Violence Victimization, Homelessness, and Severe Mental Illness Among People Who Use Opioids in Three U.S. Cities.

This study examined the associations between violence victimization, homelessness, and severe mental illness (SMI) among people who use opioids (PWUOs) in three U.S. cities. We analyzed data from a cross-sectional survey conducted from May 2019 to February 2020 across three study sites: Los Angeles, CA; Las Vegas, NV; and Atlanta, GA. We used multivariable regressions to examine how multiple victimizations and housing situation are associated with SMI. Based on K-6 scale, nearly half (44.2%) were screened positive for SMI. Meanwhile, 69.7% of the participants reported experiencing some kind of violence in their lifetime, and more than half (51.9%) reported experiencing recent violence (in the past 6 months). The most common form of lifetime violence was emotional (59.5%), followed by physical and intimate partner violence (IPV) (56.1 and 34.9%, respectively), and 34.9% of all participants reported experiencing multiple forms of victimization in the past 6 months. Participants who reported homelessness were more likely to report having experienced recent violence victimization (p < .001). In multivariable models, experiencing recent victimization was significantly associated with SMI (adjusted odds ratio (AOR) = 1.85, 95% confidence interval [CI] [1.46, 2.38]), as was homelessness (AOR = 1.57, 95% CI [1.15, 2.14]), after adjusting for study covariates. Among those with moderate and SMI (n = 927), only 22% were currently receiving mental health services, and those who reported having experienced any forms of violence in the past 6 months were more likely to utilize mental health services than those who had not experienced any recent violence victimization (25 vs. 17.9%, p < .05). To improve mental health and wellness among this high priority population, mental health facilities and syringe service programs may consider screening for experiences of violence and using trauma-informed mental health approaches. Harm reduction interventions must be responsive to the diverse individual and structural-level needs of PWUOs, especially those experiencing homelessness and housing insecurity. Holistic strategies and services are needed to meet the social and structural needs of this population.

"Take care of their hierarchy of needs first": strategies used by data-to-care staff to address barriers to HIV care engagement.

Data-to-Care (D2C) is a public health strategy designed to engage out-of-care (OOC) persons with HIV (PWH) in HIV care. OOC PWH are identified through review of state and local HIV data and engaged in care through individualized efforts that address barriers to HIV care. Perspectives of D2C program staff can contribute to D2C program development and sustainability. We conducted semi-structured interviews in 2017 with 20 D2C program staff from Louisiana (n = 10) and Virginia (n = 10), states with distinct D2C programs. We used content and thematic analysis to analyze interview transcripts. In both states, common barriers to care for OOC PWH include limited transportation, stigma, substance use, poverty, homelessness, and mental illness. To address these barriers and engage OOC clients in HIV care, staff and programs provided transportation vouchers and housing assistance, integrated substance use and mental health services into care engagement processes, provided empathy and compassion, and assessed and addressed basic unmet needs. Identifying and addressing social and structural barriers to HIV care is a critical and often a necessary first step in engaging OOC clients in HIV care. These findings can be used for D2C program design and implementation, facilitating engagement in HIV care for OOC PWH.

Overcoming Challenges to HIV Medical Care-seeking and Treatment Among Data-to-Care Program Clients in Baton Rouge and New Orleans, Louisiana.

ABSTRACT: Data to Care (D2C) uses US public health surveillance data to identify persons with diagnosed HIV who are not receiving adequate medical care. These persons are linked to care and ancillary social services through personalized outreach. We conducted semistructured interviews with 36 adults with HIV in Louisiana who were engaged for the first time or reengaged back into HIV care through D2C efforts. Before D2C program staff contact, nearly 40% were not contemplating HIV care. Program clients cited barriers to HIV care, including difficulties with appointment scheduling and transportation, health care service and drug costs, low motivation, and competing non-HIV health needs. Thirty-four of the 36 clients said that D2C staff helped them overcome these barriers. Clients also described psychosocial support from D2C staff. After receiving D2C program assistance, more than 90% of clients reported consistently receiving HIV medical care and taking medications. Our findings suggest that D2C staff successfully identified client needs and provided tailored assistance.

