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The POP (Permanent Supportive Housing Overdose Prevention) Study: protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial

Doran, Kelly M; Torsiglieri, Allison; Blaufarb, Stephanie; Hernandez, Patricia; Melnick, Emily; Velez, Lauren; Cleland, Charles M; Neighbors, Charles; O'Grady, Megan A; Shelley, Donna
BACKGROUND:Permanent supportive housing (PSH)-subsidized housing paired with support services such as case management-is a key part of national strategic plans to end homelessness. PSH tenants face high overdose risk due to a confluence of individual and environmental risk factors, yet little research has examined overdose prevention in PSH. METHODS:We describe the protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial (RCT) of overdose prevention practice implementation in PSH. We adapted evidence-based overdose prevention practices and implementation strategies for PSH using input from stakeholder focus groups. The trial will include 20 PSH buildings (with building size ranging from 20 to over 150 tenants) across New York City and New York's Capital Region. Buildings will be randomized to one of four 6-month intervention waves during which they will receive a package of implementation support including training in using a PSH Overdose Prevention (POP) Toolkit, time-limited practice facilitation, and learning collaboratives delivered to staff and tenant implementation champions appointed by each building. The primary outcome is building-level fidelity to a defined list of overdose prevention practices. Secondary and exploratory implementation and effectiveness outcomes will be examined using PSH staff and tenant survey questionnaires, and analysis of tenant Medicaid data. We will explore factors related to implementation success, including barriers and facilitators, using qualitative interviews with key stakeholders. The project is being conducted through an academic-community partnership, and an Advisory Board including PSH tenants and other key stakeholders will be engaged in all stages of the project. DISCUSSION:We describe the protocol for a hybrid type 3 stepped-wedge cluster RCT of overdose prevention practice implementation in PSH. This study will be the first controlled trial of overdose prevention implementation in PSH settings. The research will make a significant impact by testing and informing future implementation strategies to prevent overdose for a population at particularly high risk for overdose mortality. Findings from this PSH-focused research are expected to be broadly applicable to other housing settings and settings serving people experiencing homelessness. TRIAL REGISTRATION:ClinicalTrials.gov, NCT05786222 , registered 27 March 2023.
PMCID:10246871
PMID: 37287026
ISSN: 1748-5908
CID: 5541642

Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial

Shelley, Donna R; Brown, Dominique; Cleland, Charles M; Pham-Singer, Hang; Zein, Dina; Chang, Ji Eun; Wu, Winfred Y
BACKGROUND:There are well-established guidelines for treating hypertension (HTN), yet only half of patients with HTN meet the defined target of < 140/90. Team-based care (TBC) is an evidence-based strategy for improving blood pressure (BP) management and control. TBC is defined as the provision of health services by at least two health professionals "who work collaboratively with patients and their caregivers to accomplish shared goals to achieve coordinated, high-quality care". However, primary care practices experience challenges to implementing TBC principles and care processes; these are more pronounced in small independent practice settings (SIPs). Practice facilitation (PF) is an implementation strategy that may overcome barriers to adopting evidence-based TBC to improve HTN management in SIPs. METHODS:Using a stepped wedge randomized controlled trial design, we will test the effect of PF on the adoption of TBC to improve HTN management in small practices (< 5 FTE clinicians) in New York City, and the impact on BP control compared with usual care. We will enroll 90 SIPs and randomize them into one of three 12-month intervention waves. Practice facilitators will support SIPs to adopt TBC principles to improve implementation of five HTN management strategies (i.e., panel management, population health, measuring BP, supporting medication adherence, self-management). The primary outcome is the adoption of TBC for HTN management measured at baseline and 12 months. Secondary outcomes include the rate of BP control and sustainability of TBC and BP outcomes at 18 months. Aggregated data on BP measures are collected every 6 months in all clusters so that each cluster provides data points in both the control and intervention conditions. Using a mixed methods approach, we will also explore factors that influence the effectiveness of PF at the organization and team level. DISCUSSION/CONCLUSIONS:This study will provide much-needed guidance on how to optimize adoption and sustainability of TBC in independent primary care settings to reduce the burden of disease related to suboptimal BP control and advance understanding of how facilitation works to improve implementation of evidence-based interventions. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov; NCT05413252 .
PMCID:10230682
PMID: 37259081
ISSN: 1472-6963
CID: 5538272

