Social and Behavioral Intervention Pilots

Principal Investigator:  Nicky Mehtani, MD MPH, UC San Francisco

Budget:  $269,723

Start Date: February 1, 2024        End Date: January 31, 2026

Project Abstract:  Methamphetamine use was involved in over half of San Francisco’s overdose deaths in 2021, is associated with 1 in 3 HIV seroconversions among sexual and gender minority individuals, and is increasingly prevalent among Black, Latinx, and unstably housed residents—priority populations of regional efforts to End the HIV Epidemic (EHE). Yet there are no FDA-approved pharmacotherapies for methamphetamine use disorder (MAUD), and existing behavioral therapies are limited in scope and efficacy. This constitutes a major barrier in progressing toward EHE goals, highlighting a critical need to investigate innovative approaches to treat MAUD. In recent years, ketamine—an FDA-approved drug with psychedelic-like properties—has been demonstrated to induce ultra-rapid remission of depression, suicidal ideation, and anxiety at sub-anesthetic dosages, and studies have suggested the preliminary efficacy of ketamine-assisted psychotherapy in treating cocaine, alcohol, and opioid use disorders. Ketamine’s anti-addictive effects are thought to result from prefrontal cortex glutamate modulation, which may enhance neuroplasticity, ultimately supporting psychological flexibility and one’s ability to learn new, healthier behaviors. However, ketamine therapy is largely inaccessible among low-income patients—including MediCal enrollees in the San Francisco Health Plan—and no studies have examined the utility of ketamine in MAUD. In an open-label pilot clinical trial, we will evaluate the feasibility, safety, and preliminary efficacy of ketamine-assisted psychotherapy to treat MAUD among publicly insured, treatment-seeking patients enrolled in residential drug treatment programs. N=12 patients with MAUD meeting study eligibility—including co-morbid HIV or engagement in HIV risk behaviors within the past 90 days and abstinence from stimulants for at least 7 days—will be administered intramuscular ketamine (0.4-0.7 mg/kg) at 3 weekly visits in combination with 7 sessions of trauma-informed psychotherapy over a 35-day period. We hypothesize that administering this novel, integrative, and low-cost intervention will be feasible among publicly insured MAUD patients engaged in residential drug treatment and that pilot findings will demonstrate preliminary safety and efficacy of ketamine-assisted psychotherapy in reducing methamphetamine use and HIV risk behaviors among study participants.

Principal Investigator:  Calvin Chiu, MA PhD, UC San Francisco

Budget:  $348,226

Start Date: March 1, 2026           End Date: February 28, 2028

Project Abstract: In California, Latine young adults are disproportionately affected by the HIV, HCV and STI syndemic. Despite Medi-Cal expanding to include young people up to age 25, Latine young adults struggle to access healthcare services due to multiple barriers including stigma around care-seeking and discrimination from providers, exacerbated by structural inequities, syndemic factors, and structural violence and chilling effects in the current xenophobic political environment. Research to improve service delivery models that expand access to HIV, HCV, and STI treatment — especially through non-traditional care settings — and mitigate the negative effects of syndemic factors for Latine young adults is urgently needed.

Principal Investigator:  Nicole Kelly, MPH, PhD, UCSF

Budget:  $337,500

Start Date: March 1, 2026           End Date: February 28, 2028

Project Abstract: Despite California’s (CA’s) robust HIV response, new diagnoses among transgender people disproportionately affect women (98%) and people of color (83%), requiring early intervention to prevent HIV among youth. Recent federal HIV prevention funding and programming cuts will likely worsen HIV inequities for young transgender women of color (YTWOC) in CA. Efforts to offset these harms and address extant inequities among YTWOC in CA are urgently needed. In response, we propose a theory-driven collective action intervention (CAI) grounded in the Minority Strengths Model, community organizing, and action-oriented research. ACT NOW (Action for Collective Transfemme Non-partisan Organizing and Wellness) departs from traditional deficit-focused paradigms by engaging YTWOC in developing structural solutions to meet their HIV prevention needs.

