Comparison of an automated smartphone-based smoking cessation intervention versus standard quitline-delivered treatment among underserved smokers: protocol for a randomized controlled trial.

BACKGROUND: Smoking is the leading cause of preventable morbidity and mortality in the United States. Individuals with low socioeconomic status have disproportionately high smoking rates and greater difficulty quitting smoking. Efficiently connecting underserved smokers to effective tobacco cessation programs is crucial for disease prevention and the elimination of health disparities. Smartphone-based interventions have the potential to enhance the reach and efficacy of smoking cessation treatments targeting underserved smokers, but there is little efficacy data for these interventions. In this study, we will partner with a large, local hunger-relief organization to evaluate the efficacy and economic impact of a theoretically-based, fully-automated, and interactive smartphone-based smoking cessation intervention. METHODS: This study will consist of a 2-group randomized controlled trial. Participants (N = 500) will be recruited from a network of food distribution centers in West Central Florida and randomized to receive either Standard Treatment (ST, n = 250) or Automated Treatment (AT, n = 250). ST participants will be connected to the Florida Quitline for telephone-based treatment and will receive a 10-week supply of nicotine replacement therapy (NRT; transdermal patches and lozenges). AT participants will receive 10 weeks of NRT and a fully-automated smartphone-based intervention consisting of interactive messaging, images, and audiovisual clips. The AT intervention period will span 26 weeks, with 12 weeks of proactive content and 26 weeks of on-demand access. ST and AT participants will complete weekly 4-item assessments for 26 weeks and 3-, 6-, and 12-month follow-up assessments. Our primary aim is to evaluate the efficacy of AT in facilitating smoking abstinence. As secondary aims, we will explore potential mediators and conduct economic evaluations to assess the cost and/or cost-effectiveness of ST vs. AT. DISCUSSION: The overall goal of this project is to determine if AT is better at facilitating long-term smoking abstinence than ST, the more resource-intensive approach. If efficacy is established, the AT approach will be relatively easy to disseminate and for community-based organizations to scale and implement, thus helping to reduce tobacco-related health disparities. TRIAL REGISTRATION: Clinical Trials Registry NCT05004662 . Registered August 13, 2021.

Meta-Analysis of Quality of Life in Cancer Patients Treated With Immune Checkpoint Inhibitors.

BACKGROUND: Trials of immune checkpoint inhibitors (ICIs) have published patient-reported quality of life (QOL), but the size and heterogeneity of this literature can make patient education difficult. This meta-analysis aimed to describe change in QOL and symptomatology in patients receiving ICIs for cancer. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, databases were searched through November 2019 for articles or abstracts of prospective, original studies reporting longitudinal QOL in adult cancer patients treated with ICIs. The prespecified primary outcomes were change in global QOL among patients treated with ICIs and difference in change since baseline in global QOL between patients treated with ICI vs non-ICI active treatment. Secondary outcomes included physical functioning and symptomatology. All statistical tests were 2-sided. RESULTS: Of 20 323 publications, 26 met inclusion criteria. Global QOL did not change over time in patients treated with ICIs (k = 26, n = 6974; P = .19). Larger improvements in global QOL was observed in patients receiving ICI vs non-ICI regimens (k = 16, ICI: n = 3588; non-ICI: n = 2948; P < .001). Physical functioning did not change in patients treated with ICIs (k = 14, n = 3169; P = .47); there were no differences in mean change between ICI vs non-ICI regimens (k = 11, n = 4630; P = .94). Regarding symptoms, appetite loss, insomnia, and pain severity decreased, but dyspnea severity increased in patients treated with ICIs (k = 14, n = 3243-3499; P < .001). Insomnia severity was higher in patients treated with ICIs than non-ICI regimens (k = 11, n = 4791; P < .001). CONCLUSIONS: This study is among the first to quantitatively summarize QOL in patients treated with ICIs. Findings suggest ICI recipients report no change in global QOL and higher QOL than patients treated with non-ICI regimens.

HIV Risk Behaviors and Utilization of Prevention Services, Urban and Rural Men Who Have Sex with Men in the United States: Results from a National Online Survey.

