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Integrated Stepped Alcohol Treatment With Contingency Management for Unhealthy Alcohol Use Among People With HIV: A Randomized Controlled Trial
Edelman, E Jennifer; Dziura, James; Deng, Yanhong; DePhilippis, Dominick; Ferguson, Tekeda; Brown, Sheldon; Marconi, Vincent C; Goetz, Matthew Bidwell; Rodriguez-Barradas, Maria C; Simberkoff, Michael S; Molina, Patricia E; Weintrob, Amy C; Maisto, Stephen A; Paris, Manuel; Justice, Amy C; Bryant, Kendall J; Fiellin, David A
BACKGROUND:We examined the impact of integrated stepped alcohol treatment with contingency management (ISAT + CM) on alcohol abstinence among people with HIV (PWH) and unhealthy alcohol use. METHODS:In this multisite 24-week trial, we randomized PWH reporting untreated unhealthy alcohol use and with phosphatidylethanol (PEth) >20 ng/mL to receive ISAT+CM or treatment as usual (TAU). Intervention : Step 1 : Social worker-delivered CM; Step 2 : Addiction physician management plus motivational enhancement therapy. Participants were advanced to step 2 at week 12 if they lacked evidence of abstinence over the prior 21 days. TAU : Health handout, and for those who met criteria for alcohol use disorder, a referral to substance use treatment. Primary outcome: self-reported abstinence for the past 21 days at week 24. RESULTS:We enrolled 120 PWH between January 5, 2018, and March 1, 2022. Mean age was 59 years, 96% were men, and 83% were Black. Eight percent were lost to follow-up. In the ISAT+CM group, 87% were advanced to Step 2. The posterior mean proportion of participants with self-reported abstinence at 24 weeks was higher among those randomized to ISAT+CM [posterior mean proportion 9% (95% credible interval [CrI]: 0%-33%)] compared with TAU [posterior mean proportion 0.3% (95% CrI: 0%-4%)] [posterior mean treatment effect 9%, (95% CrI: 0%-32%)], the posterior probability of TAU being superior to ISAT + CM was <0.0001. DISCUSSION/CONCLUSIONS:ISAT + CM delivered in HIV clinics modestly increased self-reported 3-week abstinence among PWH. Our findings indicate a need for more effective treatments to promote abstinence and a potential role for ISAT + CM for reductions in alcohol use. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov (NCT03089320).
PMID: 39321757
ISSN: 1944-7884
CID: 5763282
Perspectives on contingency management for alcohol use and alcohol-associated conditions among people in care with HIV
Cohen, Shawn M; DePhilippis, Dominick; Deng, Yanhong; Dziura, James; Ferguson, Tekeda; Fucito, Lisa M; Justice, Amy C; Maisto, Stephen; Marconi, Vincent C; Molina, Patricia; Paris, Manuel; Rodriguez-Barradas, Maria C; Simberkoff, Michael; Petry, Nancy M; Fiellin, David A; Edelman, E Jennifer
BACKGROUND:Contingency management (CM) is an evidence-based approach for reducing alcohol use; however, its implementation into routine HIV primary care-based settings has been limited. We evaluated perspectives on implementing CM to address unhealthy alcohol use and associated conditions for people with HIV in primary care settings. METHODS:From May 2021 to August 2021, we conducted two focus groups with staff involved in delivering the intervention (n = 5 Social Workers and n = 4 Research Coordinators) and individual interviews (n = 13) with a subset of participants involved in the multi-site Financial Incentives, Randomization, and Stepped Treatment (FIRST) trial. Qualitative data collection and analyses were informed by the Promoting Action on Research Implementation in Health Service (PARIHS) implementation science framework, including evidence (perception of CM), context (HIV primary care clinic and CM procedures), and facilitation (feasibility outside the research setting). RESULTS:Several major themes were identified. Regarding the evidence, participants lacked prior experience with CM, but the intervention was well received and, by some, perceived to lead to lasting behavior change. Regarding the clinical context for the reward schedule, the use of biochemical testing, specifically fingerstick phosphatidylethanol testing, and the reward process were perceived to be engaging and gratifying for both staff and patients. Participants indicated that the intervention was enhanced by its co-location within the HIV clinic. Regarding facilitation, participants suggested addressing the intervention's feasibility for non-research use, simplifying the reward structure, and rewarding non-abstinence in alcohol use. CONCLUSIONS:Among patients and staff involved in a clinical trial, CM was viewed as a helpful, positive, and feasible approach to addressing unhealthy alcohol use and related conditions. To enhance implementation, future efforts may consider simplified approaches to the reward structure and expanding rewards to non-abstinent reductions in alcohol consumption.
