Measuring social determinants of health in the All of Us Research Program.

To accelerate medical breakthroughs, the All of Us Research Program aims to collect data from over one million participants. This report outlines processes used to construct the All of Us Social Determinants of Health (SDOH) survey and presents the psychometric characteristics of SDOH survey measures in All of Us. A consensus process was used to select SDOH measures, prioritizing concepts validated in diverse populations and other national cohort surveys. Survey item non-response was calculated, and Cronbach's alpha was used to analyze psychometric properties of scales. Multivariable logistic regression models were used to examine associations between demographic categories and item non-response. Twenty-nine percent (N = 117,783) of eligible All of Us participants submitted SDOH survey data for these analyses. Most scales had less than 5% incalculable scores due to item non-response. Patterns of item non-response were seen by racial identity, educational attainment, income level, survey language, and age. Internal consistency reliability was greater than 0.80 for almost all scales and most demographic groups. The SDOH survey demonstrated good to excellent reliability across several measures and within multiple populations underrepresented in biomedical research. Bias due to survey non-response and item non-response will be monitored and addressed as the survey is fielded more completely.

Community based participatory research as a promising practice for addressing vaccine hesitancy, rebuilding trust and addressing health disparities among racial and ethnic minority communities.

The COVID-19 pandemic disproportionately affected racial and ethnic minority communities across the United States (U.S.). Despite the disproportionate burden of COVID-19 faced by communities of color, Black and Hispanic communities are less likely to be fully vaccinated than White non-Hispanic Persons. Health inequity and vaccine hesitancy are complex phenomena that require multilevel responses tailored to the unique needs of each community, a process that inherently necessitates a high level of community engagement in order to develop the most effective health interventions. Building on the principles of community based participatory research (CBPR) and with the support of the National Institutes of Health (NIH), Project 2VIDA! was born. A multidisciplinary collaborative of academic researchers, community members, and clinicians whose aim is to foster sustainable partnerships to reduce the burden of COVID-19 in Hispanic and Black communities across Southern California. Our model was designed to meet our community members where they were - whether on their lunch break or picking their children from school. This CBPR model has been well received by community members. Future health interventions focused on reducing health disparities should prioritize the role of the community, leverage the voices of key community partners, and be grounded in equitable power sharing.

Study protocol: Project 2VIDA! SARS-CoV-2 vaccine intervention delivery for adults in Southern California.

Background: To date, the United States (US) leads the world in the number of infections and deaths due to the Coronavirus Disease 2019 (COVID-19). Racial and ethnic disparities in COVID-19 morbidity and mortality are staggering. Age-adjusted data show that AA and Latino individuals have had higher rates of death over most of the pandemic and during surges. Project 2VIDA! is community-based participatory research (CBPR) that was developed to address individual, social, and contextual factors related to access and acceptance of the COVID-19 vaccine among African American and Latino communities in Southern California. This paper describes the study protocol and overarching objectives. Methods and design: Project 2VIDA! is a multilevel intervention that builds on the principals of CBPR and is designed to increase uptake of the COVID-19 vaccine among African American and Latino individuals (≥16 years and older) in San Diego County. The intervention was developed with a working group comprised of representatives from community and academia and centers on targeted COVID-19 individual awareness and education, linkage to medical and supportive services, COVID-19 community outreach and health promotion and offering the COVID-19 vaccine through community pop-up clinics. Discussion: Findings from 2VIDA! will provide data on the impact, feasibility, and acceptability of the intervention which are all crucial for the adaptation, refinement, and improvement of vaccine outreach interventions for COVID-19 and other vaccine preventable infectious diseases that severely impact African American and Latino communities. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT05022472?term=Project+2VIDA&draw=2&rank=1, NCT05022472.

Randomized trial of an integrated care intervention among Latino adults: Sustained effects on diabetes management.

