A Fall Prevention Feasibility Trial for People With HIV and Alcohol Use.

Alcohol contributes to higher fall risk in people living with HIV (PLWH), yet fall prevention trials for PWH with alcohol use are lacking. To assess the feasibility of conducting a randomized controlled trial of a 10-week online fall prevention intervention tailored for PLWH with alcohol use. The intervention consisted of weekly virtual group discussions, individual phone check-ins, and home exercises. Of those eligible, 53.5% (23/43) enrolled (12 to the intervention and 11 to control). Mean age was 58 years; 82.6% had a past 6-month fall; 65.2% had alcohol use disorder; and 95.7% completed postintervention assessments. The intervention was highly rated (Client Satisfaction Questionnaire-8 score M = 30.4, SD = 1.6) with a wide range of group and individual phone session attendance. Preliminary analyses suggest the intervention may reduce the odds of falling and alcohol use frequency. Findings support the feasibility of a larger randomized trial. ClinicalTrials.gov Identifier: NCT04804579.

A fall prevention feasibility trial for people with HIV and alcohol useAlcohol contributes to higher fall risk in people living with HIV (PLWH), yet fall prevention studies for PLWH with alcohol use are lacking. We conducted a 10-week online fall prevention intervention for PLWH (n = 23) with recent alcohol use to assess if the intervention was feasible and acceptable for PLWH. The intervention consisted of weekly virtual group discussions and individual phone check-ins with an occupational therapist and a customized home exercise program. The mean age was 58 years. Almost all fell in the past 6 months (82.6%), had impaired physical functioning (91.3%), and had alcohol use disorder (65.2%). Participants reported high intervention satisfaction. Preliminary analyses suggest that the intervention may reduce the odds of falling and alcohol use frequency. Findings support the feasibility of an online fall prevention intervention study for PLWH.

Heavy Alcohol Use and HIV Outcomes: The Moderating Role of Pain.

Pain and heavy alcohol consumption are prevalent among people living with HIV/AIDS (PLWH), each contributing to impaired functioning and diminished quality of life. Each of these conditions may have negative effects on the HIV care continuum, but less is known about their combined influences. The current study examined how heavy drinking and pain were associated with HIV viral suppression and CD4 cell count among participants receiving antiretroviral therapy (ART). The study sample consisted of 220 PLWH with past 12-month substance dependence or ever injection drug use enrolled in a large HIV cohort study. Logistic regression analyses showed an interaction between pain level (no/mild pain vs moderate/severe) and heavy drinking on viral suppression such that heavy drinking was a significant predictor of poorer viral suppression only for those who experienced moderate/severe pain. We also examined whether ART adherence differentially mediated the association between heavy drinking and HIV viral suppression by level of pain. Although there was a significant indirect effect of heavy drinking on viral suppression among those with moderate/severe pain, moderated mediational analyses did not indicate that the indirect effect of heavy drinking on viral suppression through ART adherence differed significantly by level of pain. Pain level did not significantly moderate the association between heavy drinking and CD4 cell count. We conclude that heavy drinking may be particularly likely to be associated with poorer HIV viral suppression among PLWH with moderate or severe pain. Providers should routinely address comorbid heavy drinking and pain to improve HIV outcomes.

Self-medication of pain and discomfort with alcohol and other substances by people with HIV infection and substance use disorder: preliminary findings from a secondary analysis.

There is a limited literature regarding factors associated with self-medication of pain and discomfort using alcohol, non-prescription substances or overuse of prescription medications among people living with Human Immunodeficiency Virus (HIV). This cross-sectional analysis used data from the Boston ARCH Cohort among participants with HIV infection and a history of alcohol or other substance use. Among 248 participants, 37% were female, 50% Black, 25% Latinx; 36% reported fair to poor health and 89% had CD4 cell counts >200/mm3. Half reported self-medication and of those, 8.8% reported doing so only with alcohol, 48.8% only with other substances and 42.4% with both alcohol and other substances. Those reporting self-medication were significantly (p < .05) younger (mean 47 vs 50 years), less employed (11% vs 21%), and less likely to have HIV viral suppression (60% vs. 80%). Depression, anxiety, and HIV symptoms were associated with significantly greater odds of self-medicating, as were substance dependence, recent injection substance use, heavy alcohol use, cocaine use, opioid use, sedative use, and cannabis use. Self-medication, highly prevalent and associated with worse mental health symptoms, greater substance use, and lesser HIV disease control, should be explored by HIV clinicians caring for people who use substances.

