Computer delivered intervention for alcohol and sexual risk reduction among women attending an urban sexually transmitted infection clinic: A randomized controlled trial.

OBJECTIVE: We sought to determine if a computer delivered brief alcohol intervention (CBI) with or without interactive voice response counseling and text messages (CBI-IVR-TM), reduced alcohol use and sexual risk behaviors compared to attention control. METHODS: We conducted a 3-arm RCT among women (n = 439) recruited from Baltimore City Sexually Transmitted Infection (STI) Clinics. Eligibility included: 1) consumption of >7 drinks per week or 2) ≥2 episodes of heavy episodic drinking or ≥2 episodes of sex under the influence of alcohol in the prior three months. Research assessments conducted at baseline, 3, 6 and 12 months included a 30-day Timeline Followback querying daily alcohol use, drug use, and sexual activity. We used the MINI International Neuropsychiatric Interview-DSM-IV to ascertain drinking severity. Primary alcohol outcomes included: drinking days, heavy drinking days, drinks per drinking day. Secondary sexual risk outcomes included number of sexual partners, days of condomless sex, and days of condomless sex under the influence of drugs and alcohol. RESULTS: Median age was 31 (IQR 25-44 years), 88% were African American, 65% reported current recreational drug use, and 26% endorsed depressive symptoms. On the MINI 66% met criteria for alcohol use disorder (49% alcohol dependence, 18% abuse). At follow-up, all three groups reduced drinking days, heavy drinking days, drinks per drinking day and drinks per week with no significant differences between study arms. There was no difference in sexual risk outcomes among the groups. CONCLUSIONS:  Among women attending an urban STI clinic single session CBI with or without IVR and text message boosters was insufficient to reduce unhealthy alcohol use or sexual risk behaviors beyond control. The high severity of alcohol use and the prevalence of mental health symptoms and other substance use comorbidity underscores the importance of developing programs that address not only alcohol use but other determinants of STI risk among women.

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research.

BACKGROUND: Mobile health (mHealth) apps can provide support to people living with a chronic disease by offering resources for communication, self-management, and social support. PositiveLinks (PL) is a clinic-deployed mHealth app designed to improve the health of people with HIV. In a pilot study, PL users experienced considerable improvements in care engagement and viral load suppression. To promote its expansion to other HIV clinics, we developed an implementation strategy consisting of training resources and on-demand program support. OBJECTIVE: The objective of our study was to conduct an interim analysis of the barriers and facilitators to PL implementation at early adopting sites to guide optimization of our implementation strategy. METHODS: Semistructured interviews with stakeholders at PL expansion sites were conducted. Analysis of interviews identified facilitators and barriers that were mapped to 22 constructs of the Consolidated Framework for Implementation Research (CFIR). The purpose of the analysis was to identify the facilitators and barriers to PL implementation in order to adapt the PL implementation strategy. Four Ryan White HIV clinics were included. Interviews were conducted with one health care provider, two clinic managers, and five individuals who coordinated site PL activities. RESULTS: Ten common facilitators and eight common barriers were identified. Facilitators to PL implementation included PL's fit with patient and clinic needs, PL training resources, and sites' early engagement with their information technology personnel. Most barriers were specific to mHealth, including access to Wi-Fi networks, maintaining patient smartphone access, patient privacy concerns, and lack of clarity on how to obtain approvals for mHealth use. CONCLUSIONS: The CFIR is a useful framework for evaluating mHealth interventions. Although PL training resources were viewed favorably, we identified important barriers to PL implementation in a sample of Ryan White clinics. This enabled our team to expand guidance on identifying information technology stakeholders and procuring and managing mobile resources. Ongoing evaluation results continue to inform improvements to the PL implementation strategy, facilitating PL access for future expansion sites.

Toward understanding the impact of mHealth features for people with HIV: a latent class analysis of PositiveLinks usage.