PMCID:10828101
PMID: 37524371
ISSN: 2993-7175
CID: 5734882
Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial
Edelman, E Jennifer; Dziura, James; Deng, Yanhong; DePhilippis, Dominick; Fucito, Lisa M; Ferguson, Tekeda; Bedimo, Roger; Brown, Sheldon; Marconi, Vincent C; Goetz, Matthew Bidwell; Rodriguez-Barradas, Maria C; Simberkoff, Michael S; Molina, Patricia E; Weintrob, Amy C; Maisto, Stephen A; Paris, Manuel; Justice, Amy C; Bryant, Kendall J; Fiellin, David A
BACKGROUND:Although unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in treatment and experience variable responses to treatment. We describe the rationale, aims, and study design for the Financial Incentives, Randomization, with Stepped Treatment (FIRST) Trial, a multi-site randomized controlled efficacy trial. METHODS:PWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20 ng/mL, and were not engaged in formal alcohol treatment were randomized to integrated contingency management with stepped care versus treatment as usual. The intervention involved two steps; Step 1: Contingency management (n = 5 sessions) with potential rewards based on 1) short-term abstinence; 2) longer-term abstinence; and 3) completion of healthy activities to promote progress in addressing alcohol consumption or conditions potentially impacted by alcohol; Step 2: Addiction physician management (n = 6 sessions) plus motivational enhancement therapy (n = 4 sessions). Participants' treatment was stepped up at week 12 if they lacked evidence of longer-term abstinence. Primary outcome was abstinence at week 24. Secondary outcomes included alcohol consumption (assessed by TLFB and PEth) and the Veterans Aging Cohort Study (VACS) Index 2.0 scores; exploratory outcomes included progress in addressing medical conditions potentially impacted by alcohol. Protocol adaptations due to the COVID-19 pandemic are described. CONCLUSIONS:The FIRST Trial is anticipated to yield insights on the feasibility and preliminary efficacy of integrated contingency management with stepped care to address unhealthy alcohol use among PWH. CLINICALTRIALS:gov identifier: NCT03089320.
PMID: 37230168
ISSN: 1559-2030
CID: 5543872
Preschool-Aged Household Contacts as a Risk Factor for Viral Respiratory Infections in Healthcare Personnel
Most, Zachary M.; Nyquist, Ann Christine; Radonovich, Lewis J.; Rodriguez-Barradas, Maria C.; Price, Connie Savor; Simberkoff, Michael S.; Bessesen, Mary T.; Cummings, Derek A.T.; Rattigan, Susan M.; Warren-Gash, Charlotte; Gaydos, Charlotte A.; Gibert, Cynthia L.; Gorse, Geoffrey J.; Perl, Trish M.
Background: Viral respiratory infections (VRIs) are common and are occupational risks for healthcare personnel (HCP). VRIs can also be acquired at home and other settings among HCPs. We sought to determine if preschool-Aged household contacts are a risk factor for VRIs among HCPs working in outpatient settings. Methods: We conducted a secondary analysis of data from a cluster randomized trial at 7 medical centers in the United States over 4 influenza seasons from 2011-2012 to 2014-2015. Adult HCPs who routinely came within 6 feet of patients with respiratory infections were included. Participants were tested for respiratory viruses whenever symptomatic and at 2 random times each season when asymptomatic. The exposure of interest was the number of household contacts 0-5 years old (preschool-Aged) at the beginning of each HCP-season. The primary outcome was the rate of polymerase chain reaction-detected VRIs, regardless of symptoms. The VRI incidence rate ratio (IRR) was calculated using a mixed-effects Poisson regression model that accounted for clustering at the clinic level. Results: Among the 4476 HCP-seasons, most HCPs were female (85.4%) and between 30 and 49 years of age (54.6%). The overall VRI rate was 2.04 per 100 person-weeks. In the adjusted analysis, HCPs having 1 (IRR, 1.22 [95% confidence interval {CI}, 1.05-1.43]) and ≥2 (IRR, 1.35 [95% CI, 1.09-1.67]) preschool-Aged household contacts had higher VRI rates than those with zero preschool-Aged household contacts. Conclusions: Preschool-Aged household contacts are a risk factor for developing VRIs among HCPs working in outpatient settings.