We examined the 12-month maintenance effects of a previously successful integrated model of diabetes care at improving glycemic management and psychological well-being among Latino adults with type 2 diabetes (T2D). A randomized controlled trial (2015-19) compared an integrated care intervention (ICI) with usual care among 456 adults with T2D. The ICI included integrated medical and behavioral care and health education over 6 months. Assessments were completed at baseline, 3, 6, 9, and 12 months. Most participants were female (63.7%) with a mean age of 55.7 years. In multilevel models, significant Group × Time (quadratic) interaction effects were found for HbA1c [Bint = 0.10, 95% confidence interval (CI) 0.02, 0.17, P < .01] and anxiety symptoms (Bint = 0.20, 95% CI 0.05, 0.35, P < .009), but not depression symptoms (Bint = 0.15, 95% CI -0.01, 0.31, P < .07). Analyses of instantaneous rate of change in the ICI group showed significant decreases at 3 and 6 months for both HbAc1 (B = -0.31 at 3 months; B = -0.12 at 6 months) and anxiety symptoms (B = -0.92 at 3 months; B = -0.46 at 6 months), and no significant instantaneous changes at 9 or 12 months, suggesting that initial improvements were largely maintained. The usual care group showed a small decrease in anxiety symptoms at 6 months (B = -0.17), but no other significant changes at any time-point for anxiety or HbA1c (all Ps > .05). This culturally tailored integrated care model shows potential in producing and sustaining positive effects on clinical and psychological outcomes above standard care.

Our previous studies found that a culturally adapted, enhanced service (integrated care intervention) that we developed improved glycemic management and decreased depression and anxiety symptoms over the 6 months that the service was offered. In this study, we examined whether those improvements in diabetes management and depression and anxiety symptoms were maintained up to 6 months after the conclusion of the intervention. The integrated care intervention involved providing medical and behavioral healthcare on the same day and at the same location as well as health education for 6 months. The study participants were 456 Latino adults (aged 23­80 years) who had type 2 diabetes and were not taking insulin. Participants were randomly assigned to one of two groups: the integrated care intervention or usual care. In this study, we found that the improvements in glycemic management and in anxiety and depression symptoms previously shown were largely maintained. These findings suggest that culturally adapted health services that include both medical and behavioral care and health education programs may benefit Latino patients with type 2 diabetes.

Community-engaged optimization of COVID-19 rapid evaluation and testing experiences: roll-out implementation optimization trial.

BACKGROUND: There continues to be a need for COVID-19 testing that is pragmatic, community-centered, and sustainable. This study will refine and test implementation strategies prioritized by community partners: (1) walk-up no-cost testing, (2) community health worker (promotores)-facilitated testing and preventive care counseling, (3) vending machines that dispense no-cost, self-testing kits. METHODS: A co-designed Theory of Change from an earlier study phase and the Practical, Robust Implementation and Sustainment Model (PRISM) will guide the study design, measures selection, and evaluation. The first aim is to refine and operationalize a multi-component implementation strategy bundle and outcome measures for COVID-19 testing. A Community and Scientific Advisory Board (CSAB) will be established and include community members, clinical providers/staff from the partnering Federally Qualified Health Center (FQHC), public health researchers, policymakers, and a county health department ambassador. Engagement of CSAB members will be assessed through structured ethnography and a survey about the quality and quantity of engagement practices. The second aim is to implement and evaluate the impact of the implementation strategy bundle to optimize COVID-19 testing in communities using a roll-out implementation optimization (ROIO) design. Seven thousand and five hundred community members will be enrolled across four FQHC clinics over 18 months. Participants will be invited to complete an electronic survey about their demographics, health, and COVID-19 testing results and experiences. CSAB members and clinic partners will participate in PRISM fit and determinant assessments prior to each clinic rollout and post-trial. Interviews will be conducted with 60 community participants and 12 providers/staff following a 3-month rollout period at each clinic, inquiring about their experiences with the implementation strategies. Quantitative data will be analyzed using hierarchical multilevel models to determine the impact of implementation strategies. Qualitative data will be analyzed using rapid qualitative approaches to summarize implementation experiences and identify necessary changes prior to subsequent rollouts. A matrix approach will be used to triangulate data from quantitative and qualitative sources based on PRISM domains. DISCUSSION: This is one of the first pragmatic implementation trials to use a ROIO design and aims to co-create a sustainable and equitable COVID-19 testing program. Findings are likely to generalize to other public health prevention efforts. TRIAL REGISTRATION: NCT05894655 March 2, 2023.