Rural men who have sex with men (MSM) are heavily affected by HIV, and many lack culturally competent HIV prevention resources. Rural MSM may find sexual partners on the internet, which may also be a way to deliver prevention services to them. To understand the differences between rural and urban MSM with respect to HIV risk factors and behaviors and the utilization of online HIV prevention services, we used data from the 2012 Web-Based HIV Behavioral Survey (WHBS). Using WHBS data collected between June and August 2012, we compared the characteristics of MSM with positive or unknown HIV infection status who had sex with a male in the past 12 months, from rural vs urban areas using Chi square tests and median tests. We used logistic regression and calculated adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) to compare self-reported HIV risk behaviors, HIV/STI testing behaviors, use of prevention services, and perceived discrimination. Of the 8166 MSM included in our analysis, 3583 (44%) were from rural areas, and 4583 (56%) were from urban areas. Compared to urban MSM, rural MSM were less likely to ever test for HIV (aPR = 0.94, CI 0.92-0.95), to be tested for HIV in the last year (aPR = 0.83, CI 0.79-0.87), or to receive free condoms (aPR = 0.83, CI 0.79-0.86) or individual prevention counseling in the past year (aPR = 0.86, CI 0.78-0.95). Rural MSM were less likely to have been tested in the last year for syphilis, gonorrhea, or chlamydia (aPR = 0.70, CI 0.62-0.78; aPR = 0.72, CI 0.64-0.81; aPR = 0.75, CI 0.67-0.85, respectively). Rural MSM also reported perceiving less tolerance of gays and bisexuals within their community (aPR = 0.80, CI 0.77-0.84). HIV prevalence is lower among MSM in rural areas compared to MSM in urban areas, but rural MSM report that they are more likely to face intolerance and are less likely to use basic HIV prevention services compared to urban MSM. Therefore, this hard-to-reach population could benefit from prevention services offered through the internet.

Sexually Transmitted Disease Testing and Uptake of Human Papillomavirus Vaccine in a Large Online Survey of US Men Who Have Sex With Men at Risk for HIV Infection, 2012.

National guidelines recommend annual human immunodeficiency virus (HIV)/sexually transmitted disease testing for sexually active men who have sex with men (MSM) and vaccination against human papillomavirus for MSM through age 26. A 2012 online survey of 2,794 MSM found that 51%, 36%, and 14% reported receiving human immunodeficiency virus testing, sexually transmitted disease testing, and human papillomavirus vaccination, respectively.

Association Between Enacted Stigma and HIV-Related Risk Behavior Among MSM, National HIV Behavioral Surveillance System, 2011.

MSM bear a disproportionate burden of the HIV epidemic. Enacted stigma (overt negative actions) against sexual minorities may play an important role in increasing HIV risk among this population. Using data from the 2011 National HIV Behavioral Surveillance system, MSM cycle, we examined the independent associations between three measures of enacted stigma (verbal harassment, discrimination, physical assault) and engagement in each of four HIV-related risk behaviors as outcomes: condomless anal intercourse (CAI) at last sex with a male partner of HIV discordant or unknown status and, in the past 12 months, CAI with a male partner, ≥4 male sex partners, and exchange sex. Of 9819 MSM, 32% experienced verbal harassment in the past 12 months, 23% experienced discrimination, and 8% experienced physical assault. Discordant CAI at last sex with a male partner was associated with previous discrimination and physical assault. Past 12 month CAI with a male partner, ≥4 male sex partners, and exchange sex were each associated with verbal harassment, discrimination, and physical assault. These findings indicate that a sizable proportion of MSM report occurrences of past 12 month enacted stigma and suggest that these experiences may be associated with HIV-related risk behavior. Addressing stigma towards sexual minorities must involve an integrated, multi-faceted approach, including interventions at the individual, community, and societal level.

High HIV incidence and prevalence and associated factors among young MSM, 2008.

OBJECTIVE: To estimate HIV prevalence, annual HIV incidence density, and factors associated with HIV infection among young MSM in the United States. DESIGN: The 2008 National HIV Behavioral Surveillance System (NHBS), a cross-sectional survey conducted in 21 US cities. METHODS: NHBS respondents included in the analysis were MSM aged 18-24 with a valid HIV test who reported at least one male sex partner in the past year. We calculated HIV prevalence and estimated annual incidence density (number of HIV infections/total number of person-years at risk). Generalized estimating equations were used to determine factors associated with testing positive for HIV. RESULTS: Of 1889 young MSM, 198 (10%) had a positive HIV test; of these, 136 (69%) did not report previously testing HIV positive when interviewed. Estimated annual HIV incidence density was 2.9%; incidence was highest for blacks. Among young MSM who did not report being HIV infected, factors associated with testing HIV positive included black race; less than high school education; using both alcohol and drugs before or during last sex; having an HIV test more than 12 months ago; and reporting a visit to a medical provider in the past year. CONCLUSION: HIV prevalence and estimated incidence density for young MSM were high. Individual risk behaviors did not fully explain HIV risk, emphasizing the need to address sociodemographic and structural-level factors in public health interventions targeted toward young MSM.

Performance of premarket rapid hepatitis C virus antibody assays in 4 national human immunodeficiency virus behavioral surveillance system sites.

