cognitive behavioral approaches to managing adult and adolescent ADHD. My international studies have been both via the NIAID-funded AIDS networks (i.e. HIV Prevention Trials Network - HPTN, and the AIDS Clinical Trials Network -ACTG) which span multiple countries, via my own NIH-funded studies, and via the work of my mentees K and R level funded studies in India and Africa. Much of my work on HIV focuses on prevention and treatment with men who have sex with men (MSM), though I have worked extensively with other populations including individuals with depression and those who have struggled with substance use disorders. Finally, during my time at MGH, I worked on studies of cognitive-behavioral therapy for ADHD in adulthood and adolescence.
Currently, my funded work includes a preliminary study involving treating syndemics (intertwined psychosocial problems such as depression, childhood sexual abuse, substance use, interpersonal violence) in HIV-infected individuals with uncontrolled virus, a study on HIV prevention in men who have sex with men in two sites in India, and a pending effectiveness study on treating depression and improving adherence in HIV-infected individuals in S. Africa who have failed first line antiretroviral therapy. Anticipated future studies, based on prior collaborative pilot work, involve pre-exposure prophylaxis (PrEP) adherence in high risk MSM, interventions to reduce crystal meth and increase safer sex (condoms or PrEP) in MSM who use crystal meth, and additional studies addressing syndemics in individuals with HIV and uncontrolled virus.
For an almost-comprehensive view of my publications, please see the link below.
Specific Research Areas of Interest
1. Adherence to antiretroviral therapy (ART) for HIV treatment.
A major focus of my work has been on adherence to ART for HIV treatment. This started at the end of the 1990s when highly active antiretroviral therapy (ART) had recently transformed HIV from a terminal disease to a chronic illness. Adherence was quickly identified as a complicated but critical component for this treatment success. I developed and tested the first randomized controlled trial (RCT) of an adherence to ART treatment intervention, called "Life-Steps" which followed a cognitive-behavioral / problem-solving approach. 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, I quickly observed that depression was a strong moderator of the ability to benefit from ART, and that many brief interventions for ART adherence had shown moderate success.
As a result, I developed and began successfully testing an intervention, 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 an R21, and two R01s examining this approach; and have worked with others extending this to a Spanish version at the U.S. Mexico Border via an R34 lead by Dr. Jane Simoni at the University of Washington and Dr. John Weibe at the University of Texas, El Paso, and a tele-medicine approach for African American women with HIV living in the Deep South being lead by Dr. Mirjam Kempf at the University of Alabama. We are also, based on our some in-country pilot work, expecting to start a nurse-delivered effectiveness trial in collaboration with the University of Capetown in S. Africa. Example publications from these areas include
- A. 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. PMID: 11579986.
- B. Safren SA, Hendriksen ES, DeSousa N, Boswell SL, Mayer KH. (2003). Use of an on-line pager system to increase adherence to antiretroviral medications. AIDS Care, 15, 787-793. PMID: 14617500.
- C. Safren SA, O'Cleirigh CO, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH. (2009). A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychology, 28, 1-10. PMID: 19210012. PMCID: PMC2643364.
- D. 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
- E. Simoni, JM, Wiebe, JS, Sauceda, JA, Huh, D, Sanchez, G, Longoria, V, Bedoya, CA, Safren, SA. A Preliminary RCT of CBT-AD for Adherence and Depression Among HIV-Positive Latinos on the U.S.-Mexico Border: The Nuevo Día Study. AIDS and Behavior. 2013; 17(8): 2816-2829.
2. Primary and secondary behavioral HIV prevention interventions for men who have sex with men (MSM): domestic and global work.
My adherence work described above recruited participants at Fenway Health, the largest care provider for HIV in New England and an urban health center that focuses on affirmative care for gay, lesbian, bisexual, transgender, and other sexual minority clients. Working there, I began collaborating closely with a biomedical prevention expert, Dr. Kenneth Mayer focusing on utilizing the HIV care setting as a place to provide HIV prevention for those already infected with HIV. Together, we received funding from NIMH (R01) and a HRSA-funded trial that focused on addressing psychosocial needs of HIV-positive MSM via proactive case management, and via developing (with community and peer-interventionist input) a culturally relevant HIV risk reduction intervention. This intervention expanded upon traditional risk reduction counseling to also cover topics such as stress management, getting the relationship you want, cultures communities and you, and drug and alcohol use. The NIMH R01 was a randomized trial with medical social workers as the interventionists ("Project Enhance"), and found risk reduction regardless of intervention assignment, but did find a moderated effect for depression. The HRSA study found risk reduction in those who evidenced condomless sex at baseline.
