Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT.

BACKGROUND: Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial. METHODS: Clinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings. RESULTS: The trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest. CONCLUSIONS: This study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial. CLINICAL TRIAL REGISTRATION: NCT05700383.

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial.

BACKGROUND: Chronic pain and early cognitive decline, which are costly to treat and highly prevalent among older adults, commonly co-occur, exacerbate one another over time, and can accelerate the development and progression of Alzheimer disease and related dementias. We developed the first mind-body activity program (Active Brains [AB]) tailored to the needs of older adults with chronic pain and early cognitive decline. Results from our previous study strongly supported the feasibility of conducting AB remotely and provided evidence for improvements in outcomes. OBJECTIVE: We are conducting a single-blinded, National Institutes of Health stage-2, randomized clinical trial to establish the efficacy of AB versus a time-matched and dose-matched education control (Health Enhancement Program [HEP]) in improving self-reported and objective outcomes of physical, cognitive, and emotional functions in 260 participants. The methodology described in this paper was informed by the lessons learned from the first year of the trial. METHODS: Participants are identified and recruited through multidisciplinary clinician-referred individuals (eg, pain psychologists and geriatricians), the Rally Research platform, social media, and community partnerships. Interested participants complete eligibility screening and electronic informed consent. Baseline assessments include self-report, performance-based measures (eg, 6-min walk test) and objective measures (eg, Repeatable Battery for the Assessment of Neuropsychological Status). Participants are mailed a wrist-worn ActiGraph device (ActiGraph LLC) to passively monitor objective function (eg, steps) during the week between the baseline assessment and the beginning of the programs, which they continue to wear throughout the programs. After baseline assessments, participants are randomized to either AB or HEP and complete 8 weekly, remote, group sessions with a Massachusetts General Hospital psychologist. The AB group receives a Fitbit (Fitbit Inc) to help reinforce increased activity. Assessments are repeated after the intervention and at the 6-month follow-up. Coprimary outcomes include multimodal physical function (self-report, performance based, and objective). Secondary outcomes are cognitive function (self-report and objective), emotional function, and pain. RESULTS: We began recruitment in July 2022 and recruited 37 participants across 4 cohorts. Of them, all (n=37, 100%) have completed the baseline assessment, 26 (70%) have completed the posttest assessment, and 9 (24%) are actively enrolled in the intervention (total dropout: n=2, 5%). In the three cohorts (26/37, 70%) that have completed the AB or HEP, 26 (100%) participants completed all 8 group sessions (including minimal makeups), and watch adherence (1937/2072, 93.48%, average across ActiGraph and Fitbit devices) has been excellent. The fourth cohort is ongoing (9/37, 24%), and we plan to complete enrollment by March 2026. CONCLUSIONS: We aim to establish the efficacy of the AB program over a time-matched and dose-matched control in a live video-based trial and test the mechanisms through theoretically driven mediators and moderators. Findings will inform the development of a future multisite effectiveness-implementation trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05373745; https://classic.clinicaltrials.gov/ct2/show/NCT05373745. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47319.

A Live Video Dyadic Resiliency Intervention to Prevent Chronic Emotional Distress Early After Dementia Diagnoses: Protocol for a Dyadic Mixed Methods Study.

