Corina Lelutiu-Weinberger, Ph.D. - US grants

DESCRIPTION (provided by applicant): This project proposes to reconfigure traditional HIV prevention intervention mechanisms to better serve young men who have sex with men (YMSM), whose social and sexual patterns are increasingly shaped by social networking. Drawing on the Information Motivation Behavior model and the principles of Motivational Interviewing (MI), this project will engage HIV-negative YMSM (ages 18-29) in an intervention intended to impact their readiness to change behaviors that put them at risk for HIV infection, namely drug use and sexual risk. The proposed project is a modification of an existing intervention (the Young Men's Health Project or YMHP), in which 24% of those who consented to participate in longitudinal assessments declined participation in the intervention component. This group reported significantly more sexual risk behaviors than intervention participants, however, did not find our current mode of intervention delivery - four weekly office visits with a trained counselor - to fit their lifestyle or preferences. In response to pilot data collected from these participants, the proposed project adapts the existing intervention to support changes in (1) the intervention tailoring process (incorporating key informant feedback instead of delivering solely researcher-designed sessions) and (2) the space in which the intervention takes place (online rather than face-to-face). The study will iteratively adapt and pilot-test the existing face-to-face intervention for delivery through social networking sites, such as Facebook, to increase engagement of high-risk YMSM, who have been difficult to enroll in traditional intervention efforts. This pilot study entails a two-phase process. During Phase I, 15 former YMHP participants (intervention decliners and those who only completed one session) will participate in focus groups to advise us on the feasibility and pragmatic specifications of an HIV prevention intervention received via the instant messaging (IM) function of Facebook. Transcripts of these focus groups will be examined to isolate key recommendations for modifying the delivery modality, structure, and procedures. Once the intervention is modified, the focus groups will be reconvened for additional feedback, from which we will further adjust the intervention. During Phase II, 30 high-risk YMSM (ages 18-29) who are Facebook users will be enrolled in a pilot of the modified intervention. The intervention will span 4 weeks and contain 8 bi-weekly 30 minute MI chat-window sessions consisting of a sequential progression of intervention approaches tailored to each participant's readiness to change their drug use and high risk sexual behavior. Data from Phase II will include pre-post intervention behavioral risk assessments, as well as individual interviews with all 30 intervention participants for a qualitative evaluation regarding the feasibility and acceptability of the intervention's process, structure, and content. The proposed design provides an ideal forum to develop, implement, and iteratively fine-tune a pioneering, interactive intervention delivered via social networking, which will in turn set the stage for a larger efficacy trial. PUBLIC HEALTH RELEVANCE: Findings from the proposed study will inform existing HIV prevention interventions for high-risk drug-using young men who have sex with men (YMSM), in order to make them more acceptable, culturally appropriate, and accessible to this population. This iterative modification of a face-to-face intervention to be delivered via social networking will facilitate more successful recruitment of hard-to-engage HIV-negative behaviorally risky YMSM. This model has tangible benefits to sexual risk and drug use reduction efforts nationally as it (1) provides a pragmatic alternative to the traditional face-to-face intervention model, (2) facilitates engagement with a wider, more diverse pool of high-risk YMSM, including underserved rural populations, and (3) provides a feasible and culturally acceptable protocol for online intervention trials among high-risk YMSM to public health/service agencies, allowing them to circumvent budget, time and staffing constraints.

Project Summary This project seeks to employ mobile heath (mHealth) technologies to reduce the spread of HIV among gay, bisexual, and other men who have sex with men (MSM) in the Central Eastern European country of Romania. Rampant stigma contributes to the increasing prevalence of HIV among Romanian MSM and drives a lack of access to MSM-friendly HIV prevention services. While our established internet-based chat intervention circumvents barriers to access and supports health in stigmatizing contexts, we will translate it to a fully mobile platform and incorporate local cultural needs to ensure feasibility and appeal, and maximize efficacy among Romanian MSM. Delivering an innovative live chat counseling program alongside real-time risk behavior tracking on mobile devices can curb the increasing prevalence of HIV among Romanian MSM. In Aim 1 (months 1-6), we will conduct interviews with 5 key community informants and 15 MSM to guide us in assessing local HIV prevention needs and adapting the intervention for cultural resonance. Next, we will adapt the intervention with our Romanian collaborators. In Aim 2 (months 4-8), we will develop implementation protocols with intervention site staff and train three counselors. We will also work with our technical software developer, Data Center Solutions (DCS), to translate the intervention tools for mHealth delivery (smartphone chat intervention platform and real-time behavioral tracking tools). In Aim 3 (months 9-24), we will test the feasibility and acceptability of this mHealth intervention by delivering it to 40 high-risk MSM. Participants will be assessed (a) at baseline, (b) throughout the intervention using behavioral tracking software, and (c) at 6 months follow-up for risk (e.g., UAI) and protective (e.g., HIV testing, knowledge) patterns, and intervention acceptability. Collaborative review of findings will enable future mHealth research and preparation for an RCT. This pilot examines the feasibility of harnessing mHealth potential to build local capacity for the dissemination of an adapted online intervention to efficiently reach vulnerable MSM. If proven feasible, acceptable, and preliminarily efficacious in this pilot trial, this development project will mark the beginning of a program of applied mHealth research and practice for efficacy and effectiveness trials in other geographic locales where MSM are disproportionately affected by HIV and underserved by standard prevention approaches. Lastly, this unique research opportunity will foster the PIs? expertise in international research and provide an ideal context to apply their local US research knowledge globally.