Scaling and sustaining COVID-19 vaccination through meaningful community engagement and care coordination for underserved communities: hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial.

BACKGROUND: COVID-19 inequities are abundant in low-income communities of color. Addressing COVID-19 vaccine hesitancy to promote equitable and sustained vaccination for underserved communities requires a multi-level, scalable, and sustainable approach. It is also essential that efforts acknowledge the broader healthcare needs of these communities including engagement in preventive services. METHODS: This is a hybrid type 3 effectiveness-implementation study that will include a multi-level, longitudinal, mixed-methods data collection approach designed to assess the sustained impact of a co-created multicomponent strategy relying on bidirectional learning, shared decision-making, and expertise by all team members. The study capitalizes on a combination of implementation strategies including mHealth outreach with culturally appropriate messaging, care coordination to increase engagement in high priority preventive services, and the co-design of these strategies using community advisory boards led by Community Weavers. Community Weavers are individuals with lived experience as members of an underserved community serving as cultural brokers between communities, public health systems, and researchers to co-create community-driven, culturally sensitive public health solutions. The study will use an adaptive implementation approach operationalized in a sequential multiple assignment randomized trial design of 300 participants from three sites in a Federally Qualified Health Center in Southern California. This design will allow examining the impact of various implementation strategy components and deliver more intensive support to those who benefit from it most. The primary effectiveness outcomes are COVID-19 vaccine completion, engagement in preventive services, and vaccine confidence. The primary implementation outcomes are reach, adoption, implementation, and maintenance of the multicomponent strategy over a 12-month follow-up period. Mixed-effects logistic regression models will be used to examine program impacts and will be triangulated with qualitative data from participants and implementers. DISCUSSION: This study capitalizes on community engagement, implementation science, health equity and communication, infectious disease, and public health perspectives to co-create a multicomponent strategy to promote the uptake of COVID-19 vaccination and preventive services for underserved communities in San Diego. The study design emphasizes broad engagement of our community and clinic partners leading to culturally sensitive and acceptable strategies to produce lasting and sustainable increases in vaccine equity and preventive services engagement. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05841810 May 3, 2023.

Optimizing ATTAIN implementation in a federally qualified health center guided by the FRAME-IS.

Implementation strategies are methods or techniques used to adopt, implement, and sustain evidence-based practices (EBPs). Implementation strategies are dynamic and may require adaptation to fit implementation contexts, especially in low-resource settings, which are most likely to serve racially and ethnically diverse patients. The framework for reporting adaptations and modifications to evidence-based implementation strategies (FRAME-IS) was used to document adaptations to implementation strategies to inform an optimization pilot of Access to Tailored Autism Integrated Care (ATTAIN; an integrated care model for children with autism and co-occurring mental health needs) in a federally qualified health center (FQHC) near the United States/Mexico border. Quantitative and qualitative data were collected from 36 primary care providers who participated in the initial ATTAIN feasibility pilot to inform adaptations. Adaptations were mapped to the FRAME-IS through an iterative template analysis to inform an optimization pilot at a FQHC 1-year from the start of the COVID-19 pandemic. Four implementation strategies (training and workflow reminders, provider/clinic champions, periodic reflections, and technical assistance) were employed during the feasibility pilot and were adapted for the optimization pilot to fit the needs of the FQHC and service delivery changes prompted by the pandemic. Findings demonstrate the utility of using the FRAME-IS to systematically inform EBP optimization in a FQHC providing care to underserved communities. Findings will inform future research studies implementing integrated mental health models in low-resourced primary care settings. Implementation outcomes and provider perceptions of ATTAIN at the FQHC are also reported. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Effectiveness of an integrated primary care intervention in improving psychosocial outcomes among Latino adults with diabetes: the LUNA-D study.

