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.