PositiveLinks (PL) is a multi-feature smartphone-based platform to improve engagement-in-care and viral suppression (VS) among clinic patients living with HIV. Features include medication reminders, mood/stress check-ins, a community board, and secure provider messaging. Our goal was to examine how PL users interact with the app and determine whether usage patterns correlate with clinical outcomes. Patients (N = 83) at a university-based Ryan White clinic enrolled in PL from June 2016 to March 2017 and were followed for up to 12 months. A subset (N = 49) completed interviews after 3 weeks of enrollment to explore their experiences with and opinions of PL. We differentiated PL members based on 6-month usage of app features using latent class analysis. We explored characteristics associated with class membership, compared reported needs and preferences by class, and examined association between class and VS. The sample of 83 PL members fell into four classes. "Maximizers" used all app features frequently (27%); "Check-in Users" tended to interact only with daily queries (22%); "Moderate All-Feature Users" used all features occasionally (33%); and "As-Needed Communicators" interacted with the app minimally (19%). VS improved or remained high among all classes after 6 months. VS remained high at 12 months among Maximizers (baseline and 12-month VS: 100%, 94%), Check-in Users (82%, 100%), and Moderate All-Feature Users (73%, 94%) but not among As-Needed Communicators (69%, 60%). This mixed-methods study identified four classes based on PL usage patterns that were distinct in characteristics and clinical outcomes. Identifying and characterizing mHealth user classes offers opportunities to tailor interventions appropriately based on patient needs and preferences as well as to provide targeted alternative support to achieve clinical goals.

Estimating the prevalence of and characteristics associated with prescription opioid diversion among a clinic population living with HIV: Indirect and direct questioning techniques.

BACKGROUND: Evidence suggests that over 50 % of individuals who used prescription opioids non-medically obtained their prescription from friends or family. Despite its high consequence, reliable opioid diversion prevalence estimates are lacking due to social desirability bias. We used indirect questioning, a technique designed to measure sensitive behaviors, to assess the prevalence of prescription opioid diversion among a cohort of individuals with HIV. METHODS: We randomized 581 participants from a large urban HIV clinical cohort to answer either a direct or indirect question about opioid diversion between October 2016-July 2018. We estimated the prevalence of diversion under each method. We also estimated diversion prevalence in subsets of the sample by age, sex, race, HIV risk group, substance use, and mental health co-morbidities. RESULTS: Of 1,285 patients screened, 581 (45.2 %) reported ever having received an opioid prescription. Of these, 252 (43.4 %) directly answered whether they had ever diverted opioids and 313 (53.9 %) answered the indirect question. The prevalence of opioid diversion under direct and indirect questioning was 6.3 % (95 % CI 3.7 %-10.1 %) and 15.3 % (95 % CI 10.4 %-20.3 %), respectively. In unadjusted analyses, males, non-African Americans, and patients with a history of illicit drug use had a higher diversion prevalence. In adjusted analyses, ever having used cocaine was most associated with diversion (OR 15.67, 95 % CI 0.93-263.17). CONCLUSIONS: Opioid diversion was common among this population, with the estimated prevalence more than doubling under the indirect questioning method designed to elicit less biased responses.

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care.

BACKGROUND: PositiveLinks (PL) is a smartphone-based platform designed in partnership with people living with HIV (PLWH) to improve engagement in care. PL provides daily medication reminders, check-ins about mood and stress, educational resources, a community message board, and an ability to message providers. The objective of this study was to evaluate the impact of up to 24 months of PL use on HIV viral suppression and engagement in care and to examine whether greater PL use was associated with improved outcomes. SETTING: This study occurred between September 2013 and March 2017 at a university-based Ryan White HIV clinic. METHODS: We assessed engagement in care and viral suppression from study baseline to the 6-, 12-, 18- and 24-month follow-up time periods and compared trends among high vs. low PL users. We compared time to viral suppression, proportion of days virally suppressed, and time to engagement in care in patients with high vs. low PL use. RESULTS: 127 patients enrolled in PL. Engagement in care and viral suppression improved significantly after 6 months of PL use and remained significantly improved after 24 months. Patients with high PL use were 2.09 (95% CI 0.64-6.88) times more likely to achieve viral suppression and 1.52 (95% CI 0.89-2.57) times more likely to become engaged in care compared to those with low PL use. CONCLUSION: Mobile technology, such as PL, can improve engagement in care and clinical outcomes for PLWH. This study demonstrates long-term acceptability of PL over two years and provides evidence for long-term improvement in engagement in care and viral suppression associated with PL use.