OBJECTIVE: To compare the effectiveness of usual care (UC) versus a culturally tailored integrated care model in improving mental health symptoms for Latino patients with Type 2 diabetes mellitus (T2DM). METHODS: We conducted a two-arm randomized controlled trial from 2015 to 2019 at a federally qualified health center. Participants were 456 adults ages 23-80 years who had a previous diagnosis of T2DM and were not currently using insulin. Participants were randomly assigned to Integrated Care Intervention (ICI; including behavioral/mental healthcare, medical visits, health education and care coordination) or UC; standard of care including referrals for health education and behavioral/mental health care where appropriate. Intention-to-treat, multilevel models were used to compare group × time changes in depression and anxiety symptoms (PHQ-8; GAD-7) and perceived stress (PSS-10) across 6 months. RESULTS: Participant mean age was 55.7 years, 36.3% were male, and 63.7% were primarily Spanish speaking. Baseline sociodemographic factors and mental health symptoms across study arms were balanced. Significant group × time interaction effects were observed for anxiety and depression symptoms (p < .05). Within the ICI and UC groups, mean depression symptom changes were -0.93 and -0.39 (p < .01); anxiety symptom changes were -0.97 (p < .01) and -0.11 (p = .35); and perceived stress changes were -1.56 and -1.27 (p < .01), respectively. CONCLUSIONS: Although both ICI and UC showed decreases over time, the ICI group evidenced larger, statistically significant changes in both depression and anxiety. Adapted integrated models of behavioral and chronic disease management appear to be effective and could be considered for usual care practices. CLINICALTRIALS.GOV IDENTIFIER: NCT03983499.

We developed and tested a culturally adapted, enhanced service ("Integrated Care Intervention") for Latino patients with Type 2 diabetes (T2D) to support their physical and mental health. The Integrated Care Intervention included receiving mental healthcare (i.e., "behavioral healthcare") services and health education during a routine appointment. Patients receiving the Integrated Care Intervention were compared to patients receiving standard primary care services (i.e., "Usual Care"), which may include a referral for health education and behavioral health services if their provider feels it is warranted. The study was conducted from 2015 to 2019 at a community health center. Study participants were 456 adults ages 23­80 years who had a previous diagnosis of T2D and were not currently using insulin. Participants were randomly assigned to an Integrated Care Intervention group or Usual Care group. We compared changes in depression and anxiety symptoms and perceived stress over a 6-month period for the two study participant groups. Patients assigned to the Integrated Care Intervention group showed larger improvements in both depression and anxiety symptoms over 6 months than the patients assigned to the Usual Care group. These findings indicate that Latino patients may benefit from receiving both behavioral and chronic disease management services during routine visits with their primary care provider.

Interest in Receiving HIV PrEP Among Biological Male Latinx Migrants at High-Risk of HIV Living in Mexico.

OBJECTIVE: We examined the prevalence and correlates of interest in receiving HIV pre-exposure prophylaxis (PrEP) in Latinx migrants at high-risk of HIV infection in Tijuana, Mexico, a migrant sending/receiving community bordering California. METHODS: In 2016, 870 HIV-seronegative biologically male Latinx migrants ages 18 and older responded to interviewer-administered surveys. Univariate statistics and multivariable analyses were estimated. RESULTS: In multivariable logistic regression analyses, emerging adults (18-24 years) were significantly less likely than participants ages 45 and older to be interested in PrEP (AOR: 0.35; 95% CI: 0.13, 0.89). Those who ever had sex with another male (AOR: 1.78; 95% CI: 1.13, 2.80), and who recently used illicit drugs (AOR: 1.74, 95% 1.09, 2.75) were significantly more likely to be interested in receiving PrEP. CONCLUSIONS: Provision of PrEP to migrant males at high-risk of HIV is needed. In Mexico, expanding access to federal health insurance and reducing the costs of PrEP are urgently needed.

Wearable fitness tracker use in federally qualified health center patients: strategies to improve the health of all of us using digital health devices.

As the use of connected devices rises, an understanding of how digital health technologies can be used for equitable healthcare across diverse communities is needed. We surveyed 1007 adult patients at six Federally Qualified Health Centers regarding wearable fitness trackers. Findings indicate the majority interest in having fitness trackers. Barriers included cost and lack of information, revealing that broad digital health device adoption requires education, investment, and high-touch methods.

Barriers to sexual and reproductive care among cisgender, heterosexual and LGBTQIA + adolescents in the border region: provider and adolescent perspectives.