Principal Investigator:  Wayne Steward, MPH, PhD UCSD

Budget:  $312,565

Start Date: March 1, 2026           End Date: February 28, 2028

Project Abstract: Despite advances in treatment, approximately 35% of people living with HIV (PLHIV) in California are not virally suppressed (California Office of AIDS). Insufficient access to treatment contributes to disparities in mortality and morbidity among PLHIV and to new infections. The changing federal landscape is likely to exacerbate these gaps in care. Risks are especially high for immigrants, who face heightened threats of deportation; transgender and non-binary individuals, who must navigate escalating barriers to gender affirming care; and people whose care is covered by federally supported programs that face budget cuts.

Principal Investigator:  Natasha Ludwig-Barron, MPH PhD, UC San Francisco

Budget:  $330,799

Start Date: March 1, 2026           End Date: February 28, 2028

Project Abstract: National reductions in HIV and co-morbidity prevention funding could lead to 75,000 new HIV cases by 2030, disproportionately affecting California and people who use and/or inject drugs (PWUD). PWUD face a syndemic of HIV, substance use, STIs, chronic illness, housing instability, and limited access to primary care, but frequently access low-barrier harm reduction drop-in centers (DICs). We propose piloting a universal, multi-disease test-and-treat program in DICs to address HIV and associated co-morbidities within low-barrier settings. Our collaborators, Bienestar Human Services, Inc., a nonprofit serving Latinx, PWUD, and LGBTQ+ communities, offers bilingual/bicultural HIV care and harm reduction services through DICs in East Los Angeles and Pomona, including mobile units. In 2024, their HIV clinic served 723 patients (85% Latinx; 83% male) and the DICs served 4,910 clients—70% unstably housed, 67% Latinx, 70% male, and 86% Medi-Cal patients. Using an “opt-out” approach, we will pilot a rapid health screening using point-of-care tests and linkage program for HIV, hepatitis C, seven STIs, opioid use disorder, mental health, diabetes, and hypertension within two of Bienestar’s DICs and mobile units. Trusted staff and peer navigators will link screen-positive clients to one of Bienestar’s clinics using a referral system and track follow-up for up to 3 months. This proposal builds upon the applicant’s K01 training aims in implementation science and the longstanding collaborations of mentors, Drs. John Sauceda, Julia Lechuga and Ronald Brooks, all experts in Latinx mental health, HIV/STIs, PWUD, and intervention science. Primary outcomes include (a) feasibility and uptake of the universal screening and (b) the timing, success and resources needed to test and link patients to PrEP or HIV treatment, hepatitis treatment or vaccination, opioid use disorder treatment, and primary care. Second, we will follow-up with PWUD who opt-out of the screening program to assess rationale and structural barriers. Pilot data will inform a large-scale trial that leverages the RE-AIM Framework. Applying a quasi-experimental design paired with geospatial data to expand services at a trusted community organization can durably reduce HIV risks and associated comorbidities, improving the long-term health of PWUD —essential knowledge for ending the HIV epidemic.

Principal Investigator:  Rachel Logan, MPH PhD, UC San Francisco

Budget:  $337,500

Start Date: March 1, 2026           End Date: February 28, 2028

Project Abstract: San Francisco has the highest HIV incidence rate in California, with significant disparities in HIV incidence and pre-exposure prophylaxis (PrEP) uptake across gender and racial identities. In San Francisco, Black and Latina women are overrepresented in HIV incidence and related mortality; however, these groups constitute only a small fraction of the 4.5% of women using PrEP. Although PrEP implementation strategies addressing these inequities have increased, few have effectively improved the PrEP care cascade in reproductive care settings.