Disparities in Hepatitis C Linkage to Care in the Direct Acting Antiviral Era: Findings From a Referral Clinic With an Embedded Nurse Navigator Model.

Background: Direct acting antivirals (DAAs) have simplified and expanded access to Hepatitis C virus (HCV) treatment. Only 17% of the 2.4 million Americans with HCV have linked to HCV care. We aimed to evaluate linkage to care (LTC) in a non-urban HCV referral clinic with a nurse navigator model and identify disparities in LTC. Methods: A single-center retrospective cohort analysis was performed among all patients referred to an infectious diseases HCV clinic between 2014 and 2018. The primary outcome was LTC, defined as attendance at a clinic appointment. A multivariable Poisson regression model estimated the association of variables with LTC. Results: Among 824 referred patients, 624 (76%) successfully linked to care and 369 (45%) successfully achieved sustained virologic response. Forty-six percent of those referred were uninsured. On multivariable analysis, LTC rates were higher among women (Incidence Rate Ratio [IRR] 1.11, 95% CI 1.03-1.20, p-value = 0.01) and people with cirrhosis (IRR 1.20, 95% CI 1.11-1.30, p-value < 0.001). Lower LTC rates were found for young people (<40 years; IRR 0.88, 95% CI 0.79-0.98, p-value = 0.02) and uninsured people (IRR 0.85, 95% CI 0.77-0.94, p-value = 0.002). Among those without LTC, 10% were incarcerated. Race, proximity to care, substance use, and HIV status were not associated with LTC. Conclusions: Using an embedded nurse navigator model, high LTC rates were achieved despite the prevalence of barriers, including a high uninsured rate. Disparities in LTC based on age, sex, and insurance status are present. Substance use was not associated with LTC. Future interventions to improve care should include expanded access to insurance and programs bridging care for incarcerated populations.

An application of restricted mean survival time in a competing risks setting: comparing time to ART initiation by injection drug use.

BACKGROUND: Restricted mean survival time (RMST) is an underutilized estimand in time-to-event analyses. Herein, we highlight its strengths by comparing time to (1) all-cause mortality and (2) initiation of antiretroviral therapy (ART) for HIV-infected persons who inject drugs (PWID) and persons who do not inject drugs. METHODS: RMST to death was determined by integrating the Kaplan-Meier survival curve to 5 years of follow-up. To account for the competing risks of death and loss-to-clinic when estimating time to ART, we calculated RMST to ART initiation by estimating the area between the survival curve for ART initiation and the cumulative incidence curve for death or loss-to-clinic. We standardized all curves using inverse probability of exposure weights. RESULTS: We followed 3044 HIV-positive, ART-naive persons from enrollment into the Johns Hopkins HIV Clinical Cohort from 1996 to 2014. PWID had a - 0.19 year (95% confidence interval (CI): - 0.29, - 0.10) difference in survival over 5 years of follow-up compared to persons who did not inject drugs. There was no difference between the two groups in time not on ART while alive and in clinic (RMST difference = 0.08, 95% CI: -0.10, 0.36). CONCLUSIONS: PWID have similar expected time to ART initiation after properly accounting for their greater risk of death and loss-to-clinic.

High-Risk Prescription Opioid Use Among People Living With HIV.