BACKGROUND: By 2030, approximately 75 million adults will be living with Alzheimer disease and related dementias (ADRDs). ADRDs produce cognitive, emotional, and behavioral changes for persons living with dementia that undermine independence and produce considerable stressors for persons living with dementia and their spousal care-partners-together called a "dyad." Clinically elevated emotional distress (ie, depression and anxiety symptoms) is common for both dyad members after ADRD diagnosis, which can become chronic and negatively impact relationship functioning, health, quality of life, and collaborative management of progressive symptoms. OBJECTIVE: This study is part of a larger study that aims to develop, adapt, and establish the feasibility of Resilient Together for Alzheimer Disease and Related Dementias (RT-ADRD), a novel dyadic skills-based intervention aimed at preventing chronic emotional distress. This study aims to gather comprehensive information to develop the first iteration of RT-ADRD and inform a subsequent open pilot. Here, we describe the proposed study design and procedures. METHODS: All procedures will be conducted virtually (via phone and Zoom) to minimize participant burden and gather information regarding feasibility and best practices surrounding virtual procedures for older adults. We will recruit dyads (up to n=20) from Mount Sinai Hospital (MSH) clinics within 1 month of ADRD diagnosis. Dyads will be self-referred or referred by their treating neurologists and complete screening to assess emotional distress and capacity to consent to participate in the study. Consenting dyads will then participate in a 60-minute qualitative interview using an interview guide designed to assess common challenges, unmet needs, and support preferences and to gather feedback on the proposed RT-ADRD intervention content and design. Each dyad member will then have the opportunity to participate in an optional individual interview to gather additional feedback. Finally, each dyad member will complete a brief quantitative survey remotely (by phone, tablet, or computer) via a secure platform to assess feasibility of assessment and gather preliminary data to explore associations between proposed mechanisms of change and secondary outcomes. We will conduct preliminary explorations of feasibility markers, including recruitment, screening, live video interviews, quantitative data collection, and mixed methods analyses. RESULTS: This study has been approved by the MSH Institutional Review Board. We anticipate that the study will be completed by late 2023. CONCLUSIONS: We will use results from this study to develop the first live video telehealth dyadic resiliency intervention focused on the prevention of chronic emotional distress in couples shortly after ADRD diagnoses. Our study will allow us to gather comprehensive information from dyads on important factors to address in an early prevention-focused intervention and to explore feasibility of study procedures to inform future open pilot and pilot feasibility randomized control trial investigations of RT-ADRD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45532.

Effects of physical exercise, LEGO, and Minecraft activities on anxiety in underserved children with autism: Study design and methodological strategies.

Anxiety is a common comorbidity for individuals with ASD, and there is some preliminary data about the efficacy of physical exercise to alleviate anxiety. However, we are not aware of any studies that have compared the effects of a physical exercise program on anxiety in underserved children with ASD using a randomized controlled research design. This paper describes a method to evaluate and compare the efficacy of an 8-week physical exercise intervention with a sedentary play intervention to alleviate anxiety in young children with autism spectrum disorders (ASD) from underserved backgrounds. We assessed anxiety and its physical symptoms using the parent-rated Child Behavior Checklist DSM-5 anxiety (CBCL DSM-5) subscale, the child-rated Screen for Childhood Anxiety Related Emotional Disorder (SCARED), the parent-rated Child's Sleep Habits Questionnaire (CSHQ), and salivary cortisol. We also utilized the Physical Activity Questionnaire for Older Children (PAQ-C) to assess physical activity level and identify compounds. Unique components of this study include: •Implementation of novel physical exercise and sedentary play interventions that have been designed for children with ASD.•Recruitment of predominantly underserved and non-English speaking families.

Focus Group Study of Medical Stakeholders to Inform the Development of Resilient Together for Dementia: Protocol for a Postdiagnosis Live Video Dyadic Resiliency Intervention.

BACKGROUND: Alzheimer disease and related dementias (ADRD) are increasingly common conditions that disrupt the lives of persons living with dementia and their spousal care partners. At the time of ADRD diagnoses, many couples experience challenges that produce emotional distress and relationship strain. At present, there are no interventions to address these challenges early after diagnoses to promote positive adjustment. OBJECTIVE: The study protocol described here is part of the first phase of a larger program of research that aims to develop, adapt, and establish the feasibility of Resilient Together for Dementia (RT-ADRD), a novel dyadic skills-based intervention to be delivered over live video early after diagnosis, with the goal of preventing chronic emotional distress. This study will elicit and systematically summarize perspectives of ADRD medical stakeholders to inform the procedures (eg, recruitment and screening methods, eligibility, timing of intervention, and intervention delivery) of the first iteration of RT-ADRD prior to pilot-testing. METHODS: We will recruit interdisciplinary medical stakeholders (eg, neurologists, social workers, neuropsychologists, care coordinators, and speech language pathologists) from academic medical center clinics in the departments treating persons living with dementia such as neurology, psychiatry, and geriatric medicine via flyers and word-of-mouth referrals from clinic directors and members of relevant organizations (eg, dementia care collaboratives and Alzheimer disease research centers). The participants will complete electronic screening and consent procedures. Consenting individuals will then participate in a 30- to 60-minute qualitative virtual focus group, held either via telephone or Zoom, using an interview guide designed to assess provider experiences with postdiagnosis clinical care and to gather feedback on the proposed RT-ADRD protocol. The participants will also have the opportunity to participate in an optional exit interview and web-based survey to gather additional feedback. Qualitative data will be analyzed using a hybrid inductive-deductive approach and the framework method for thematic synthesis. We will conduct approximately 6 focus groups with 4-6 individuals in each group (maximum N=30 individuals; until saturation is reached). RESULTS: Data collection began in November 2022 and will continue through June 2023. We anticipate that the study will be completed by late 2023. CONCLUSIONS: The results from this study will inform the procedures of the first live video RT-ADRD dyadic resiliency intervention focused on the prevention of chronic emotional and relational distress in couples shortly after ADRD diagnoses. Our study will allow us to gather comprehensive information from stakeholders on ways to best deliver our early prevention-focused intervention and gain detailed feedback on study procedures prior to further testing. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45533.

