Three Lessons Learned About Power and Improving Recruitment of Underrepresented Populations in Clinical Trials.

This Open Forum is relevant for investigators who conduct research with historically understudied and marginalized populations. The authors introduce a U.S. Department of Veterans Affairs clinical trial that experienced challenges with recruitment of African American or Black veterans and was terminated for not achieving its recruitment goals. The role of power dynamics in clinical research is discussed, specifically how unequal distributions of power may create recruitment challenges. The authors summarize three lessons learned and offer recommendations for sharing power equitably between investigators and potential participants. By recounting these experiences, the authors seek to promote culturally sensitive, veteran-centered approaches to recruitment in future clinical trials.

Racial Disparities in Prescription of Antidepressants Among U.S. Veterans Referred to Behavioral Health Care.

Objective: Antidepressants are often prescribed in primary care to treat veterans who have depression. An evaluation of current racial disparities in integrated primary care is warranted. This study examined the association between race and prescription of antidepressants among veterans in primary care. Methods: Veterans in primary care (Black, N=4,120; White, N=4,372) who were referred from primary care to a collaborative care program completed an assessment of demographic characteristics and clinical symptoms, including of current antidepressant prescription before the referral, verified by chart review. Patient data were collected from January 1, 2015, to December 22, 2020. Logistic regression analyses were conducted to examine the relationships between patient race and both depression symptoms and antidepressant prescription. Analyses were also stratified by severity of depression symptoms to understand the results in the context of clinical guidelines. Results: White patients were almost two times (odds ratio=1.96, 95% confidence interval [CI]=1.75­2.19, p<0.001) more likely than Black patients to receive an antidepressant prescription, after the analysis was controlled for depression symptoms, demographic characteristics, and other clinical symptoms. Among patients with severe depression, for whom prescription of antidepressants is clinically indicated, White patients were 1.87 times more likely than Black patients to receive an antidepressant prescription (95% CI=1.40­2.50, p<0.001). Conclusions: The findings reveal racial disparities in antidepressant prescription for veterans in primary care. Regular clinical review of antidepressant prescription is recommended to identify disparities in individual clinics. Future research should aim to identify drivers of racial disparities and provide recommendations for health care systems, providers, and patients.

Perceived barriers to physical activity during and after a behavioural weight loss programme.

BACKGROUND: Most adults with overweight/obesity participating in behavioural weight loss (BWL) programmes never achieve prescribed physical activity (PA) levels. This study examined changes in PA barriers, their relationships with accelerometer-measured PA during and after a 12-month BWL programme, and associations between PA barriers and participant characteristics. METHODS: Adults (N = 283) in a BWL programme completed the Barriers to Being Active Quiz, a 21-item self-report measure that assesses seven perceived PA barriers, and they wore an accelerometer for seven consecutive days at baseline and at 6 (midtreatment), 12 (end of treatment), 18 (6-mo follow-up), and 24 months (12-mo follow-up). Weight and height were measured, and demographic information was collected at baseline. RESULTS: Repeated-measures analyses of variance (ANOVAs) revealed a significant quadratic effect of time on total PA barriers, P < .001, such that PA barriers decreased by midtreatment, remained below baseline levels by end of treatment, but increased to near-baseline levels by follow-up. Perceived PA barriers were negatively associated with baseline moderate-to-vigorous PA (MVPA), P < .001, and decreases in perceived PA barriers were related to greater MVPA at 6 (P = .004), 12 (P < .001), and 24 months (P = .007). Participants who were younger, P = .02, and white, P = .009, reported more baseline barriers. CONCLUSIONS: Perceived PA barriers meaningfully decreased during BWL treatment, which in turn was associated with greater MVPA. This pattern suggests that, on average, BWL effectively addresses perceived PA barriers, which contributes to increased PA. Future research should identify interventions to maintain decreases in barriers after end of treatment.

Breastfeeding Practices Among Women Living with HIV in KwaZulu-Natal, South Africa: An Observational Study.

