LGBTQ+

Name of Grant

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

Funding Source

National Institute on Drug Abuse (R01DA042805-01A1)

Pls

Mimiaga and Safren

Background

Problematic stimulant (i.e., crystal methamphetamine [meth], cocaine, crack) use is a prevalent and treatment refractory problem in some men who have sex with men (MSM), and highly predictive of both condomless sex and HIV infection. This application builds off of our successful formative and pilot work and is designed to assess the efficacy, in a two-arm randomized controlled trial (RCT), of Project IMPACT—a behavioral intervention to reduce high-risk sex in MSM with stimulant use disorder who are at risk for HIV acquisition. The intervention incorporates risk reduction counseling with behavioral activation (BA) to help participants re-engage in enjoyable and meaningful life activities not involving drugs. Behavioral activation is an evidence-based, easy to administer, cognitive behavioral approach to treat depression and other problems that focuses on helping individuals reengage in activities that generate feelings of enjoyment (i.e., mastery and pleasure). We chose this strategy for MSM with stimulant use disorder because our formative work revealed that MSM who abuse stimulants report becoming unable to enjoy activities that they previously enjoyed as a result of ongoing stimulant use. This lack of enjoyment (i.e., anhedonia, one of the core symptoms of depression) in activities that do not involve stimulant use or sex contributes to the continued use of stimulants and potentially condomless sex (not protected by PrEP). We developed and openly field-tested this intervention in a NIDA-funded nonrandomized pilot (R03 DA023393), and, subsequently, conducted a NIDA-funded pilot RCT (R34 DA031028) of this intervention compared to a standard of care condition (SOC) and found it to be feasible, acceptable, and successful at reducing both condomless anal sex and stimulant use. The proposed efficacy trial is the next logical step in this program of research.

Conceptual Model

The conceptual model focuses on anhedonia—a loss of interest in previously enjoyed activities—as a consequence of continued stimulant use. Accordingly, for individuals with stimulant use disorder, drug use becomes the central means for obtaining enjoyment, and hence BA will augment HIV risk reduction counseling.

Name of Grant

Developing and pilot testing an adaptive intervention to facilitate PrEP uptake and maximize PrEP adherence among at-risk transgender women.

Funding Source

National Institute of Mental Health (R34 MH122499-01A1)

Pls

Mimiaga and Biello

Background

PrEP has dramatically changed the promise of HIV prevention, particularly for transgender women (TGW) who are among the highest risk group for HIV in the U.S. While PrEP reduces HIV acquisition by >90% with adequate adherence, TGW face multiple transgender-specific barriers with PrEP access, uptake, adherence, and retention. The PIs have longstanding partnerships with community-based organizations that provide gender-affirming services to this group in Providence, RI and operate one of the first clinical PrEP programs in the U.S., led by our team at Miriam Hospital/Brown University.

Conceptual Model

The intervention package (“PrEP N’ Shine”) is based on over a decade of formative and programmatic work grounded in the social-cognitive and contextual realities of high-risk TGW, and as such, the conceptual model underlying the intervention draws on Empowerment Theory and Social Cognitive Theory. The “PrEP N’ Shine” package includes two separate but complementary interventions: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a resource-efficient, adaptive “stepped-care” technology and counseling intervention to optimize PrEP adherence. “Stepped-care” is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who continue to have problems adhering to PrEP receive the more resource-intensive components.

Approach

Initially, we will continue to work with community members and a community advisory board to further inform the “PrEP N’ Shine” intervention (Aim 1a). Next, we will iteratively refine the intervention, in an open pilot trial with exit interviews, with up to 10 TGW to enhance participant acceptability, feasibility of study procedures, and finalize study protocols (Aim 1b). For Aim 2, we will conduct a pilot randomized controlled trial (RCT) of the “PrEP N’ Shine” intervention using a 2-stage randomization design: For Stage 1, we aim randomize 106 TGW who are candidates for PrEP to receive either the peer-led SBCM for PrEP linkage and uptake or standard of care (SOC; i.e., PrEP referrals only). For Stage 2, those from Stage 1 who initiate PrEP (n~44), regardless of their randomization condition, will then be equally re-randomized to either the resource-efficient, adaptive “stepped-care” intervention to optimize PrEP adherence (initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and then those continuing to have poor adherence will receive the 4 more intensive counseling sessions) or the SOC condition. Primary outcomes include PrEP linkage and uptake; PrEP adherence (both biomedical and self-report assessments); and retention in PrEP care.