SUMMARY: Performance characteristics of rapid assays for hepatitis C virus antibody were evaluated in 4 National HIV Behavioral Surveillance System injection drug use sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira and OraSure tests were 94.0%, 78.9%, and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. BACKGROUND: The Centers for Disease Control and Prevention (CDC) estimates that 4.1 million Americans have been infected with hepatitis C virus (HCV) and 75%-80% of them are living with chronic HCV infection, many unaware of their infection. Persons who inject drugs (PWID) account for 57.5% of all persons with HCV antibody (anti-HCV) in the United States. Currently no point-of-care tests for HCV infection are approved for use in the United States. METHODS: Surveys and testing for human immunodeficiency virus (HIV) and anti-HCV were conducted among persons who reported injection drug use in the past 12 months as part of the National HIV Behavioral Surveillance System in 2009. The sensitivity and specificity of point-of-care tests (finger-stick and 2 oral fluid rapid assays) from 3 manufacturers (Chembio, MedMira, and OraSure) were evaluated in field settings in 4 US cities. RESULTS: Sensitivity (78.9%-97.4%) and specificity (80.0%-100.0%) were variable across assays and sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira, and OraSure tests were 94.0%, 78.9% and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. In multivariate analysis, false-negative anti-HCV results were associated with HIV positivity for the Chembio oral assay (adjusted odds ratio, 8.4-9.1; P < .01) in 1 site (New York City). CONCLUSIONS: Sensitive rapid anti-HCV assays are appropriate and feasible for high-prevalence, high-risk populations such as PWID, who can be reached through social service settings such as syringe exchange programs and methadone maintenance treatment programs.

Implementation of rapid HIV testing programs in community and outreach settings: perspectives from staff at eight community-based organizations in seven U.S. cities.

OBJECTIVES: The goals of this research were to evaluate perceptions of staff about the effectiveness of methods used by eight community-based organizations (CBOs) to implement human immunodeficiency virus (HIV) counseling and rapid testing in community and outreach settings in seven U.S. cities, and to identify operational challenges. METHODS: A survey was administered to CBO staff to determine their perceptions about the effectiveness of methods used to select testing venues, promote their testing programs, recruit people for testing, provide test results, and link HIV-positive people to health care. Using a Likert scale, respondents rated the effectiveness of methods, their agreement with statements about using mobile testing units (MTUs) and rapid HIV test kits, and operational challenges. RESULTS: Most respondents perceived the methods they used for selecting testing venues, and particularly using recommendations from people receiving testing, to be effective. Most respondents also thought their promotional activities were effective. Respondents believed that using MTUs improved their capacity to reach high-risk individuals, but that MTUs were associated with substantial challenges (e.g., costs to purchase and maintain them). Programmatic challenges included training staff to provide counseling and testing, locating and providing confirmatory test results to people with reactive rapid tests, and sustaining testing programs. CONCLUSIONS: CBO staff thought the methods used to select venues for HIV testing were effective and that using MTUs increased their ability to provide testing to high-risk individuals. However, using MTUs was expensive and posed logistical difficulties. CBOs planning to implement similar programs should take these findings into consideration and pay particular attention to training needs and program sustainability.

Implementing rapid HIV testing in outreach and community settings: results from an advancing HIV prevention demonstration project conducted in seven U.S. cities.

OBJECTIVES: The goals of this project were to assess the feasibility of conducting rapid human immunodeficiency virus (HIV) testing in outreach and community settings to increase knowledge of HIV serostatus among groups disproportionately affected by HIV and to identify effective nonclinical venues for recruiting people in the targeted populations. METHODS: Community-based organizations (CBOs) in seven U.S. cities conducted rapid HIV testing in outreach and community settings, including public parks, homeless shelters, and bars. People with reactive preliminary positive test results received confirmatory testing, and people confirmed to be HIV-positive were referred to health-care and prevention services. RESULTS: A total of 23,900 people received rapid HIV testing. Of the 267 people (1.1%) with newly diagnosed HIV infection, 75% received their confirmatory test results and 64% were referred to care. Seventy-six percent were from racial/ethnic minority groups, and 58% identified themselves as men who have sex with men, 72% of whom reported having multiple sex partners in the past year. Venues with the highest proportion of new HIV diagnoses were bathhouses, social service organizations, and needle-exchange programs. The acceptance rate for testing was 60% among sites collecting this information. CONCLUSIONS: Findings from this demonstration project indicate that offering rapid HIV testing in outreach and community settings is a feasible approach for reaching members of minority groups and people at high risk for HIV infection. The project identified venues that would be important to target and offered lessons that could be used by other CBOs to design and implement similar programs in the future.