Alcohol Consumption and Illicit Drug Use: Associations With Fall, Fracture, and Acute Health Care Utilization Among People With HIV Infection.

BACKGROUND: Given alcohol and/or other drug (AOD) use occurs among people with HIV (PWH), we examined its association with falls and fall-related outcomes and whether frailty moderates the association. SETTING: Northeastern US city. METHODS: We analyzed an observational cohort of PWH with current or past AOD use. Alcohol measures were any past 14-day heavy use, average alcohol/day, and days with heavy use. Drug use measures were past 30-day illicit use of cocaine, opioids, and sedatives. Repeated cross-sectional associations were estimated with separate multivariable generalized estimating equation regression models for each fall-related outcome. RESULTS: Among PWH (n = 251; mean age 52 [SD = 10]), 35% reported heavy alcohol use, 24% cocaine, 16% illicit opioids, 13% illicit sedatives, and 35% any fall; 27% were frail. Heavy alcohol use was associated with a fall (AOR = 1.49, 95% CI: 1.08 to 2.07), multiple falls (AOR = 1.55 95% CI: 1.10 to 2.19), and fall/fracture-related emergency department visit or hospitalization (AOR = 1.81, 95% CI: 1.10 to 2.97). Higher average alcohol/day and more heavy drinking days were associated with multiple falls. Illicit sedative use was associated with a fall, multiple falls, and emergency department visit/hospitalization and opioid use with fracture. Frailty moderated the association of heavy alcohol use and a fall (AOR = 2.26, 95% CI: 1.28 to 4.01 in those frail) but not in those not frail. CONCLUSION: The effect of AOD use on falls and fall-related outcomes was most pronounced with alcohol, particularly among frail PWH. Heavy alcohol, illicit sedative, and illicit opioid use are high-priority targets for preventing falls and fall-related consequences for PWH.

Methamphetamine use and illicit opioid use during buprenorphine treatment.

Introduction: Although methamphetamine use is rising in the United States, its impacts on patient outcomes among persons undergoing treatment for opioid use disorder (OUD) remain unclear. This study aims to assess the association between baseline methamphetamine/amphetamine (MA/A) use and subsequent illicit opioid use among patients with OUD initiating buprenorphine in an office-based setting. Methods: We conducted a secondary analysis of a pilot randomized controlled trial of a behavioral mobile health intervention for buprenorphine adherence conducted over a 12-week study period at two clinic sites. The study defined baseline MA/A use by a positive urine drug test (UDT) and/or self-report of use within the past 30-days. Separate Poisson regression models with robust standard errors evaluated associations between MA/A and: i) illicit opioid use measured by weekly UDT (primary) and ii) self-reported past 30-day use at end of study (secondary). Other secondary outcomes included buprenorphine positive UDTs throughout the study and retention in OUD treatment at both weeks 12 and 24 post-randomization. Results: At baseline, 28 (36%) of the 78 participants had MA/A use and use was associated with a statistically significant increase in risk of testing positive for illicit opioids on UDT during the study follow-up period (adjusted relative risk (aRR)=1.54; 95% CI=1.09-2.17; p=0.015), as well as an increased risk for reported past 30-day illicit opioid use at week 12 (aRR=3.86; 95% CI=1.47-10.18; P=0.006). The study found no significant associations between MA/A use and buprenorphine positive UDT or retention in OUD treatment. Conclusions: In this sample of patients initiating buprenorphine, methamphetamine/amphetamine use at baseline was associated with illicit opioid use over a 12-week period. These findings demonstrate how co-use of methamphetamine can impede attainment of ideal OUD treatment outcomes.

Use of Video Directly Observed Therapy and Characteristics Associated With Use Among Patients Treated With Buprenorphine in an Office-based Setting.