BACKGROUND: Prescription opioid use is greater among people living with HIV (PLWH), yet little is known about the prevalence of specific types of high-risk use among these individuals. SETTING: We analyzed clinical and demographic data from the HIV Research Network and prescribing data from Medicaid for noncancer patients seeking HIV treatment at 4 urban clinics between 2006 and 2010. METHODS: HIV Research Network patients were included in the analytic sample if they received at least one incident opioid prescription. We examined 4 measures of high-risk opioid use: (1) high daily dosage; (2) early refills; (3) overlapping prescriptions; and (4) multiple prescribers. RESULTS: Of 4605 eligible PLWH, 1814 (39.4%) received at least one incident opioid prescription during follow-up. The sample was 61% men and 62% African American with a median age of 44.5 years. High-risk opioid use occurred among 30% of incident opioid users (high daily dosage: 7.9%; early refills: 15.9%; overlapping prescriptions: 16.4%; and multiple prescribers: 19.7%). About half of the cumulative incidence of high-risk use occurred within 1 year of receiving an opioid prescription. After adjusting for study site, high-risk opioid use was greater among patients with injection drug use as an HIV risk factor [adjusted hazard ratio (aHR) = 1.39, 95% confidence interval: 1.11 to 1.74], non-Hispanic whites [aHR = 1.61, (1.21 to 2.14)], patients age 35-45 [aHR = 1.94, (1.33 to 2.80)] and 45-55 [aHR = 1.84, (1.27 to 2.67)], and patients with a diagnosis of chronic pain [aHR = 1.32, (1.03 to 1.70)]. CONCLUSIONS: A large proportion of PLWH received opioid prescriptions, and among these opioid recipients, high-risk opioid use was common. High-risk use patterns often occurred within the first year, suggesting this is a critical time for intervention.

Health-related quality-of-life scores, spine-related symptoms, and reoperations in young adults 7 to 17 years after surgical treatment of adolescent idiopathic scoliosis.

The goal of surgical treatment of adolescent idiopathic scoliosis (AIS) is to prevent disability associated with curve progression. Few investigators have considered whether the function of patients with AIS becomes adversely affected by major spine fusion surgery. Tertiary referral center patients (age, 10-17 years) who underwent spinal deformity correction a minimum of 5 years earlier were identified. Scoliosis Research Society-22R (SRS-22R) and Short Form-12 (SF-12) were administered. Data were available for 118 patients. Mean age was 14.1 years at surgery and 26.8 years at follow-up. Mean outcome scores were 50.9 (SF-12 physical composite summary), 49.4 (SF-12 mental composite summary), and 4.0 (SRS-22R total). One hundred patients (85%) were working. Common symptoms included occasional back pain (90, 76%), limited range of motion (52, 44%), activity limitations (54, 46%), waistline imbalance (41, 35%), rib prominence (28, 24%), wound/scar problems (18, 15%), and shortness of breath (18, 15%). Prominent implants were reported by 11 patients (9%). Seven of 14 reoperations were for instrumentation removal. There was a high incidence of occasional back pain and activity complaints after surgery for AIS in our cohort. However, normal SF-12 scores suggested that these symptoms did not lower the patients' general health.

Blood salvage produces higher total blood product costs in single-level lumbar spine surgery.

