Faculty Bibliography

INTRODUCTION: Low rates of adherence to smoking cessation pharmacotherapy may limit the effectiveness of treatment. However, few studies have examined adherence in smoking cessation trials thus, there is a limited understanding of factors that influence adherence behaviors. This brief report analyzes correlates of adherence to varenicline among people living with HIV/AIDS. METHODS: Study participants were recruited from three HIV care centers in New York City and enrolled in a three-arm randomized controlled pilot study in which all subjects received varenicline. At the 1-month study visit, there were no significant differences in adherence by study condition, therefore we combined treatment arms to examine correlates of adherence (n = 127). We used pill counts to assess varenicline adherence, defined as taking at least 80% of the prescribed dose. We conducted a multivariate path analysis to assess factors proposed by the information-motivation-behavioral skills model to predict adherence. RESULTS: Only 56% of smokers were at least 80% adherent to varenicline at 1 month. Adherence-related information, self-efficacy, a college degree, and non-Hispanic white race/ethnicity were associated with increased varenicline adherence. In path analysis, information and motivation were associated with increased adherence self-efficacy, and adherence self-efficacy was associated with increased adherence, but with marginal significance. These associations with adherence were no longer significant after controlling for race/ethnicity and education. CONCLUSIONS: Further exploration of the role of a modifiable correlates of adherence, such as adherence-related information, motivation and self-efficacy is warranted. Interventions are needed that can address disparities in these and other psychosocial factors that may mediate poor medication adherence.

Many breast cancer survivors have coexistent chronic diseases or comorbidities at the time of their cancer diagnosis. The purpose of the study was to evaluate the association of comorbidities on breast cancer survivors' quality of life. A prospective design was used to recruit 140 women before cancer surgery, 134 women completed the study. Comorbidities were assessed using self-report and verified by medical record review and the Charlson Comorbidity Index (CCI) before and 12-month after cancer surgery. Quality of life was evaluated using Short-Form Health Survey (SF-36 v2). Descriptive statistics, chi-square tests, t-tests, Fisher's exact test, and correlations were performed for data analysis. A total of 28 comorbidities were identified. Among the 134 patients, 73.8% had at least one of the comorbidities, 54.7% had 2-4, and only 7.4% had 5-8. Comorbidities did not change at 12 months after surgery. Numbers of comorbidities by patients' self-report and weighted categorization of comorbidities by CCI had a similar negative correlation with overall quality of life scores as well as domains of general health, physical functioning, bodily pain, and vitality. Comorbidities, specifically hypertension, arthritis, and diabetes, were associated with poorer quality of life in multiple domains among breast cancer survivors. Future research should consider the combined influence of comorbidity and cancer on patients' quality of life.

BACKGROUND: Very brief single-item screening questions (SISQs) for alcohol and other drug use can facilitate screening in health care settings, but are not widely used. Self-administered versions of the SISQs could ease barriers to their implementation. OBJECTIVE: We sought to validate SISQs for self-administration in primary care patients. DESIGN: Participants completed SISQs for alcohol and drugs (illicit and prescription misuse) on touchscreen tablet computers. Self-reported reference standard measures of unhealthy use, and more specifically of risky consumption, problem use, and substance use disorders, were then administered by an interviewer, and saliva drug tests were collected. PARTICIPANTS: Adult patients aged 21-65 years were consecutively enrolled from two urban safety-net primary care clinics. MAIN MEASURES: The SISQs were compared against reference standards to determine sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for alcohol and drug use. KEY RESULTS: Among the 459 participants, 22 % reported unhealthy alcohol use and 25 % reported drug use in the past year. The SISQ-alcohol had sensitivity of 73.3 % (95 % CI 65.3-80.3) and specificity of 84.7 % (95 % CI 80.2-88.5), AUC = 0.79 (95 % CI 0.75-0.83), for detecting unhealthy alcohol use, and sensitivity of 86.7 % (95 % CI 75.4-94.1) and specificity of 74.2 % (95 % CI 69.6-78.4), AUC = 0.80 (95 % CI 0.76-0.85), for alcohol use disorder. The SISQ-drug had sensitivity of 71.3 % (95 % CI 62.4-79.1) and specificity of 94.3 % (95 % CI 91.3-96.6), AUC = 0.83 (95 % CI 0.79-0.87), for detecting unhealthy drug use, and sensitivity of 85.1 (95 % CI 75.0-92.3) and specificity of 88.6 % (95 % CI 85.0-91.6), AUC = 0.87 (95 % CI 0.83-0.91), for drug use disorder. CONCLUSIONS: The self-administered SISQs are a valid approach to detecting unhealthy alcohol and other drug use in primary care patients. Although self-administered SISQs may be less accurate than the previously validated interviewer-administered versions, they are potentially easier to implement and more likely to retain their fidelity in real-world practice settings.