OBJECTIVES: Video directly observed therapy (video DOT) is a tool for confirming buprenorphine adherence that could complement the use of urine toxicology; research is needed to characterize the patients who are receptive and able to use this technology. We aimed to describe video DOT utilization and assess participant characteristics associated with use. METHODS: We performed a secondary analysis of data from a pilot randomized controlled trial of adults who recently initiated sublingual buprenorphine in office-based programs, restricting to intervention arm participants, which consisted of 12 weeks of video DOT via a mobile health technology platform. Participants were instructed to record at least 1 daily video of buprenorphine self-administration. Poisson regression models with robust standard errors were used to measure associations between participant characteristics and frequency of submitted videos. RESULTS: The sample included 39 participants. Of 3276 possible videos, 1002 (31%) were submitted. Age ≥40 years (relative risk [RR], 2.54 [95% confidence interval {CI}, 1.31-4.91]) and once-daily buprenorphine dosing (RR, 3.10 [95% CI, 1.76-5.48]) were positively associated with video submissions. Non-White race (RR, 0.43 [95% CI, 0.19-0.97]), less than high school education (RR, 0.27 [95% CI, 0.10-0.74]), history of previous buprenorphine treatment (RR, 0.50 [95% CI, 0.25-0.97]), and ≥3 previous treatment attempts (RR, 0.16 [95% CI, 0.07-0.37]) were negatively associated. CONCLUSIONS: Video DOT utilization resulted in about a third of expected videos, although there were differences in use according to age, race, buprenorphine treatment factors, and educational status. Such differences underscore that mobile-health interventions such as video DOT may not be equally used by all patients.Trial Registration : ClinicalTrails.gov , NCT03779997 , registered on December 19, 2018.

Buprenorphine adherence and illicit opioid use among patients in treatment for opioid use disorder.

Background: Buprenorphine is a partial mu opioid agonist medication that has been shown to decrease non-prescribed opioid use, cravings, and opioid related morbidity and mortality. There is an assumption that full adherence is needed to achieve ideal treatment outcomes, and that non-adherence is associated with ongoing opioid use. However, literature documenting the strength of that assertion is lacking.Objectives: Evaluate the association between daily buprenorphine adherence and illicit opioid use.Methods: Secondary analysis of a 12-week randomized controlled trial of adults with opioid use disorder who recently initiated buprenorphine. Weekly study visits included self-report of daily buprenorphine adherence over the past 7 days (Timeline Follow Back method) and urine drug tests (UDT). A log-linear regression model accounting for clustering by participant was used to assess the association between buprenorphine adherence and illicit opioid use. Buprenorphine adherence was measured as a continuous variable (0-7 days).Results: Among 78 participants (56 men, 20 women, 2 nonbinary) with 737 visits, full 7-day adherence was reported at 70% of visits. The predominant form of non-adherence was missed doses (92% of cases). Each additional day of adherence was associated with an 8% higher rate of negative UDT for illicit opioids (RR = 1.08; 95% CI:1.03-1.13, p = .0002).Conclusion: In this sample of participants starting buprenorphine, missed doses were not uncommon. Fewer missed days was significantly associated with a lower risk of illicit opioid use. These findings suggest that efforts to minimize the number of missed days of buprenorphine are beneficial for treatment outcomes.

Impact of alcohol use disorder severity on human immunodeficiency virus (HIV) viral suppression and CD4 count in three international cohorts of people with HIV.

BACKGROUND: Alcohol use has been linked to worse human immunodeficiency virus (HIV) immunologic/virologic outcomes, yet few studies have explored the effects of alcohol use disorder (AUD). This study assessed whether AUD severity is associated with HIV viral suppression and CD4 count in the three cohorts of the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH) Consortium. METHODS: People with HIV (PWH) in Uganda (n = 301), Russia (n = 400), and Boston (n = 251), selected in-part based on their alcohol use, were included in analyses. Logistic and linear regressions were used to assess the cross-sectional associations between AUD severity (number of DSM-5 diagnostic criteria) and (1) HIV viral suppression, and (2) CD4 count (cells/mm3 ) adjusting for covariates. Analyses were conducted separately by site. RESULTS: The proportion of females was 51% (Uganda), 34% (Russia), and 33% (Boston); mean age (SD) was 40.7 (9.6), 38.6 (6.3), and 52.1 (10.5), respectively. All participants in Uganda and all but 27% in Russia and 5% in Boston were on antiretroviral therapy. In Uganda, 32% met criteria for AUD, 92% in Russia, and 43% in Boston. The mean (SD) number of AUD criteria was 1.6 (2.4) in Uganda, 5.6 (3.3) in Russia, and 2.4 (3.1) in Boston. Most participants had HIV viral suppression (Uganda 92%, Russia 57%, Boston 87%); median (IQR) CD4 count was 673 (506, 866), 351 (201, 542), and 591 (387, 881), respectively. In adjusted models, there were no associations between AUD severity and HIV viral suppression: adjusted odds ratios (AOR) (95%CI) per 1 additional AUD criterion in Uganda was 1.08 (0.87, 1.33); Russia 0.98 (0.92, 1.04); and Boston 0.95 (0.84, 1.08) or CD4 count: mean difference (95%CI) per 1 additional criterion: 5.78 (-7.47, 19.03), -3.23 (-10.91, 4.44), and -8.18 (-24.72, 8.35), respectively. CONCLUSIONS: In three cohorts of PWH, AUD severity was not associated with HIV viral suppression or CD4 count. PWH with AUD in the current era of antiretroviral therapy can achieve virologic control.