INTRODUCTION: Exclusive breastfeeding (EBF) is the safest infant feeding option in resource-limited settings, though women living with HIV have the lowest rates of EBF. Barriers to EBF in the absences of a formal intervention in women living with HIV in KwaZulu-Natal, where the prevalence of HIV among pregnant women is among the highest in the world, are understudied. Thus, this study sought to describe barriers to EBF and examine differences in social support, disclosure status, mood, and HIV-related stigma among women with different feeding methods. METHODS: Women living with HIV enrolled in preventing mother-to-child transmission treatment (n = 156) were interviewed postpartum (M = 13.1 weeks) at a district hospital and self-reported infant feeding method, reasons not breastfeeding (if applicable), and HIV disclosure status. Mood, HIV-related stigma, functional social support, and HIV-related social support were also assessed. RESULTS: No participants reported mixed feeding, 30% reported EBF, and 70% reported exclusive formula feeding. Commonly reported reasons for not breastfeeding included fear of HIV transmission to the infant and being away from the infant for extended periods of time. Social support (p = 0.02) and HIV-related social support (p < 0.01) were significantly higher in women who had attempted breastfeeding compared to women who never attempted breastfeeding. DISCUSSION: Rates of EBF in this sample are lower than in other recent studies, suggesting this sample experiences multiple barriers to EBF. Healthcare providers should seek to correct misconceptions regarding HIV transmission and breastfeeding practices. Social and logistical support for EBF may be important considerations for future interventions.

Executive Functioning as a Predictor of Weight Loss and Physical Activity Outcomes.

BACKGROUND: Executive functioning, which is fundamental for carrying out goal-directed behaviors, may be an underappreciated predictor of outcomes in lifestyle modification programs for adults with obesity. PURPOSE: This study tested the hypotheses that higher levels of baseline executive functioning would predict greater weight loss and physical activity after 6 months of behavioral treatment. METHODS: Participants (N = 320) were recruited from the community and provided with 16 treatment sessions. Executive functioning was measured with the tower task component of the Delis-Kaplan Executive Function System (D-KEFS). At months 0 and 6, weight was measured in the clinic and physical activity was measured with tri-axial accelerometers. RESULTS: Baseline D-KEFS achievement score, rule violations, and completion time significantly predicted weight loss at 6 months. For example, among participants without any rule violations (n = 162), weight loss averaged 11.0%, while those with rule violations (n = 158) averaged 8.7% weight loss. Rule violations also significantly predicted physical activity at 6 months. Among participants without any rule violations, physical activity at 6 months averaged 169.8 min/week, versus 127.2 min/week among those with rule violations. CONCLUSIONS: Particular aspects of executive functioning may predict the relative ease or difficulty of changing eating and exercise-related behaviors, albeit with small effect sizes. This study is the first to our knowledge to detect a predictive relationship between components of executive functioning and objectively measured physical activity in adult lifestyle modification, and one of the first to predict weight loss in adults using an objective measure of executive functioning. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT02363010.

I think therefore I Am? Examining the relationship between exercise identity and exercise behavior during behavioral weight loss treatment.

OBJECTIVES: Identification as an exerciser may promote physical activity. This study examined exercise identity (EI) and its relationship with demographic characteristics and exercise among adults participating in behavioral weight loss treatment, which is a key target population for increasing exercise. DESIGN: Longitudinal. METHOD: Participants (N = 320) completed a measure of EI and exercise was assessed with accelerometers at baseline and 6 months. RESULTS: Baseline EI and exercise were positively related and EI and exercise increased over time. However, change in EI was not meaningfully related to change in exercise, baseline EI did not predict change in exercise, and 6-month EI was not related to 6-month exercise. Participants identifying as non-White reported greater EI but lower exercise. CONCLUSIONS: Although EI and exercise may increase among weight loss participants, the two may not be meaningfully related during active weight loss treatment. The relationship between EI and exercise may also differ based on race.