Vaccine confidence among people who use drugs: A cross-sectional survey.

Adult immunization coverage remains low in the US, particularly for people who use drugs (PWUD), a population that experiences a disproportionate burden of vaccine-preventable diseases. The extent of and characteristics associated with vaccine confidence (VC) held by PWUD is poorly understood. As VC strongly correlates with vaccine uptake, this cross-sectional study identifies mutable factors associated with VC and quantifies its relationship to immunization status within a highly vulnerable, underimmunized population of PWUD. Using a community-engaged research strategy with select partner organizations hosting syringe exchange programs in Atlanta, Los Angeles, and Las Vegas, USA, we surveyed participants ages 18-69 years served by these organizations from 2019 to 2020. Survey measures included sociodemographics, health behavior including immunization receipt, and vaccine confidence in adult vaccinations using a modified Emory Vaccine Confidence Index (EVCI). The findings reflect relatively low VC among the 1,127 recruited participants, with 56% expressing low VC (EVCI 0-12), 35% medium (EVCI 13-20) and 10% high (EVCI 21-24). EVCI varied by city, with lowest confidence in Atlanta and highest in Las Vegas. VC was associated with past receipt of specific vaccines, including hepatitis A, MMR, Tdap, and influenza. VC varied by specific sociodemographic correlates such as housing insecurity (reduced confidence) and receipt of public benefits or disability (increased confidence). This study identified correlates associated with VC based on site and sociodemographic characteristics for this priority population, highlighting the need for specific interventions to raise VC among PWUD, especially among those experiencing housing insecurity and without public benefits.

Acceptability of injectable pre-exposure prophylaxis among people who inject drugs in three urban U.S. settings.

BACKGROUND: Outbreaks of new HIV transmission among people who inject drugs (PWID) are a major public health concern. Oral daily PrEP, has been identified as a critical addition to the biomedical toolkit for this population. However, limited research on the acceptability of long-acting injectable PrEP has been conducted with this population. METHODS: We conducted a cross sectional multi-site survey with 1127 participants from May 2019-February 2020 to assess the acceptability of novel PrEP regimens. We computed bivariate and multivariable logistic regressions to evaluate correlates of the outcome variable: acceptability of 3-month injectable-PrEP. SAS v.9.4 was used to conduct statistical analysis. RESULTS: Limited knowledge of or use of PrEP, past or present, was evident within the sample. Injection drug use in the past six months was significantly associated with LA injectable PrEP acceptability, with the odds of acceptability being 1.885 (CI: 1.376, 2.582) times greater than those who did not inject drugs. After adjusting for confounders, injection drug use was significantly associated with the outcome, such that the odds of acceptability of LA injectable PrEP were 1.705 (CI: 1.198, 2.427) times greater among PWID compared to those who did not inject drugs (p < 0.03). The results demonstrate acceptability (38.2%) in a durable (3-month) injectable PrEP modality among participants who also identified as PWID. CONCLUSIONS: PrEP promotion efforts among PWID to increase access to long-acting injectable PrEP are necessary. Through efforts to increase acceptance and regular use of long-acting injectable PrEP, public health strategies may be able to effectively lessen chances of future HIV outbreaks among PWID.

HIV Testing Program Activities and Challenges in Four U.S. Urban Areas.

The national "Ending the HIV Epidemic: A Plan for America" supports expanded testing in jurisdictions and groups with disproportionate HIV burden. Public health planners benefit from learning HIV testing service (HTS) strengths, challenges, and innovations. We conducted semistructured interviews with 120 HTS staff from local health departments, community-based organizations, and community members in Houston, Texas; Miami, Florida; New Orleans, Louisiana; and Washington, DC. We coded interview transcripts using qualitative methods to identify themes. Program strengths include HIV testing integration with other client services; prioritized testing and tailored incentives; multiple advertising methods; and partnerships among HTS providers. Challenges include stigma, fear, and disparities; funding requirements that create competition between providers; and service accessibility, unnecessary repeat testing, and insufficient innovation. The four jurisdictions addressed some, but not all, of these challenges. Cross-jurisdictional collaboration, together with state and federal partners plus program data may help identify additional strategies for strengthening HTS.