Post-traumatic stress disorder and risky opioid use among persons living with HIV and chronic pain.

Persons with HIV (PWH) experience chronic pain and Post-Traumatic Stress Disorder (PTSD) at higher rates than the general population, and more often receive opioid medications to treat chronic pain. A known association exists between PTSD and substance use disorders, but less is known about the relationship between PTSD and risky opioid use among PWH taking prescribed opioid medications. In this observational study of PWH on long-term opioid medications for pain we examined associations between PTSD symptom severity based on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5, response range 0-80) and the following outcomes: 1) risk for opioid misuse (COMM score ≥13); 2) risky alcohol use (AUDIT score ≥8); 3) concurrent benzodiazepine prescription; and 4) morphine equivalent dose. Among 166 patients, 38 (23%) had a PCL-5 score over 38, indicating high PTSD symptom burden. Higher PCL-5 score (per 10 point difference) was associated with increased odds of opioid misuse (aOR 1.55; 95%CI: 1.31-1.83) and risky drinking (aOR: 1.28;1.07-1.52). No significant association was observed between PCL-5 score and benzodiazepine prescriptions or morphine equivalent dose. These findings suggest that when addressing alcohol and opioid use in PWH on long term opioid therapy, attention to PTSD symptoms is especially important given the higher risk for risky alcohol and opioid use among patients with this common comorbid condition.

Study Protocol for a Pilot Randomized Trial of a Virtual Occupational Therapy Fall Prevention Intervention for People With HIV and Alcohol Use.

Background: People living with HIV (PLWH) are at risk for falls due to polypharmacy, unhealthy substance (risky alcohol and/or illicit drug) use, low physical activity, and frailty combined with typical age-related physical changes. Fall prevention is needed to reduce the morbidity related to falls and fractures, however, there is a paucity of data on the design of a fall prevention intervention and whether it can be delivered virtually. We describe the protocol of a pilot randomized trial of a virtual occupational therapy fall prevention intervention for people with HIV at high risk for falls and recent alcohol and/or drug use. Method: PLWH will be recruited from the Boston ARCH 4F Cohort study, an observational study of PLWH to examine the impact of alcohol on falls. Trial participants will be randomized to either an occupational therapy-led fall prevention intervention or provided with written education about fall prevention and alcohol use (control). The 10-week fall prevention intervention was based upon results from qualitative interviews with PLWH about falls and will consist of weekly virtual group sessions, home exercises and phone-check-ins, delivered by occupational therapists. The primary outcome measures will be number of groups attended and a participant-completed satisfaction survey. Change in number of falls, alcohol and other drug use, and physical functioning will be examined. Discussion: A virtual occupational therapy fall prevention intervention addresses the emerging concern of fall risk in PLWH and alcohol use. This pilot study will provide preliminary estimates of fall-related outcomes as well as feasibility of study procedures for a larger trial. ClinicalTrialsgov Identifier: NCT04804579. Boston University Protocol Record H-41041.

Alcohol and falls among people with HIV infection: A view from Russia and the United States.

