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9 result(s) for "Santostefano, Christopher M."
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Positive STEPS – a randomized controlled efficacy trial of an adaptive intervention for strengthening adherence to antiretroviral HIV treatment among youth: study protocol
Background HIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, “adaptive” ART adherence intervention protocol for HIV-infected adolescents and young adults. Methods This is a randomized controlled trial (RCT) to establish the efficacy of “Positive STEPS,” a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report. Discussion Behavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings. Trial registration ClinicalTrials.gov number NCT03092531 , registered March 28, 2017.
A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol
Background In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM. Methods This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits. Discussion Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings. Trial registration ClinicalTrials.gov number NCT03175159 , registered June 5, 2017.
MSM at Highest Risk for HIV Acquisition Express Greatest Interest and Preference for Injectable Antiretroviral PrEP Compared to Daily, Oral Medication
Men who have sex with men (MSM) account for nearly 70% of new HIV diagnoses, with young black MSM at the highest risk for infection in the United States. Pre-exposure prophylaxis (PrEP) can decrease HIV acquisition in at-risk individuals by over 90%. However, therapeutic efficacy requires a daily pill, posing adherence challenges. Experimental modalities, including injectable PrEP given once every 2 months, may improve adherence among those most in need. To assess interest in and preference for injectable PrEP, an online survey was mounted on two popular MSM sexual networking apps. Differences by age, race, and other characteristics were examined using multinomial logistic regressions. Of 4638 respondents, 73% expressed interest in injectable PrEP and 47% indicated they would prefer an injection (compared to 17% who prefer a daily pill and 36% who were unsure). Within this sample, interest in and preference for injectable PrEP was highest among MSM at highest risk for HIV infection (i.e., younger age groups, racial/ethnic minorities, those with risker sexual behavior). As a result, if proven effective in clinical trials, injectable PrEP has the potential to reduce social disparities in HIV transmission among MSM.
Infections, Hospitalizations, and Deaths Among US Nursing Home Residents With vs Without a SARS-CoV-2 Vaccine Booster
A SARS-CoV-2 vaccine booster dose has been recommended for all nursing home residents. However, data on the effectiveness of an mRNA vaccine booster in preventing infection, hospitalization, and death in this vulnerable population are lacking. To evaluate the association between receipt of a SARS-CoV-2 mRNA vaccine booster and prevention of infection, hospitalization, or death among nursing home residents. This cohort study emulated sequentially nested target trials for vaccination using data from 2 large multistate US nursing home systems: Genesis HealthCare, a community nursing home operator (system 1) and Veterans Health Administration community living centers (VHA CLCs; system 2). The cohort included long-term (≥100 days) nursing home residents (10 949 residents from 202 community nursing homes and 4321 residents from 128 VHA CLCs) who completed a 2-dose series of an mRNA vaccine (either BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna]) and were eligible for a booster dose between September 22 and November 30, 2021. Residents were followed up until March 8, 2022. Receipt of a third mRNA vaccine dose, defined as a booster dose (boosted group), or nonreceipt of a booster dose (unboosted group) on an eligible target trial date. If participants in the unboosted group received a booster dose on a later target trial date, they were included in the booster group for that target trial; thus, participants could be included in both the boosted and unboosted groups. Test-confirmed SARS-CoV-2 infection, hospitalization, or death was followed up to 12 weeks after