Health Behavior Survey Among People Who Use Opioids: Protocol for Implementing Technology-Based Rapid Response Surveillance in Community Settings.

BACKGROUND: In 2018, 2 million Americans met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition diagnostic criteria for an opioid use disorder, and 9.9 million Americans had misused prescription pain relievers the previous year. Despite a rapid increase in opioid misuse, opioid use disorders, and overdoses, data are limited on the behavioral and contextual risks as well as the protective factors fueling the opioid epidemic in some hard hit US cities-Atlanta, Los Angeles, and Las Vegas. Opioid use also contributes to the risk of other health problems such as HIV and hepatitis C virus infections or mental health disorders and is linked to behavioral and environmental risks (eg, homelessness, experiences of violence, involvement in the justice system). Knowledge of the relationships between these linked vulnerabilities and how they influence service utilization is critical to effective policy and interventions. OBJECTIVE: This survey explores the relationships between demographic and economic characteristics, behavioral and environmental risk factors, and service utilization of people who use opioids to inform public health practice, policy, and future efforts to mitigate the risks faced by this population experiencing multiple health, social, and economic vulnerabilities. The results of this survey will be used to identify needs and intervention points for people who use drugs currently served by public health organizations. METHODS: We implemented a community-engaged strategy that involved development and execution of a two-stage purposive sampling plan involving selection of partner organizations (syringe exchange programs in urban settings) and recruitment and enrollment of participants aged 18-69 years served by these organizations in Atlanta, Los Angeles, and Las Vegas from 2019 to 2020. The recruited participants completed a survey, including a variety of measures to assess health (physical and mental) and health behaviors such as sexual behavior, vaccine receipt, and HIV/ hepatitis C virus infection testing. Additional items assessed drug use and misuse, syringe exchange and health service utilization, sex exchange, histories of interpersonal violence, and vaccine confidence. RESULTS: This protocol was successfully implemented despite challenges such as real-time technology issues and rapidly finding and surveying a difficult-to-reach population. We sampled 1127 unique participants (248 in Atlanta, 465 in Los Angeles, and 414 in Las Vegas). CONCLUSIONS: The establishment and utilization of strong community partnerships enabled the rapid collection of data from a typically difficult-to-reach population. Local efforts such as these are needed to develop policies and practices that promote harm reduction among people who use opioids. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/25575.

Identifying Missed Opportunities for Routine Vaccination among People Who Use Drugs.

In the US, adult immunization coverage remains low, especially among vulnerable populations, as recent hepatitis A outbreaks have demonstrated. We studied the vaccination history variation among the US adults who use drugs by implementing a community-engaged research survey to identify reported immunization coverage, missed opportunities (MO), and places where immunizations might be delivered. Our analysis of a sample of 1127 participants recruited at community syringe exchanges in three cities identified higher overall vaccination receipt in Los Angeles compared to Atlanta or Las Vegas (e.g., HAV receipt 52.2% LA, 42.1% LV, 41.4% Atlanta). Overall, fewer participants reported having received HAV (45.9%), HBV (47.5%), or influenza (47.6%) vaccines than MMR (57.1%) or Td/Tdap (61.1%). Across sites, HAV receipt was higher for participants incarcerated ≥ 5 years (54.2% vs. 43.6% for those incarcerated < 5 years, 49.4% no incarceration history, p = 0.02). HBV receipt was higher among participants who were not intravenous drug users (56.1% vs. 46.0%, p = 0.03). Additionally, income >$20k predicted higher rates of MMR receipt (67.0% vs. 56.5%, p = 0.009), as did stable housing (62.8% vs. 54.3%, p = 0.01). To address the need to expand vaccine coverage among vulnerable adults, delivering vaccine at sites where persons who use drugs access services, or in correctional facilities, may be warranted.

"To Me, Everybody Is infected": Understanding Narratives about HIV Risk among HIV-negative Black Men Who Have Sex with Men in the Deep South.

