Design and rationale of the Botswana Smoking Abstinence Reinforcement Trial: a protocol for a stepped-wedge cluster randomized trial.

BACKGROUND: With expanded and sustained availability of HIV treatment resulting in substantial improvements in life expectancy, the need to address modifiable risk factors associated with leading causes of death among people living with HIV/AIDS (PLWH), such as tobacco smoking, has increased. Tobacco use is highly prevalent among PLWH, especially in southern Africa, where HIV is heavily concentrated, and many people who smoke would like to quit but are unable to do so without assistance. SBIRT (Screening, Brief Intervention and Referral to Treatment) is a well-established evidence-based approach successful at supporting smoking cessation in a variety of settings. Varenicline is efficacious in supporting smoking cessation. We intend to assess the effectiveness of SBIRT and varenicline on smoking cessation among PLWH in Botswana and the effectiveness of our implementation. METHODS: BSMART (Botswana Smoking Abstinence Reinforcement Trial) is a stepped-wedge, cluster randomized, hybrid Type 2 effectiveness-implementation study guided by the RE-AIM framework, to evaluate the effectiveness and implementation of an SBIRT intervention consisting of the 5As compared to an enhanced standard of care. SBIRT will be delivered by trained lay health workers (LHWs), followed by referral to treatment with varenicline prescribed and monitored by trained nurse prescribers in a network of outpatient HIV care facilities. Seven hundred and fifty people living with HIV who smoke daily and have been receiving HIV care and treatment at one of 15 health facilities will be recruited if they are up to 18 years of age and willing to provide informed consent to participate in the study. DISCUSSION: BSMART tests a scalable approach to achieve and sustain smoking abstinence implemented in a sustainable way. Integrating an evidence-based approach such as SBIRT, into an HIV care system presents an important opportunity to establish and evaluate a modifiable cancer prevention strategy in a middle-income country (MIC) setting where both LHW and non-physician clinicians are widely used. The findings, including the preliminary cost-effectiveness, will provide evidence to guide the Botswanan government and similar countries as they strive to provide affordable smoking cessation support at scale. CLINICAL TRIAL REGISTRATION: NCT05694637 Registered on 7 December 2022 on clinicaltrials.gov, https://clinicaltrials.gov/search?locStr=Botswana&country=Botswana&cond=Smoking%20Cessation&intr=SBIRT.

Cognitive and Behavioral Contributions to Depression Severity, Quality of Life, and Functioning Among People Living With HIV in South Africa.

Cognitive-behavioral treatments for depression typically address both behavioral (e.g., activation) and cognitive (e.g., rumination) components, and consequently improve quality of life (QOL) and function in high-resource settings. However, little is known about the cross-cultural applicability and relative contribution of these components to depression symptom severity, QOL, and functional impairment in South Africa and other resource-limited global settings with high HIV prevalence rates. Persons with HIV (N = 274) from a peri-urban community outside Cape Town, South Africa, were administered multiple measures of depression (Hamilton Depression Scale, Centre for Epidemiological Studies Depression Scale, South African Depression Scale), cognitive and behavioral components related to depression (Ruminative Response Scale, Behavioral Activation for Depression Scale), and measures of QOL and functioning (Sheehan Disability Scale, Quality of Life Enjoyment and Satisfaction Scale-Short Form). Multiple linear regression models were fit to assess the relative contribution of behavioral and cognitive components to depression severity, QOL, and functional impairment in this population. Models accounting for age and sex revealed that lower levels of behavioral activation (BA) were significantly associated with all measures of depression, as well as with QOL and functional impairment (all ps < .01). Rumination was associated with all measures of depression (all ps < .01), but not with QOL or functional impairment. The consistent and unique association of BA with depression, QOL, and functional impairment bolsters its importance as a treatment target for this population.

Evaluating the causal effect of tobacco smoking on white matter brain aging: a two-sample Mendelian randomization analysis in UK Biobank.