SCOPUS:85159345982
ISSN: 2328-8957
CID: 5501682
Influence of Preseason Antibodies Against Influenza Virus on Risk of Influenza Infection Among Healthcare Personnel
Gorse, Geoffrey J; Rattigan, Susan M; Kirpich, Alexander; Simberkoff, Michael S; Bessesen, Mary T; Gibert, Cynthia; Nyquist, Ann-Christine; Price, Connie Savor; Gaydos, Charlotte A; Radonovich, Lewis J; Perl, Trish M; Rodriguez-Barradas, Maria C; Cummings, Derek A T
BACKGROUND:The association of hemagglutination inhibition (HAI) antibodies with protection from influenza among healthcare personnel (HCP) with occupational exposure to influenza viruses has not been well-described. METHODS:The Respiratory Protection Effectiveness Clinical Trial was a cluster-randomized, multisite study that compared medical masks to N95 respirators in preventing viral respiratory infections among HCP in outpatient healthcare settings for 5180 participant-seasons. Serum HAI antibody titers before each influenza season and influenza virus infection confirmed by polymerase chain reaction were studied over 4 study years. RESULTS:In univariate models, the risk of influenza A(H3N2) and B virus infections was associated with HAI titers to each virus, study year, and site. HAI titers were strongly associated with vaccination. Within multivariate models, each log base 2 increase in titer was associated with 15%, 26% and 33%-35% reductions in the hazard of influenza A(H3N2), A(H1N1), and B infections, respectively. Best models included preseason antibody titers and study year, but not other variables. CONCLUSIONS:HAI titers were associated with protection from influenza among HCP with routine exposure to patients with respiratory illness and influenza season contributed to risk. HCP can be reassured about receiving influenza vaccination to stimulate immunity.
PMID: 34534319
ISSN: 1537-6613
CID: 5189932
Risk Factors for Healthcare Personnel Infection with Endemic Coronaviruses (HKU1, OC43, NL63, 229E): Results from the Respiratory Protection Effectiveness Clinical Trial (ResPECT)
Cummings, Derek A T; Radonovich, Lewis J; Gorse, Geoffrey J; Gaydos, Charlotte A; Bessesen, Mary T; Brown, Alexandria C; Gibert, Cynthia L; Hitchings, Matthew D T; Lessler, Justin; Nyquist, Ann-Christine; Rattigan, Susan M; Rodriguez-Barradas, Maria C; Price, Connie Savor; Reich, Nicholas G; Simberkoff, Michael S; Perl, Trish M
BACKGROUND:SARS-CoV-2 presents a large risk to healthcare personnel. Quantifying the risk of coronavirus infection associated with workplace activities is an urgent need. METHODS:We assessed the association of worker characteristics, occupational roles and behaviors, and participation in procedures with the risk of endemic coronavirus infection among healthcare personnel who participated in the Respiratory Protection Effectiveness Trial (ResPECT), a cluster randomized trial to assess personal protective equipment to prevent respiratory infections and illness conducted from 2011 to 2016. RESULTS:Among 4,689 HCP-seasons, we detected coronavirus infection in 387 (8%). HCP who participated in an aerosol generation procedure (AGP) at least once during the viral respiratory season were 105% (95% CI 21%, 240%) more likely to be diagnosed with a laboratory-confirmed coronavirus infection. Younger individuals, those who saw pediatric patients and those with household members under the age of five were at increased risk of coronavirus infection. CONCLUSIONS:Our analysis suggests the risk of HCP becoming infected with an endemic coronavirus increases approximately two-fold with exposures to AGP. Our findings may be relevant to the Coronavirus Disease 2019 (COVID-19) pandemic; however, SARS-COV-2, the virus that causes COVID-19, may differ from endemic coronaviruses in important ways.