booster vaccination. The primary measure of estimated vaccine effectiveness was the ratio of cumulative incidences in the boosted group vs the unboosted group at week 12, adjusted with inverse probability weights for treatment and censoring. System 1 included 202 community nursing homes; among 8332 boosted residents (5325 [63.9%] female; 6685 [80.2%] White) vs 10 886 unboosted residents (6865 [63.1%] female; 8651 [79.5%] White), the median age was 78 (IQR, 68-87) years vs 78 (IQR, 68-86) years. System 2 included 128 VHA CLCs; among 3289 boosted residents (3157 [96.0%] male; 1950 [59.3%] White) vs 4317 unboosted residents (4151 [96.2%] male; 2434 [56.4%] White), the median age was 74 (IQR, 70-80) vs 74 (IQR, 69-80) years. Booster vaccination was associated with reductions in SARS-CoV-2 infections of 37.7% (95% CI, 25.4%-44.2%) in system 1 and 57.7% (95% CI, 43.5%-67.8%) in system 2. For hospitalization, reductions of 74.4% (95% CI, 44.6%-86.2%) in system 1 and 64.1% (95% CI, 41.3%-76.0%) in system 2 were observed. Estimated vaccine effectiveness for death associated with SARS-CoV-2 was 87.9% (95% CI, 75.9%-93.9%) in system 1; however, although a reduction in death was observed in system 2 (46.6%; 95% CI, -34.6% to 94.8%), this reduction was not statistically significant. A total of 45 SARS-CoV-2-associated deaths occurred in system 1 and 18 deaths occurred in system 2. For the combined end point of SARS-CoV-2-associated hospitalization or death, boosted residents in system 1 had an 80.3% (95% CI, 65.7%-88.5%) reduction, and boosted residents in system 2 had a 63.8% (95% CI, 41.4%-76.1%) reduction. In this study, during a period in which both the Delta and Omicron variants were circulating, SARS-CoV-2 booster vaccination was associated with significant reductions in SARS-CoV-2 infections, hospitalizations, and the combined end point of hospitalization or death among residents of 2 US nursing home systems. These findings suggest that administration of vaccine boosters to nursing home residents may have an important role in preventing COVID-19-associated morbidity and mortality.
Effectiveness of a Second COVID-19 Vaccine Booster Dose Against Infection, Hospitalization, or Death Among Nursing Home Residents — 19 States, March 29–July 25, 2022
Nursing home residents continue to experience significant COVID-19 morbidity and mortality (1). On March 29, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended a second mRNA COVID-19 vaccine booster dose for adults aged ≥50 years and all immunocompromised persons who had received a first booster ≥4 months earlier.* On September 1, 2022, ACIP voted to recommend bivalent mRNA COVID-19 vaccine boosters for all persons aged ≥12 years who had completed the primary series using monovalent vaccines ≥2 months earlier (2). Data on COVID-19 booster dose vaccine effectiveness (VE) in the nursing home population are limited (3). For this analysis, academic, federal, and private partners evaluated routine care data collected from 196 U.S. community nursing homes to estimate VE of a second mRNA COVID-19 vaccine booster dose among nursing home residents who had received 3 previous COVID-19 vaccine doses (2 primary series doses and 1 booster dose). Residents who received second mRNA COVID-19 vaccine booster doses during March 29-June 15, 2022, with follow-up through July 25, 2022, were found to have 60-day VE of 25.8% against SARS-CoV-2 (the virus that causes COVID-19 infection), 73.9% against severe COVID-19 outcomes (a combined endpoint of COVID-19-associated hospitalizations or deaths), and 89.6% against COVID-19-associated deaths alone. During this period, subvariants BA.2 and BA.2.12.1 (March-June 2022), and BA.4 and BA.5 (July 2022) of the B.1.1.529 and BA.2 (Omicron) variant were predominant. These findings suggest that among nursing home residents, second mRNA COVID-19 vaccine booster doses provided additional protection over first booster doses against severe COVID-19 outcomes during a time of emerging Omicron variants. Facilities should continue to ensure that nursing home residents remain up to date with COVID-19 vaccination, including bivalent vaccine booster doses, to prevent severe COVID-19 outcomes.Nursing home residents continue to experience significant COVID-19 morbidity and mortality (1). On March 29, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended a second mRNA COVID-19 vaccine booster dose for adults aged ≥50 years and all immunocompromised persons who had received a first booster ≥4 months earlier.