Project Summary Lesbian, gay, bisexual and transgender individuals (LGBTI) present increased morbidity compared to the general population, which is attributed to healthcare discrimination and lack of LGBT-specific expertise, especially in high-stigma countries. Motivated by fear, Romanian LGBTI conceal their identities and report significantly more barriers to healthcare access than heterosexuals. Poor mental health, specifically anxiety and depression, is elevated for Romanian LGBTI, and associated with poor physical health (e.g., HIV risk, alcohol abuse.) However, LGBT-competent mental health professionals (MHPs) are nearly non-existent in Romania, and thus the negative impact of homophobia on mental health cannot be ameliorated. Neither universities nor continuing education include LGBT identity and health curricula, to the contrary, the dominant discourse promotes homosexuality as a dangerous anomaly in need of eradication. Given that a pilot of our in- person LGBT-affirmative MHP training we tested recently in Romania showed significant receptivity and increased competence among MHPs, this training is now ripe for testing its feasibility and efficacy in creating significant change via mobile delivery, in a randomized controlled trial (RCT). Proving the efficacy of this first mobile training and supervision model has high potential for cost-effective and expeditious boundless dissemination. In Aim 1, we will test the relative feasibility and efficacy of our mHealth MHP training by conducting an RCT comparing a mobile training (MT) of our MHP LGBT-competency program (n=60) to the equivalent in-person training (IPT) (n=60) we recently piloted. Both programs' content and structure will be identical (3-day trainings and two boosters 6 months apart). At baseline, 4, 8, and 12 months, we will assess, in a mobile fashion, all MHPs' LGBT-related attitudes, knowledge of LGBT health needs and clinical practice, and LGBT caseload. In Aim 2, we will test the efficacy of a companion mHealth supervision and consultation program in maintaining LGBT competency and enhancing LGBT-friendly practice. Half of the MHPs in each group will receive our mHealth supervision and expert consultation program, consisting of monthly 2-hour virtual group meetings to discuss case studies, in order to determine the added benefit of mobile supervision. After the training, 10 MHPs will provide interview-based program feedback. In Aim 3, we will build mHealth research capacity among MHPs by demonstrating how to integrate mobile data collection tools in clinical practice to monitor client progress for personalized treatment plans. We have chosen four types of partners to maximize the project's sustainability and benefit from the power of their multidisciplinarity: academics, direct service agencies supporting LGBTI, practicing MHPs, and a technical developer. This first RCT testing of an mHealth training in LGBT-competent mental healthcare in Romania affords us an unparalleled opportunity to introduce much needed expertize and mHealth methodologies in universities and clinical practice, and create a seed infrastructure for an implementation science R01 of national and global public health significance.

