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The purpose of this study is to assess the feasibility and acceptability of SHEROES, a theory-driven, culturally grounded intervention to reduce sexual risk behavior among male-to-female transgender women (transwomen) at risk for HIV acquisition or transmission. HIV prevalence estimates among this population are markedly higher than estimates for other at-risk groups, and transwomen also experience severe stigma, discrimination, alienation, poverty, and victimization. Despite elevated risk for HIV, the rates of HIV testing among transwomen are much lower than other at-risk groups, and our team's research with transwomen living with HIV indicates unique barriers to treatment uptake and antiretroviral medication adherence, which puts them at elevated risk of poor HIV-related clinical outcomes, including morbidity, mortality, and transmission of HIV to uninfected partners. There is a dire need for rigorously-evaluated interventions designed specifically to meet the unique needs of transwomen. To address this need, we developed 'Sheroes,' a group-based intervention that addresses the unifying lived experiences of HIV-positive, HIV-negative, and unknown status high-risk transwomen. SHEROES was designed in close collaboration with the transgender community and is grounded in our team's innovative Model of Gender Affirmation. While a number of investigators have observed an intense need for (and often lack of access to) gender affirmation among transgender individuals, its relationship to high-risk behavior has rarely been directly investigated. This study is a pilot randomized controlled trial (RCT) comparing the SHEROES intervention to a time- and attention-matched film-based control condition. From a projected 223 to be screened, 60 self-identified transwomen who are at least 18 years of age, of any HIV status, and reporting unprotected receptive and/or insertive anal intercourse (UAI) in the past 3 months will be stratified by HIV status and randomized to receive the 5-session SHEROES intervention or a time- and attention- matched control group. Follow-up assessments will be conducted at 3 and 6 months post-randomization. While this pilot study is not powered for a formal test of outcomes or effect size estimation, we will collect data on our primary and secondary outcomes of interest to determine feasibility and acceptability of data collection and to explore our hypotheses via preliminary analyses. We hypothesize that following intervention exposure relative to control group, SHEROES participants will report a lower mean number of unprotected sexual partners. Moreover, we will test the secondary/exploratory hypotheses that SHEROES participants will report a) higher HIV testing rates (for HIV-negative transwomen at baseline); b) higher STI testing rates (for all serostatus transwomen), and c) higher HIV medical appointment attendance and ART readiness or ART use and adherence (for HIV-positive transwomen). An additional secondary/exploratory aim is to examine mediators/mechanisms of change based on the Model of Gender Affirmation (e.g., need for gender affirmation, self-objectification) and moderators of the intervention (e.g., HIV status, drug use).

Among the numerous health disparities disproportionately burdening people of color, HIV/AIDS is Among the highest. In the African American community the HIV/AIDS epidemic is one of the most urgent public health issues. In order to address the health disparity in HIV/AIDS, detection of HIV in the African American community is crucial. the benefits for early detection of HIV include potentially prolonged duration and quality of life for those living with the virus. HIV testing has also been proposed as a HIV preventive strategy. Detection of HIV has a number of potential preventive benefits, including reduced Transmission Risk behaviors by those infected9 and reduced viral load by those taking antiretroviral medications, whereby potentially reducing Transmission. the proposed study makes a significant public health impact by developing and pilot testing an innovative strategy to increase the number of high-risk adolescents receiving HIV screening. In response to PA-09-146 (Pilot and Feasibility Studies in Preparation for Drug Abuse Prevention Trials [r34]), we propose a pilot study to examine the acceptability and feasibility of a peer-driven, HIV-testing campaign. Peer education and outreach strategies have been successful at reducing sexual Risk behavior and increasing the use of health resources in adolescents and other at-risk groups, including adults residing in census tracts where STI rates are high. A potential vehicle for outreach to adolescents is socially interactive technologies (e.g., text messages). the proposed study makes a scientific impact in examining the effectiveness of messaging diffused through the social network of adolescents. A total of 100 current patients at an urban adolescent health clinic serving predominately African Americans will be recruited to disseminate at least 5 text messages to friends they believe are sexually active. Youth will be provided with a brief guide to help them develop their messages. the youth generated text messages will encourage their friends to Visit the clinic and get tested. the specific aims of this project are to: Aim 1: Develop protocols and a theory-informed message guide for a peer-driven text message intervention for adolescents recruited from an adolescent health clinic. Aim 2: Examine the acceptability and feasibility of sending text messages related to obtaining HIV/STI testing. We will obtain participant feedback and examine the recruitment rate, number of youth failing to meet inclusion criteria, number of youth verified to have sent text messages, and number of text messages sent. We will also obtain feedback from the clinic providers regarding impact on patient and services flow, provider reactions, and impact on clinical Visit. Aim 3: Preliminarily examine the efficacy of a youth generated messaging intervention to increase the: 1) number of high-risk youth seeking services and 2) clinic volume as measured by: a) number of new patients at clinic, b) increase in rate of new patient appointments, and c) number of STI tests conducted. If successful, the proposed study will significantly contribute to the field of HI prevention by examining the acceptability, feasibility and potential impact of an innovative strategy for delivering messages to high-risk youth, which encourage connection with the healthcare system and screening for HIV. This trial will fill a critical need to improve the sexual health outcomes of high-risk African American youth and lay the groundwork for a subsequent R01 proposal with a larger sample and that would include control sites.