For black MSM living in the Deep South, the intersection of sexuality, race, and geography impacts HIV risk substantially. Between July and September 2016, we conducted a qualitative study among HIV-negative black MSM in five southern cities in the US with elevated HIV prevalence. Analysis included assessment of interrater reliability, cluster analysis, and descriptive statistics. We enrolled 99 black MSM (mean age: 33.6; SD = 12.8; range: 17-68 years). Four overarching themes emerged: harboring fear of HIV and the internalization of HIV stigma; scrutinizing potential partners to assess riskiness and HIV status; embracing distance and isolation from those perceived as a threat to HIV status; and exhibiting self-efficacy toward HIV prevention and utilizing risk reduction strategies. Future HIV prevention efforts may benefit by balancing risk and deficit based strategies with those that emphasize resilience, address disenfranchisement via structural interventions, and assess and treat inherent trauma(s).

Patient Decision Making Related to Maternal and Childhood Vaccines: Exploring the Role of Trust in Providers Through a Relational Theory of Power Approach.

Immunization is one of the most effective ways to prevent infectious diseases. However, vaccination rates are suboptimal in the United States. Obstetric providers are critical in influencing vaccine decision making among pregnant women, as trust between a patient and provider may facilitate willingness to accept vaccination. Little is known about how power between a patient and provider affects vaccine acceptance. This study explored pregnant women's trust in obstetric providers within the context of vaccines. Using concepts from the relational theory of power, we conducted 40 in-depth interviews with a purposive sample of pregnant women from four Ob-Gyn practices each in Georgia and Colorado. Results suggest that to enhance trust, providers could gain distributive power by conveying empathy. Designated power through medical experience was associated with both trust and distrust, as some women trusted their providers because of their authority and medical credentials, while others viewed authority and experience as reasons to distrust their provider. To increase acceptance, providers should acknowledge the underlying power dynamics within these interpersonal relationships and strengthen rapport with patients through empathy and dialogue.

Adherence to Timely Vaccinations in the United States.

OBJECTIVES: To estimate (1) the proportion of children not adhering to the Advisory Committee on Immunization Practices (ACIP) recommended early childhood immunization schedule and (2) associations between schedule adherence, sociodemographic characteristics, and up-to-date immunization status by 19 to 35 months of age. METHODS: We used 2014 National Immunization Survey provider-verified vaccination data to classify vaccination patterns as "recommended" (ie, in line with ACIP dose- and age-specific recommendations), "alternate" (ie, in line with either limiting the number of shots per visit or skipping at least 1 vaccine series), or "unknown or unclassifiable" (ie, not in line with ACIP recommendations or clearly limiting shots per visit or vaccine series). We evaluated the association between vaccination patterns and up-to-date status for all ACIP-recommended vaccinations (including rotavirus and hepatitis A vaccines) using Poisson regression. RESULTS: The majority of children's patterns were classified as "recommended" (63%), with 23% and 14% following alternate or unknown or unclassifiable patterns, respectively; 58% of children were up-to-date with all ACIP-recommended immunizations by 19 to 35 months. Not being up-to-date was associated with alternate (prevalence ratio = 4.2, 95% confidence interval: 3.9-4.5) and unknown or unclassifiable (prevalence ratio = 2.4, 95% confidence interval: 2.2-2.7) patterns. CONCLUSIONS: High vaccine coverage by 19 to 35 months of age may miss nonadherence to the recommended immunization schedule in the first 18 months of life, leaving children vulnerable to preventable diseases. With more than one-third of US children not following the ACIP schedule, targeted interventions are needed to minimize vaccine delays and disease susceptibility.

Barriers and Facilitators for Antiretroviral Treatment Adherence Among HIV-Positive African American and Latino Men Who Have Sex With Men.

Some Black/African American and Hispanic/Latino men who have sex with men (MSM) living with HIV do not take antiretroviral therapy (ART). We conducted semistructured interviews with 84 adult, Black/African American and Hispanic/Latino MSM with HIV to understand ART barriers and facilitators. We used chi-square statistics to identify factors associated with ART use (p ≤ .05), and selected illustrative quotes. Over half (51.2%) said they followed their doctor's instructions; however, only 27.4% reported consistently taking ART. Some men delayed ART until overcoming diagnosis denial or becoming very sick. ART use was facilitated by encouragement from others, treatment plans, side effect management, lab test improvements, pill-taking reminders, and convenient care facilities that provide "one-stop shop" services. Men were more likely to take ART when having providers who communicated effectively and were perceived to treat them with respect. Healthcare personnel can use our findings to strengthen services for MSM of color.