Project Summary This project is designed to remedy unaddressed and interlocking HIV-prevention and mental health needs among gay and bisexual men (GBM) in the Central Eastern European country of Romania, and their underpinning stigma-related mechanisms. Rampant stigma contributes to the increasing prevalence of HIV among Romanian GBM (from under 10% in 2009 to close to 20% in 2014, by best available estimates) and keeps GBM out-of-reach of HIV-prevention services. Our mHealth pilot intervention (titled ?Despre Mine. Despre Noi.? [DMDN] translated as ?About Me. About Us.?), which reduced US and Romanian GBM?s risk for HIV infection while also reducing depression and alcohol abuse in initial pre-post trials, is now ready for testing in a randomized controlled trial with a large national sample. The DMDN intervention entails eight 60-minute live chat sessions delivered by trained counselors on our mobile study platform using motivational interviewing (MI) and cognitive-behavioral skills training (CBST). First, during pre-trial (mos 1-5), in collaboration with a community advisory board consisting of GBM community members, GBM-affirmative physical and mental health providers, and our technical developer, we will fine-tune the DMDN intervention based on our pilot findings and evaluation interviews, and expand the original DMDN education materials for an education attention condition (EAC) that will serve as our control. Second, during the intervention phase (mos 6-45), we will recruit, screen, assess, and randomize GBM at risk for HIV infection and alcohol abuse to either the DMDN intervention (n=163) or EAC (n=163). The conditions are content matched, and both are hosted on our study platform. While DMDN will consist of eight weekly mHealth live chat sessions, EAC will consist of eight self- administered educational modules. Third, during the follow-up phase (mos 8-55), we will assess at 4, 8, and 12 months post-baseline, in a mobile fashion identical to the baseline, the primary outcome of condomless anal sex with male partners and secondary outcomes of alcohol abuse, depression, biologic HIV/STI infection, HIV/STI testing, and psychosocial mechanisms rooted in the Information-Motivation-Behavioral Skills (IMB) model (e.g., HIV/STI knowledge, condom use self-efficacy) and minority stress theory (e.g., identity concealment, internalized homophobia). We hypothesize that 1) compared to GBM randomized to EAC, those randomized to the mHealth DMDN condition will report significant reductions in condomless anal sex across the 12-month follow-up, 2) IMB and minority stress mechanisms will statistically mediate intervention efficacy, and 3) compared to EAC, the DMDN intervention will prove cost-effective in terms of HIV infections averted and reduced depression and alcohol abuse. If efficacious and cost-effective, DMDN presents a highly disseminable intervention that could significantly prevent HIV infection among GBM in high-stigma, low- resource areas, where GBM are disproportionately affected by HIV, yet kept out-of-reach of brick-and-mortar prevention services.

Project Summary Despite the effectiveness of pre-exposure prophylaxis (PrEP) in preventing HIV acquisition, PrEP is not currently medically prescribed in Romania, although demand is rapidly growing. Evidence-based knowledge is urgently needed to guide PrEP?s effective rollout in Romania. First, Romania has the 2nd highest increasing HIV incidence of 15 Central-Eastern European (CEE) countries, with gay and bisexual men (GBM) being one of the few epidemic-driving groups; however, there is no national HIV programming for GBM. Second, in a large 2019 GBM report, Romania was the 8th of 44 European countries with the largest gap between PrEP use (1%) and demand (70%). Third, Romania displays some of the highest homophobic attitudes in CEE, keeping GBM in hiding and underutilizing healthcare. Consequently, many Romanian GBM obtain PrEP on their own and use it without medical guidance, thereby increasing their HIV and other health risks. To address the unmet HIV-prevention needs of Romanian GBM, our established US-Romanian team proposes to introduce a culturally-responsive pre-exposure prophylaxis (PrEP) program in Romania. We will integrate and adapt two tools that we developed and tested in the US 1) SPARK, an in-person motivational intervention for uptake of and adherence to PrEP using an empowering sexual health approach; and 2) P3 (Prepared, Protected, emPowered), a PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling. We will work with our local Partner Consortium of GBM-competent health providers and GBM to create PrEP Romania, composed of both in-person (adapted SPARK to build initial motivation for PrEP uptake and adherence) and mHealth (adapted P3 to provide ongoing app-based PrEP motivation, education, and adherence support) components. Aim 1 (R21). In mos 2-11, using the ADAPT-ITT Model, we will systematically combine and culturally adapt SPARK and P3. Aim 2 (R21). In mos 12-20, we will enroll 20 GBM in a one-arm pilot to test PrEP Romania?s feasibility (e.g., medical visit attendance), acceptability (e.g., intervention staff protocol feedback, GBM interviews about counseling, app usability, and PrEP use), and PrEP uptake (e.g., filled prescriptions), adherence (i.e., self- reported, biomarker verified) and persistence (i.e., still on PrEP) at 3 mos. R21-R33 Transition Aim. In mos 21-24, we will summarize PrEP Romania?s promise and anticipated R33 plans. Aim 3 (R33). In mos 1-4, we will make necessary adjustments to PrEP Romania. In mos 5-30, we will randomize 120 PrEP-eligible GBM in two cities to receive either 1) PrEP Romania or 2) a PrEP education condition. We will examine differences across arms in PrEP uptake, adherence, persistence (self-reported and biomarker verified) at 3- and 6-mos post-PrEP initiation. Aim 4 (R33). In mos 31-36, we will identify individual and institutional barriers and facilitators of implementing PrEP Romania by examining Aim 3 feasibility and acceptability data, and via provider, clinic director, and GBM interviews to inform a future hybrid effectiveness-implementation trial.