Learning to address multiple syndemics for people living with HIV through client perspectives on CBT.

OBJECTIVE: The mental health burden among people living with HIV/AIDS (PLWHA) is high and often involves multiple comorbid psychological and substance use-related psychosocial problems. These co-occurring problems, or syndemics, additively impair engagement in HIV disease management. Existing psychotherapies for mental health and HIV health have generally focused on a single psychosocial problem and little research exists to guide future psychotherapies that address multiple mental health issues. METHOD: To address this gap in understanding, we conducted qualitative interviews with multiply comorbid PLWHA (N = 30) who completed cognitive-behavioural therapy (CBT) for depression and medication adherence. RESULTS: Themes emerged regarding participants' perspectives on how overlapping substance use and mood disorders interacted to reduce the benefit of CBT. Substance use was a dominant theme compared to other syndemics, highlighting the need for integrated mental health and substance use interventions. Interviews also suggested modifications of which psychosocial concerns participants felt should be prioritized in treatment delivery. Finally, participants described content they would want in a psychotherapy intervention, including intimacy and sexual health. CONCLUSIONS: Future psychotherapeutic interventions for syndemic problems and HIV self-care will need to comprehensively address complex concerns, including issues salient to the overall well-being of PLWHA. This may improve client engagement and, ultimately, mental, and physical health outcomes. Clinical or methodological significance of this article: Although mental health comorbidity is common and often complex among clients living with HIV, little research exists to guide psychotherapy for such intricate mental health concerns. The current study used content analysis of in-depth qualitative interviews with clients living with HIV and multiple mental health comorbidities who had recently completed cognitive-behavioural therapy. Recommendations based on these findings suggest strategies for clinicians working with similar clients to consider and offers suggestions for future treatment development research.

Stigmatizing weight experiences in health care: Associations with BMI and eating behaviours.

INTRODUCTION: Individuals with overweight or obesity often experience stigmatizing weight-related interactions in health care, though how these experiences are associated with body mass index (BMI) and eating behaviour is unknown. This study had three aims: (a) characterize types and frequency of stigmatizing health care experiences, (b) assess relationships among BMI, eating behaviour, and stigmatizing experiences, and (c) examine whether internalized weight stigma mediates the relationship between stigmatizing experiences, weight, and eating behaviour. METHODS: Adults (N = 85) enrolled in behavioural weight loss completed measures of stigmatizing health care experiences, weight bias internalization, eating behaviours, and BMI. Cross-sectional correlational and mediational analyses were conducted. RESULTS: The majority (70.6%) of participants reported at least one stigmatizing health care experience in the past year. Greater amounts of stigmatizing experiences were associated with higher BMI (r = 0.32, P < .01) and greater uncontrolled (r = 0.22, P = .04) and emotional eating (r = 0.28, P < .01). Internalized weight stigma significantly mediated the relationship between stigmatizing experiences and maladaptive eating. CONCLUSION: Experiences of health care weight stigma were associated with eating behaviour and BMI. Participants with a higher BMI or greater maladaptive eating behaviours may be more susceptible to stigmatizing experiences. Reducing internalized weight stigma and health care provider stigma may improve patient health outcomes.

Communication between patients and primary care physicians after behavioural weight loss: an observational study.

Primary care physicians can play a key role in supporting patients after behavioural weight loss, though little is known about communication between patients and physicians during this time. Adults (n=139) in a behavioural weight loss trial (delivered outside of primary care) who attended a primary care appointment after an initial weight loss period were surveyed to assess weight-related communication at their most recent appointment. Most participants (78%) reported discussing weight with their physician. Participants who discussed weight, compared to those who did not, lost more weight, had higher blood pressure, and were more likely to be male. Most (89%) reported that their physician was supportive of their weight loss, but only a few participants (6.9%) reported that their physician gave feedback on medical parameters. Areas for improvement identified include physicians providing universal support for modest weight changes and providing interpretation of medical measurements that changed due to weight loss.

