A Spotlight on our COVID-19 and HIV Research
In this e-newsletter, we share our response to COVID-19 as well as how COVID-19 has affected studies at the Division of Prevention Science
In this issue
  1. Director's Message
  2. COVID-19 HIV-Related Research
  3. HIV Research Adapted During COVID-19
  4. Town Hall Videos
  5. Announcements
Marguerita Lightfoot, PhD - Director's Message
I am excited to bring you the first CAPS/PRC newsletter of 2021. This edition highlights significant COVID-19 related research and the innovative strategies employed to continue research during the global pandemic.

The projects presented here are testaments to CAPS/PRC scientists’ nimble response to the pandemic, quickly developing and implementing new research strategies that allowed study activities to continue (recruitment, interventions, etc.), and to their commitment to research-partnerships to ensure a comprehensive understanding of the COVID-19 pandemic and it's relation to HIV. The success of these international, national, and local projects in no small way set a precedent and established ways forward when research is faced with unforeseen occurrences that impede progress.

I am thrilled to share these research summaries which will add to your understanding of

  1. individual behaviors made in response to SARS-CoV-2 and the use of digital tools for symptom surveillance/reporting
  2. the long-term impact of SARS-CoV-2
  3. access and uptake of COVID-19 testing among majority Latinx communities and reasons for case rate disparities; and
  4. the interplay between HIV and COVID-19 including clinical, health care systems, social support, and socio-behavioral interventions.

It is my hope that this new resource of information is beneficial and useful to you and the communities that you serve. Enjoy!
COVID-19 HIV-Related Research
Findings from a probability-based survey of U.S. households about prevention measures based on race, ethnicity, and age in response to SARS-CoV-2

John Sauceda, Torsten Neilands, Marguerita Lightfoot, and Parya Saberi investigated individual behaviors taken by White, African American, and Latino U.S. households in response to SARS-CoV-2, and the likelihood of using digital tools for symptom surveillance/reporting. Cross-sectional data for week one (April 2020) of the COVID Impact Survey – a large, nationally-representative sample of U.S. adults – were analyzed. Individual behaviors to protect against exposure to SARS-CoV-2 were nearly identical across White, African American, and Latino respondents, however, Whites reported being more likely to use digital tools to report/act on symptoms and seek testing, versus African Americans and Latinos. Based on these findings, individual behaviors may not explain COVID-19 case disparities; additionally, digital tools for tracking should focus on uptake among race/ethnic minorities.
Long-term Impact of Infection with Novel Coronavirus (LIINC) Study

The COVID-19 pandemic has existed for a year with no data on resources that might be beneficial or useful to recover from COVID-19 available to the general population. John Sauceda, social science co-investigator on the UCSF LIINC Study, along with Andres Maiorana and Edda I. Santiago-Rodriguez, are working in partnership with UCSF Gladstone Center for AIDS Research (CFAR) faculty to understand the social impact and ramifications that a COVID-19 diagnosis has on a person. Semi-structured interviews are being conducted to capture responses and nuanced information on topics that are fairly unknown and urgently needed; 24 people diagnosed and recovered from COVID-19, including those living with HIV co-infection, have been interviewed. This exploratory study will help researchers to gain an understanding of underlying opinions and experiences from participants about how people are managing being diagnosed and recovering from COVID-19 in the San Francisco Bay Area.
NIH RADx Study - Aliados por la Salud

Led by UCSF Mulitple Principal Investigators (MPSs) Gabe Chamie and Carina Marquez, John Sauceda is co-investigator on a project to evaluate community-engaged approaches to improving access and uptake of COVID-19 testing among the majority Latinx communities in Northern California and examining local epidemiology and factors that are driving the stark ethnic disparities observed in COVID-19 case rates. The aims are to:

  1. evaluate the implementation of a Latino Task Force (LTF) collaborative network across 3 counties in California (Marin, Merced, and San Francisco) to promote locally-adapted COVID-19 test and respond initiatives in two majority-Latinx communities: one suburban (Marin) and one rural (Merced);
  2. determine the population-level prevalence of active (PCR+ or BinaxNOW™ rapid antigen test-positive) SARS-CoV-2 infection, most at-risk subgroups, and attitudes and preferences of community members regarding COVID-19 testing services; and to
  3. conduct a 3-arm randomized controlled trial to determine the comparative effectiveness of two behavioral strategies – one that leverages incentives (extrinsic motivation) and another that relies on altruism framing (intrinsic motivation) compared to standard offer of retesting (control) – to increase frequent SARS-CoV-2 retesting among most at-risk sub-groups.

