Kristine E. Gamarel, Ph.D. - US grants

Transgender (`trans') women (i.e., individuals with a feminine and/or female gender identity who were assigned male at birth) are among the populations at highest risk for HIV in the United States and worldwide. One of the most consistently reported contexts for HIV transmission among trans women is within a primary partnership with a non-transgender male. Despite the critical importance of primary partnerships for HIV prevention, the vast majority of HIV prevention studies and interventions for trans women have been individually-focused. For the past 10 years we have conducted research to identify intervention targets for reducing HIV transmission among trans women and their male partners using qualitative, survey, and intervention adaptation methodologies (R01DA018621; R34MH093232). Based on our conceptual and empirical understandings of HIV transmission risks among these couples, we recently developed and pilot tested the first known couples- based HIV prevention intervention for trans women and their male primary partner dyads (called ?Couples HIV Intervention Program?; CHIP), which was feasible, acceptable, and produced significant reductions in sexual risk behavior compared to the control group. Based on our highly successful R34 findings, we propose to test the efficacy of the CHIP program in large-scale randomized controlled trial (RCT) to reduce HIV risk among seroconcordant negative and serodiscordant couples. We will enroll racially diverse trans women and their male partners and randomize couples to either the CHIP intervention or an enhanced standard of care (SOC) control condition. Couples will be followed quarterly over 12-months. Analysis of study outcomes will utilize both individual- and dyadic-level data. Our primary outcome is a composite measure of risk for HIV transmission which encompasses validated behavioral indicators of HIV risk as well as biomedical confirmation of viral suppression and PrEP adherence. The CHIP intervention builds on years of formative work that targets interpersonal and social factors as mechanisms of HIV risk behavior among trans women and their male partners. If the CHIP intervention demonstrates efficacy in comparison to an enhanced SOC control condition, there will be support for implementing this approach within HIV prevention and care settings in order to reduce disparities in HIV transmission and acquisition among some of the highest priority HIV prevention populations.

Project Summary Heavy alcohol use in HIV-infected patients contributes to suboptimal adherence to antiretroviral therapy (ART), greater sexual risk taking, higher viral loads, and worsened liver and cognitive functioning. Gay, bisexual, and other men who have sex with men (MSM) continue to represent almost half of all HIV/AIDS cases in the United States, and heavy drinking is particularly high among this HIV-infected sub-group. Brief motivational interventions have been shown to reduce alcohol consumption among HIV-infected MSM; however, these individual-level interventions have demonstrated only modest effects in reducing drinking in this population, indicating that sustained behavior change requires attending to social and interpersonal contexts as well. To date, there are no existing brief, couples-based interventions to address heavy alcohol use among HIV-infected MSM and their primary partners that do not require alcohol abstinence treatment goals. Furthermore, there are no published data on the extent to which changes in couples alcohol use relate to key HIV-related outcomes (ART adherence, viral suppression, sexual risk). The overall aim of this project is to develop and test the feasibility, acceptability, and preliminary efficacy of a brief couples-based motivational intervention to address heavy alcohol use among HIV-infected MSM and their primary partner. This treatment development project builds on our individual-level motivational intervention (MI) with HIV- infected MSM by using components from our significant other-involved motivational intervention (SO-MI) and couples-based HIV prevention interventions, and seeks to provide insights into the mechanisms of couple-level behavior change, including motivation, individual and dyadic self-efficacy, and partner support. A two-step sequence of treatment development will be used to achieve these aims. Stage 1a includes interviews with key informants (N = 15 couples), manual development, therapist training, and a one-arm pilot with qualitative exit interviews (N = 12 couples). Stage 1b consists of a small-randomized clinical trial in which 50 heavy drinking HIV-infected MSM will be randomly assigned to either couples intervention, which involves participation of their partner, or to the existing individual intervention, which does not. Both conditions will consist of four sessions conducted over a one-month period. Participants will be interviewed at baseline, and 3-months and 6-months. Findings will provide data on the feasibility, acceptability and preliminary efficacy of the couples-based motivational intervention to reduce alcohol use among HIV- infected MSM and their primary partners. If this research shows initial promise, we will use findings to support an R01 application to test the intervention efficacy in a fully powered randomized controlled trial. This research could provide a foundation for improving the health of HIV-infected heavy drinking MSM.