An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol.

BACKGROUND: Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality after open abdominal surgery. Optimized perioperative lung expansion may minimize the synergistic factors responsible for the multiple-hit perioperative pulmonary dysfunction. This ongoing study will assess whether an anesthesia-centered bundle focused on perioperative lung expansion results in decreased incidence and severity of PPCs after open abdominal surgery. METHODS: Prospective multicenter randomized controlled pragmatic trial in 750 adult patients with at least moderate risk for PPCs undergoing prolonged (≥2 hour) open abdominal surgery. Participants are randomized to receive either a bundle intervention focused on perioperative lung expansion or usual care. The bundle intervention includes preoperative patient education, intraoperative protective ventilation with individualized positive end-expiratory pressure to maximize respiratory system compliance, optimized neuromuscular blockade and reversal management, and postoperative incentive spirometry and early mobilization. Primary outcome is the distribution of the highest PPC severity by postoperative day 7. Secondary outcomes include the proportion of participants with: PPC grades 1-2 through POD 7; PPC grades 3-4 through POD 7, 30 and 90; intraoperative hypoxemia, rescue recruitment maneuvers, or cardiovascular events; and any major extrapulmonary postoperative complications. Additional secondary and exploratory outcomes include individual PPCs by POD 7, length of postoperative oxygen therapy or other respiratory support, hospital resource use parameters, Patient-Reported Outcomes Measurements (PROMIS®) questionnaires for dyspnea and fatigue collected before and at days 7, 30 and 90 after surgery, and plasma concentrations of lung injury biomarkers (IL6, IL-8, RAGE, CC16, Ang-2) analyzed from samples obtained before, end of, and 24 hours after surgery. DISCUSSION: Participant recruitment for this study started January 2020; results are expected in 2024. At the conclusion of this trial, we will determine if this anesthesia-centered strategy focused on perioperative lung expansion reduces lung morbidity and healthcare utilization after open abdominal surgery. TRIAL REGISTRATION: ClinicalTrial.gov NCT04108130.

Geographic variation in 5-year mortality following HIV diagnosis: implications for clinical interventions.

Characterizing spatial distribution of HIV outcomes is vital for targeting interventions to areas most at risk. We performed spatial analysis to identify geographic clusters and factors associated with mortality in KwaZulu-Natal, South Africa. We utilized Sizanani trial (NCT01188941) data, which enrolled participants August 2010-January 2013 and obtained vital status at 5.8 (IQR 5.0-6.4) years of follow-up. We mapped geocoded addresses to 2011 Census-defined small area layer (SAL) centroids, used Kulldorff's spatial scan statistic to identify mortality clusters, and compared socio-demographic factors for SALs within and outside mortality clusters. We assigned 1,143 participants living with HIV (260 [23%] of whom died during follow-up) to 677 SALs. One lower mortality cluster (n = 90, RR = 0.23, p = 0.022) was identified near a hospital outside Durban. SALs in the cluster were younger (24y vs 25y, p < 0.001); had fewer bedrooms/household (3 vs 4, p < 0.001); had more females (52% vs 51%, p = 0.013) and residents with no schooling past age 20 (4% vs 3%, p < 0.001) or no education at all (4% vs 3%, p < 0.001); had fewer residents with income >3,200 ZAR/month (5% vs 9%, p < 0.001); and had reduced access to piped water (p < 0.001), refuse disposal (p < 0.001), and toilets (p < 0.001). Targeted interventions may improve outcomes in areas with similar characteristics.

The relationship between mindfulness and enduring somatic threat severity in long-term cardiac arrest survivors.