BACKGROUND: Both human immunodeficiency virus (HIV) infection and alcohol use predispose to autonomic/sensory neuropathy, imbalance symptoms, and cognitive impairment-conditions associated with a greater risk of falls-yet it is unclear how to identify people with HIV (PWH) whose drinking is associated with falls. Research on alcohol and falls using the same instruments in different countries could help to specify the level of alcohol use associated with fall risk. We examined whether a consumption-based measure (the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]) and/or a symptom-based measure (DSM-5 criteria for alcohol use disorder [AUD]) are associated with sustaining a fall among PWH in St Petersburg, Russia and Boston, Massachusetts in the United States. METHODS: Separate multivariate logistic regressions were used for each cohort to examine cross-sectional associations for each alcohol measure predicting fall. Potential confounders included physical functioning, depressive symptoms, and other substance use (measured with the Addiction Severity Index). RESULTS: A fall was reported by 35% (87/251) of the sample in Boston and 12% (46/400) in St Petersburg. Each additional AUD criterion-but not higher AUDIT-C score-was significantly associated with a fall in both Boston (odds ratio [OR] = 1.10; 95% confidence interval [CI] 1.02, 1.18) and St Petersburg (adjusted OR AOR = 1.10; 95% CI 1.02, 1.18). Heavy alcohol use (>6 drinks/occasion, any vs. none) was associated with more than twice the odds of a fall (AOR = 2.24; 95% CI 1.21, 4.13) in Boston. CONCLUSIONS: These findings suggest that while fall risk may vary by setting and population, heavy alcohol use and AUD symptom severity are potential targets for interventions to prevent falls. Studies in diverse global settings advance our understanding of the relationship between alcohol and falls in PWH.

Functional Impairment and Cognitive Symptoms Among People with HIV Infection on Chronic Opioid Therapy for Pain: The Impact of Gabapentin and Other Sedating Medications.

Gabapentin is associated with dizziness, falls, and somnolence yet commonly prescribed to people with HIV (PWH) treated with chronic opioid therapy (COT). Physical function and cognition are understudied when prescribed together. Among PWH on COT, we evaluated whether co-prescribed gabapentin is associated with (a) functional impairment; (b) trouble thinking clearly; and (c) difficulty controlling drowsiness using logistic regression models adjusted for prescribed opioid dose, other (non-gabapentin) sedating medication, substance use disorder, and mental/physical health indicators in a cross-sectional study. Among 166 participants, 40% were prescribed gabapentin, 41% reported functional impairment, 41% trouble thinking clearly, and 38% difficulty controlling drowsiness. Gabapentin co-prescribed with COT was significantly associated with trouble thinking clearly but not with functional impairment or difficulty controlling drowsiness. Clinicians should be cognizant of potential problems with thinking clearly when co-prescribing gabapentin and opioid medication.

Bridge clinic implementation of "72-hour rule" methadone for opioid withdrawal management: Impact on opioid treatment program linkage and retention in care.

BACKGROUND: Methadone for opioid use disorder (OUD) treatment is restricted to licensed opioid treatment programs (OTPs) with substantial barriers to entry. Underutilized regulations allow non-OTP providers to administer methadone for opioid withdrawal for up to 72 h while arranging ongoing care. Our low-barrier bridge clinic implemented a new pathway to treat opioid withdrawal and facilitate OTP linkage utilizing the "72-hour rule." METHODS: Patients presenting to a hospital-based bridge clinic were evaluated for OUD, opioid withdrawal, and treatment goals. Eligible patients were offered methadone opioid withdrawal management with rapid OTP referral. OTPs accepted patients as direct admissions. We described bridge clinic patients who received at least one dose of methadone between March-August 2021 and key clinical outcomes including OTP referral completion within 72 h. For the subset of patients referred to our two primary OTP partners, we described OTP linkage (i.e., attended at least one OTP visit within one month) and OTP retention at one month. RESULTS: Methadone was administered during 150 episodes of care for 142 unique patients, the majority of whom were male (73%), white (67%), and used fentanyl (85%). In 92% of episodes (138/150), a plan for ongoing care was in place within 72 h. Among 121 referrals to two primary OTP partners, 87% (105/121) linked and 58% (70/121) were retained at one month. CONCLUSIONS: Methadone administration for opioid withdrawal with direct OTP admission under the "72-hour rule" is feasible in an outpatient bridge clinic and resulted in high OTP linkage and 1-month retention rates. This model has the potential to improve methadone access.

Prevalence and Correlates of Positive Follow-up Screens in Primary Care for Unhealthy Alcohol and Other Drug Use After a Negative Screen.