Innovation

The “PrEP N’ Shine” intervention is highly scalable and sustainable in the real world, as it takes into account the “future of PrEP access,” while simultaneously 1) addressing the barriers surrounding access, 2) aiding in navigating linkage, and for those who need it, both insurance and free PrEP program options, and 3) reducing barriers to, and building skills to support, PrEP adherence (once TGW have access to PrEP).

Name of Grant

Adaptive intervention strategies trial for strengthening adherence to antiretroviral HIV treatment among youth

Funding Source

National Institute of Nursing Research (1R01NR017098-01)

Pls

Mimiaga and Garofalo

Background

A significant and growing population of young people are acquiring and living with HIV in the US. An estimated >12,200 adolescents were diagnosed with HIV infection in 2010, a 22% increase since 2008(1). Although HIV can be managed with ongoing antiretroviral therapy (ART), exceptionally high levels of adherence are required. Our recently published systematic literature review found that of the 21 articles published that reported data on medication adherence in HIV infected adolescents, seven described pilot interventions to enhance medication adherence; and only two utilized education / counseling sessions to promote adherence skills-building – a component that has shown to be necessary to improving adherence among HIV-infected adults. To our knowledge, there are no demonstrated efficacious ART adherence interventions for HIV infected adolescents to date. This is particularly concerning given that overall rates of adherence among adolescents is generally suboptimal.

Overview of Proposal

This proposal is culmination of 6 years of formative work with this population, including conducting two pilot randomized controlled trials (RCT). The current study is to test the efficacy of a stepped-care “adaptive” ART adherence intervention (“Positive STEPS”) for HIV infected adolescents, ages 16 to 24. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who do not improve then receive the high intensity, more resource intensive part of an intervention.

Conceptual Model

The conceptual model is based on our formative work that led to the development of a theoretically-driven intervention curriculum (“Positive STEPS”), grounded in the social and contextual realities of HIV infected adolescents. Our intervention begins with 2-way daily text messaging aimed at improving ART adherence. For many adolescents (over 1/3 from our pilot RCT), text messaging is not sufficient to overcome the barriers to ART adherence. These individuals will then also receive the more intensive component based on general principles of cognitive-behavioral therapy. Informational, problem solving, and cognitive-behavioral “steps” are addressed over 5, in-person, intervention-counseling sessions (incorporating digital video vignettes that are specific to the adherence challenges faced by adolescents).

Overview of Research Plan

192 HIV infected adolescents, aged 16 to 24, and prescribed ART will be recruited in two major U.S. cities with excellent access to and research experience with the population. Participants will be equally randomized to: (1) “Positive STEPS” – a stepped care, adherence intervention with integrated technology and counseling; or (2) Standard of Care comparison group. Participants will be followed for one-year post-randomization. The primary outcomes are improvements in measures of ART adherence (i.e., Wisepill, HIV viral load, and self-report); secondary outcomes include improvements in CD4 cell count, HIV symptoms, and quality of life.

Name of Grant

Los Angeles CRS for the MACS/WIHS combined cohort study

Funding Source

National Heart, Lung, and Blood Institute (U01 HL 146333)

Pls

Detels and Mimiaga

Background

The Multicenter AIDS Cohort Study (MACS) / Women’s Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CSS) is a collaborative research effort that aims to understand and reduce the impact of chronic health conditions—including heart, lung, blood, and sleep (HLBS) disorders—that affect people living with HIV. For decades, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), has supported the separate MACS and WIHS cohort studies. MACS was a study of gay and bisexual men, while WIHS was a study of women who had other risk factors for HIV. The Multicenter AIDS Cohort Study is the first (1984) and largest study specifically created to examine the natural history of AIDS. This study involves 7,000+ gay and bisexual men nationwide; the UCLA site is the largest. The study has produced ~1500 papers and contributed landmark findings on the epidemiology of HIV infection and the virologic, immunologic, psychosocial, clinical and neurologic aspects of the disease. In 2019, the NHLBI became the primary steward of the new MACS/WIHS-CSS. The Combined Cohort Study includes continuing participants from the earlier studies. We are also recruiting new participants with a special focus on hard-hit population groups, such as Black/African American and Hispanic/Latinx men and women and residents of southern states.