BACKGROUND: Cardiac arrest (CA) survivors experience continuous exposures to potential traumas though chronic cognitive, physical and emotional sequelae and enduring somatic threats (ESTs) (i.e., recurring somatic traumatic reminders of the event). Sources of ESTs can include the daily sensation of an implantable cardioverter defibrillator (ICD), ICD-delivered shocks, pain from rescue compressions, fatigue, weakness, and changes in physical function. Mindfulness, defined as non-judgmental present-moment awareness, is a teachable skill that might help CA survivors cope with ESTs. Here we describe the severity of ESTs in a sample of long-term CA survivors and explore the cross-sectional relationship between mindfulness and severity of ESTs. METHODS: We analyzed survey data of long-term CA survivors who were members of the Sudden Cardiac Arrest Foundation (collected 10-11/2020). We assessed ESTs using 4 cardiac threat items from the Anxiety Sensitivity Index-revised (items range from 0 "very little" to 4 "very much") which we summed to create a score reflecting total EST burden (range 0-16). We assessed mindfulness using the Cognitive and Affective Mindfulness Scale-Revised. First, we summarized the distribution of EST scores. Second, we used linear regression to describe the relationship between mindfulness and EST severity adjusting for age, gender, time since arrest, COVID-19-related stress, and loss of income due to COVID. RESULTS: We included 145 CA survivors (mean age: 51 years, 52% male, 93.8% white, mean time since arrest: 6 years, 24.1% scored in the upper quarter of EST severity). Greater mindfulness (ß: -30, p = 0.002), older age (ß: -0.30, p = 0.01) and longer time since CA (ß: -0.23, p = 0.005) were associated with lower EST severity. Male sex was also associated with greater EST severity (ß: 0.21, p = 0.009). CONCLUSION: ESTs are common among CA survivors. Mindfulness may be a protective skill that CA survivors use to cope with ESTs. Future psychosocial interventions for the CA population should consider using mindfulness as a core skill to reduce ESTs.

The Impact of a Recent Concussion on College-Aged Individuals with Co-Occurring Anxiety: A Qualitative Investigation.

College-aged individuals with anxiety are vulnerable to developing persistent concussion symptoms, yet evidence-based treatments for this population are limited. Understanding these individuals' perspectives is critical for developing effective interventions. We conducted qualitative interviews with 17 college-aged individuals (18-24 years old) with a recent (≤10 weeks) concussion and at least mild anxiety (≥5 on the GAD-7 questionnaire) to understand the life impact of their concussion. We identified 5 themes: (1) disruption to daily activities (e.g., reduced participation in hobbies and physical activity); (2) disruption to relationships (e.g., reduced social engagement, feeling dismissed by others, stigma, and interpersonal friction); (3) disruptions in school/work (e.g., challenges participating due to light sensitivity, cognitive or sleep disturbance, and related emotional distress); (4) changes in view of the self (e.g., feeling "unlike oneself", duller, or more irritable), and (5) finding "silver linings" after the injury (e.g., increased motivation). Concussions impact the lives of college-aged individuals with co-occurring anxiety in a broad range of domains, many of which remain largely neglected in standard concussion clinical assessment and treatment. Assessing and addressing these issues has the potential to limit the negative impact of concussion, promote recovery, and potentially help prevent persistent concussion symptoms in this at-risk population.

Diet, physical activity, and obesity among ART-experienced people with HIV in South Africa.

The prevalence of non-communicable diseases (NCDs) is increasing in South Africa, in part due to poor nutrition, physical inactivity, and obesity. We characterized the habits and understanding of diet, exercise, and obesity among people with HIV (PWH) taking antiretroviral therapy (ART). We conducted a cross-sectional study of ART-experienced PWH attending an HIV community health center near Cape Town, South Africa. We included PWH currently prescribed ART, older than 21y, and not pregnant. We collected demographic and clinical information and interviewed participants regarding their behaviors and knowledge related to diet, physical activity, and obesity. From March 2015 - February 2016, we enrolled 458 participants. Self-reported diets were low in nutritional diversity: 202 reported eating only starch and protein without vegetable/fruit in the prior 24 h. Although most participants (96%) acknowledged that exercise had health benefits, only 215 participants engaged in daily 30-minute walking or exercise. One quarter of participants recognized nocontributors to obesity, and almost 20% identified no health problems associated with obesity. Participants had diets low in nutritional diversity, modest exercise habits, and limited understanding of the impact of obesity on health. Further understanding of barriers to improving diet and exercise and reducing obesity are essential, especially as PWH age.

Experiences of participants in a decentralized antiretroviral therapy program in South Africa during the COVID-19 pandemic.