BACKGROUND AND AIMS: Tobacco smoking is a risk factor for impaired brain function, but its causal effect on white matter brain aging remains unclear. This study aimed to measure the causal effect of tobacco smoking on white matter brain aging. DESIGN: Mendelian randomization (MR) analysis using two non-overlapping data sets (with and without neuroimaging data) from UK Biobank (UKB). The group exposed to smoking and control group consisted of current smokers and never smokers, respectively. Our main method was generalized weighted linear regression with other methods also included as sensitivity analysis. SETTING: United Kingdom. PARTICIPANTS: The study cohort included 23 624 subjects [10 665 males and 12 959 females with a mean age of 54.18 years, 95% confidence interval (CI) = 54.08, 54.28]. MEASUREMENTS: Genetic variants were selected as instrumental variables under the MR analysis assumptions: (1) associated with the exposure; (2) influenced outcome only via exposure; and (3) not associated with confounders. The exposure smoking status (current versus never smokers) was measured by questionnaires at the initial visit (2006-10). The other exposure, cigarettes per day (CPD), measured the average number of cigarettes smoked per day for current tobacco users over the life-time. The outcome was the 'brain age gap' (BAG), the difference between predicted brain age and chronological age, computed by training machine learning model on a non-overlapping set of never smokers. FINDINGS: The estimated BAG had a mean of 0.10 (95% CI = 0.06, 0.14) years. The MR analysis showed evidence of positive causal effect of smoking behaviors on BAG: the effect of smoking is 0.21 (in years, 95% CI = 6.5 × 10-3 , 0.41; P-value = 0.04), and the effect of CPD is 0.16 year/cigarette (UKB: 95% CI = 0.06, 0.26; P-value = 1.3 × 10-3 ; GSCAN: 95% CI = 0.02, 0.31; P-value = 0.03). The sensitivity analyses showed consistent results. CONCLUSIONS: There appears to be a significant causal effect of smoking on the brain age gap, which suggests that smoking prevention can be an effective intervention for accelerated brain aging and the age-related decline in cognitive function.

Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors.

BACKGROUND: Oral anti-cancer treatments such as adjuvant endocrine therapies (AET) for breast cancer survivors are commonly used but adherence is a challenge. Few low-touch, scalable interventions exist to increase ET adherence. PURPOSE: To evaluate the acceptability, feasibility, and initial efficacy of a low-touch, remotely-delivered values plus AET education intervention (REACH) to promote AET adherence. METHODS: A mixed-methods trial randomized 88 breast cancer survivors 1:1 to REACH or Education alone. Wisepill real-time electronic adherence monitoring tracked monthly AET adherence during a 1-month baseline through 6-month follow-up (FU) (primary outcome). Patient-reported outcomes were evaluated through 3- and 6-month FU (secondary). Multiple indices of intervention feasibility and acceptability were evaluated. Qualitative exit interviews (n = 38) further assessed participants' perceptions of feasibility/acceptability and recommendations for intervention adaptation. RESULTS: The trial showed strong feasibility and acceptability, with an eligible-to-enrolled rate of 85%, 100% completion of the main intervention sessions, and "good" intervention satisfaction ratings on average. For Wisepill-assessed AET adherence, REACH outperformed Education for Month 1 of FU (p = .027) and not thereafter. Participants in REACH maintained high adherence until Month 4 of FU, whereas in Education, adherence declined significantly in Month 1. Conditions did not differ in self-reported adherence, positive affective attitudes, future intentions, or necessity beliefs. REACH trended toward less negative AET attitudes than Education at 3-month FU (p = .057) reflecting improvement in REACH (p = .004) but not Education (p = .809). Exploratory moderator analyses showed that average to highly positive baseline AET affective attitudes and oncologist-patient communication each predicted higher adherence following REACH than Education; low levels did not. Participants identified recommendations to strengthen the interventions. CONCLUSIONS: REACH, a low-touch values intervention, showed good feasibility and acceptability, and initial promise in improving objectively-assessed AET adherence among breast cancer survivors (relative to education alone). Future research should target improving REACH's tailoring and endurance.

Implementing Cognitive Behavioral Therapy in Specialty Medical Settings.

This article is an introduction to the second issue of a two-part special series on integrating cognitive behavioral therapy (CBT) into medical settings. The first issue focused on integrating CBT into primary care, and this issue focuses on implementing CBT in other specialty medical settings, including cancer treatment, HIV care, and specialized pediatric medical clinics. Models for treatment delivery to improve ease of implementation are also discussed, including telehealth and home-delivered treatment. The six articles in this series provide examples of how to transport CBT techniques that are largely designed for implementation in outpatient mental health settings to specialized medical settings, and discuss unique considerations and recommendations for implementation. Reprinted from Cogn Behav Pract, Vol. 21:4, pp. 367-371, with permission from Elsevier. Copyright 2014.