INTRODUCTION: The United States (U.S.) has higher rates of sexually transmitted infections (STIs) and adolescent pregnancy than most other industrialized countries. Furthermore, health disparities persist among racial and ethnic minority adolescents (e.g., African American and Latinx) and in counties located along the U.S.-Mexico border region-they demonstrate the highest rates of STIs and unintended pregnancy among adolescents. METHODS: Qualitative data were collected as part of formative research for the development of a mobile app that provides gender-inclusive sexual education to adolescents living in the U.S.-Mexico border region. From August 2019 to March 2020, the study team conducted 11 in-depth interviews with healthcare providers and three focus groups with cisgender, heterosexual, and SGM adolescents ages 15-18 (n = 20). RESULTS: Providers and adolescents reported similar barriers to accessing SRH in this region such as transportation, lack of insurance and cost of services or accessing services without their parent's knowledge. However, providers shared that some adolescents in this region face extreme poverty, family separation (i.e., parent has been deported), have a mixed family legal status or are binational and have to travel every day from Mexico to the U.S. for school. These challenges further limit their ability to access SRH. CONCLUSIONS: Adolescents in the U.S.-Mexico border region face unique economic and social challenges that further limit their access to SRH care, making them uniquely vulnerable to STIs and unintended pregnancy. The prototype of the app was developed based on the needs expressed by providers and adolescents, including providing comprehensive Sex Ed and mapping of free comprehensive and confidencial SRH services available in the region and is being pilot tested. Our findings provide further evidence for the need for interventions and service delivery, programs tailored for residents in the border region.

Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes.

We developed and tested a culturally appropriate, team-based, integrated primary care and behavioral health intervention in low income, Spanish-speaking Latinos with type 2 diabetes, at a federally qualified health center. This pragmatic randomized controlled trial included 456 Latino adults, 23-80 years, 63.7% female, with diabetes [recruitment glycosylated hemoglobin (HbA1c) ≥ 7.0%/53.01 mmol/mol)]. The Special Intervention occurred over 6 months and targeted improvement of HbA1c, blood pressure, and lipids. The intervention included: (i) four, same-day integrated medical and behavioral co-located visits; (ii) six group diabetes self-management education sessions addressing the cultural dimensions of diabetes and lifestyle messages; (iii) and care coordination. Usual Care participants received primary care provider led standard diabetes care, with referrals to health education and behavioral health as needed. HbA1c and lipids were obtained through electronic health records abstraction. Blood pressure was measured by trained research staff. Multi-level models showed a significant group by time interaction effect (B = -0.32, p < .01, 95% CI -0.49, -0.15), indicating statistically greater improvement in HbA1c level over 6 months in the Special Intervention group (ΔHbA1c = -0.35, p = <.01) versus Usual Care (ΔHbA1c = -0.02, p = .72). Marginally significant group by time interactions were also found for total cholesterol and diastolic blood pressure, with significant improvements in the Special Intervention group (p < .05). This culturally appropriate model of highly integrated care offers strategies that can assist with self-management goals and disease management for Latinos with diabetes in a federally qualified health center setting.

Outreach and Inreach Strategies for Colorectal Cancer Screening Among Latinos at a Federally Qualified Health Center: A Randomized Controlled Trial, 2015-2018.

Objectives. To compare usual care, inreach consisting of one-on-one education, mailed outreach offering a fecal immunochemical test (FIT), and a combination of outreach and inreach for promoting colorectal cancer (CRC) screening.Methods. We conducted a 4-arm randomized controlled trial from 2015 to 2018 at a US federally qualified health center near the California-Mexico border primarily serving low-income Hispanics/Latinos. A total of 673 individuals aged 50 to 75 years not up to date with screening were assigned to 1 of the 4 intervention groups. The primary outcome was CRC screening through 6 months follow-up.Results. A total of 671 patients were included in intention-to-screen analyses. Their mean age was 59.9 years, 48.9% were male, and 86.3% were primarily Spanish-speaking. Screening was 27.5% for usual care (95% confidence interval [CI] = 0.21, 0.34), 52.7% for inreach (95% CI = 0.45, 0.60), 77.2% for outreach (95% CI = 0.71, 0.83), and 78.9% for combination of inreach and outreach (95% CI = 0.73, 0.85; P < .001 for all comparisons except P = .793 for outreach vs combination).Conclusions. Among individuals at high risk for noncompletion, inreach with one-on-one education nearly doubled, and outreach offering mailed FIT alone or in combination with inreach nearly tripled screening compared with usual care. Mailed FIT outreach was superior to inreach for promoting screening.