Name of Grant

Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women

Funding Source

National Institute of Allergy and Infectious Diseases (1U01AI156875-01)

Pls

Mimiaga, Belzer, and Kuhns

Background

Young transgender women (YTW) have the highest HIV prevalence/incidence than any other risk group in the U.S. The repeated exposure to gender minority stigma compounded by the psychosocial challenges associated with social disadvantage and economic marginalization exacerbates disparities in HIV incidence and invalidates YTW’s gender identity. This can lead to behaviors (e.g., substance use, sex work, healthcare avoidance) that potentiate HIV acquisition risk. In order to decrease HIV incidence among YTW, an intervention needs to 1) address HIV risk as part of YTW’s life contexts; 2) be accessible and far-reaching such that the entire at-risk population can participate (e.g., rural areas) during a time most convenient for them; and 3) be highly sustainable with low associated costs to implement in real-world settings.

Conceptual Model

LifeSkills Mobile is an mHealth intervention to promote biobehavioral HIV prevention strategies based on empowerment theory and was developed using a community-based participatory research approach.

Overview of Study Design

We propose to conduct an RCT to assess the efficacy of the LifeSkills Mobile intervention in comparison to a standard of care (SOC) condition among 5,000 YTW recruited online. The primary outcome is reduction in incident HIV infections; a secondary outcome is total condomless anal/ vaginal sex acts occurring in the context of insufficient PrEP protection. At baseline and every 6 months through 48 months, enrolled participants will complete an online survey sent via a link to their mobile phone and will be mailed an OraQuick In-Home HIV Test kit . We will also estimate the total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives. Real World Applicability. Given inherent limitations to widespread dissemination of face-to-face, group-based interventions, LifeSkills Mobile extends the potential reach of the intervention via the development of a mobile version, and provides content on, and access to, current biobehavioral prevention technologies (e.g., PrEP).

Name of Grant

Making universal, free-of-charge antiretroviral therapy work for sexual and gender minority youth in Brazil

Funding Source

National Institute of Mental Health (R34 MH126894-01)

Pls

Matthew Mimiaga and Katie Biello

Background

Sexual and gender minority (SGM) youth account for the largest number of incident HIV infections in Brazil. Although HIV can be managed with ongoing antiretroviral therapy (ART), exceptionally high levels of adherence are required. Brazil has implemented a comprehensive HIV treatment program with broad access to ART, but this program does not specifically address barriers to optimal ART adherence, particularly for SGM youth who experience many challenges taking their medication as prescribed.

Overview

This application seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among HIV infected SGM youth (ages 15-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence. To inform the content, structure, and format of the proposed intervention, the MPIs recently conducted focus groups with SGM youth (N = 18) and key informant interviews (N = 7) with medical providers and staff at local HIV service organizations working closely with SGM youth in Rio de Janeiro. Across focus groups and key informant interviews there was universal agreement that an intervention should capitalize on and enhance social support structures among SGM youth, and address their specific concerns, especially as related to the individual (e.g., ART side effects, mood, substance use), social (e.g., HIV/SGM stigma), and structural (e.g., clinic hours, transportation challenges) barriers that they regularly face.

Theoretical Model

The intervention is guided by Social Cognitive and Social Support Theories and is grounded in the social and contextual realities of SGM youth living with HIV in Brazil. Specifically, social support is emphasized and informational, problem-solving and cognitive-behavioral “steps” are addressed over 4-group adherence counseling sessions, which include short video vignettes that seek to normalize adherence challenges. In addition, daily tailored SMS text messages are delivered as part of the intervention to facilitate social-cognitive cues to take medications as prescribed.

Research Plan

Phase 1: Refine and enhance participant acceptability of the intervention and resolve any issues with intervention delivery/implementation; this will be achieved by convening and obtaining feedback from our youth community advisory board throughout this phase and subsequent phases; and by conducting an open-phase pilot with up to 12 SGM youth, with post-intervention exit interviews, as well as obtaining feedback from our youth community advisory board throughout this and subsequent phases. Phase 2: Examine, in a pilot randomized controlled trial, the feasibility, acceptability and potential impact of the proposed intervention among 72 SGM youth who will be equally randomized to the intervention or a time- and attention-matched control condition with standard of care. The outcomes are improved ART adherence (Wisepill, pharmacy assessment and self-report), retention in care and viral load suppression. Study assessments will be conducted at baseline, 3- and 6-months.sss

Name of Grant

Efficacy of a PrEP uptake & Adherence Intervention among male sex workers using a 2-stage randomization design

Funding Source

National Institute of Nursing Research (R01NR020227-01A1)

Pls

Katie Biello, Matthew Mimiaga, and Philip Chan

Background:

Male sex workers (MSWs), or men who exchange sex for money, goods, drugs, or other items of value with other men, are at exceptionally high risk for HIV infection. Pre-exposure prophylaxis (PrEP) is effective at reducing HIV acquisition among HIV uninfected individuals, but its efficacy is highly dependent on uptake and excellent adherence. However, uptake of and adherence to PrEP among those who might benefit the most from using PrEP, such as MSWs, remains suboptimal. A successful PrEP uptake and adherence package must be responsive and tailored to MSWs’ distinct psychosocial and contextual circumstances.