Effects of Behavioral Intervention Components for African American/Black and Latino Persons Living with HIV with Non-suppressed Viral Load Levels: Results of an Optimization Trial

Cleland, Charles M; Gwadz, Marya; Collins, Linda M; Wilton, Leo; Leonard, Noelle R; Ritchie, Amanda S; Martinez, Belkis Y; Silverman, Elizabeth; Sherpa, Dawa; Dorsen, Caroline
There is an urgent need for efficient behavioral interventions to increase rates of HIV viral suppression for populations with serious barriers to engagement along the HIV care continuum. We carried out an optimization trial to test the effects of five behavioral intervention components designed to address barriers to HIV care continuum engagement for African American/Black and Latino persons living with HIV (PLWH) with non-suppressed HIV viral load levels: motivational interviewing sessions (MI), focused support groups (SG), peer mentorship (PM), pre-adherence skill building (SB), and navigation with two levels, short (NS) and long (NL). The primary outcome was HIV viral suppression (VS) and absolute viral load (VL) and health-related quality of life were secondary outcomes. Participants were 512 African American/Black and Latino PLWH poorly engaged in HIV care and with detectable HIV viral load levels in New York City, recruited mainly through peer referral. Overall, VS increased to 37%, or 45% in a sensitivity analysis. MI and SG seemed to have antagonistic effects on VS (z = - 1.90; p = 0.057); the probability of VS was highest when either MI or SG was assigned, but not both. MI (Mean Difference = 0.030; 95% CI 0.007-0.053; t(440) = 2.60; p = 0.010) and SB (Mean Difference = 0.030; 95% CI 0.007-0.053; t(439) = 2.54; p = 0.012) improved health-related quality of life. This is the first optimization trial in the field of HIV treatment. The study yields a number of insights into approaches to improve HIV viral suppression in PLWH with serious barriers to engagement along the HIV care continuum, including chronic poverty, and underscores challenges inherent in doing so.
PMCID:10211286
PMID: 37227621
ISSN: 1573-3254
CID: 5504752

Trends in drug use among nightclub and festival attendees in New York City, 2017-2022

Palamar, Joseph J; Le, Austin; Cleland, Charles M; Keyes, Katherine M
BACKGROUND:Drug use is prevalent among people who attend electronic dance music (EDM) parties at nightclubs or festivals. This population can serve as a sentinel population to monitor trends in use of party drugs and new psychoactive substances (NPS) that may diffuse through larger segments of the population. METHODS:We surveyed adults entering randomly selected EDM parties at nightclubs and dance festivals in New York City about their drug use in 2017 (n=954), 2018 (n=1,029), 2019 (n=606), 2021 (n=229), and 2022 (n=419). We estimated trends in past-year and past-month use of 22 drugs or drug classes based on self-report from 2017-2022 and examined whether there were shifts pre- vs. post-COVID (2017-2019 vs. 2021-2022). RESULTS:Between 2017 and 2022, there were increases in past-year and past-month use of shrooms (psilocybin), ketamine, poppers (amyl/butyl nitrites), synthetic cathinones ("bath salts"), and novel psychedelics (lysergamides and DOx series), increases in past-year cannabis use, and increases in past-month use of 2C series drugs. Between 2017 and 2022, there were decreases in past-year heroin use and decreases in past-month cocaine use, novel stimulant use, and nonmedical benzodiazepine use. The odds of use of shrooms, poppers, and 2C series drugs significantly increased after COVID, and the odds of use of cocaine, ecstasy, heroin, methamphetamine, novel stimulants, and prescription opioids (nonmedical use) decreased post-COVID. CONCLUSIONS:We estimate shifts in prevalence of various drugs among this sentinel population, which can inform ongoing surveillance efforts and public health response in this and the general populations.
PMCID:10164102
PMID: 36934660
ISSN: 1873-4758
CID: 5495562

Use of electronic nicotine delivery system (ENDS) devices among U.S. Youth and adults: Findings from the Population Assessment of Tobacco and Health Study Waves 1-5