STUDY DESIGN: Retrospective review. OBJECTIVE: To determine the incremental cost-effectiveness of cell saver for single-level posterior lumbar decompression and fusion (PLDF). SUMMARY OF BACKGROUND DATA: Intraoperative cell salvage is used during surgery to reduce the need for perioperative allogeneic blood transfusion. Although the use of cell saver may be beneficial in certain circumstances, its utility has not been clearly established for the common procedure of an adult single-level PLDF. METHODS: Randomly selected adult patients treated with a single-level PLDF between July 2010 and June 2011 at a single institution were identified. Patients who had a combined anterior and posterior approach were excluded. The final study sample for analysis consisted of 180 patients. Hospital records were reviewed to determine whether: (1) cell saver was available during surgery, (2) recovered autologous blood was infused, and (3) the patient received intra- or postoperative allogeneic transfusions. Estimated blood loss, levels fused, volume(s) transfused, and all related complications were recorded. Costs included the cost of allogeneic blood transfusion, setting up the cell saver recovery system, and infusing autologous blood from cell saver, whereas effectiveness measures were allogeneic blood transfusions averted and quality adjusted life years. RESULTS: The incremental cost-effectiveness ratio was $55,538 per allogeneic transfusion averted, with a decrease in the transfusion rate from 40.0% to 38.7% associated with the cell saver approach. This translated into an incremental cost-effectiveness ratio of $5,555,380 per quality adjusted life years gained, which is well above the threshold for an intervention to be considered cost-effective ($100,000 per quality adjusted life years gained). CONCLUSION: The use of cell saver during a single-level PLDF does not significantly reduce the need for allogeneic blood transfusion and is not cost-effective. The high cost of cell saver in combination with the low complication rate of allogeneic blood transfusion, suggest that cell saver should not be used for single-level PLDF. Further studies are needed to evaluate the necessity for cell saver among other types of spinal surgery.

Predictive factors for the use of autologous cell saver transfusion in lumbar spinal surgery.

STUDY DESIGN: Retrospective review. OBJECTIVE: To identify risk factors for cell saver transfusion in lumbar spinal surgery and determine if cell saver transfusions affected intraoperative or postoperative transfusion rates. SUMMARY OF BACKGROUND DATA: Cell saver has been used to minimize allogeneic blood transfusion in lumbar spinal surgery. Conflicting reports exist, which call into question the efficacy of cell saver use. METHODS: We reviewed medical records of randomly selected patients who underwent posterolateral fusion with or without transforaminal interbody fusion from July 2010 to June 2011. Transfusion rates and transfusion-related complications were determined. Binary logistic regression was performed to identify risk factors for use of autologous cell saver transfusion. RESULTS: There were 178 females and 107 males, with a mean age of 57.2 years. Of the 285 cases, 39 had no cell saver available, 147 had cell saver available but no autologous blood was recovered or transfused and 99 had an autologous cell saver transfusion. Patients who had cell saver transfusion had a higher rate of intraoperative allogeneic blood transfusion (52%) compared with those who did not (22%). There was no significant difference in the rate of postoperative transfusions or transfusion-related reactions between patients who did and did not have cell saver transfusion. Patient's age, smoking status, American Society of Anesthesiologists grade, use of anticoagulants preoperatively, primary or revision surgery, iliac crest bone graft harvest, anesthesiologist, or surgeon had no significant effect on cell saver infusion. Body mass index (odds ratio [OR] = 1.06), number of posterolateral fusion levels fused (OR = 2.50), and number of transforaminal interbody fusions performed (OR = 2.41) were independent risk factors for the use of autologous cell saver transfusion. CONCLUSION: Body mass index, multi-level fusion and transforaminal interbody fusion result in increased use of autologous cell saver transfusion in lumbar spinal surgery. Use of autologous cell saver transfusion did not reduce the requirement for intraoperative or postoperative allogeneic blood transfusion. LEVEL OF EVIDENCE: 2.

Differentiating minimum clinically important difference for primary and revision lumbar fusion surgeries.