BACKGROUND: Over 50,000 individuals become infected with HIV annually in the U.S, and over a quarter of HIV infected individuals are heterosexuals. Undiagnosed HIV infection, as well as a lack of retention in care among those diagnosed, are both primary factors contributing to ongoing HIV incidence. Further, there are racial/ethnic disparities in undiagnosed HIV and engagement in care, with African Americans/Blacks and Latinos remaining undiagnosed longer and less engaged in care than Whites, signaling the need for culturally targeted intervention approaches to seek and test those with undiagnosed HIV infection, and link them to care with high retention. METHODS/DESIGN: The study has two components: one to seek out and test heterosexuals at high risk for HIV infection, and another to link those found infected to HIV care with high retention. We will recruit sexually active African American/Black and Latino adults who have opposite sex partners, negative or unknown HIV status, and reside in locations with high poverty and HIV prevalence. The "Seek and Test" component will compare the efficacy and cost effectiveness of two strategies to uncover undiagnosed HIV infection: venue-based sampling and respondent-driven sampling (RDS). Among those recruited by RDS and found to have HIV infection, a "Treat and Retain" component will assess the efficacy of a peer-driven intervention compared to a control arm with respect to time to an HIV care appointment and health indicators using a cluster randomized controlled trial design to minimize contamination. RDS initial seeds will be randomly assigned to the intervention or control arm at a 1:1 ratio and all recruits will be assigned to the same arm as the recruiter. Participants will be followed for 12 months with outcomes assessed using medical records and biomarkers, such as HIV viral load. DISCUSSION: Heterosexuals do not test for HIV as frequently as and are diagnosed later than other risk groups. The study has the potential to contribute an efficient, innovative, and sustainable multi-level recruitment approach and intervention to the HIV prevention portfolio. Because the majority of heterosexuals at high risk are African American/Black or Latino, the study has great potential to reduce racial/ethnic disparities in HIV/AIDS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01607541 , Registered May 23, 2012.

BACKGROUND: Substance use screening is widely encouraged in healthcare settings, but the lack of a screening approach that fits easily into clinical workflows has restricted its broad implementation. The Substance Use Brief Screen (SUBS) was developed as a brief, self-administered instrument to identify unhealthy use of tobacco, alcohol, illicit drugs, and prescription drugs. We evaluated the validity and test-retest reliability of the SUBS in adult primary care patients. METHODS: Adults age 18-65 were enrolled from urban safety net primary care clinics to self-administer the SUBS using touch-screen tablet computers for a test-retest reliability study (n=54) and a two-site validation study (n=586). In the test-retest reliability study, the SUBS was administered twice within a 2-week period. In the validation study, the SUBS was compared to reference standard measures, including self-reported measures and saliva drug tests. We measured test-retest reliability and diagnostic accuracy of the SUBS for detection of unhealthy use and substance use disorder for tobacco, alcohol, and drugs (illicit and prescription drug misuse). RESULTS: Test-retest reliability was good or excellent for each substance class. For detection of unhealthy use, the SUBS had sensitivity and specificity of 97.8% (95% CI 93.7 to 99.5) and 95.7% (95% CI 92.4 to 97.8), respectively, for tobacco; and 85.2% (95% CI 79.3 to 89.9) and 77.0% (95% CI 72.6 to 81.1) for alcohol. For unhealthy use of illicit or prescription drugs, sensitivity was 82.5% (95% CI 75.7 to 88.0) and specificity 91.1% (95% CI 87.9 to 93.6). With respect to identifying a substance use disorder, the SUBS had sensitivity and specificity of 100.0% (95% CI 92.7 to 100.0) and 72.1% (95% CI 67.1 to 76.8) for tobacco; 93.5% (95% CI 85.5 to 97.9) and 64.6% (95% CI 60.2 to 68.7) for alcohol; and 85.7% (95% CI 77.2 to 92.0) and 82.0% (95% CI 78.2 to 85.3) for drugs. Analyses of area under the receiver operating curve (AUC) indicated good discrimination (AUC 0.74-0.97) for all substance classes. Assistance in completing the SUBS was requested by 11% of participants. CONCLUSIONS: The SUBS was feasible for self-administration and generated valid results in a diverse primary care patient population. The 4-item SUBS can be recommended for primary care settings that are seeking to implement substance use screening.