OBJECTIVE: To determine the proportion and characteristics of adults in primary care (PC) who screen positive for unhealthy substance use (SU) (alcohol and/or other drug) 1 year or more after screening negative. METHODS: Screening consisted of single-item questions for unhealthy use of alcohol and other drugs (illicit drugs and prescription medications). Health educators conducted in-person screening of patients presenting for a PC appointment. SU severity (low, moderate, high) was assessed with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Multivariate logistic regression models estimated predictors of a positive follow-up screen. RESULTS: Among 9215 patients who previously screened negative, 237 (2.6%) screened positive for unhealthy SU (42% alcohol only, 43% other drug only, 15% alcohol and other drug). The mean interval between screens was 19 months. Most alcohol use was low risk (ASSIST score ≤10) (81%), whereas most drug use was moderate risk (ASSIST score 4-26) (77%). Patients between ages of 18 to 25 had a higher proportion of positive follow-up screens (7.4% [33/ 443]) as well as those with a self-identified history of SU problems (9.4% [40/421]). Patients with a higher odds of a positive follow-up screen were male (adjusted odds ratio [AOR] 2.64; 95% CI: 2.02-3.45), used tobacco (AOR 2.38; 95% CI: 1.75-3.23), had a longer interval between screenings (AOR 3.26; 95% CI: 1.84-5.75). CONCLUSIONS: Screening for unhealthy SU 1 year or more after screening negative identified additional patients at-risk. These findings highlight the need to empirically determine the incremental benefits of screening all PC patients annually.

Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial.

BACKGROUND: We conducted a pilot study to assess feasibility of using video directly-observed therapy (DOT) for patients initiating buprenorphine to evaluate whether it is associated with better opioid use disorder (OUD) outcomes when compared to treatment-as-usual (TAU). METHODS: Pilot randomized controlled trial of adult patients with OUD initiating buprenorphine treatment (n = 78) at two sites (Seattle, WA and Boston, MA) from January 2019 to May 2020. Intervention was video DOT using a HIPAA-compliant smartphone application to record taking daily buprenorphine. Study smartphones, text reminders to upload a video, and calendar summaries of video DOT adherence were provided. Main outcomes were 1) percentage of 12 weekly urine drug tests (UDT) negative for illicit opioids and 2) engagement in treatment at week 12 (i.e., having an active prescription for buprenorphine within the last 7 days). RESULTS: Of 78 enrolled, 20 (26 %) were female; 29 (37 %) non-white; and 31 (40 %) homeless. The mean (standard deviation) percentage of doses confirmed by video was 31 % (34 %). In intention-to-treat analysis, the average percentage of weekly opioid negative UDT was 50 % (95 % CI: 40-63 %) in the intervention arm versus 64 % (95 % CI: 55-74 %) among controls; RR = 0.78 (95 % CI: 0.60-1.02, p = 0.07). Engagement at week 12 was 69 % (95 % CI: 56-86 %) v. 82 % (95 % CI: 71-95 %) in the intervention vs. TAU arms, respectively; RR = 0.84 (95 % CI: 0.65-1.10, p = 0.20). CONCLUSIONS: The video DOT intervention did not result in improvements in illicit opioid use and treatment engagement compared to TAU. The study was limited by low rates of intervention use. TRIAL REGISTRATION: ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

Naloxone receipt and overdose prevention care among people with HIV on chronic opioid therapy.

This cross-sectional study describes naloxone rescue kit receipt among people with HIV (PWH) on chronic opioid therapy (COT) and HIV clinician opioid overdose prevention care in two clinics between 2015 and 2017. Naloxone rescue kit receipt was uncommon. History of overdose was associated with receiving naloxone but having a clinician who reported providing overdose prevention care was not. This study suggests that clinicians prescribing COT to PWH should improve overdose prevention care, including naloxone co-prescribing.

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial.

BACKGROUND: Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. METHODS: Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. DISCUSSION: Video DOT delivered through mHealth technology platform offers possibility of improving patients' buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

Alcohol and Bone Turnover Markers among People Living with HIV and Substance Use Disorder.