Study findings will address some of the information gaps and could potentially be leveraged to reduce disparities.
Evaluation of the Interplay Between HIV and Covid-19 In Safety-Net HIV Clinics

Very little is known about how HIV and the virus that causes COVID-19 (SARS- CoV-2) interact, if at all. Harnessing the research infrastructure of the UCSF CFAR, San Francisco citywide COVID-19 registries, and People With HIV (PWH) served by the Zuckerberg San Francisco General Hospital (ZSFGH) Ward 86 and eight other clinics across the US with computerized national identity cards (CNICS), CFAR and CAPS researchers put immediate, high-impact studies in place to track the colliding pandemics and address information gaps. They aim to:

  1. provide novel, urgently needed insights into how SARS-CoV-2 infection risk, prevalence, and clinical outcomes vary by HIV status and/or antiretroviral regimen (i.e. tenofovir)
  2. explore whether HIV infection will impair humoral or T-cell responses to COVID-19, providing insights for therapeutic and vaccine development; and
  3. evaluate the impact of disruption of healthcare and social support systems on PWH, including viral suppression; retention in care; hospitalizations, co-morbidity outcomes, and non-COVID-19 related death; healthcare utilization during COVID019; and socio-behavioral outcomes during and after social distancing to assess isolation, food insecurity, stress, substance use, stigma, and resilience.

Study findings will provide an understanding of any interplay between HIV and CIVID-19 and allow for appropriate clinical, health care systems, social support, and socio-behavioral interventions.
Research in the Time of Coronavirus: Continuing Ongoing Studies in the Midst of the COVID‑19 Pandemic

In late 2019, a novel human coronavirus, SARS-CoV-2, was identified in Wuhan, China, leading to a pandemic that required physical distancing and isolation. As a result, many medical research activities, such as participant recruitment, study visits, and outcomes assessments were halted. Parya Saberi summarizes considerations for conducting remote research during a pandemic while keeping research participants and staff safe, providing a starting place for a fundamental shift in how research can be conducted across the research cycle from advertisement and recruitment to monitoring and assessment of study outcomes. Aligning research activities with remotely-conducted research methodology (e.g., use of social media to advertise, web forms on a study website to screen/enroll, telehealth for study interventions, etc.) has the potential benefits of reducing time and cost for conducting the study, improving ease of participation for many individuals, enhancing the generalizability of findings, and increasing the speed of publication of study findings, all while preventing exposure to airborne viruses and transmission to research participants or staff.
HIV Research Adapted During COVID-19
Tel-me-Box: Validating and testing a novel, low-cost, real-time monitoring device with hair level analysis among adherence-challenge patients

Maria Ekstrand and her team at St. John’s Research Institute in Bangalore, India have developed a wireless real-time adherence monitoring device called Tel-Me-Box (TMB), that sends wireless signals to a server whenever opened. It is small, low-cost, and rechargeable with a micro-USB cord, and can be programmed to deliver tailored reminders via sound or light. Since it cannot assess actual drug ingestion, this study will validate the TMB data against hair ARV concentrations as a biological measure of adherence in collaboration with Monica Gandhi’s HAL lab at UCSF. This study will also assess if tailored real-time reminders improve ART adherence in a pilot RCT. The results could have utility for adherence interventions, both in India and globally.

During the COVID-19 lockdown in India, the usual in-person interview was replaced with a telephone interview, and the collection of blood and hair samples were postponed. We added questions on COVID-19 and the impact of the pandemic on their HIV management to the questionnaire. In-person visits have restarted with those participants who did not temporarily relocate to their native place with the necessary safety precautions. We are currently in the 4th round of COVID-19 questions, and the focus has shifted from knowledge of symptoms, transmission, and prevention to testing to vaccination knowledge and willingness.
Stigma as a barrier to cancer palliative care outcomes among people with HIV in India

Maria Ekstrand is collaborating with Manipal Academy of Higher Education and King’s College, London on a study to understand the role of HIV and cancer stigma in care-seeking and palliative care in South India. Findings from their prior research demonstrate that HIV stigma is a barrier to engagement and retention in HIV care. However, little is known about the experiences of PLWH who are dually diagnosed with cancer. This study will adapt and test the team’s measures of HIV stigma and palliative care outcomes for use among PLWH seeking cancer treatment in India. The results will inform the adaption of an effective intervention for use with patients and family members in India to improve cancer and palliative care outcomes.

During the Indian lockdown, we suspended recruitment and in-person interviews since our participants are immunocompromised. In-person interviews have restarted with the necessary safety precautions, but we are unlikely to complete enrollment for one patient group, since they are much harder to recruit. We also modified the protocol by adding family members to obtain additional data, since they are healthy and easier to recruit, even during a pandemic.
Improving Mental Health through Integration with Primary Care in Rural Karnataka

Maria Ekstrand is collaborating with St. John’s Research Institute in Bangalore, India on a study to test whether a “collaborative care model” can reduce depression and anxiety in rural patients who also have cardiovascular disease or type-2 diabetes. Participants were recruited either during their visit to the primary care clinic or at community health fairs. The trial is evaluating whether participants who receive integrated physical and mental health care from their primary care doctors, with support from specialists, plus education and support from lay community health workers, show better mental and physical health outcomes after the intervention than a control group receiving standard care. 
  