Jiang, Nan; Xu, Shu; Li, Le; Cleland, Charles M; Niaura, Raymond S
INTRODUCTION/BACKGROUND:Electronic nicotine delivery system (ENDS) devices evolve rapidly and impact nicotine dependence. This study described the type of ENDS devices used most frequently by U.S. youth and adults from 2013/14 to 2018/19. METHODS:We analyzed Waves 1-5 data of the Population Assessment of Tobacco and Health Study. Among current ENDS users, descriptive statistics summarized the most frequently used ENDS devices (i.e., disposable cigalike, refillable cartridge, nonrefillable cartridge, tank, mod, prefilled pod, disposable pod) among youth (12-17 years), young adults (18-34 years), and older adults (≥35 years) for each wave. RESULTS:The proportion of current ENDS users who reported they most frequently used disposable cigalikes and cartridge-based devices declined over time across all age groups. At Waves 1-4, tank was generally the most popular type for all ages and an increasing proportion of ENDS users reported they most frequently used tanks. The primary use of mods decreased among youth, and fluctuated among young and older adults. At Wave 5, prefilled pods became the dominant type (youth: 55.0%; young adults: 44.7%; older adults: 42.7%), and 4.2-10.0% of ENDS users reported using disposable pods most often. The popularity of tanks, mods, and prefilled pods was more evident in youth and young adults, and primary use of disposable pods was more common in older adults. CONCLUSIONS:The primary use of ENDS devices changed over the years and varied by age. More research is warranted to continuously monitor the characteristics of ENDS devices in youth and adults to inform product regulations and intervention efforts.
PMCID:9840694
PMID: 36549101
ISSN: 1873-6327
CID: 5409312

Study protocol for a multisite randomized controlled trial of a peer navigator intervention for emergency department patients with nonfatal opioid overdose

Doran, Kelly M; Welch, Alice E; Jeffers, Angela; Kepler, Kelsey L; Chambless, Dominique; Cowan, Ethan; Wittman, Ian; Regina, Angela; Chang, Tingyee E; Parraga, Susan; Tapia, Jade; Diaz, Cesar; Gwadz, Marya; Cleland, Charles M; McNeely, Jennifer
BACKGROUND:Patients presenting to emergency departments (EDs) after a nonfatal opioid-involved overdose are at high risk for future overdose and death. Responding to this risk, the New York City (NYC) Department of Health and Mental Hygiene operates the Relay initiative, which dispatches trained peer "Wellness Advocates" to meet patients in the ED after a suspected opioid-involved overdose and follow them for up to 90 days to provide support, education, referrals to treatment, and other resources using a harm reduction framework. METHODS:In this article, we describe the protocol for a multisite randomized controlled trial of Relay. Study participants are recruited from four NYC EDs and are randomized to receive the Relay intervention or site-directed care (the control arm). Outcomes are assessed through survey questionnaires conducted at 1-, 3-, and 6-months after the baseline visit, as well as through administrative health data. The primary outcome is the number of opioid-related adverse events, including any opioid-involved overdose or any other substance use-related ED visit, in the 12 months post-baseline. Secondary and exploratory outcomes will also be analyzed, as well as hypothesized mediators and moderators of Relay program effectiveness. CONCLUSION/CONCLUSIONS:We present the protocol for a multisite randomized controlled trial of a peer-delivered OD prevention intervention in EDs. We describe how the study was designed to minimize disruption to routine ED operations, and how the study was implemented and adapted during the COVID-19 pandemic. This trial is registered with ClinicalTrials.gov [NCT04317053].
PMID: 36746325
ISSN: 1559-2030
CID: 5420772

Exploring behavioral intervention components for African American/Black and Latino persons living with HIV with non-suppressed HIV viral load in the United States: a qualitative study