Following the theme of integrating psychosocial with HIV risk reduction, I have mentored (and served as co-PI) on two programmatic research areas in the area of primary prevention. One (lead by Matthew Mimiaga) is on integrating behavioral activation with traditional risk reduction counseling for MSM with crystal methamphetamine dependence. The other is on integrating cognitive processing therapy for childhood sexual abuse (CAS) in MSM with sexual risk and a CAS history collaborating with Dr. Conall O'Cleirigh in Boston and Dr. Gail Ironson here at the University of Miami. These studies involve pilot and efficacy studies.
Additionally, I have extended my primary HIV prevention work to MSM in India. Starting with a Harvard funded study, we demonstrated high levels of condomless sex in the context of important culturally relevant psychosocial concerns. I then received an Indo-U.S. R21 to develop (via community input, focus group and key informant interviews, then open pilot then pilot randomized trial) an intervention that fosters resilience to psychosocial and HIV risk in Indian MSM. Currently we are in year 1 of an R01 to test the efficacy of this approach in two cities in India (Chennai and Mumbai).
Representative publications from these areas include:
- A. 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. PMID: 20853023.
- B. 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. PMID: 22746262. PMCID: PMC3651590.
- C. Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. (2012). A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care and STDs, 26(11), 681-693. PMCID: PMC3495110.
- D. 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.
- E. Safren SA, Thomas BE, Mayer KH, Biello KB, Mani J, Vijaylakshmi R, Periyasamy M, Swaminathan S, Mimiaga MJ.(2014). A pilot RCT of an intervention to reduce HIV sexual risk and increase self-acceptance among MSM in Chennai, India. AIDS and Behavior. 18(10): 1904-12. PMCID: PMC4175143.
3. Antiretroviral therapy for prevention: Treatment as Prevention and Pre-exposure Prophylaxis (PrEP) studies - domestic and international.
I have been involved in a number of trials that have addressed the issue of ART for HIV prevention. First, I was a behavioral scientist on HPTN052 which definitively found that, across 9 countries and 13 sites, that early ART prevents sexual HIV transmission in serodiscordant couples. I designed the adherence counseling using my Life-Steps intervention as the base, and lead the development of the psychosocial assessments. We found that across all predictors, depression (mental health quality of life) was the only psychosocial variable to predict, over time, non-adherence in those who started ART early. I also was the key behavioral scientist on an HIV treatment trial (ACTG5175) which found different sets of predictors but in similar settings. I am also the 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. This has both qualitative and quantitative components, and we are, given the various components involved in actual "HIV risk behavior" modeling outcomes on projected infections.
Pre-exposure prophylaxis (PrEP), taking ART to prevent the acquisition of HIV, has been demonstrated efficacious in men who have sex with men in the U.S. and Latin America, and in serodiscordant couples in Africa, but adherence and uptake are key components of success. Along with my mentee and collaborator, Dr. 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 have just completed a PrEP adherence intervention for men who have sex with men in Boston, which Dr. Mayer presented the results on this past summer (2014); finding high levels of protection using either PrEP or condoms during sex. We used real time monitoring of adherence with a Wisepill device and assessment of condomless sex via daily text messages. Finally, I am collaborating with Dr. Raphael Landovitz on his PreP demonstration project in California that will utilize our intervention for those who do not respond to initial adherence counseling, and, along with Dr. Psaros, are working on HPTN 083, a study of long acting injectable PrEP in MSM, leading the adherence components of this trial.
