Faculty Bibliography

BACKGROUND:Rates of participation in HIV care, medication uptake, and viral suppression are improving among persons living with HIV (PLWH) in the United States. Yet, disparities among African American/Black and Latino PLWH are persistent, signaling the need for new conceptual approaches. To address gaps in services and research (e.g., insufficient attention to structural/systemic factors, inadequate harm reduction services and autonomy support) and improve behavioral interventions, we integrated critical race theory, harm reduction, and self-determination theory into a new conceptual model, then used the model to develop a set of six intervention components which were tested in a larger study. The present qualitative study explores participants' perspectives on the study's acceptability, feasibility, and impact, and the conceptual model's contribution to these experiences. METHODS:Participants in the larger study were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City (N = 512). We randomly selected N = 46 for in-depth semi-structured interviews on their experiences with and perspectives on the study. Interviews were audio-recorded and professionally transcribed verbatim, and data were analyzed using directed qualitative content analysis. RESULTS:On average, participants were 49 years old (SD = 9) and had lived with HIV for 19 years (SD = 7). Most were male (78%) and African American/Black (76%). All had taken HIV medication previously. Challenging life contexts were the norm, including poverty, poor quality/unstable housing, trauma histories exacerbated by current trauma, health comorbidities, and substance use. Participants found the study highly acceptable. We organized results into four themes focused on participants' experiences of: 1) being understood as a whole person and in their structural/systemic context; 2) trustworthiness and trust; 3) opportunities for self-reflection; and 4) support of personal autonomy. The salience of nonjudgment was prominent in each theme. Themes reflected grounding in the conceptual model. Participants reported these characteristics were lacking in HIV care settings. CONCLUSIONS:The new conceptual model emphasizes the salience of systemic/structural and social factors that drive health behavior and the resultant interventions foster trust, self-reflection, engagement, and behavior change. The model has potential to enhance intervention acceptability, feasibility, and effectiveness with African American/Black and Latino PLWH.

BACKGROUND:Among those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient. METHODS/DESIGN:The proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews. DISCUSSION:This optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic. TRIAL REGISTRATION:ClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0.

PURPOSE:Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS:The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS:All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS:.

BACKGROUND:Black sexual minority men (BSMM) and Black transgender women face a disproportionate risk of incarceration and sexually transmitted infection (STI)/HIV, yet research on the longitudinal association between incarceration and STI/HIV risk in these groups is limited. METHODS:We used data from the HIV Prevention Trials Network (HPTN) 061 study conducted among BSMM and Black transgender women in Atlanta, Boston, Los Angeles, New York City, San Francisco, and Washington, DC, restricting analyses to those who returned for the 6-month follow-up visit when recent incarceration was measured (n = 1169). Using inverse probability of treatment weighting, we measured associations between incarceration and next 6-month multiple partnerships; selling or buying sex; condomless anal intercourse; and incident chlamydia, gonorrhea, syphilis, and HIV. We explored differences by study city, and among BSMM who had sex with men only, BSMM who had sex with men and women, and Black transgender women. RESULTS:Approximately 14% reported past 6-month incarceration. Incarceration was associated with next 6-month selling sex (adjusted risk ratio [ARR], 1.80; 95% confidence interval [CI], 1.12-2.87) in the overall sample and multiple partnerships among BSMM who had sex with men and women (ARR, 1.34; 95% CI, 1.10-1.63) and transgender women (ARR, 1.77; 95% CI, 1.22-2.57). There is evidence suggesting that incarceration may predict gonorrhea (ARR, 2.35; 95% CI, 0.95-5.77), with particularly strong associations observed in Los Angeles (ARR, 6.48; 95% CI, 1.48-28.38). CONCLUSIONS:Incarceration may increase STI/HIV risk among BSMM and Black transgender women. Additional mixed-methods research is needed to validate associations and understand pathways.

INTRODUCTION/BACKGROUND:Strategies are needed to increase implementation of evidence-based tobacco dependence treatment (TDT) in health care systems in low-and middle-income countries (LMICs). METHODS:We conducted a two-arm cluster randomized controlled trial to compare the effectiveness of two strategies for implementing TDT guidelines in community health centers (n=26) in Vietnam. Arm 1 included training and a tool kit (e.g., reminder system) to promote and support delivery of the 4As (Ask about tobacco use, Advise to quit, Assess readiness, Assist with brief counseling) (Arm 1). Arm 2 included Arm 1 components plus a system to refer smokers to a community health worker (CHW) for more intensive counseling (4As+R). Provider surveys were conducted at baseline, six- and 12-months to assess the hypothesized effect of the strategies on provider and organizational-level factors. The primary outcome was provider adoption of the 4As. RESULTS:Adoption of the 4As increased significantly across both study arms (all p<.001). Perceived organizational priority for TDT, compatibility with current workflow, and provider attitudes, norms and self-efficacy related to TDT also improved significantly across both arms. In Arm 2 sites, 41% of smokers were referred to a CHW for additional counseling. CONCLUSION/CONCLUSIONS:The study demonstrated the effectiveness of a multicomponent and multilevel strategy (i.e., provider and system) for implementing evidence-based TDT in the Vietnam public health system. Combining provider-delivered brief counseling with opportunities for more in-depth counseling offered by a trained CHW may optimize outcomes and offers a potentially scalable model for increasing access to TDT in health care systems like Vietnam. IMPLICATIONS/CONCLUSIONS:Improving implementation of evidence-based tobacco dependence treatment (TDT) guidelines is a necessary step towards reducing the growing burden of non-communicable disease (NCDs) and premature death in LMICs. The findings provide new evidence on the effectiveness of multilevel strategies for adapting and implementing TDT into routine care in Vietnam, and offers a potentially scalable model for meeting FCTC Article 14 goals in other LMICs with comparable public health systems. The study also demonstrates that combining provider-delivered brief counseling with referral to a community health worker for more in-depth counseling and support can optimize access to evidence-based treatment for tobacco use.