PMID: 32645144
ISSN: 1537-6591
CID: 4519002
Outpatient Healthcare Personnel Knowledge and Attitudes Towards Infection Prevention Measures for Protection from Respiratory Infections
Bessesen, Mary T; Rattigan, Susan; Frederick, John; Cummings, Derek A T; Gaydos, Charlotte A; Gibert, Cynthia L; Gorse, Geoffrey J; Nyquist, Ann-Christine; Price, Connie S; Reich, Nicholas G; Simberkoff, Michael S; Brown, Alexandria C; Radonovich, Lewis J; Perl, Trish M; Rodriguez-Barradas, Maria C
BACKGROUND:Healthcare personnel (HCP) knowledge and attitudes toward infection control measures are important determinants of practices that can protect them from transmission of infectious diseases. METHODS:Healthcare personnel were recruited from Emergency Departments and outpatient clinics at seven sites. They completed knowledge surveys at the beginning and attitude surveys at the beginning and end of each season of participation. Attitudes toward infection prevention and control measures, especially medical masks and N95 respirators, were compared. The proportion of participants who correctly identified all components of an infection control bundle for seven clinical scenarios was calculated. RESULTS:The proportion of participants in the medical mask group who reported at least one reason to avoid using medical masks fell from 88.5% on the pre-season survey to 39.6% on the post-season survey (odds ratio [OR] for preseason vs. postseason 0.11, 95% CI 0.10-0.14). Among those wearing N95 respirators, the proportion fell from 87.9% to 53.6% (OR 0.24, 95% CI 0.21-0.28). Participants correctly identified all components of the infection control bundle for 4.9% to 38.5% of scenarios. CONCLUSIONS:Attitudes toward medical masks and N95 respirators improved significantly between the beginning and end of each season. The proportion of HCP who correctly identified the infection control precautions needed for clinical scenarios was low, but it improved over successive years of participation in the study.
PMID: 34182066
ISSN: 1527-3296
CID: 4926312
Impact of mandatory vaccination of healthcare personnel on rates of influenza and other viral respiratory pathogens
Simberkoff, Michael S; Rattigan, Susan M; Gaydos, Charlotte A; Gibert, Cynthia L; Gorse, Geoffrey J; Nyquist, Ann-Christine; Price, Connie S; Reich, Nicholas; Rodriguez-Barradas, Maria C; Bessesen, Mary; Brown, Alexandria; Cummings, Derek A T; Radonovich, Lewis J; Perl, Trish M
OBJECTIVE:The implementation of mandatory influenza vaccination policies among healthcare personnel (HCP) is controversial. Thus, we examined the affect of mandatory influenza vaccination policies among HCP working in outpatient settings. SETTING/METHODS:Four Veterans' Affairs (VA) health systems and three non-VA medical centers. METHODS:We analyzed rates of influenza and other viral causes of respiratory infections among HCP working in outpatient sites at 4 VA health systems without mandatory influenza vaccination policies and 3 non-VA health systems with mandatory influenza vaccination policies. RESULTS:Influenza vaccination was associated with a decreased risk of influenza (odds ratio, 0.17; 95% confidence interval [CI], 0.13-0.22) but an increased risk of other respiratory viral infections (incidence rate ratio, 1.26; 95% CI, 1.02-1.57). CONCLUSIONS:Our fitted regression models suggest that if influenza vaccination rates in clinics where vaccination was not mandated had equalled those where vaccine was mandated, HCP influenza infections would have been reduced by 52.1% (95% CI, 51.3%-53.0%). These observations, their possible causes, and additional strategies to reduce influenza and other viral respiratory illnesses among HCP working in ambulatory clinics warrant further investigation.