Pilot Trial of an Acceptance-Based Behavioral Intervention to Promote Physical Activity Among Adolescents.

Prior interventions have shown limited efficacy in increasing the number of adolescents engaging in adequate physical activity (PA). Preliminary evidence suggests acceptance-based behavioral treatments (ABTs) may increase PA; however, this approach has not been tested in adolescents. This was a nonrandomized experimental pilot study that examined feasibility, acceptability, and treatment outcomes of a school-based, acceptance-based behavioral intervention for PA. Adolescents (n = 20) with low activity received a PA tracking device and were allocated to device use only or device use plus 10-weeks of ABT. PA, cardiovascular fitness, and physiological outcomes were measured pre- and postintervention. The intervention was found to be feasible and acceptable. PA, cardiovascular fitness, and physiological outcomes improved over time in the intervention group, but not in the comparison condition. This study demonstrated feasibility, acceptability, and preliminary treatment efficacy based on effect sizes for an acceptance-based behavioral intervention to increase PA in adolescents.

Do participants with children age 18 and under have suboptimal weight loss?

OBJECTIVES: Parenthood is a time marked by behaviors that may promote risk for weight gain, including decreased physical activity and increased unhealthy eating. Little is known about parents in the context of behavioral weight loss, such as whether they differ in weight losses, and related barriers, or behaviors. METHOD: We compared parents of children aged 18 and younger (n = 105) to other participants who did not have children, or whose children were in adulthood (n = 215) in a behavioral weight loss program to evaluate six-month weight losses, and weight loss barriers and behaviors. RESULTS: Parents of minor children lost less weight than other participants, and parental status interacted with gender such that men without minor children lost the most weight. Although parents of minor children identified greater stress, depression, time-related barriers to physical activity, and had less adherence to calorie goals, they did not differ from other participants in session attendance, emotional overeating, disinhibited eating, or physical activity. DISCUSSION: Parents of minor children appear to have greater weight loss barriers, greater difficulty adhering to calorie goals, and less weight loss. Additional research is needed to identify ways to better serve parents in behavioral weight loss programs.

Treatment of Obesity in Primary Care.

This article outlines some of the behavioral, pharmacologic, and surgical interventions available to primary care physicians (PCPs) to help their patients with weight management. Studies on lifestyle modification, commercial weight loss programs, and medical and surgical options are reviewed. Several clinical suggestions on obesity management that PCPs can take back and use immediately in office practice are offered.

Relationship between depressive symptoms, alcohol use, and antiretroviral therapy adherence among HIV-infected, clinic-attending patients in South Africa.

Despite the prevalence of depression and alcohol use among HIV-infected individuals, few studies have examined their association together in relation to nonadherence to antiretroviral therapy in sub-Saharan Africa. This study examined depressive symptoms, alcohol use, and other psychosocial factors (stigma, demographic characteristics) in relation to nonadherence to antiretroviral therapy among clinic-attending, HIV-infected individuals in South Africa ( n = 101). Nonadherence was assessed using event-level measurement (missed doses over the past weekend). Multivariable logistic regression analyses revealed that only alcohol use, over and above depressive symptoms and education level, was associated with antiretroviral therapy nonadherence(AOR = 1.15; 95%CI = 1.02-1.29; p < .05). Findings point to the independent association of alcohol use and nonadherence to antiretroviral therapy above and beyond depressive symptoms.

A randomized controlled trial of cognitive behavioral therapy for ADHD in medication-treated adolescents.