Example publications from this area include the following:
- A. Safren SA, Biello KB, Smeaton L, Mimiaga MJ, Walawander A, Lama JR, Rana A, Nyirenda M, Kayoyo VM, Samaneka W0, Joglekar A, Celentano, D, Martinez A, Remmert, JE, Lalloo UG, Kumarasamy N, Hakim J, Campbell TB, for the PEARLS (ACTG A5175) Study Team. (2014). Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: Data from the ACTG A5175/PEARLS trial. PLOS ONE, 9(8), 1-10. PMCID: PMC4143224.
- B. 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. JAIDS. 2015: 62(2) 234-240.
- C. Closson EF, Mimiaga MJ, Sherman SG, Tangmukongvorakul A, Friedman R, Limbada M, Moore AT, Srithanaviboonchai K, Alves CA, Roberts S, Oldenburg CE, Elharrar V, Mayer KH, Safren SA. Intimacy versus isolation: A qualitative study of sexual practices among sexually active HIV-infected patients in HIV care in Brazil, Thailand, and Zambia. PLOS One. 2015; 10(3): e0120957. PMCID: PMC4368566.
- D. 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
- E. Haberer J, Baeten J, Campbell J, Wangisi J, Katabira E, Ronald A, Tumwesigye E, Psaros C, Safren SA, Ware NC, Thomas KK, Donnell D, Krows M, Kidoguchi L, Celum C., Bangsberg DR. Adherence to antiretroviral prophylaxis for HIV prevention: A substudy cohort within a clinical trial of serodiscordant couples in East Africa. PLoS Med. 2013;10:e1001511. PMID 24058300. PMCID: PMC3769210.
4. Work with other illnesses and selected mentee work.
In the area of HIV, I have a variety of additional mentee work that I have been collaborating on, including studies of body image in HIV-positive men who have sex with men with Dr. Aaron Blashill who is now at SDSU, HIV prevention and treatment in women in S. Africa with Dr. Christina Psaros at Mass General, retention in care in U.S. Hispanic immigrants with Dr. Julie Levinson at Mass General, global substance use / mental health in individuals living with HIV (primary mentor on pending Magidson K award), and PTSD in African American women living with HIV (primary mentor on pending Dale K award). I mentor and work closely with my colleague 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.
Additionally, I have extended my work on treating depression and adherence in HIV to type 2 diabetes where we found both behavioral and medical (HbA1c) outcomes.
Selected publications from this area include:
- A. Blashill AJ, Goshe BM, Robbins GK, Mayer KH, Safren SA. Body image disturbance and health behaviors among sexual minority men living with HIV. Health Psychology. 2014; 33(7): 677-680. PMCID: PMC4094355.
- B. Psaros C, Barinas J, Robbins GK, Bedoya CA, Safren SA, Park, ER. Intimacy and sexual decision making: Exploring the perspective of HIV positive women over 50. AIDS Patient Care STDs. 2012; 26(12), 755-760. PMCID: PMC3513978.
- C. 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: PMC3481900.
- D. 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.
In addition to my work in HIV/AIDS and behavioral medicine, I also developed and tested the first U.S. based psychosocial (cognitive behavioral) treatment for ADHD in adults. This work was funded first by an R03 for our pilot study, and R01 for our efficacy study (results published in JAMA), and then an R34 for an adaptation for adolescents (publication under revision).
Selected publications in this area include the following:
- 1. 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.
- 2. 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.
- 3. Knouse LE, Safren SA. Current status of cognitive behavioral therapy for adult ADHD. Psychiatric Clinics of North America, 2010: 33, 497-509.
- 4. 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.
- 5. Sprich SE, Burbridge J, Lerner JA, Safren SA. Cognitive behavioral therapy for ADHD in adolescents: Clinical considerations and a case series. Cognitive and Behavioral Practice. In press.
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.
- 3. Safren SA, Sprich S, Perlman CA, Otto MW. Mastery of your adult ADHD, Therapist Manual. Oxford University Press, 2005.
- 4. 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.
- 5. 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.
- 6. Naar-King, S & Safren SA. Integrating motivational interviewing with cognitive behavioral therapy. NY: Guilford Press. Under agreement.
- 7. Vranceanu AM, Greer JA, Safren SA. The MGH Handbook of Behavioral Medicine. NY: Springer. Under agreement.