Overview of Proposal

The current proposal is a culmination of over 10 years of research with this population, including qualitative research, epidemiological assessments and programmatic work. These formative data led to an NIMH-funded R34 (MPIs: Biello, Mimiaga, Chan), which allowed our interdisciplinary team and community partners to collaborate on the development and pilot testing of a theory-based intervention— “PrEPare for Work”—to address 1) access to and uptake of PrEP at local PrEP clinics/providers via strengthbased case management using principles of motivational interviewing (e.g., focusing on values, strengths and change efforts, making reflective and empathetic statements), and 2) provide cognitive-behavioral therapyinformed PrEP adherence counseling (e.g., problem-solving skill-building) with personalized, daily text message reminders to optimize PrEP adherence among MSWs. The pilot RCT demonstrated the feasibility, acceptability and preliminary efficacy of “PrEPare for Work”.

Conceptual Model

The “PrEPare for Work” intervention is based on Social Cognitive Therapy (SCT), which specifies a core set of mechanisms that influence health behavior with a primary emphasis on self-regulation and self-reflection, including self-efficacy.

Overview of Study Design

We now propose to test the efficacy of the “PrEPare for Work” package in the Greater Providence area and in Los Angeles County using a two-stage randomization design. Stage 1: 500 MSW will be equally randomized to receive either the “PrEPare for Work Stage 1 intervention” (strength-based case management and facilitated PrEP linkage) or standard of care to evaluate successful PrEP uptake (verified by real-time tenofovir urinalysis; prescription data) within 2 months. Stage 2: those who initiate PrEP (n~156; ~55% from Stage 1 intervention arm and ~20% from Stage 1 SOC arm) will be equally re-randomized to the “PrEPare for Work Stage 2 intervention” (1-on-1 skills training, problem solving, and motivational interviewing adherence counseling and personalized, daily text messaging reminders) or SOC to assess PrEP adherence (tenofovir concentration in hair sample) and retention in PrEP care (appointments attended) over 12 months. We will also examine the degree to which improvements in PrEP uptake and adherence occur in the context of the conceptual mediators (e.g., PrEP motivation, self-efficacy) and moderators (e.g., race/ethnicity, substance use, perceived HIV risk) of the intervention. Intervention cost-effectiveness will be assessed.

Name of Grant

Fostering resilience to psychosocial and HIV risk in Indian MSM

Funding Source

National Institute of Mental Health (R01MH100627-01A1)

Pls

Mimiaga and Safren

Background

India has the world’s third largest HIV epidemic1, 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 in India have an estimated seroprevalence of 14.7%. HIV prevention efforts for MSM in India are limited to condom distribution and HIV education, with no existing efficacy trials of interventions and therefore no evidenced based interventions this population. They are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which increases the risk for HIV transmission to their wives. This proposal is the culmination of our ongoing, successful > 10-year community-based research collaboration with two NGOs dedicated to HIV prevention among MSM, Sahodaran (Chennai) and The Humsafar Trust (Mumbai), and investigators from the India Council of Medical Research (ICMR), National Institute for Research in Tuberculosis (NIRT) in Chennai. We have, in every phase of the development of this proposal (and throughout each of our preliminary studies), engaged the community in developing the research ideas, forming the program of research, designing / refining the studies, and disseminating the results to inform next-steps. Preliminary studies include: 1) documenting the exceptionally high rates of distress / mental health problems in MSM in Mumbai, 2) documenting, in Chennai, the high prevalence of HIV and sexual risk, and the important surrounding psychosocial context, 3) conducting a three-phased Indo-U.S. sponsored R21 including extensive formative work from CABs, focus groups with representative MSM, and key informant interviews to develop our self-acceptance based model of self-care in the context of pervasive stigma and discrimination facing Indian MSM. We field tested and then conducted a feasibility pilot RCT (with CAB feedback throughout) of the resulting intervention comparing it to HIV voluntary counseling and testing (VCT) alone. This field test and pilot RCT showed high participant acceptability and feasibility of study procedures, and success reducing HIV sexual risk behavior.

Design

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.