OBJECTIVE: To test cognitive behavioral therapy (CBT) for persistent attention-deficit hyperactivity disorder (ADHD) symptoms in a sample of medication-treated adolescents. METHODS: Forty-six adolescents (ages 14-18), with clinically significant ADHD symptoms despite stable medication treatment were randomly assigned to receive CBT for ADHD or wait list control in a cross-over design. Twenty-four were randomized to CBT, 22 to wait list, and 15 crossed-over from wait list to CBT. A blind independent evaluator (IE) rated symptom severity on the ADHD Current Symptom Scale, by adolescent and parent report, and rated each subject using the Clinical Global Impression Severity Scale (CGI), a global measure of distress and impairment. These assessments were performed at baseline, 4-months (post-CBT or post wait list), and 8-months (post-treatment for those originally assigned to the wait list condition and 4-month follow-up for those originally assigned to CBT). TRIAL REGISTRATION: http://clinicaltrials.gov/show/NCT01019252. RESULTS: Using all available data, mixed effects modeling, and pooling for the wait list cross-over, participants who received CBT received a mean score 10.93 lower on the IE-rated parent assessment of symptom severity (95% CI: -12.93, -8.93; p < .0001), 5.24 lower on the IE-rated adolescent assessment of symptom severity (95% CI: -7.21, -3.28; p < .0001), and 1.17 lower IE-rated CGI (95% CI: -1.39, -.94; p < .0001). Results were consistent across 100 multiple imputations (all p < .0001). There was a greater proportion of responders after CBT by parent (50% vs. 18%, p = .00) and adolescent (58% vs. 18% p = .02) report. CONCLUSIONS: This study demonstrates initial efficacy of CBT for adolescents with ADHD who continued to exhibit persistent symptoms despite medications.

Implementation of Cognitive-Behavioral Substance Abuse Treatment in Sub-Saharan Africa: Treatment Engagement and Abstinence at Treatment Exit.

AIMS: This study documented the treatment cascade for engagement in care and abstinence at treatment exit as well as examined correlates of these outcomes for the first certified Matrix Model® substance abuse treatment site in Sub-Saharan Africa. DESIGN: This retrospective chart review conducted at a resource-limited community clinic in Cape Town, South Africa, assessed treatment readiness and substance use severity at treatment entry as correlates of the number of sessions attended and biologically confirmed abstinence at treatment exit among 986 clients who initiated treatment from 2009-2014. Sociodemographic and clinical correlates of treatment outcomes were examined using logistic regression, modeling treatment completion and abstinence at treatment exit separately. RESULTS: Of the 2,233 clients who completed screening, approximately 44% (n = 986) initiated treatment. Among those who initiated treatment, 45% completed at least four group sessions, 30% completed early recovery skills training (i.e., at least eight group sessions), and 13% completed the full 16-week program. Approximately half (54%) of clients who provided a urine sample had negative urine toxicology results for any substance at treatment exit. Higher motivation at treatment entry was independently associated with greater odds of treatment completion and negative urine toxicology results at treatment exit. CONCLUSIONS: Findings provide initial support for the successful implementation the Matrix Model in a resource-limited setting. Motivational enhancement interventions could support treatment initiation, promote sustained engagement in treatment, and achieve better treatment outcomes.

Small weight gains during obesity treatment: normative or cause for concern?

OBJECTIVES: The objectives of the study are to characterize the frequency and size of small weight gains during behavioural weight loss treatment and to evaluate the relationship between small weight gains and weight loss outcomes. METHODS: Participants (n = 281) in a year-long behavioural weight loss programme were weighed at treatment sessions, and between-session weight gains were classified into several categories based on size. The occurrence of different gain magnitudes and their relation to weight loss were examined during both the active weight loss (months 1-6) and weight loss maintenance (months 7-12) phases of treatment. RESULTS: Weight gains were common during both phases of treatment, with smaller gains occurring more frequently than larger gains. Greater frequency of all gain magnitudes was associated with lesser weight loss during both phases. Additionally, participants who had just one or two weight gains of the smallest size examined (1.0-1.9 lb) lost less weight than those who had no gains. CONCLUSIONS: Small gains appear to reflect true weight gain due to poor adherence to behavioural recommendations and are associated with worse weight loss outcomes, even when limited in number. Future research should examine how best to prevent small weight gains from occurring and how clinicians and participants should respond when a weight gain does occur to promote weight control success.