Cluesman, Sabrina R; Gwadz, Marya; Freeman, Robin; Collins, Linda M; Cleland, Charles M; Wilton, Leo; Hawkins, Robert L; Leonard, Noelle R; Silverman, Elizabeth; Maslow, Carey B; Israel, Khadija; Ritchie, Amanda; Ory, Sarah
BACKGROUND:The persistence of racial/ethnic inequities in rates of engagement along the HIV care continuum signals the need for novel approaches. We developed six behavioral intervention components for use in an optimization trial, grounded in a model that integrates critical race theory, harm reduction, and self-determination theory, designed to address various barriers that African American/Black and Latino persons living with HIV (PLWH) experience to the HIV care continuum. The components were: health education, motivational interviewing sessions, pre-adherence skill building, peer mentorship, focused support groups, and navigation. The present qualitative exploratory study describes participants' perspectives on the components' acceptability, feasibility, and impact. METHODS:Participants were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City. From a larger trial, we randomly selected 46 participants for in-depth semi-structured interviews. Interviews were audio-recorded and transcribed verbatim, and data were analyzed using directed content analysis. Quantitative data on sociodemographic and background characteristics and components' acceptability and feasibility were also collected. RESULTS:On average, participants were 49 years old and had lived with HIV for 19 years. Most were cisgender-male and African American/Black. Participants reported a constellation of serious social and structural challenges to HIV management including chronic poverty, unstable housing, and stigma. Across components, a non-judgmental and pressure-free approach and attention to structural and cultural factors were seen as vital to high levels of engagement, but lacking in most medical/social service settings. Prominent aspects of individual components included establishing trust (health education); developing intrinsic motivation, goals, and self-reflection (motivational interviewing sessions); learning/practicing adherence strategies and habits (pre-adherence skill building); reducing social isolation via peer role models (peer mentorship); reflecting on salient goals and common challenges with peers without stigma (focused support groups); and circumventing structural barriers to HIV management with support (navigation). Components were found acceptable and feasible. Findings suggested ways components could be improved. CONCLUSIONS:The present study advances research on interventions for African American/Black and Latino PLWH, who experience complex barriers to engagement along the HIV care continuum. Future study of the components is warranted to address racial/ethnic health inequities in HIV.
PMCID:9886533
PMID: 36717920
ISSN: 1475-9276
CID: 5422752

Association between recent methamphetamine use, antiretroviral therapy and HIV viral load; a mediation analysis from a cohort of HIV positive persons who inject drugs in Hai Phong, Vietnam

Feelemyer, Jonathan; Des Jarlais, Don; Nagot, Nicolas; Duong Thi, Huong; Thi Hai, Oanh Khuat; Pham Minh, Khuê; Hoang Thi, Giang; Nham Thi Tuyet, Thanh; Cleland, Charles M; Arasteh, Kamyar; Caniglia, Ellen; Chen, Yu; Bart, Gavin; Moles, Jean Pierre; Vu Hai, Vinh; Vallo, Roselyne; Quillet, Catherine; Rapoud, Delphine; Sao, Mai Le; Michel, Laurent; Laureillard, Didier; Khan, Maria R
BACKGROUND:There has been a significant increase in methamphetamine use among persons who use drugs in Vietnam in the last 5-10 years. We examined the degree to which adherence to antiretroviral therapy (ART) mediates the relationship between recent methamphetamine use and unsuppressed HIV viral load among people who inject drugs (PWID) in Hai Phong, Vietnam. METHODS:We recruited PWID from October 2016-October 2018 and enrolled HIV positive PWID into a cohort, with up to three years of total follow-up. We assessed relationships among recent methamphetamine use frequency, ART adherence and unsuppressed HIV viral load. Mediation analysis was used to estimate the total and natural direct effects of recent methamphetamine use on unsuppressed HIV viral load and the indirect effect proportion. RESULTS:We enrolled 792 HIV seropositive PWID into the cohort; approximately 75.9% reported high/perfect ART adherence at baseline and 81.3% were virally suppressed. In mediation analysis, the total effect for the association between methamphetamine use and unsuppressed HIV viral load (1000 copies/mL) was 3.94 (95% CI: 1.95, 7.96); the natural direct effect was 2.14 (95% CI: 1.29, 3.55); the proportion mediated by self-reported ART adherence was 0.444. Similar results were found when examining lower unsuppressed HIV viral load cutpoints of 250 copies/mL and 500 copies/mL. CONCLUSIONS:Methamphetamine use is associated with unsuppressed HIV viral load among PWID despite high levels of ART adherence. Further research is needed to better understand these relationships, with emphasis on potential biological pathways that may interact with ART.
PMID: 36637437
ISSN: 1758-1052
CID: 5403302

Posttraumatic Stress Disorder Symptoms and Incarceration: The Impact on Sexual Risk-Taking, Sexually Transmitted Infections, and Depression Among Black Sexual Minority Men in HIV Prevention Trials Network (HPTN) 061

