Research

Background/Overview: This project involves various research studies as well as mentoring junior investigators in behavioral interventions related to HIV treatment and prevention, specifically focusing on associated psychosocial syndemics relevant to HIV prevention and care. Mental health problems, including substance abuse, are of the most frequent comorbidities to HIV and are consistently identified as barriers to adherence, engagement in care, and reductions in risk behavior. Typically, these problems co-occur as "syndemics" (co-occurring psychosocial problems that interact with each other and with HIV risk). Studies have found exceptionally high levels of comorbidity in patients with HIV and depression. This has raised the need to address other syndemics (e.g. substance abuse, PTSD, other anxiety disorders) in addition to depression in the context of care. Studies for this project include 1) using cognitive behavioral therapy to address syndemics in the context of HIV care in patients with uncontrolled virus, 2) analyses of cohort data on syndemics in individuals living with HIV care who are in treatment, and 3) qualitative data to examine the impact of syndemics on HIV transmission risk and adherence in individuals living with HIV in care.

Current study open for enrollment: If you are interested in participating in this study, please visit this link to see if you preliminarily qualify.

Background/Overview: This study is a two-arm hybrid type 3 effectiveness-implementation study using a clinic randomized parallel cluster RCT design. Across 10 clinics, we will compare a core set and enhanced set of implementation strategies to increase the reach of evidence-based treatments to patients with HIV and depression in South Africa. This is an implementation focused study, building off our previous research that found nurse delivered cognitive behavioral therapy for depression and adherence (CBT-AD) integrated into the HIV primary care setting in S. Africa to be an effective intervention. Using the RE-AIM framework, the primary implementation outcome is “reach”, the proportion of patients who start an evidence-based treatment for depression (i.e., CBT-AD and/or psychopharmacotherapy), though we will also examine, effectiveness, adoption, implementation, maintenance, and costs. This study is in collaboration with the University of Cape Town (UCT) in South Africa (Dr. John Joska), and Massachusetts General Hospital / Harvard Medical School (Dr. Conall O’Cleirigh).

Background/Overview: Project CHARM (Clinic HIV/AIDS Registry of Miami) is a project aiming to create a clinic registry of patients with HIV receiving care in the UM/Jackson system. We aim to document the need for additional interventions/services that may be necessary for individuals living with HIV in the greater Miami area. If you are living with HIV and are a patient of the UM/Jackson system and receiving your HIV care at ACC East, you qualify to participate in this study!

Background/Overview: Project IMPACT (Intervention with MSM to Prevent Acquisition of HIV through Crystal Methamphetamine Treatment) targets both stimulant use and sexual risk reduction in an effort to help individuals relearn how to enjoy safe but pleasurable activities with up to 14 sessions of individual therapy. The intervention integrates Behavioral Activation, a cognitive behavior therapy for improving mood and increasing activity, incorporated with HIV Risk Reduction counseling aimed to reduce risky sexual practices, and potential HIV acquisition. This randomized control trial is a three-arm efficacy trial, comparing the Project IMPACT Intervention with a time and intensity matched control arm and a Standard of Care arm.

The first aim is to compare Project IMPACT intervention efficacy to a (1) time and intensity matched control and a (2) Standard of Care arm. Our primary outcome is the number of condomless anal sex (CAS) acts with men without PrEP at baseline, four-, eight-, and 12-month. Our secondary outcome is the reductions in number of stimulant use episodes at baseline, four-, eight-, and 12-month. The second aim is to examine the degree to which: a) Reductions in sexual risk are mediated by reductions in stimulant use; b) Conceptual mediators, including increases in information, motivation, behavioral skills, and decreases in depressed mood, and decreases in polydrug use, are associated with increases in pleasurable (but safe) activities by; and c) Reductions in sexual risk are associated with epidemiologically-identified moderators of sexual risk and stimulant use: age, race/ethnicity, and psychosocial factors. 4-, 8-, and 12-month follow up visits will determine if improvements in stimulant use precede and statistically mediate outcome improvements The third aim is to estimate the cost-effectiveness of the Project IMPACT intervention. Assessing the cost-effectiveness of this behavioral intervention will include evaluating the feasibility of scale-up and replicability in future efficacy trials. Project IMPACT is a Multiple Principal Investigator (MPI) study between Dr. Matthew Mimiaga at Brown University in Providence, RI and Dr. Steven Safren at the University of Miami in Miami, FL.