PMID: 34350820
ISSN: 1559-6834
CID: 4972572
Take-home kits to detect respiratory viruses among healthcare personnel: Lessons learned from a cluster randomized clinical trial
Los, Jenna; Gaydos, Charlotte A; Gibert, Cynthia L; Gorse, Geoffrey J; Lykken, Jacquelyn; Nyquist, Ann-Christine; Price, Connie S; Radonovich, Lewis J; Rattigan, Susan; Reich, Nicholas; Rodriguez-Barradas, Maria; Simberkoff, Michael; Bessesen, Mary; Brown, Alexandria; Cummings, Derek A T; Perl, Trish M
BACKGROUND:Health care personnel (HCP) working in outpatient settings routinely interact with patients with acute respiratory illnesses. Absenteeism following symptom development and lack of staff trained to obtain samples limit efforts to identify pathogens among infected HCP. METHODS:The Respiratory Protection Effectiveness Clinical Trial assessed respiratory infection incidence among HCP between 2011 and 2015. Research assistants obtained anterior nasal and oropharyngeal swabs from HCP in the workplace following development of respiratory illness symptoms and randomly while asymptomatic. Participants received take-home kits to self-collect swabs when absent from work. Samples mailed to a central laboratory were tested for respiratory viruses by reverse transcription polymerase chain reaction. RESULTS:Among 2,862 participants, 3,467 swabs were obtained from symptomatic participants. Among symptomatic HCP, respiratory virus was detected in 904 of 3,467 (26.1%) samples. Self-collected samples by symptomatic HCP at home had higher rates of viral detection (40.3%) compared to 24% obtained by trained research assistants in the workplace (P < .001). CONCLUSIONS:In this randomized clinical trial, take-home kits were an easily implemented, effective method to self-collect samples by HCP. Other studies have previously shown relative equivalence of self-collected samples to those obtained by trained healthcare workers. Take-home kit self-collection could diminish workforce exposures and decrease the demand for personnel protective equipment worn to protect workers who collect respiratory samples.
PMCID:7874979
PMID: 33581146
ISSN: 1527-3296
CID: 4806512
Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial
Edelman, E Jennifer; Maisto, Stephen A; Hansen, Nathan B; Cutter, Christopher J; Dziura, James; Deng, Yanhong; Fiellin, Lynn E; O'Connor, Patrick G; Bedimo, Roger; Gibert, Cynthia L; Marconi, Vincent C; Rimland, David; Rodriguez-Barradas, Maria C; Simberkoff, Michael S; Tate, Janet P; Justice, Amy C; Bryant, Kendall J; Fiellin, David A
BACKGROUND:At-risk levels of alcohol use threaten the health of patients with HIV (PWH), yet evidence-based strategies to decrease alcohol use and improve HIV-related outcomes in this population are lacking. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among PWH and at-risk alcohol use. METHODS:In this multi-site, randomized trial conducted between January 28, 2013 through July 14, 2017, we enrolled PWH and at-risk alcohol use [defined as alcohol consumption of ≥ 14 drinks per week or ≥ 4 drinks per occasion in men ≤ 65 years old or ≥ 7 drinks per week or ≥ 3 drinks per occasion in women or men > 65 years old]. ISAT (n = 46) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 47) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat principles. RESULTS:Despite a multi-pronged approach, we only recruited 37% of the target population (n = 93/254). Among ISAT participants, 50% advanced to Step 2, among whom 57% advanced to Step 3. Participants randomized to ISAT and TAU had no observed difference in drinks per week over the past 30 days at week 24 (primary outcome) [least square means (Ls mean) (95% CI) = 8.8 vs. 10.6; adjusted mean difference (AMD) (95% CI) =  - 0.4 (- 3.9, 3.0)]. CONCLUSION/CONCLUSIONS:An insufficient number of patients were interested in participating in the trial. Efforts to enhance motivation of PWH with at-risk alcohol use to engage in alcohol-related research and build upon ISAT are needed. Trial registration Clinicaltrials.gov: NCT01410123, First posted August 4, 2011.
PMCID:7388231
PMID: 32727618
ISSN: 1940-0640
CID: 4540322