Scanlon, Faith; Remch, Molly; Scheidell, Joy D.; Brewer, Russell; Dyer, Typhanye V.; Albis-Burdige, Blaise; Irvine, Natalia; Turpin, Rodman; Parker, Sharon; Cleland, Charles M.; Hucks-Ortiz, Christopher; Gaydos, Charlotte A.; Mayer, Kenneth H.; Khan, Maria R.
Black men and people belonging to sexual minority groups are disproportionately impacted by criminal legal involvement and sexually transmitted infections (STIs). Traumatic experiences are often associated with later criminal legal involvement, depression symptoms, sexual risk behavior, and STIs. Research on the joint influence of trauma and incarceration on STI risk among racial and/or sexual minority people is limited. This study tested the association between posttraumatic stress disorder (PTSD) symptoms and incarceration on sexual risk behavior and STI among Black sexual minority men (SMM), a population that may be at higher risk for contracting STIs. Using data from the HIV Prevention Trials Network 061 Study, a longitudinal study of adult Black SMM in six U.S. cities (N = 855), we tested associations between past 6-month incarceration and subsequent sexual risk behavior, STI, and depression symptoms, for those with and without preincarceration PTSD symptoms. PTSD symptoms were elevated among participants who reported Hispanic ethnicity, having sex with both men and women, and previous incarceration. Although there were no significant differences between recent incarceration and sexual risk for those with and without PTSD, incarceration was linked to some sexual risk behaviors regardless of PTSD symptoms. Among people with PTSD symptoms, there was a higher prevalence of sexual risk and depression symptoms, regardless of incarceration. These findings suggest a potentially compounding influence of PTSD symptoms and incarceration on sexual risk and infection among Black SMM.
SCOPUS:85183153833
ISSN: 1524-9220
CID: 5630722

A virtual pilot optimization trial for African American/Black and Latino persons with non-suppressed HIV viral load grounded in motivational interviewing and behavioral economics

Filippone, Prema; Serrano, Samantha; Gwadz, Marya; Cleland, Charles M; Freeman, Robin; Linnemayr, Sebastian; Cluesman, Sabrina R; Campos, Stephanie; Rosmarin-DeStefano, Corey; Amos, Brianna; Israel, Khadija
INTRODUCTION:Virtual and low-touch behavioral interventions are needed for African American/Black and Latino persons living with HIV (PLWH) with barriers to HIV viral suppression, particularly during COVID-19. Guided by the multiphase optimization strategy, we explored three components for PLWH without viral suppression, grounded in motivational interviewing and behavioral economics: (1) motivational interviewing counseling, (2) 21-weeks of automated text messages and quiz questions about HIV management, and (3) financial rewards for viral suppression (lottery prize vs. fixed compensation). METHODS:This pilot optimization trial used sequential explanatory mixed methods to explore the components' feasibility, acceptability, and preliminary evidence of effects using an efficient factorial design. The primary outcome was viral suppression. Participants engaged in baseline and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. A subset engaged in qualitative interviews. We carried out descriptive quantitative analyses. Then, qualitative data were analyzed using directed content analysis. Data integration used the joint display method. RESULTS:= 80) were 49 years old, on average (SD = 9), and 75% were assigned male sex at birth. Most (79%) were African American/Black, and the remainder were Latino. Participants were diagnosed with HIV 20 years previously on average (SD = 9). Overall, components were feasible (>80% attended) and acceptability was satisfactory. A total of 39% (26/66) who provided laboratory reports at follow-up evidenced viral suppression. Findings suggested no components were entirely unsuccessful. The lottery prize compared to fixed compensation was the most promising component level. In qualitative analyses, all components were seen as beneficial to individual wellbeing. The lottery prize appeared more interesting and engaging than fixed compensation. However, structural barriers including financial hardship interfered with abilities to reach viral suppression. The integrated analyses yielded areas of convergence and discrepancy and qualitative findings added depth and context to the quantitative results. CONCLUSIONS:The virtual and/or low-touch behavioral intervention components tested are acceptable and feasible and show enough potential to warrant refinement and testing in future research, particularly the lottery prize. Results must be interpreted in the context of the COVID-19 pandemic. TRIAL REGISTRATION:NCT04518241 (https://clinicaltrials.gov/ct2/show/NCT04518241).
PMCID:10205984
PMID: 37234760
ISSN: 2296-2565
CID: 5504762