Requiring smartphone ownership for mHealth interventions: who could be left out?

BACKGROUND: Mobile health (mHealth) interventions have the potential to improve health through patient education and provider engagement while increasing efficiency and lowering costs. This raises the question of whether disparities in access to mobile technology could accentuate disparities in mHealth mediated care. This study addresses whether programs planning to implement mHealth interventions risk creating or perpetuating health disparities based on inequalities in smartphone ownership. METHODS: Video Directly Observed Therapy (VDOT) is an mHealth intervention for monitoring tuberculosis (TB) treatment adherence through videos sent by patients to their healthcare provider using smartphones. We conducted secondary analyses of data from a single-arm trial of VDOT for TB treatment monitoring by San Diego, San Francisco, and New York City health departments. Baseline and follow-up treatment interviews were used to assess participant smartphone ownership, sociodemographics and TB treatment perceptions. Univariate and multivariable logistic regression analyses were used to identify correlates of smartphone ownership. RESULTS: Of the 151 participants enrolled, mean age was 41 years (range: 18-87 years) and 41.1% were female. Participants mostly identified as Asian (45.0%) or Hispanic/Latino (29.8%); 57.8% had at most a high school education. At baseline, 30.4% did not own a smartphone, which was similar across sites. Older participants (adjusted odds ratio [AOR] = 1.09 per year, 95% confidence interval [CI]: 1.05-1.12), males (AOR = 2.86, 95% CI: 1.04-7.86), participants having at most a high school education (AOR = 4.48, 95% CI: 1.57-12.80), and those with an annual income below $10,000 (AOR = 3.06, 95% CI: 1.19, 7.89) had higher odds of not owning a smartphone. CONCLUSIONS: Approximately one-third of TB patients in three large United States of America (USA) cities lacked smartphones prior to the study. Patients who were older, male, less educated, or had lower annual income were less likely to own smartphones and could be denied access to mHealth interventions if personal smartphone ownership is required.

Development of the Initial Surveys for the All of Us Research Program.

BACKGROUND: The All of Us Research Program is building a national longitudinal cohort and collecting data from multiple information sources (e.g., biospecimens, electronic health records, and mobile/wearable technologies) to advance precision medicine. Participant-provided information, collected via surveys, will complement and augment these information sources. We report the process used to develop and refine the initial three surveys for this program. METHODS: The All of Us survey development process included: (1) prioritization of domains for scientific needs, (2) examination of existing validated instruments, (3) content creation, (4) evaluation and refinement via cognitive interviews and online testing, (5) content review by key stakeholders, and (6) launch in the All of Us electronic participant portal. All content was translated into Spanish. RESULTS: We conducted cognitive interviews in English and Spanish with 169 participants, and 573 individuals completed online testing. Feedback led to over 40 item content changes. Lessons learned included: (1) validated survey instruments performed well in diverse populations reflective of All of Us; (2) parallel evaluation of multiple languages can ensure optimal survey deployment; (3) recruitment challenges in diverse populations required multiple strategies; and (4) key stakeholders improved integration of surveys into larger Program context. CONCLUSIONS: This efficient, iterative process led to successful testing, refinement, and launch of three All of Us surveys. Reuse of All of Us surveys, available at http://researchallofus.org, may facilitate large consortia targeting diverse populations in English and Spanish to capture participant-provided information to supplement other data, such as genetic, physical measurements, or data from electronic health records.

Tuberculosis Treatment Monitoring by Video Directly Observed Therapy in 5 Health Districts, California, USA.