BACKGROUND AND OBJECTIVES: Promoted globally as an evidence-based intervention in the prevention of HIV and treatment of heroin addiction among people who inject drugs (PWID), opioid substitution treatment (OST) can help control emerging HIV epidemics among PWID. With implementation in December 2014, Kenya is the third Sub-Saharan African country to have introduced OST. We combine dynamic mathematical modelling with qualitative sociological research to examine the 'promise of methadone' to Kenya. METHODS, SETTING AND PARTICIPANTS: We model the HIV prevention impact of OST in Nairobi, Kenya, at different levels of intervention coverage. We draw on thematic analyses of 109 qualitative interviews with PWID, and 43 with stakeholders, to chart their narratives of expectation in relation to the promise of methadone. RESULTS: The modelled impact of OST shows relatively slight reductions in HIV incidence (5-10%) and prevalence (2-4%) over 5 years at coverage levels (around 10%) anticipated in the planned roll-out of OST. However, there is a higher impact with increased coverage, with 40% coverage producing a 20% reduction in HIV incidence, even when accounting for relatively high sexual transmissions. Qualitative findings emphasise a culture of 'rationed expectation' in relation to access to care and a 'poverty of drug treatment opportunity'. In this context, the promise of methadone may be narrated as a symbol of hope-both for individuals and community-in relation to addiction recovery. CONCLUSIONS: Methadone offers HIV prevention potential, but there is a need to better model the effects of sexual HIV transmission in mediating the impact of OST among PWID in settings characterised by a combination of generalised and concentrated epidemics. We find that individual and community narratives of methadone as hope for recovery coexist with policy narratives positioning methadone primarily in relation to HIV prevention. Our analyses show the value of mixed methods approaches to investigating newly-introduced interventions.

Aims: Implementation of substance use screening in general medical settings is hindered by the lack of a brief yet precise and comprehensive screening tool that is compatible with clinical workflows. To address this need, we developed the Substance Use Brief Screen (SUBS); a 4-item screener for tobacco, alcohol, and drug use (illicit and prescription) that is self-administered and may be easily integrated with electronic health records. Methods: Adult patients were recruited consecutively in the waiting area of an urban safety net primary care clinic. The SUBS was self-administered in English on touchscreen tablet computers. Reference standard measures of unhealthy substance use and substance use disorders were then administered, including self reported measures and saliva drug tests. The SUBS was compared against the reference standards to determine its sensitivity, specificity, and area under the curve (AUC) for each substance class. Results: Among the 390 participants, rates of past year use reported on the SUBS were 37% tobacco, 43% alcohol (4+ drinks/day), 20% illicit drugs, and 12% prescription drugs. Sensitivity and specificity of the SUBS for detecting past year unhealthy use were: tobacco 99% and 91% (AUC = .95); alcohol 94% and 68% (AUC = .81); drugs (illicit or prescription) 84% and 89% (AUC = .86). Sensitivity was lower for prescription drugs (57%) than for illicit drugs (78%). For detecting a substance use disorder, sensitivity and specificity were: tobacco 100% and 73% (AUC = .87); alcohol 93% and 64% (AUC = .79); drugs 85% and 82% (AUC = .84). Conclusions: The SUBS accurately identified unhealthy tobacco, alcohol, and drug use in this primary care sample, and had high sensitivity but lower specificity for identifying substance use disorders. Individuals screening positive on the SUBS should receive further assessment. Our findings support use of the SUBS for substance use screening in primary care, but additional tools may be needed for prescription drugs

BACKGROUND: In light of the current sentencing disparity (18:1) between crack and powder cocaine possession in the United States, we examined socioeconomic correlates of use of each, and relations between use and arrest, to determine who may be at highest risk for arrest and imprisonment. METHODS: We conducted secondary data analyses on the National Survey on Drug Use and Health, 2009-2012. Data were analyzed for adults age >/=18 to determine associations between use and arrest. Socioeconomic correlates of lifetime and annual use of powder cocaine and of crack were delineated using multivariable logistic regression and correlates of frequency of recent use were examined using generalized negative binomial regression. RESULTS: Crack users were at higher risk than powder cocaine users for reporting a lifetime arrest or multiple recent arrests. Racial minorities were at low risk for powder cocaine use and Hispanics were at low risk for crack use. Blacks were at increased risk for lifetime and recent crack use, but not when controlling for other socioeconomic variables. However, blacks who did use either powder cocaine or crack tended to use at higher frequencies. Higher education and higher family income were negatively associated with crack use although these factors were sometimes risk factors for powder cocaine use. CONCLUSIONS: Crack users are at higher risk of arrest and tend to be of lower socioeconomic status compared to powder cocaine users. These findings can inform US Congress as they review bills (e.g., The Smarter Sentencing Act), which would help eliminate cocaine-related sentencing disparities.

African American/Black and Hispanic persons living with HIV/AIDS ("AABH-PLHA") are under-represented in HIV/AIDS medical studies (HAMS). This paper evaluates the efficacy of a social/behavioral intervention to increase rates of screening for and enrollment into HAMS in these populations. Participants (N = 540) were enrolled into a cluster randomized controlled trial of an intervention designed to overcome multi-level barriers to HAMS. Primary endpoints were rates of screening for and enrollment into therapeutic/treatment-oriented and observational studies. Intervention arm participants were 30 times more likely to be screened than controls (49.3 % vs. 3.7 %; p < .001). Half (55.5 %) of those screened were eligible for HAMS, primarily observational studies. Nine out of ten found eligible enrolled (91.7 %), almost all into observational studies (95.2 %), compared to no enrollments among controls. Achieving appropriate representation of AABH-PLHA in HAMS necessitates modification of study inclusion criteria to increase the proportion found eligible for therapeutic HAMS, in addition to social/behavioral interventions.