West Los Angeles, California

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

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.

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.

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.

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

New HIV infections among people who inject drugs (PWID) are increasing in the United States and San Francisco. Methamphetamine is a driving force in the transmission of HIV. Multiple studies across diverse populations have found methamphetamine use to be independently associated with both injection and sexual risk behaviors for HIV acquisition. Men who have sex with men (MSM) who inject methamphetamine are at particularly elevated risk for HIV from both injection and sexual risk behaviors. Daily, oral pre-exposure prophylaxis (PrEP) is safe and highly effective for HIV prevention when taken consistently. The Centers for Disease Control and other health agencies recommend PrEP for PWID. Despite this recommendation and increasing PrEP use in the US, almost no PrEP studies or demonstration projects have focused on PWID. The small number of studies that have evaluated PrEP use among MSM who inject methamphetamine have shown slow PrEP uptake and adherence challenges. The PRIME study will randomize 140 people assigned male sex at birth who use methamphetamine, are HIV-negative, and have recently engaged in an HIV sexual risk behavior to video directly observed therapy with contingency management (VDOT-CM) and counseling or counseling alone for 24 weeks. The primary aim of this study is to evaluate if VDOT-CM helps people who were assigned male sex at birth who use methamphetamine adhere to daily PrEP for HIV prevention. Participants will be assigned male sex at birth, age 18 years or older, who have used methamphetamine within the past 30 days, are HIV negative and interested in initiating PrEP, and report condomless sero-unknown/discordant sex in the past 12 months. Participants may also be individuals who recently started PrEP with an outside provider. All subjects will complete the following study visits: screening, enrollment, follow-up visits 6, 12, and 18 weeks from enrollment, and a final follow-up visit at 24 weeks. At screening, enrollment, and all follow-up visits, laboratory testing for HIV, gonorrhea, chlamydia, and methamphetamine metabolites will be done. Syphilis and creatinine testing will be done at screening and week 24. Syphilis testing will also be done at enrollment and week 12. In addition, hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCV) testing will be done at the screening visit. HCV testing will also be done at the week 24 visit. At screening a medical history and physical exam will be performed; during enrollment and follow-up a symptom-directed exam will be performed at all visits, and under clinician discretion, a medical history and full exam will be done if needed. AEs will be assessed starting at enrollment and throughout follow-up. Vital signs and weight will be checked at all visits. Some lab procedures will vary if the participant receives PrEP from their own provider or is enrolled remotely. At enrollment, participants will be randomized 1:1 to receiving only Integrated Next Step Counseling (iNSC) or iNSC and video directly-observed therapy (VDOT) with contingency management (CM). All participants will receive iNSC throughout their participation to support PrEP adherence and help their reduce risk for HIV. Dried blood spots (DBS) will be collected for FTC/TAF drug level testing at weeks 6, 12, 18, and 24. Participants randomized to the VDOT-CM arm will be asked to record taking their daily PrEP dose on VDOT every day from enrollment through week 24. In-depth interviews will be conducted with at least 36 participants (18/arm) and participants who discontinue PrEP early or become infected with HIV during the study.