We assessed video directly observed therapy (VDOT) for monitoring tuberculosis treatment in 5 health districts in California, USA, to compare adherence between 174 patients using VDOT and 159 patients using in-person directly observed therapy (DOT). Multivariable linear regression analyses identified participant-reported sociodemographics, risk behaviors, and treatment experience associated with adherence. Median participant age was 44 (range 18-87) years; 61% of participants were male. Median fraction of expected doses observed (FEDO) among VDOT participants was higher (93.0% [interquartile range (IQR) 83.4%-97.1%]) than among patients receiving DOT (66.4% [IQR 55.1%-89.3%]). Most participants (96%) would recommend VDOT to others; 90% preferred VDOT over DOT. Lower FEDO was independently associated with US or Mexico birth, shorter VDOT duration, finding VDOT difficult, frequently taking medications while away from home, and having video-recording problems (p<0.05). VDOT cost 32% (range 6%-46%) less than DOT. VDOT was feasible, acceptable, and achieved high adherence at lower cost than DOT.

Evaluating Two Evidence-Based Intervention Strategies to Promote CRC Screening Among Latino Adults in a Primary Care Setting.

Regular use of colorectal cancer screening can reduce incidence and mortality, but participation rates remain low among low-income, Spanish-speaking Latino adults. We conducted two distinct pilot studies testing the implementation of evidence-based interventions to promote fecal immunochemical test (FIT) screening among Latinos aged 50-75 years who were not up-to-date with CRC screening (n = 200) at a large Federally Qualified Health Center (FQHC) in San Diego, CA. One pilot focused on an opportunistic clinic visit "in-reach" intervention including a 30-min session with a patient navigator, review of an educational "flip-chart," and a take-home FIT kit with instructions. The second pilot was a system-level "outreach" intervention consisting of mailed materials (i.e., FIT kit, culturally and linguistically tailored instructions, and a pre-paid return envelope). Both received follow-up calls to promote screening completion and referrals for additional screening and treatment if needed. The primary outcome was FIT kit completion and return within 3 months assessed through electronic medical records. The in-reach pilot consisted of mostly insured (85%), women (82%), and Spanish-speaking (88%) patients. The outreach pilot consisted of mostly of Spanish-speaking (73%) women (64%), half of which were insured (50%). At a 3-month follow-up, screening completion was 76% for in-reach and 19% for outreach. These data demonstrate that evidence-based strategies to promote CRC screening can be implemented successfully within FQHCs, but implementation (particularly of mailed outreach) may require setting and population-specific optimization. Patient, provider, and healthcare system related implementation approaches and lessons learned from this study may be implemented in other primary care settings.

Validity of the Mexican version of the combined Foot Care Confidence / Foot-Care Behavior scale for diabetes.

OBJECTIVE: To 1) translate / transculturally adapt the original (English-language) combined Foot Care Confidence Scale / Foot-Care Behavior instrument (FCCS-FCB) to produce a Mexican-Spanish version and 2) determine its validity and reliability in a population with diabetes in Tijuana, Mexico. METHODS: The original FCCS-FCB was translated (and back-translated), the content validated (by a group of health professional experts), and the instrument applied to 304 patients 23-78 years old in diabetes support groups in Tijuana, Mexico. Internal consistency for the study constructs ("self-efficacy," and risk / preventive foot self-care behaviors) was measured using Cronbach's alpha. The constructs were validated using principal component factor analysis. RESULTS: The Cronbach's alpha values for internal consistency were 0.782 for self-efficacy and 0.505 for behaviors. Based on the analysis, two factors explained 49.1% of the total variance for self-efficacy, and six factors explained 57.7% of the total variance for behaviors. The results were consistent with those for the original (English) version of the FCCS-FCB. CONCLUSIONS: The Mexican version of the FCCS-FCB is a reliable and valid instrument recommended for use with Mexican-Spanish-speaking patients with diabetes.

Prevalence and Correlates of the Use of Prefilled Syringes Among Persons Who Inject Drugs in San Diego, CA.