Development of a US trust measure to assess and monitor parental confidence in the vaccine system.

OBJECTIVE: To develop a Vaccine Confidence Index (VCI) that is capable of detecting variations in parental confidence towards childhood immunizations centered on trust and concern issues that impact vaccine confidence. METHODS: We used a web-based national poll of 893 parents of children <7 years in 2016 to assess the measures created for the Emory VCI (EVCI). EVCI measures were developed using constructs related to vaccine confidence identified by the U.S. National Vaccine Advisory Committee (i.e., "Information Environment", "Trust", "Healthcare Provider", "Attitudes and Beliefs", and "Social Norms"). Reliability for EVCI was assessed using Cronbach's alpha. Using the variables related to each of the constructs, we calculated an overall EVCI score that was then assessed against self-reported childhood vaccine receipt using chi-square and the Cochrane-Armitage trend tests. RESULTS: Respondents' EVCI scores could range from 0 to 24, and the full range of values was observed in this sample (Mean = 17.5 (SD 4.8)). EVCI scores were significantly different (p ≤ 0.006 for all comparisons) between parents who indicated their child(ren) received routinely recommended vaccines compared with parents who indicated they had delayed or declined recommended immunizations. There was also a significant, consistent association between higher EVCI scores and greater reported vaccine receipt. CONCLUSIONS: We developed EVCI to reliably measure parental vaccine confidence, with individuals' scores linked to parental vaccine-related attitudes, intentions, and behaviors. As such, EVCI may be a useful tool for future monitoring of both population and individual confidence in childhood immunization.

Development of a measure to assess vaccine confidence among men who have sex with men.

BACKGROUND: Recent serogroup C meningococcal disease outbreaks led to meningococcal vaccine recommendations for Southern California men who have sex with men (MSM). Assessment of vaccine confidence is critical to improving vaccine coverage in the context of disease outbreaks wherein immunization(s) are recommended. METHODS: We surveyed MSM using venue-based sampling and began development of the vaccine confidence index (VCI) with 30 survey items corresponding to trust- and safety-related perceptions. We performed exploratory factor analyses and computed the Cronbach's alpha coefficient to assess internal consistency of the VCI. We created a categorical confidence variable (low, medium, and high confidence) and conducted bivariate and multivariate analyses to evaluate associations with reported confidence and immunization uptake. RESULTS: Ten survey items were included in the final VCI and formed the confidence measure. Participants with low confidence had the lowest levels of reported uptake for both meningococcal vaccines. Confidence differed significantly (p ≤ 0.05) between MSM who indicated they received vaccines recommended within the context of the outbreak and those who did not. CONCLUSIONS: Our VCI is sensitive to a number of issues that may influence vaccine confidence. It is useful for assessing MSM trust and acceptance of recommended immunizations and may be used to inform intervention development.

Provider insight on surmounting specialty practice challenges to improve Tdap immunization rates among pregnant women.