OBJECT: Previous studies have reported on the minimum clinically important difference (MCID), a threshold of improvement that is clinically relevant for lumbar degenerative disorders. Recent studies have shown that pre- and postoperative health-related quality of life (HRQOL) measures vary among patients with different diagnostic etiologies. There is also concern that a patient's previous care experience may affect his or her perception of clinical improvement. This study determined if MCID values for the Oswestry Disability Index (ODI), 36-Item Short-Form Health Survey (SF-36), and back and leg pain are different between patients undergoing primary or revision lumbar fusion. METHODS: Prospectively collected preoperative and 1-year postoperative patient-reported HRQOLs, including the ODI, SF-36 physical component summary (PCS), and numeric rating scales (0-10) for back and leg pain, in patients undergoing lumbar spine fusion were analyzed. Patients were grouped into either the primary surgery or revision group. As the most widely accepted MCID values were calculated from the minimum detectable change, this method was used to determine the MCID. RESULTS: A total of 722 patients underwent primary procedures and 333 patients underwent revisions. There was no statistically significant difference in demographics between the groups. Each group had a statistically significant improvement at 1 year postoperatively compared with baseline. The minimum detectable change-derived MCID values for the primary group were 1.16 for back pain, 1.36 for leg pain, 12.40 for ODI, and 5.21 for SF-36 PCS. The MCID values for the revision group were 1.21 for back pain, 1.28 for leg pain, 11.79 for ODI, and 4.90 for SF-36 PCS. These values are very similar to those previously reported in the literature. CONCLUSIONS: The MCID values were similar for the revision and primary lumbar fusion groups, even when subgroup analysis was done for different diagnostic etiologies, simplifying interpretation of clinical improvement. The results of this study further validate the use of patient-reported HRQOLs to measure clinical effectiveness, as a patient's previous experience with care does not seem to substantially alter an individual's perception of clinical improvement.

SF-6D values stratified by specific diagnostic indication.

STUDY DESIGN: Longitudinal cohort. OBJECTIVE: To present Oswestry Disability Index scores and SF-6D utility values among patients with different diagnostic etiologies who underwent fusion surgery. SUMMARY OF BACKGROUND DATA: Several studies have increased our understanding of health-related quality-of-life measures in patients with low back pain. With rising health care costs, cost-utility analysis is increasingly used by decision makers. Thus, clinicians and researchers need to understand the psychometrics and clinical importance of health state utility values in patients with spine disorders. METHODS: A total of 1104 patients who had decompression and lumbar fusion with complete data to compute the SF-6D score at baseline and 2-year follow-up were identified. Primary surgical cases were classified as disc pathology (n = 200), spondylolisthesis (n = 288), instability (n = 43), stenosis (n = 134), or scoliosis (n = 44). Revision cases were classified as nonunion (n = 94), adjacent-level degeneration (n = 98), or postdiscectomy revision (n = 203). Baseline SF-6D and change in SF-6D scores at 2 years were compared among the groups as well as primary versus revision cases. RESULTS: There were 674 women and 430 men. The mean age at surgery was 56.65 ± 12.7 years. There were 220 (19.9%) smokers. The worst mean baseline SF-6D score was in patients with nonunion (0.492), followed by disc pathology (0.493), adjacent-level degeneration (0.494), postdiscectomy revision (0.499), stenosis (0.504), instability (0.512), spondylolisthesis (0.520), and scoliosis (0.530). There was a statistically significant difference in baseline SF-6D score among the different groups (P = 0.002). The mean change in SF-6D score was greatest in patients with stenosis (0.088), followed by spondylolisthesis (0.085), scoliosis (0.076), disc pathology (0.076), instability (0.073), postdiscectomy revision (0.070), adjacent-level degeneration (0.066), and nonunion (0.050). There was no statistically significant difference in change in SF-6D score among the different groups (P = 0.096). However, revision cases had statistically significantly smaller gains in SF-6D score (0.064) than primary cases (0.082, P = 0.012). CONCLUSION: Patients with lumbar degenerative disorders have health state values similar to patients with chronic renal disease, Crohn's disease, or coronary artery disease. Health state values of patients with different indications for surgery differ at baseline and after surgery. Revision cases have worse baseline SF-6D scores and less improvement in scores at 2 years after surgery than primary cases. Further studies are needed to gain a greater understanding of health state utility values in patients with lumbar degenerative disorders.