The Achilles heel of successful HIV treatment is adherence to antiretroviral (ARV) therapy, as non-adherence remains one of the strongest predictors of progression to AIDS and death. The recognition of the supportive role of technology for ARV adherence by the U.S. Department of Health and Human Services underscores the importance of the need for stronger evidence of the effectiveness of these interventions. As a result, several studies have examined the efficacy of electronic reminder devices on ARV adherence. However, most of these studies have not revealed clinically significant improvements in adherence; which may be because they have primarily investigated the role of a single method, irrespective of patient-specific reasons for non-adherence. Thus, instead of using tailored Technology-based methods to address distinct non-adherence reasons, most studies compel the participant to "fit" the technology. Therefore, to most effectively use technology to improve adherence, customized interventions that focus on the patients' specific non-adherence reasons need to be considered. With protected time, training, and mentoring during this K23 career development award, I propose to acquire the skills needed to address these issues and to achieve my long-term career goal of becoming an independent clinical researcher. My training to date has provided me with a strong and basic foundation of research and affirmed my decision of becoming a clinical investigator. However, I require further training in the use of technology and Informatics to improve ARV adherence, conducting focus groups and advanced training in qualitative research, designing and implementing behavioral interventions, advanced training in biostatistics, and creating and testing rules for adaptive treatment strategies. I have identified Dr. Mallory Johnson as my primary mentor, who is an expert in the area of treatment adherence and has an outstanding record of mentorship. Drs. Nicolas Sheon, Ida Sim, Michael Silverberg, and Eric Vittinghoff will serve as co-mentors. Through mentorship and training, I plan to pursue four interconnected career goals: 1) become an expert in Technology-based methods of improving ARV adherence; 2) acquire expertise in adaptive treatment strategies; 3) become proficient in the use of mixed methods (qualitative and quantitative) research for the design and evaluation of behavioral interventions; and 4) move the field of clinical pharmacy forward by researching evidence-based HIV clinical pharmacist-led initiatives in advancing HIV care. The overarching objective of my research is to identify and develop individually-tailored Technology-based approaches that have the potential to overcome specific reasons for non-adherence in HIV+ youth. The advanced training I will receive during this K23 award will fill the gaps in my knowledge and enable me to successfully compete for an R34 grant to conduct a pilot study of Technology-based adaptive interventions to improve adherence in young HIV+ men and women; which will lead to an R01 to evaluate the efficacy of this Intervention.

Project Director/Lead Investigator: Hilary Seligman, MD (UCSF PI); Kirsten Bibbins-Domingo, PhD (Co-PI); Dean Schillinger, MD (Co-PI); Elaine Waxman, PhD (Co-PI); Michelle Marshall (Co-PI);  Marguerita Lightfoot, PhD (UCSF PRC PI)   Coordinating Center Aim 1: Identify critical gaps in nutrition policy research, and insure that cost-effective and time-efficient projects are conducted to fill those gaps Coordinating Center Aim 2: Disseminate findings broadly and engage external and non-traditional stakeholders by employing multiple communication channels Coordinating Center Aim 3: Facilitate translation of effective policies into local communities by leveraging the infrastructure of the Working Groups and our engagement with varied stakeholders   CVP faculty and staff, under the leadership of Dr. Hilary Seligman, bring a unique skill set to the coordination of CDC’s nutrition policy through NOPREN:

• Depth of expertise working with community groups and county and state health departments, with a particular focus on nutrition policy, diabetes prevention, and health disparities.
• Infrastructure and experience in leading and coordinating trans-disciplinary, multi-site programs for research and evaluation.
• Deep skill in all phases of policy and implementation research, from intervention design, evaluation, and implementation; to dissemination; to sophisticated modeling of policy interventions.
• Experience directing state public health programs in chronic disease prevention and control.
• Expertise in the health consequences of poor nutrition and poverty, informed by our continued work as primary care physicians at an urban, safety net hospital run by the local health department.

As a Collaborating Member Center, we will continue our longstanding collaboration with a national network of food banks (Feeding America) to answer a critical nutrition policy research question: how can we leverage the infrastructure and enormous capacity of the existing food bank system to support national nutrition priorities in low-income communities? We will answer this question by completing the following Aims:   Project Aim 1: Systematically interview Executive Directors of food banks across the US to rigorously examine barriers to and opportunities for distribution of healthier foods (particularly fresh vegetables and fruits) Project Aim 2: Establish policies and goals for the distribution of healthier foods by food banks, create and nationally disseminate the first toolkit to assist in implementation, and monitor policy success at the level of the food bank Project Aim 3: Create a protocol for monitoring policy success at the level of the individual by measuring client dietary intake over time

Project Director/Lead Investigator: Ma Somsouk, MD (UCSF PI); Uri Ladabaum (Stanford Co-PI); Eric Vittinghoff (Co-I); Ellen Chen (Co-I);  Marguerita Lightfoot, PhD (UCSF PRC PI)

Research Findings Summary

This study enrolled more than 9,500 patients - men and women ages 50-75 - from six clinics in the San Francisco Health Network. About half of them received routine care, while the other half were mailed a stool sample test kit called (FIT). The FIT kit is a non-invasive colon cancer screening that checks for blood in the stool as a possible sign of colon cancer. Results show that mailing the FIT kits increased the number of patients who completed the screening from 21% to 49%. Participants who did not speak English, or who had done a FIT test before, were more likely to complete the test. Common barriers to participants returning the FIT kits were forgetting, not understanding, not wanting to test, or other health problems, which may be addressed during follow-up calls. Specific Aim 1: To determine if centralized panel management with mailed fecal immunochemical tests (FIT) outreach improves uptake of CRC screening compared with usual care. In collaboration with primary care providers, we will leverage the EHR system to identify asymptomatic patients not up-to-date with CRC screening. Patients will be randomized 1:1, stratified by clinic and race to mailed FIT outreach versus usual care. The primary outcome will be the difference between groups in completion rates of FIT tests at one-year from randomization. Secondary outcomes include the FIT completion rate 28 days after mailing, reasons for incomplete tests, FIT test positivity, colonoscopy completion rates and pathology findings, and the programmatic efficacy of the delivery model over time on proportion of patients up-to-date with CRC screening. Other outcomes include the CRC-specific mortality, incidence, and stage in those receiving usual care versus mailed FIT. Specific Aim 2: To determine if the mailed outreach program can be used to improve other health maintenance practices. We hypothesize that a centralized panel model program supporting CRC screening could also be used to improve other health maintenance efforts. Among patients appropriate for screening, patients will be randomized to receive information about age-appropriate health maintenance measures (e.g., mammogram, vaccinations). Specific Aim 3: To describe and compare the cost and effectiveness of the centralized panel management for mailed FIT versus usual care. We hypothesize that the administrative cost and utilization of FIT kits will drive cost up, but will be balanced by increased uptake of CRC screening. Adapting previously developed decision analytic models with Markov processes12-18, the cost and effectiveness of mailed FIT outreach versus usual care will be examined. Outcomes reported include implementation and operational cost of the outreach program (e.g., personnel, capital expenditure, and colonoscopy utilization), cost per clinical outcome (e.g., patient screened, cancer diagnosed, quality-adjusted life year), and performance incentives needed to break even.