BACKGROUND: Pertussis, or "whooping cough," is an acute, contagious pulmonary disease that, despite being vaccine-preventable, has become an increasingly widespread problem in the United States. As a result, the Advisory Committee on Immunization Practices and American College of Obstetricians and Gynecologists updated recommendations stating clinicians should give a Tdap dose during every pregnancy, preferably at 27-36 weeks. Despite this recommendation, reported Tdap vaccine receipt rates during pregnancy vary from 16-61%, and previous studies have shown that clinician recommendation and vaccine administration are strongly associated with vaccine uptake among pregnant women. METHODS: Our aim was to inform new strategies to increase uptake of the Tdap vaccine among pregnant women and, ultimately, reduce pertussis-related morbidity and mortality in infants. We conducted interviews with a sample of 24 ob-gyns. We subsequently performed grounded theory analyses of transcripts using deductive and inductive coding strategies followed by intercoder reliability assessment. RESULTS: All physicians interviewed were familiar with the most recent recommendation of giving the Tdap vaccine during the third trimester of every pregnancy, and the majority of physicians stated that they felt that the vaccine was important and effective due to the transfer of pertussis antibodies from the mother to the fetus. Most physicians indicated that they recommended the vaccine to patients during pregnancy, but not all reported administering it on site because it was not stocked at their practice. Implementation challenges for physicians included insurance reimbursement and other challenges (i.e., patient refusal). Tdap vaccination during pregnancy was a lower clinical priority for some physicians. Physicians recognized the benefits associated with Tdap vaccination during pregnancy. CONCLUSIONS: Findings indicate while most ob-gyns recognize the benefits of Tdap and recommend vaccination during pregnancy, barriers such as insurance reimbursement and financial concerns for the practice can outweigh the perceived benefits. This resulted in some ob-gyns reporting choosing not to stock and administer the vaccine in their practice. Recommendations to address these concerns include 1) structural support for Tdap vaccine administration in ob-gyns practices; 2) Continuing medical education-equivalent educational interventions that address management techniques, vaccine coding, and other relevant information; and 3) interventions to assist physicians in communicating the importance of Tdap vaccination during pregnancy.

Barriers and Facilitators for Clinical Care Engagement Among HIV-Positive African American and Latino Men Who Have Sex with Men.

Achieving optimal health among people living with HIV (PLWH) requires linkage to clinical care upon diagnosis, followed by ongoing engagement in HIV clinical care. A disproportionate number of black/African American and Hispanic/Latino men who have sex with men (MSM) living with HIV do not, however, achieve ongoing care. We conducted semistructured interviews in 2014 with 84 urban black/African American and Hispanic/Latino MSM living with HIV to understand their barriers and facilitators to engagement. We classified men as care-engaged or not at the time of the interview, and conducted content analysis of the interview transcripts to identify barriers and facilitators to engagement. Respondent mean age was 42.4 years (range, 20-59). Over half (59.5%, n = 50) were black/African American. Slightly more than a third (38.1%, n = 32) reported not being continuously care-engaged since diagnosis, and 17.9% (n = 15) delayed entry, although they have subsequently entered and remained in care. Sustained engagement began with overcoming denial after diagnosis and having treatment plans, as well as having conveniently located care facilities. Engagement also was facilitated by services tailored to meet multiple patient needs, effective patient-provider communication, and providers who show empathy and respect for their patients. Respondents were less likely to be care-engaged when these factors were absent. It can be difficult for racial and ethnic minority MSM living with HIV to begin and sustain care engagement. To optimize care engagement, our findings underscore the value of (1) convenient multipurpose HIV care facilities that meet patient needs; (2) excellent provider-patient communication that reinforces respect, trust, and HIV treatment literacy; and (3) assisting PLWH to create personalized treatment plans and overcome possible challenges such as diagnosis denial.

Clinician perspectives on strategies to improve patient maternal immunization acceptability in obstetrics and gynecology practice settings.

Pregnancy is an ideal time to communicate with women about vaccines for themselves and their infants, yet maternal immunization rates remain suboptimal. This study aimed to identify clinic, provider, and staff-related attributes and facilitators to be utilized for a comprehensive vaccine intervention in ob-gyn clinical settings. We conducted in-depth interviews with 24 providers, both healthcare providers (e.g., physicians, nurse practitioners, midwives) and practice managers, from urban and suburban ob-gyn practices in Georgia and Colorado about their immunization attitudes, practices, and patient experiences. Qualitative analyses included Pearson correlation tests to evaluate patterns and relationships within the data to determine themes. Six major themes emerged: 1) strong provider "buy in" for maternal immunization; 2) the supporting role of clinical/interpersonal cues for vaccine promotion; 3) varying provider-patient communication approaches and its influence on maternal and pediatric uptake; 4) an urgent need for a designated office immunization champion; 5) reimbursement and practice implementation challenges; and 6) region differences in attitudes and values toward maternal immunization. Although providers expressed strong support for maternal immunization practices and offered environmental cues for vaccine promotion, practices often lacked a designated, structured role for an immunization champion equipped to manage delicate conversations with patients. The findings reflect needs for immunization champion identification, training, and support, along with best practices guidelines to improve coordination of vaccine promotion and delivery efforts in ob-gyn provider offices. Additionally, provider training on communication approaches to enhance acceptance and uptake of maternal vaccines is warranted.