BACKGROUND:Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD. METHODS:In an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms. DISCUSSION/CONCLUSIONS:Despite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke. Trial Registration ClinicalTrials.gov Identifier: NCT04465318.

PURPOSE/OBJECTIVE:To outline a method for obtaining more accurate estimates of drug use in the United States (US) general population by correcting survey data for underreported and unknown drug use. METHODS:We simulated a population (n=100,000) reflecting the demographics of the US adult population per the 2018 American Community Survey. Within this population, we simulated the "true" and self-reported prevalence of past-month cannabis and cocaine use by using available estimates of underreporting. We applied our algorithm to samples of the simulated population to correct self-reported estimates and recover the "true" population prevalence, validating our approach. We applied this same method to 2018 National Survey on Drug Use and Health data to produce a range of underreporting-corrected estimates. RESULTS:Simulated self-report sensitivities varied by drug and sampling method (cannabis: 77.6-78.5%, cocaine: 14.3-22.1%). Across repeated samples, mean corrected prevalences (calculated by dividing self-reported prevalence by estimated sensitivity) closely approximated simulated "true" prevalences. Applying our algorithm substantially increased 2018 NSDUH estimates (self-report: cannabis=10.5%, cocaine=0.8%; corrected: cannabis=15.6-16.6%, cocaine=2.7-5.5%). CONCLUSION/CONCLUSIONS:National drug use prevalence estimates can be corrected for underreporting using a simple method. However, valid application of this method requires accurate data on the extent and correlates of misclassification in the general US population.

BACKGROUND/UNASSIGNED:Unintentional drug overdose has increased markedly in the United States. Studies document an association between psychiatric disorder and unintentional overdose; we extend this research through a preliminary test of a causal model of recurrent injection drug use mediating this relationship. METHODS/UNASSIGNED:In a cross-sectional study of 241 adults in New York City with a possible current substance use disorder, we conducted conventional and Imai's mediation analyses to examine if psychiatric disorder is associated with increased prevalence of ever overdosing and if recurrent injection drug use mediates this association. Our cross-sectional data permit the first step of assessing causal models: testing if statistical associations are consistent with the model. RESULTS/UNASSIGNED: = 0.02) of the association between psychiatric diagnosis and ever overdosing. Conventional mediation analysis produced similar results. CONCLUSIONS/UNASSIGNED:Our results provide a warrant for taking the necessary next step for assessing a causal model using longitudinal data, potentially providing a strong rationale for intervening on psychiatric disorders to stem overdose.

Introduction/UNASSIGNED:Sustained HIV viral suppression is the ultimate goal of HIV treatment. African American/Black and Latino persons with HIV (PWH) in the United States are less likely than their White peers to achieve and sustain viral suppression. To address these disparities, we developed a "low-touch" behavioral intervention drawing on motivational interviewing and behavioral economics. The intervention had three main components: (1) a motivational interviewing counseling session, (2) 16 weeks of automated text messages and quiz questions about HIV management, where participants earned points by answering quiz questions, and 3) a lottery prize, based on viral suppression status, number of points earned, and chance (max. $275). Materials and methods/UNASSIGNED:The intervention was tested in a pre-test/post-test design. The present pilot study used mixed methods to explore the intervention's feasibility, acceptability, impact, and ways it could be improved. Participants engaged in a baseline assessment, qualitative interview, and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. We carried out descriptive quantitative analyses. Qualitative data were analyzed using a directed content analysis approach. Data integration was carried out using the joint display method. Findings/UNASSIGNED:= 40) were 50 years old, on average (SD = 11), and approximately half (58%) were male. Close to two-thirds (68%) were African American/Black and 32% were Latino. Participants were diagnosed with HIV 22 years ago on average (SD = 8). The intervention was feasible (e.g., mean number of quiz questions answered = 13/16) and highly acceptable. While not powered to assess efficacy, the proportion with suppressed HIV viral load increased from baseline to follow-up (46% participants at the first, 52% participants at the second follow-up evidenced HIV viral suppression). In qualitative analyses, perspectives included that overall, the intervention was acceptable and useful, it was distinct from other programs, lottery prizes were interesting and appreciated but not sufficient to motivate behavior change, and the structure of lottery prizes was not sufficiently clear. Regarding data integration, qualitative data shed light on and extended quantitative results, and added richness and context. Conclusion/UNASSIGNED:This low-touch intervention approach is sufficiently promising to warrant refinement and study in future research.