Recreational ART use among individuals living with HIV/AIDS in South Africa: Examining longitudinal ART initiation and viral suppression.

BACKGROUND: South Africa has the highest number of people living with HIV (PLWH) and one of the largest antiretroviral therapy (ART) programs globally. High rates of substance use comorbidity exist, including speculation of recreational ART use (i.e., mixing ART with other illicit drugs). Recreational ART use may affect viral load among PLWH due to ART nonadherence and/or viral resistance; however, prior quantitative research has not examined rates of recreational ART use, nor associations with HIV treatment outcomes longitudinally. METHODS: Data were drawn from a prospective, observational cohort study (n = 500) of ART-eligible adults recruited from two HIV voluntary counseling and testing centers in Cape Town, and Johannesburg, South Africa. Multiple logistic regression models assessed recreational ART use as a predictor of ART initiation over six months and viral load suppression over nine months, above and beyond other substance use (binge drinking and illicit drug use). RESULTS: Approximately 5% (n = 24) reported recreational ART use, which was less frequent in Cape Town compared to Johannesburg (AOR = 0.025; 95%CI: 0.003-0.19; p < 0.001). Recreational ART use was not significantly associated with ART initiation or viral suppression. Other substance use, but not recreational ART use, was significantly associated with lower odds of ART initiation (AOR = 0.54; 95%CI: 0.33-0.87; p = .01) and viral suppression (AOR = 0.47; 95%CI: 0.25-0.89; p = .02). CONCLUSIONS: Recreational ART use was infrequent and not uniquely associated with ART initiation or viral suppression. Findings suggest that comorbid use of other substances is ultimately what may make recreational ART use problematic for ongoing engagement in care and viral suppression.

Factors Associated With Patients' Perceived Importance of Opioid Prescribing Policies in an Orthopedic Hand Surgery Practice.

PURPOSE: The purpose of this study was to survey the attitudes and beliefs about opioids and opioid prescribing policies among patients presenting to an orthopedic hand surgery practice. METHODS: Patients (n = 118; median age, 49 years) who presented to their regularly scheduled appointment at a major urban university medical center completed surveys assessing their sociodemographic and clinical characteristics, beliefs about prescription opioids, beliefs about opioid prescribing policies, and perceived importance of opioid prescribing policies in the department. RESULTS: Many patients were aware of potential risks of opioids (eg, 80% are aware of addictive properties) and would support opioid prescribing policies that aim to decrease opioid misuse and diversion. However, a small but important number of patients have concerning beliefs about prescription opioids (eg, 28% believe opioids work well for long-term pain) or believe that doctors should prescribe "as much medication as the patient needs" (7%). The vast majority (98%) indicated that they would like more education on opioids and that information about prescription opioids should be provided to all patients in orthopedic practices. Patients with higher educational attainment reported a greater perceived importance of opioid prescribing policies. CONCLUSIONS: The results of this study suggest that opioid prescribing strategies that promote safe and effective alleviation of pain and optimal opioid stewardship will be well received by patients. CLINICAL RELEVANCE: Efforts to develop and test the effects of opioid prescribing policies and nonopioid pain relief strategies on opioid prescribing are merited.

Implementing cognitive behavioral therapy in specialty medical settings.

This article is an introduction to the second issue of a two-part Special Series on integrating cognitive behavioral therapy (CBT) into medical settings. The first issue focused on integrating CBT into primary care, and this issue focuses on implementing CBT in other specialty medical settings, including cancer treatment, HIV care, and specialized pediatric medical clinics. Models for treatment delivery to improve ease of implementation are also discussed, including telehealth and home-delivered treatment. The six articles in this series provide examples of how to transport CBT techniques that are largely designed for implementation in outpatient mental health settings to specialized medical settings, and discuss unique considerations and recommendations for implementation.

Treatment failure in behavior therapy: focus on behavioral activation for depression.

Behavioral activation (BA) has come to be recognized as an empirically supported treatment for depression. Despite the general success of the approach, many patients experience treatment failure. Based on behavioral models of depression, we present several reasons for treatment failure in BA, including patient inability to understand and adopt the treatment rationale, lack of awareness or ability to articulate and behave according to life values, behavioral noncompliance, and ineffectiveness of contingency management to increase exposure to environmental rewards and reduce contact with both aversive environmental events and reinforcement of depressed behavior. A case study of treatment failure with a depressed breast cancer patient is presented, along with recommendations to reduce failure rates in BA.