Principal Investigator:  Henry Honghu Liu, PhD, UC Los Angeles

Budget:  $346,250

Start Date: March 1, 2026           End Date: February 28, 2028

Project Abstract: Despite the transformative success of antiretroviral therapy (ART), a substantial number of people living with HIV (PLWH) struggle to achieve durable viral suppression due to inconsistent adherence. This limitation remains a major obstacle to ending the HIV epidemic in California, as poor adherence contributes to drug resistance and a higher risk of HIV transmission. Supported by NIH, our team was the first in the nation to have successfully tested the most objective, accurate ingestible sensor (IS) system for measuring, monitoring, and leveraging medication-taking among adult PLWH (Liu, et al., Ebiomedicine/Lancet, 2022). Although the IS system can accurately identify non-adherence and remind patients to take their medication, it does not address the underlying causes of non-adherence. Our team is currently conducting an NIH-funded study using the FDA-approved ID-Cap™ IS system to identify non-adherence patterns and trigger a real-time intervention to address underlying social-behavioral determinants of health (SBDOH), as well as other causes of non-adherence. This IS-SBDOH integrated intervention is expected to be highly effective but may be challenging in scalability and large-scale implementation. Building on this ongoing trial of the integrated intervention, we propose to develop and test a social-behavioral theory-based, information technology-supported intervention that will be easier to use, lower in cost, and more scalable. This new intervention, as a “third arm” of the ongoing trial, will use social-behavioral based multimedia videos to educate and motivate patients to adhere to ART, and AI-driven smartphone app to send automated reminders with frequency adjusted, based upon adherence level in the preceding four weeks; a survey to identify non-adherence causes, if adherence is low; and a real-time digital intervention addressing the underlying causes. We will recruit 30 PLWH with sub-optimal adherence and/or detectable viral load from a Los Angeles County HIV clinic serving a large number of PLWH that reflects the demographics of the HIV population in California. Outcomes will include levels of adherence, viral load, as well as feasibility, acceptability, and satisfaction with the intervention, which will be compared with outcomes from the IS-SBDOH integrated intervention and the usual care arm in the ongoing integrated intervention trial.

Principal Investigator:  Joanna Barreras, MSW PhD ,California State University, Long Beach Research Foundation

Budget:  $337,276

Start Date: March 1, 2026           End Date: February 28, 2028

Project Abstract: Latino sexual minority men (LSMM) face HIV disparities in the U.S. Few evidence-based HIV prevention interventions are culturally tailored for LSMM or implementation-ready for community-based organizations (CBOs). Siempre Seguiré is an 8-session group cognitive behavior therapy (CBT) intervention developed for LSMM that addresses coping with intersectional stigma and medical mistrust. A pilot conducted by Dr. Laura Bogart (Co-I on this application), with Dr. Joanna Barreras (early-stage investigator & PI of this application), demonstrated improved ART adherence, coping, and reduced internalized stigma and medical mistrust among LSMM with HIV. Their subsequent randomized controlled trial (RCT) with immigrant LSMM, which was terminated early by NIH in March 2025, showed increased HIV testing and PrEP readiness, and reduced PrEP stigma and medical mistrust. Dr. Barreras served as a Co-I on these prior studies, supervising intervention facilitators, contributing to intervention development, and guiding the data collection team throughout the project.

Principal Investigator:  Janet Myers, MA MPH PhD, UC San Francisco

Budget:  $400,000

Start Date: July 1, 2025       End Date: June 30, 2026

Project Abstract: The purpose of this project is to support capacity building, implementation, and evaluation of outreach and education activities designed to enhance awareness of and linkage to needed HIV/AIDS medications and Ryan White HIV/AIDS program services for justice-involved people living with HIV who are people of color (JI-PWH-POC) living in California. In this context, the consumers of interest are defined as members of an ethnic/racial minority group who have had recent contact or interaction with the criminal justice system as a defendant and are also living with HIV (JI-PWH). This vulnerable population often faces substantial structural and interpersonal barriers to obtaining consistent access to medical care, particularly when they have a history of returning to incarceration. Supporting continuity of care and maintenance of virologic suppression for JI-PWH is critical to improving individual lives, ending the HIV epidemic and curtailing future pandemics.