BACKGROUND: Although unhealthy alcohol use and low bone density are prevalent among people living with HIV (PLWH), it is not clear whether alcohol use is associated with bone turnover markers (BTMs), and if so, at what quantity and frequency. The study objective was to examine the association between alcohol and BTMs in PLWH with substance use disorder. METHODS: We studied a prospective cohort recruited from 2 HIV clinics who met criteria for DSM-IV substance dependence or reported ever injection drug use. Outcomes were BTM of (i) bone formation (serum procollagen type 1 N-terminal propeptide [P1NP]) and (ii) bone resorption (serum C-telopeptide type 1 collagen [CTx]). Alcohol consumption measures included (i) mean number of drinks/d (Timeline Follow-Back [TLFB]) (primary predictor), (ii) any alcohol use on ≥20 of the past 30 days, and phosphatidylethanol (PEth), a biomarker of recent alcohol consumption. Linear regression analysis examined associations between (i) each alcohol measure and each BTM and (ii) change in alcohol and change in BTM over 12 months. RESULTS: Among 198 participants, baseline characteristics were as follows: The median age was 50 years; 38% were female; 93% were prescribed antiretroviral medications; 13% had ≥20 drinking days/month; mean drinks/day was 1.93 (SD 3.89); change in mean drinks/day was -0.42 (SD 4.18); mean P1NP was 73.1 ng/ml (SD 34.5); and mean CTx was 0.36 ng/ml (SD 0.34). Higher drinks/day was significantly associated with lower P1NP (slope -1.09 ng/ml; 95% confidence interval [CI] -1.94, -0.23, per each additional drink). On average, those who drank on ≥ 20 days/month had lower P1NP (-15.45 ng/ml; 95% CI: -26.23, -4.67) than those who did not. Similarly, PEth level ≥ 8ng/ml was associated with lower P1NP. An increase in drinks/d was associated with a decrease in P1NP nonsignificantly (-1.14; 95% CI: -2.40, +0.12; p = 0.08, per each additional drink). No significant associations were detected between either alcohol measure and CTx. CONCLUSIONS: In this sample of PLWH with substance use disorder, greater alcohol consumption was associated with lower serum levels of bone formation markers.

Exploring Quality of Primary Care for Patients Who Experience Homelessness and the Clinicians Who Serve Them: What Are Their Aspirations?

To develop and evaluate an effective model of patient-centered, high-quality, homeless-focused primary care, our team explored key domains of primary care that may be important to patients. We anchored our conceptual framework in two reports from the Institute of Medicine (IOM) that defined components of primary care and quality of care. Using questions developed from this framework, we conducted semistructured interviews with 36 homeless-experienced individuals with past-year primary care engagement and 24 health care professionals (clinicians and researchers) who serve homeless-experienced patients in the primary care setting. Template analysis revealed factors important to this population. These included stigma, respect, and perspectives on patient control of medical decision-making in regard to both pain and addiction. For patients experiencing homelessness, the results suggest that quality primary care may have different meanings for patients and professionals, and that services should be tailored to meet homeless-specific needs.

Alcohol Consumption and Bone Mineral Density in People with HIV and Substance Use Disorder: A Prospective Cohort Study.

BACKGROUND: People living with HIV (PLWH) commonly have low bone mineral density (BMD) (low bone mass and osteoporosis) and are at high risk for fractures. Fractures and low BMD are significant causes of morbidity and mortality, increasingly relevant as PLWH age. Alcohol use is common among PLWH and known to affect bone health. The association between alcohol use and changes in BMD among PLWH is not well understood. METHODS: We conducted a 3.5-year prospective cohort study of 250 PLWH with substance use disorder or ever injection drug use. Annual alcohol consumption was measured as a mean of grams per day of alcohol, mean number of heavy drinking days per month, mean number of days abstinent per month, and any heavy drinking, using the 30-day Timeline Followback method twice each year. The primary outcome was annual change in BMD measured each year by dual energy X-ray absorptiometry in grams per square centimeter (g/cm2 ) at the femoral neck. Additional dependent variables included annual change in total hip and lumbar spine BMD, >6% annual decrease in BMD at any site, and incident fractures in the past year. Regression models adjusted for relevant covariates. RESULTS: The median age of participants was 50 years. The median duration of HIV infection was 16.5 years and the mean time since antiretroviral therapy initiation was 12.3 years. At study entry, 67% of participants met criteria for low BMD (46% low bone mass, 21% osteoporosis). Median follow-up was 24 months. We found no significant associations between any measure of alcohol consumption and changes in BMD (g/cm2 ) at the femoral neck (adjusted ß for g/d of alcohol = -0.0032, p = 0.7487), total hip, or lumbar spine. There was no significant association between any measure of alcohol consumption and >6% annual decrease in BMD at any site, or incident fractures. CONCLUSIONS: In this sample of PLWH and substance use disorders or ever injection drug use, we detected no association between any of the alcohol measures used in the study and changes in BMD or incident fractures.