The role of functional, social, and mobility dynamics in facilitating older African Americans participation in clinical research.

PURPOSE: Older African Americans experience disproportionately higher incidence of morbidity and mortality related to chronic and infectious diseases, yet are significantly underrepresented in clinical research compared to other racial and ethnic groups. This study aimed to understand the extent to which social support, transportation access, and physical impediments function as barriers or facilitators to clinical trial recruitment of older African Americans. METHODS: Participants (N=221) were recruited from six African American churches in Atlanta and surveyed on various influences on clinical trial participation. RESULTS: Logistic regression models demonstrated that greater transportation mobility (odds ratio [OR]=2.10; p=0.007) and social ability (OR=1.77; p=0.02) were associated with increased intentions of joining a clinical trial, as was greater basic daily living ability (OR=3.25; p=0.03), though only among single participants. Among adults age ≥65 years, those with lower levels of support during personal crises were more likely to join clinical trials (OR=0.57; p=0.04). CONCLUSION: To facilitate clinical trial entry, recruitment efforts need to consider the physical limitations of their potential participants, particularly basic physical abilities and disabilities. Crisis support measures may be acting as a proxy for personal health issues among those aged >65 years, who would then be more likely to seek clinical trials for the personal health benefits. Outreach to assisted living homes, hospitals, and other communities is a promising avenue for improved clinical trial recruitment of older African Americans.

Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064).

BACKGROUND: We sought to understand the multilevel syndemic factors that are concurrently contributing to the HIV epidemic among women living in the US. We specifically examined community, network, dyadic, and individual factors to explain HIV vulnerability within a socioecological framework. METHODS: We gathered qualitative data (120 interviews and 31 focus groups) from a subset of women ages 18-44 years (N = 2,099) enrolled in the HPTN 064 HIV seroincidence estimation study across 10 US communities. We analyzed data from 4 diverse locations: Atlanta, New York City (the Bronx), Raleigh, and Washington, DC. Data were thematically coded using grounded theory methodology. Intercoder reliability was assessed to evaluate consistency of team-based coding practices. RESULTS: The following themes were identified at 4 levels including 1) exosystem (community): poverty prevalence, discrimination, gender imbalances, community violence, and housing challenges; 2) mesosystem (network): organizational social support and sexual concurrency; 3) microsystem (dyadic): sex exchange, interpersonal social support, intimate partner violence; and 4) individual: HIV/STI awareness, risk taking, and substance use. A strong theme emerged with over 80 % of responses linked to the fundamental role of financial insecurity underlying risk-taking behavioral pathways. CONCLUSIONS: Multilevel syndemic factors contribute to women's vulnerability to HIV in the US. Financial insecurity is a predominant theme, suggesting the need for tailored programming for women to reduce HIV risk. TRIAL REGISTRATION: Clinicaltrials.gov, NCT00995176.

Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans.

This is a report of a cluster randomized clinical trial evaluating the effectiveness of a church-based educational intervention aimed at improving African Americans' (AA) participation in clinical trials. Two hundred and twenty-one AA subjects ages ≥50 years from six predominantly AA churches were randomized to intervention or control condition. The intervention included three educational sessions about clinical trials and health disparities; control participants completed questionnaires. Primary endpoints of the study were differences in individual subjects' intentions to obtain clinical trial information and intention to join a clinical trial, as determined by 10 point scale items at baseline, three and six months. A statistically significant increase in the intention to obtain clinical trial information at the three and six month time points was observed in the intervention group, but not the control group. Older participants (65-95 years) were less likely than younger participants (50-64 years) to increase their motivation to seek clinical trial information by the three and six month time points. No significant increases were observed in intention to join clinical trials. This randomized trial shows that AA church-based educational interventions are likely to increase the motivation of AA subjects to obtain clinical trial information and are therefore potentially effective at ameliorating the underrepresentation of AA subjects in clinical trials.