* On September 1, 2022, ACIP voted to recommend bivalent mRNA COVID-19 vaccine boosters for all persons aged ≥12 years who had completed the primary series using monovalent vaccines ≥2 months earlier (2). Data on COVID-19 booster dose vaccine effectiveness (VE) in the nursing home population are limited (3). For this analysis, academic, federal, and private partners evaluated routine care data collected from 196 U.S. community nursing homes to estimate VE of a second mRNA COVID-19 vaccine booster dose among nursing home residents who had received 3 previous COVID-19 vaccine doses (2 primary series doses and 1 booster dose). Residents who received second mRNA COVID-19 vaccine booster doses during March 29-June 15, 2022, with follow-up through July 25, 2022, were found to have 60-day VE of 25.8% against SARS-CoV-2 (the virus that causes COVID-19 infection), 73.9% against severe COVID-19 outcomes (a combined endpoint of COVID-19-associated hospitalizations or deaths), and 89.6% against COVID-19-associated deaths alone. During this period, subvariants BA.2 and BA.2.12.1 (March-June 2022), and BA.4 and BA.5 (July 2022) of the B.1.1.529 and BA.2 (Omicron) variant were predominant. These findings suggest that among nursing home residents, second mRNA COVID-19 vaccine booster doses provided additional protection over first booster doses against severe COVID-19 outcomes during a time of emerging Omicron variants. Facilities should continue to ensure that nursing home residents remain up to date with COVID-19 vaccination, including bivalent vaccine booster doses, to prevent severe COVID-19 outcomes.
Distribution of Adult Day Health Centers and Persons Living with Dementia Among Hospital Service Areas in Rhode Island
Adult day health centers (ADHCs) provide an important service to community-dwelling adults with functional dependency. This includes persons living with dementia (PLWD) and their caregivers, but we don't know how well ADHC capacity matches the distribution of PLWD. For this cross-sectional study, we identified community-dwelling PLWD using Medicare claims, and ADHC capacity using licensure data. We aggregated both features by Hospital Service Area. By linear regression, we determined the association between ADHC capacity and community-dwelling PLWD. We identified 3836 community-dwelling Medicare beneficiaries living with dementia. We included 28 ADHCs, with licensed capacity for 2127 clients. The linear regression coefficient (95% Confidence Interval) for number of community-dwelling beneficiaries with dementia was 1.07 (0.6-1.53). Rhode Island's ADHC capacity distribution roughly approximates the distribution of persons with dementia. Plans for the future of dementia care in Rhode Island should consider these findings.
Distribution of Adult Day Health Centers and Persons Living with Dementia Among Hospital Service Areas in Rhode Island
INTRODUCTION: Adult day health centers (ADHCs) provide an important service to community-dwelling adults with functional dependency. This includes persons living with dementia (PLWD) and their caregivers, but we don't know how well ADHC capacity matches the distribution of PLWD. METHODS: For this cross-sectional study, we identified community-dwelling PLWD using Medicare claims, and ADHC capacity using licensure data. We aggregated both features by Hospital Service Area. By linear regression, we determined the association between ADHC capacity and community-dwelling PLWD. RESULTS: We identified 3836 community-dwelling Medicare beneficiaries living with dementia. We included 28 ADHCs, with licensed capacity for 2127 clients. The linear regression coefficient (95% Confidence Interval) for number of community-dwelling beneficiaries with dementia was 1.07 (0.6-1.53). DISCUSSION: Rhode Island's ADHC capacity distribution roughly approximates the distribution of persons with dementia. Plans for the future of dementia care in Rhode Island should consider these findings.