Adherence to HIV care after pregnancy among women in sub-Saharan Africa: falling off the cliff of the treatment cascade.

Increased access to testing and treatment means HIV can be managed as a chronic illness, though successful management requires continued engagement with the health care system. Most of the global HIV burden is in sub-Saharan Africa where rates of new infections are consistently higher in women versus men. Pregnancy is often the point at which an HIV diagnosis is made. While preventing mother to child transmission (PMTCT) interventions significantly reduce the rate of vertical transmission of HIV, women must administer ARVs to their infants, adhere to breastfeeding recommendations, and test their infants for HIV after childbirth. Some women will be expected to remain on the ARVs initiated during pregnancy, while others are expected to engage in routine testing so treatment can be reinitiated when appropriate. The postpartum period presents many barriers to sustained treatment adherence and engagement in care. While some studies have examined adherence to postpartum PMTCT guidelines, few have focused on continued engagement in care by the mother, and very few examine adherence beyond the 6-week postpartum visit. Here, we attempt to identify gaps in the research literature and make recommendations on how to address barriers to ongoing postpartum HIV care.

Psychosocial Syndemics are Additively Associated with Worse ART Adherence in HIV-Infected Individuals.

Adherence to antiretroviral therapy (ART) among HIV-infected individuals is necessary to both individual and public health, and psychosocial problems have independently been associated with poor adherence. To date, studies have not systematically examined the effect of multiple, co-occurring psychosocial problems (i.e., "syndemics") on ART adherence. Participants included 333 HIV-infected individuals who completed a comprehensive baseline evaluation, as part of a clinical trial to evaluate an intervention to treat depression and optimize medication adherence. Participants completed self-report questionnaires, and trained clinicians completed semi-structured diagnostic interviews. ART non-adherence was objectively measured via an electronic pill cap (i.e., MEMS). As individuals reported a greater number of syndemic indicators, their odds of non-adherence increased. Co-occurring psychosocial problems have an additive effect on the risk for poor ART adherence. Future behavioral medicine interventions are needed that address these problems comprehensively, and/or the core mechanisms that they share.

Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial.

BACKGROUND: PEARLS, a large scale trial of antiretroviral therapy (ART) for HIV (n = 1,571, 9 countries, 4 continents), found that a once-daily protease inhibitor (PI) based regimen (ATV+DDI+FTC), but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) regimen (EFV+FTC/TDF), had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen (EFV+3TC/ZDV). The present study examined non-adherence in PEARLS. METHODS: Outcomes: non-adherence assessed by pill count and by self-report, and time to treatment failure. Longitudinal predictors: regimen, quality of life (general health perceptions  =  QOL-health, mental health  =  QOL-mental health), social support, substance use, binge drinking, and sexual behaviors. "Life-Steps" adherence counseling was provided. RESULTS: In both pill-count and self-report multivariable models, both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen; although these associations attenuated with time in the self-report model. In both multivariable models, hard-drug use was associated with non-adherence, living in Africa and better QOL-health were associated with less non-adherence. According to pill-count, unprotected sex was associated with non-adherence. According to self-report, soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence. Both pill-count (HR = 1.55, 95% CI: 1.15, 2.09, p<.01) and self-report (HR = 1.13, 95% CI: 1.08, 1.13, p<.01) non-adherence were significant predictors of treatment failure over 72 weeks. In multivariable models (including pill-count or self-report nonadherence), worse QOL-health, age group (younger), and region were also significant predictors of treatment failure. CONCLUSION: In the context of a large, multi-national, multi-continent, clinical trial there were variations in adherence over time, with more simplified regimens generally being associated with better adherence. Additionally, variables such as QOL-health, regimen, drug-use, and region play a role. Self-report and pill-count adherence, as well as additional psychosocial variables, such QOL-health, age, and region, were, in turn, associated with treatment failure.