Persons who inject drugs (PWID) are at increased risk for blood-borne virus (BBV) infections and overdose resulting from high-risk injecting practices. Studies of prefilled syringe use ([PFSU] using a syringe that already contained drug solution when it was obtained by the user), an injection practice previously described in Eastern Europe, suggest that it increases susceptibility to BBV. However, little is known about this practice in the USA. Data were obtained from an ongoing cohort study of PWID to determine the prevalence and assess correlates of PFSU in San Diego, CA. Baseline interviews assessed socio-demographics and drug use behaviors. Logistic regression was used to identify factors independently associated with ever using a prefilled syringe (yes/no). Participants (n = 574) were predominately males (73.9%) and white (50.9%) with a mean age of 43.4 years (range 18-80); 33.3% reported ever using prefilled syringes, although only 4.9% reported use in the past 6 months. In multivariable analyses, PFSU was independently associated with ever having a rushed injection due to police presence [adjusted odds ratio (AOR) = 2.51, 95% CI 1.66, 3.79], ever being in prison (AOR = 1.80, 95% CI 1.23, 2.63), injecting most often in public versus private places in the past 6 months (AOR = 1.66, 95% CI 1.11, 2.48), and injecting drugs in Mexico (AOR = 1.70, 95% CI 1.16, 2.49). Results indicate that a history of PFSU is common and associated with environmental factors that may also increase risk for adverse health outcomes. Studies are needed to better understand PFSU in order to develop interventions to prevent adverse outcomes associated with their use.

Validity of the Mexican version of the combined Foot Care Confidence / Foot-Care Behavior scale for diabetes / Validez de la versión mexicana del instrumento combinado de las escalas Foot Care Confidence Scale y Foot Care Behavior para la diabetes

OBJECTIVE: To 1) translate / transculturally adapt the original (English-language) combined Foot Care Confidence Scale / Foot-Care Behavior instrument (FCCS-FCB) to produce a Mexican-Spanish version and 2) determine its validity and reliability in a population with diabetes in Tijuana, Mexico. METHODS: The original FCCS-FCB was translated (and back-translated), the content validated (by a group of health professional experts), and the instrument applied to 304 patients 23-78 years old in diabetes support groups in Tijuana, Mexico. Internal consistency for the study constructs ("self-efficacy," and risk / preventive foot self-care behaviors) was measured using Cronbach's alpha. The constructs were validated using principal component factor analysis. RESULTS: The Cronbach's alpha values for internal consistency were 0.782 for self-efficacy and 0.505 for behaviors. Based on the analysis, two factors explained 49.1% of the total variance for self-efficacy, and six factors explained 57.7% of the total variance for behaviors. The results were consistent with those for the original (English) version of the FCCS-FCB. CONCLUSIONS: The Mexican version of the FCCS-FCB is a reliable and valid instrument recommended for use with Mexican-Spanish-speaking patients with diabetes.

OBJETIVO: 1) traducir o adaptar transculturalmente el instrumento original combinado (en inglés) de las escalas Foot Care Confidence Scale (Escala de Competencia en el Cuidado del Pie) y Foot Care Behavior (Comportamientos del Cuidado del Pie) (FCCS-FCB) para crear una versión en español de México, y 2) determinar su validez y fiabilidad en una población de personas con diabetes de Tijuana, México. MÉTODOS: Se tradujo al español la escala original FCCS-FCB (y se volvió a traducir al inglés), su contenido fue validado (por un grupo de expertos), posteriormente se aplicó el instrumento a 304 pacientes de 23 a 78 años de edad, pertenecientes a grupos de apoyo al control de la diabetes de Tijuana, México. Mediante el alfa de Cronbach, se midió la coherencia interna de los constructos ("competencia personal" y "comportamientos de riesgo o preventivos de autocuidado del pie"). Los constructos fueron validados mediante análisis factorial de componentes principales. RESULTADOS: El valor de alfa de Cronbach correspondiente a competencia personal fue de 0,782 y de 0,505 para los comportamientos. En el análisis factorial, dos factores explicaron el 49,1% de la variancia total para la competencia personal, y seis factores explicaron el 57,7% de la variancia total para los comportamientos. Los resultados concordaron con los de la versión original (en inglés) del FCCS-FCB. CONCLUSIONES: La versión mexicana del FCCS-FCB es un instrumento fiable y válido recomendado para su empleo en pacientes mexicanos de habla hispana con diabetes.