Background/Overview: The Life-Steps study was a two-arm randomized trial to evaluate the efficacy of Life-Steps for PrEP (Pre-exposure prophylaxis), a stepped-care (text messaging, then counseling) intervention to increase medication adherence in men who have sex with men (MSM) prescribed PrEP who evidence a risk factor for non-adherence. Additional aims include examining the degree to which enhanced maintenanceof PrEP adherence occurs in the context of the conceptual mediators and potential moderators of the intervention, and estimating the total and incremental costs of the Life-Steps for PrEP, stepped-care PrEP adherence intervention relative to SOC, from healthcare sector and societal perspectives. This study is in collaboration with the Fenway Insitute at Fenway Health in Boston, MA with participant recruitment occurring in Boston and the University of Miami in Miami, FL.

Background/Overview: This study is a two arm randomized effectiveness trial investigating whether a task shifting/sharing model of treating depression and improving adherence to ART in patients who fail first line antiretroviral therapy (ART) can occur using nurses in South Africa trained in cognitive behavioral therapy (CBT). South Africa is the country with the highest number of HIV infections in the world and the highest number of HIV/AIDS-related deaths, and where access to third line ART treatment is not currently available in the public healthcare system. Clinical depression, like elsewhere, is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Given that CBT is a validated treatment for depression, and that dissemination of evidenced-based interventions in HIV is a noted priority, this is a two-arm effectiveness RCT (stratified by antidepressant medication initiation/use or not) of nurse-delivered CBT for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who have failed first line ART, and have a unipolar depressive mood disorder. The primary outcomes (Aim 1) include adherence to ART (assessed by WisePill), depression (assessed by an independent evaluator), and proportion of (second line) treatment failures in each condition. Comparing this integrated care model to usual care (enhanced adherence counseling for first-line treatment-failures in this setting), will allow for an incremental cost-effectiveness analysis in Aim 2. This study is in collaboration with the University of Cape Town (UCT) in South Africa (Drs. John Joska and Lena Andersen), and Massachusetts General Hospital / Harvard Medical School (Drs. Conall O’Cleirigh and Ken Freedberg).

Background/Overview: ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men’s (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM’s health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. The Unified Protocol changes underlying stress pathways using motivational interviewing, emotional and situational exposure, cognitive restructuring, mindfulness, and self-monitoring exercises.

The first aim is to test the efficacy of ESTEEM against (1) community mental health treatment (CMHT) and (2) HIV voluntary counseling and testing (VCT). Our primary outcome is condomless anal sex in the absence of either PrEP or known undetectable viral load of HIV+ primary partners. Knowing whether ESTEEM yields greater improvement than time-matched CMHT will establish the benefit of our transdiagnostic approach. Comparing ESTEEM to VCT offers a strong test of ESTEEM’s incremental cost-effectiveness. The second aim is to determine whether ESTEEM works through its hypothesized cognitive, affective, and behavioral minority stress processes. 3-, 6-, and 12-month follow-ups will determine if improvements in minority stress processes precede and statistically mediate outcome improvements. Mediation will validate the minority stress theory of ESTEEM and provide transdiagnostic targets for future YGBM health interventions. The third aim is to estimate ESTEEM’s incremental cost-effectiveness compared to VCT in terms of HIV infections averted and improved mental health. ESTEEM shows preliminary efficacy for improving the full spectrum of YGBM health. We will collect resource use and cost data to estimate return on investment of this transdiagnostic health approach compared to standard single outcome/stand-alone treatment approaches. The overall study PI is Dr. John Pachankis of Yale University School of Public Health.

Background/Overview: India has the world's third largest HIV epidemic, and given the population size, one of the largest, if not the largest, populations of men who have sex with men (MSM) in the world. MSM are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which increases the risk for HIV transmission to their wives. In the current 2-arm randomized controlled trial, MSM in Chennai and Mumbai will be randomized to either: 1) a self-acceptance based HIV sexual risk reduction intervention and HIV/STI VCT, or 2) HIV/STI VCT. Those randomized to the experimental intervention will receive 4 group sessions focused on building self-acceptance, social support, and HIV risk reduction skills and 6 individual sessions focused on personalized HIV risk reduction plans and, as needed, prevention case management. Participants will be followed for one year, with STI incidence and HIV risk behavior as primary outcomes and psychosocial mediators secondary. Cost effectiveness of the intervention will be calculated compared to HIV/STI VCT alone, considering individual and public health benefits as well as downstream cost-savings due to infections averted. This study is in collaboration with the National Institute for Research In Tuberculosis in Chennai India (Drs. Beena Thomas and Soumya Swaminathan), The Humsafar Trust in Mumbai India (Alpana Dange, Vivek Anand, Shruta Rawat), Massachusetts General Hospital / Harvard Medical School (Drs. Conall O’Cleirigh, Ken Freedberg, C. Andres Bedoya), Brown University (Drs. Matthew Mimiaga and Katie Biello), and Fenway Health (Dr. Kenneth H. Mayer).