PROJECT SUMMARY Transgender (`trans') women of color experience violence in a variety of contexts, including from partners, strangers, law enforcement, healthcare providers, and in public accommodations. Violence is consistently linked with HIV transmission risk and avoiding HIV prevention services via pathways including chronic stress, posttraumatic stress disorder (PTSD) symptoms, and substance use. These epidemics are concurrent and mutually reinforcing, constituting a ?syndemic? or synergistic interaction that contributes to documented inequities in HIV Prevention Continuum outcomes. In Detroit, Michigan, trans women of color are one of the `most-at-risk' groups for HIV, with significant disparities in sustained engagement in HIV prevention services. In this R21 exploratory/developmental research application, we propose to adapt, integrate, and pilot test a culturally-relevant evidence-based trauma-informed violence prevention intervention to improve HIV Prevention Continuum outcomes. Guided by the ADAPT-ITT model, our first aim seeks to conduct a systematic adaptation of three interventions and integrate these components into a trauma-informed combination prevention intervention for TWOC, with a focus on HIV Prevention Continuum outcomes by conducting interviews with trans women of color and key stakeholders to inform the adaptation. Our community advisory board consisting of trans women of color will review all adapted materials. The second aim seeks to examine the feasibility and acceptability of the trauma-informed combination prevention intervention in a one-arm pilot with follow-ups immediate and 3-month post-intervention. The primary outcome is improvements in HIV Prevention Continuum outcomes and the secondary outcomes are mental health and substance use. The project also seeks to gather qualitative data from one-arm pilot participants to identify strategies to overcome barriers to implementing rigorous randomized controlled trial research designs with trans women of color. Study findings will provide the necessary groundwork for a community-engaged efficacy trial in a subsequent, large-scale clinical trial.

PROJECT SUMMARY Transgender (`trans') women of color experience violence in a variety of contexts, including from partners, strangers, law enforcement, healthcare providers, and in public accommodations. Violence is consistently linked with avoiding care, suboptimal ART adherence, and lower odds of viral suppression via pathways including chronic stress, immune inflammatory response, posttraumatic stress disorder (PTSD) symptoms, and substance use. These epidemics are concurrent and mutually reinforcing, constituting a ?syndemic? or synergistic interaction that contributes to documented inequities in HIV continuum of care outcomes. In Detroit, Michigan, trans women of color are one of the `most-at-risk' groups for HIV, with significant disparities in engagement in HIV care. In this R21 exploratory/developmental research application, we propose to adapt and pilot test a culturally-responsive, evidence-based, and trauma-informed intervention to improve engagement in HIV care (primary outcome), reduce PTSD symptoms (secondary outcome), and increase sustained viral suppression (tertiary outcome) among trans women of color living with HIV. Guided by the ADAPT-ITT model, our first aim seeks to conduct a systematic adaptation of the intervention, with a focus on the unique aspects of violence, gender affirmation needs, and engagement in HIV care by conducting interviews with trans women of color and key stakeholders to inform the adaptation. Our community advisory board consisting of trans women of color will review all adapted materials. The second aim seeks to examine the feasibility, acceptability, and preliminary efficacy of the adapted intervention in a one-arm pilot with follow-ups immediate and 3-month post- intervention. The third aim seeks to gather qualitative data from one-arm pilot participants to identify strategies to overcome barriers to implementing rigorous randomized controlled trial research designs with trans women of color within limited-resources settings. Study findings will provide the necessary groundwork for a subsequent community-engaged large-scale randomized controlled trial. Findings also have the potential to provide a blueprint to guide future research efforts with trans women of color who are often embedded in close- knit communities with few existing culturally-responsive services.