Examination of Staffing Shortages at US Nursing Homes During the COVID-19 Pandemic
Importance Staffing shortages have been widely reported in US nursing homes during the COVID-19 pandemic, but traditional quantitative research analyses have found mixed evidence of staffing shortfalls. Objective To examine whether nursing home administrator perspectives can provide context for conflicting aggregate staffing reports in US nursing homes during the COVID-19 pandemic. Design, Setting, and Participants In a qualitative study, convergent mixed-methods analysis integrating qualitative and quantitative data sets was used. Semistructured qualitative interviews were conducted between July 14, 2020, and December 16, 2021. Publicly available national Payroll Based Journal data were retrieved from January 1, 2020, to September 30, 2022, on 40 US nursing homes in 8 health care markets that varied by region and nursing home use patterns. Staffing and resident measures were derived from Payroll Based Journal data and compared with national trends for 15 436 US nursing homes. Nursing home administrators were recruited for interviews. Of the 40 administrators who consented to participate, 4 were lost to follow-up. Exposure Four repeated, semistructured qualitative interviews with participants were conducted. Interview questions focused on the changes noted during the COVID-19 pandemic in nursing homes. Main Outcomes and Measures Thematic description of nursing home administrator compensatory strategies to provide context for quantitative analyses on nursing home staffing levels during the COVID-19 pandemic. Results A total of 156 interviews were completed with 40 nursing home administrators. Administrators reported experiencing staff shortages during the COVID-19 pandemic and using compensatory strategies, such as overtime, cross-training, staff-to-resident ratio adjustments, use of agency staff, and curtailing admissions, to maintain operations and comply with minimum staffing regulations. Payroll Based Journal data measures graphed from January 1, 2020, to September 30, 2022, supported administrator reports showing that study facilities had reductions in staff hours, increased use of agency staff, and decreased resident census. Findings were similar to national trends. Conclusions and Relevance In this qualitative, convergent mixed-methods study, nursing home administrators reported the major staffing strain they experienced at their facilities and the strategies they used to offset staffing shortages. Their experiences provide context to quantitative analyses on aggregate nursing home census data. The short-term compensatory measures administrators used to comply with regulations and maintain operations may be detrimental to the long-term stability of this workforce.
Association Between the Patient Driven Payment Model and Therapy Utilization and Patient Outcomes in US Skilled Nursing Facilities
In October 2019, Medicare changed its skilled nursing facility (SNF) reimbursement model to the Patient Driven Payment Model (PDPM), which has modified financial incentives for SNFs that may relate to therapy use and health outcomes. To assess whether implementation of the PDPM was associated with changes in therapy utilization or health outcomes. This cross-sectional study used a regression discontinuity (RD) approach among Medicare fee-for-service postacute-care patients admitted to a Medicare-certified SNF following hip fracture between January 2018 and March 2020. Skilled nursing facility admission after PDPM implementation. Main outcomes were individual and nonindividual (concurrent and group) therapy minutes per day, hospitalization within 40 days of SNF admission, SNF length of stay longer than 40 days, and discharge activities of daily living score. The study cohort included 201 084 postacute-care patients (mean [SD] age, 83.8 [8.3] years; 143 830 women [71.5%]; 185 854 White patients [92.4%]); 147 711 were admitted pre-PDPM, and 53 373 were admitted post-PDPM. A decrease in individual therapy (RD estimate: -15.9 minutes per day; 95% CI, -16.9 to -14.6) and an increase in nonindividual therapy (RD estimate: 3.6 minutes per day; 95% CI, 3.4 to 3.8) were observed. Total therapy use in the first week following admission was about 12 minutes per day (95% CI, -13.3 to -11.3) (approximately 13%) lower for residents admitted post-PDPM vs pre-PDPM. No consistent and statistically significant discontinuity in hospital readmission (0.31 percentage point increase; 95% CI, -1.46 to 2.09), SNF length of stay (2.7 percentage point decrease in likelihood of staying longer than 40 days; 95% CI, -4.83 to -0.54), or functional score at discharge (0.04 point increase in activities of daily living score; 95% CI, -0.19 to 0.26) was observed. Nonindividual therapy minutes were reduced to nearly zero in late March 2020, likely owing to COVID-19-related restrictions on communal activities in SNFs. In this cross-sectional study of SNF admission after PDPM implementation, a reduction of total therapy minutes was observed following the implementation of PDPM, even though PDPM was designed to be budget neutral. No significant changes in postacute outcomes were observed. Further study is needed to understand whether the PDPM is associated with successful discharge outcomes.