In-person interviews were suspended in Spring 2020 due to COVID-19 because the required travel to rural health centers was impossible/illegal under lockdown, and telephone interviews were not an option. Travel and interviews have resumed, with the necessary safety precautions. We were able to suspend operations without further consequences because we received approval for a second no-cost extension from our funder.
HIV pre-exposure prophylaxis in the time of COVID-19: How a robust and responsive HIV PrEP intervention can avert loss of HIV prevention coverage during a global pandemic

Due to the COVID-19 pandemic, sex with casual and non-primary partners among gay and bisexual men decreased and sharp reductions in HIV pre-exposure prophylaxis (PrEP) initiation and continuation have been observed. The PrEP Optimization Intervention (PrEP-OI) study, initiated by Parya Saberi and colleagues in 2018 to examine the impact of a PrEP panel management strategy involving a PrEP Coordinator and a web-based panel management tool on PrEP initiation in 12 SFDPH primary care clinics, was fully underway March 16, 2020, when the San Francisco (SF) shelter-in-place orders from the SARS-CoV-2 pandemic went into effect. Researchers instituted several measures to maintain a connection with patients and tailor PrEP care to their changing needs, including sustained diverse communication methods, development of internal PrEP guidelines to address laboratory visits and PrEP refills, communicating nuances of 2-1-1 PrEP to MSM and transgender women, PrEP by mail, providing ride-sharing vouchers, and communicating non-PrEP health-related questions/concerns to patients’ provider. Unlike previous reports of reduced PrEP continuation, measures implemented for the PrEP-OI study resulted in no reduction in PrEP use by patients in SFDPH primary care clinics following the SARS-CoV-2 pandemic shelter-in-place restrictions.

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DuoPACT Study: Changing Strategies During the COVID-19 Pandemic

This randomized gender and sexual minority couple’s intervention study – designed by Mallory Johnson and colleagues to improve engagement in HIV care and antiretroviral adherence – was temporarily halted due to the COVID-19 pandemic. On March 14, 2020, researchers paused enrollment and implemented new recruitment strategies. Participants with access to a smartphone, tablet, or computer were moved to remote, online study activities, including follow-up assessments and Zoom delivery of the control and experimental arms of the intervention. Informed consent, randomization, and phlebotomy were paused until June 1 when participants were invited and agreed to visit Quest for blood collection. Given the success of remote enlistment and blood collection, recruitment was expanded to all of California; enrollment visits were changed to Zoom and DocuSign. All paper screening forms were converted to online PDFs, new procedures were developed for all remote study activities, and participants were mailed reloadable ClinCards for payments. In 2020, 6 (37.5%) of 16 missing viral loads (due to shelter-in-place) were obtained via a Medical Release of Information Form from the study subjects’ provider. Overall, participation levels were quite high and for much of 2020 participants seemed happy to hear from researchers. Participants with reliable Wi-Fi, a device that supports DocuSign and Zoom, and a private place for counseling sessions were seamlessly moved to remote activities. This wasn’t the case for participants who lacked any of those items, where continued participation in DuoPACT was hard and often frustrating. After research staff is vaccinated, researchers will resume modified in-person visits for couples unable to complete study procedures remotely.

Town Hall Videos
Adapting to a Pandemic Reality
Judy Tan Ph.D.

Judy Tan, Ph.D., is Assistant Professor of Medicine at CAPS/DPS. She is a behavioral and prevention scientist trained in social and health psychological theory, quantitative research methods, and intervention development.

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Analytical Issues for Pandemic Disruptions
Charles McCulloch, Professor

Dr. Charles McCulloch is Professor and Head of the Division of Biostatistics at UCSF. He has expertise in the development and use of statistical methods for longitudinal data analysis, mixed models, and latent class models.

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ANNOUNCEMENTS
UCSF is responding to the outbreak of the respiratory illness COVID-19. This website provides regularly updated information for the UCSF community. https://coronavirus.ucsf.edu/
HIV and COVID-19. Here you will find guidance and resources prepared by leading HIV organizations: https://prevention.ucsf.edu/COVID19 
CAPS/PRC Town Hall presents Steve Gregorich, Ph.D. Introduction to Exploratory Factor Analysis (EFA). This talk is Part I in a 3-part series being offered by CAPS Methods Core faculty member, Dr. Steve Gregorich, prior to his retirement later this year. Tuesday, March 2nd, 2021. 11:00 a.m. - 12:30 p.m. PST. Register here.
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The mission of Center for AIDS Prevention Studies is to end the HIV epidemic and associated health and social disparities by conducting high impact HIV prevention science and building capacity among researchers and communities to effectively address HIV. Project #: 2P30MH062246
The mission of the UCSF Prevention Research Center is to maintain an interdependent network of community, academic, and public health partners to design and implement prevention research aimed at answering significant and innovative HIV research questions and promoting the wide use of practices proven to promote health for those infected and affected by HIV. Project #: 5U48DP004998