Bouguenais, France

A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW

The investigators will be testing a pharmacist-led model of PrEP delivery combined with mobile app-based PrEP support developed by the investigator's team to improve PrEP initiation and persistence. Alto Pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. Alto can provide PrEP prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (CPA) with SFDPH that allows transfer of these responsibilities. The investigators have integrated online tools with Alto Pharmacy's technology platform to create PrEP-3D: Digital Diary and Delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. By removing the requirement for initiation and quarterly visits with a primary care physician for PrEP, the PrEP-3D model will expand access to PrEP visits (including for persons who choose not to go to their primary care provider for PrEP) and reduce burden on the health care system.

mHealth Systems Navigation- Breaking Systems Barriers for Trans Women Living With HIV

Trans women carry the largest population burden of HIV in San Francisco and have low utilization of mental health and substance use services. The investigators' goal is to use lessons learned in a prior previously-funded Special Projects of National Significance to conduct a pilot peer delivered mHealth support and navigation intervention for trans women living with HIV. The investigators will work with partners in San Francisco Department of Public Health (SFDPH) clinics. The SFDPH is a HRSA-funded entity with trans-specific clinics and a host of in-house referrals to trans-competent mental health and substance use services. Despite availability of trans-specific services, considerable systems barriers exist. Trans clinics have limited clinic hours, and providers have large patient loads wherein medical gender affirmation and HIV care needs must be attended to in short visits. Visit and clinic time and large patient volume leaves providers with little time to ensure continuity in mental health and substance use referrals. To overcome these issues, a peer navigator will deliver mobile and in-person support and navigation to increase substance use and mental health service initiation and engagement among trans women living with HIV in trans health clinics. The research team has already conducted formative research with community members, key stakeholders and providers in San Francisco to help shape and refine the intervention model during the implementation phase of the research.In the implementation phase, the research team will pilot the mSN intervention to improve initiation and engagement in mental health and substance use (MHSU) services.

Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention

This is a clinic-based, multi-site, randomized, two-arm study to compare the effectiveness of two mobile technologies designed to support PrEP adherence and continuation in cisgender and transgender men who have sex with men (MSM) and transgender women (TGW). All study participants will receive PrEP per standard of care at each of the study sites. Participants randomized to PrEPmate will receive an interactive bidirectional text-messaging intervention that supports PrEP use through personalized communication between patients and providers. Key components include (1) weekly short message service (SMS) check-ins and a bidirectional SMS messaging platform; (2) customized daily SMS pill-taking reminders; (3) link to online PrEP Basics and videos and testimonials. Participants randomized to Dot Diary will receive a mobile app that promotes self-management of PrEP use and sexual health. Key components include (1) a digital pill-taking and sexual diary, with pill-taking reminders; (2) sex-positive badges earned via app use; and (3) real-time feedback on protection levels afforded by PrEP. Each participant will be followed for approximately 12 months. Staff at the participating clinics will also participate in in-depth interviews to give feedback on implementation challenges and experiences in the clinic-setting, and experience working with patients using the mobile technologies.

Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI

Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders

Background and Significance The high rate of combustible tobacco use among persons with schizophrenia, affective, post traumatic stress and substance misuse disorders is well documented. Over 40% of the estimated 9.8 million Americans, or 4.0% of the total population, who have serious behavioral health disorders smoke cigarettes, at a rate two to three times higher than the general population. The adverse health consequences and abbreviated lifespan for these persons is also well documented. Given the greater rate of tobacco use, persons with behavioral health disorders are at greater risk for morbidity, e.g., respiratory and cardio-vascular illness, and pre-mature mortality. The relationship of individuals in these communities to combustible tobacco in its pharmacological, sensorimotor and behavioral aspects is compelling. There is a significant literature documenting the endorsement and benefit of nicotine and smoking behavior for individuals in these communities. Clinical or personal context contribute to the barriers in making change, e.g., the social acceptability of smoking, lack of support, poor access to interventions, the need to mitigate stress and other symptoms of serious mental illness. The need for meaningful structure and daily engagement leads many to use tobacco to fill time and as a distraction. However, many individuals express a desire to quit or further reduce their tobacco consumption. Conventional tobacco interventions and approaches, e.g., smoking cessation, quit lines, informal telephone counseling, FDA approved Nicotine Replacement Therapies (NRTs) and medications have limited documented success. Existing evidence indicates that the combination of pharmacological intervention along with behavioral support is superior to either of these interventions alone. However the behavioral support aspect is usually limited to four to eight sessions. Local Need As documented by the State,California has led the way in the progressive decrease in combustible tobacco use. San Francisco County has a 10.8% rate of smoking. Over 25,000 adults received service on an annual basis from the San Francisco Department of Public Health. Of these service recipients at least 6028 adults or 24% (18 or older) are smokers, 5722 persons report having never smoked and for another 7926 (31.5%) smoking status is unknown. The larger department of public health offers smoking cessation services however there are no dedicated services targeting the behavioral health service user. Tobacco use is increasingly of concern for behavioral health program administrators and managers. Recruitment of programs for this research effort was met with enthusiasm and an unambiguous expression of a need for an intensive, harm reduction approach to tobacco intervention. The local Health Department division of Behavioral Health Services maintains a dedicated Harm Reduction policy regarding substance use behaviors. Consultants were retained to conduct, record and analyze the experience, barriers, challenges and satisfaction with smoking and smoking cessation attempts for individuals with behavioral health disorders through the facilitation of four focus groups. In summary, focus group participants report an understanding of smoking as an addiction integral to their daily lives; that its pleasurable effects override health concerns; that cigarettes are a "friend" and something to pass time and overcome boredom; that they understood restrictions on smoking but also feel harassed or demeaned for smoking; and that not smoking requires "willpower" against a powerful addiction. Some felt that a "harm reduction" approach, e.g., gradual reduction was best and most acknowledge that relapse was a common experience. There was a wealth of experience with smoking cessation and a diversity of satisfaction with various intervention strategies. Gum and patch were generally reported as not satisfying; Chantix was found to be helpful and a curiosity about inhaler or vaping as long as it is safe. Individuals also reported on personal strategies to help with reduction or cessation. More generally, individuals wanted more information about the range of choices. Some noted that access through insurance was a barrier except for those who had both Medicaid and Medicare. It is notable that participants report that they did not appreciate preaching or lecturing about the need to stop smoking. The conclusion is that individuals express a desire to reduce or abstain from tobacco use and also express the need for more help in doing so. Interest in the various intervention choices is diverse however gradual reduction with some aide appears to be the modal choice. Hypotheses 1. A Harm Reduction approach will result in a decrease in daily combustible tobacco use when compared to baseline use. 2. Support and harm reduction approaches will be important to acceptability. Research Questions 1. Does this Harm Reduction approach reduce combustible tobacco use when compared to baseline use? 2. Which strategies or combination of strategies demonstrate a greater or lesser impact in combustible tobacco use? 3. At what service intensity points, e.g., intervention dose as defined by number of weeks, does combustible tobacco use decrease? 4. To what degree does this Harm Reduction approach retain individuals in this intervention, i.e., acceptability of intervention? 5. What are participants' experiences with factors that enable success or barriers?