The COVID-19 pandemic and associated restrictions could adversely affect long-term HIV care. We evaluated the experiences of people receiving antiretroviral therapy (ART) through a decentralized delivery program in South Africa during the COVID-19 pandemic. We telephoned a random subsample of participants enrolled in a prospective cohort study in KwaZulu-Natal in April and May 2020 and administered a semi-structured telephone interview to consenting participants. We completed interviews with 303 of 638 contacted participants (47%); 66% were female, with median age 36y. The most common concerns regarding the COVID-19 pandemic were food running out (121, 40%), fear of becoming infected with COVID-19 (103, 34%), and being unable to work/losing employment or income (102, 34%). Twenty-five (8%) participants had delayed ART pick-up due to the pandemic, while 212 (70%) had new concerns about ART access going forward. Mental health scores were worse during the pandemic compared to baseline (median score 65.0 vs 80.0, p < 0.001). Decentralized ART distribution systems have the potential to support patients outside of health facilities during the COVID-19 pandemic, but economic concerns and mental health impacts related to the pandemic must also be recognized and addressed.

Willingness to accept COVID-19 vaccination among people living with HIV in a high HIV prevalence community.

BACKGROUND: People living with HIV (PLWH) may have a poorer prognosis with COVID-19 infection and are an important population for COVID-19 vaccination. We assessed the willingness and reasons for COVID-19 vaccine acceptance or hesitancy among PLWH in South Africa. METHODS: We conducted a cross-sectional study consisting of telephone interviews with a randomly selected subset of participants enrolled in a prospective observational cohort study evaluating a decentralized antiretroviral therapy (ART) delivery program in South Africa. Questions assessed willingness to accept a future COVID-19 vaccine, concerns regarding COVID-19 vaccination, and overall vaccine confidence. Interviews were conducted between September 2020 and January 2021. We evaluated participant demographics, sources of COVID-19 information, stigma and medical mistrust, uptake of non-pharmaceutical interventions, and socioeconomic impacts of the COVID-19 pandemic as potential covariates of willingness to accept vaccination. RESULTS: We completed interviews with 213 participants; 153 (72%) were female, median age 35y, and 100 (47%) had completed secondary school. Among the participants, 121 (57%) were willing to accept future vaccination, 46 (22%) were unsure, and 45 (21%) stated they did not intend to be vaccinated. Fear of side effects, reported by 42 (20%), was the most common concern about COVID-19 vaccination. Older age was associated with willingness to accept vaccination (aOR 1.75 for every 10-year increase in age, 95% CI 1.10-2.78, p = 0.02), while higher medical mistrust related to COVID-19 (aOR 0.21, 95% CI 0.093-0.45, p < 0.001) and use of social media for COVID-19 information (aOR 0.30, 95% CI 0.11-0.84, p = 0.02) were associated with lower willingness to accept vaccination. CONCLUSIONS: In this cohort of PLWH in South Africa, over half were willing to accept COVID-19 vaccination, although a substantial proportion remained unsure or were not willing to be vaccinated. Public health messaging should emphasize the safety and efficacy of COVID-19 vaccination and address misinformation and medical mistrust among PLWH. Ongoing efforts to ensure access to COVID-19 vaccines for vulnerable populations are crucial.

Willingness to accept COVID-19 vaccination among people living with HIV in a high HIV prevalence community.

Background People living with HIV (PLWH) may have a poorer prognosis with COVID-19 infection and are an important population for COVID-19 vaccination. We assessed the willingness and reasons for COVID-19 vaccine acceptance or hesitancy among PLWH in South Africa. Methods We conducted a cross-sectional study consisting of telephone interviews with a randomly selected subset of participants enrolled in a prospective observational cohort study evaluating a decentralized antiretroviral therapy (ART) delivery program in South Africa. Questions assessed willingness to accept a future COVID-19 vaccine, concerns regarding COVID-19 vaccination, and overall vaccine confidence. Interviews were conducted between September 2020 and January 2021. We evaluated participant demographics, sources of COVID-19 information, stigma and medical mistrust, uptake of non-pharmaceutical interventions, and socioeconomic impacts of the COVID-19 pandemic as potential covariates of willingness to accept vaccination. Results We completed interviews with 213 participants; 153 (72%) were female, median age 35y, and 100 (47%) had completed secondary school. Among the participants, 121 (57%) were willing to accept future vaccination, 46 (22%) were unsure, and 45 (21%) stated they did not intend to be vaccinated. Fear of side effects, reported by 42 (20%), was the most common concern about COVID-19 vaccination. Older age was associated with willingness to accept vaccination (aOR 1.75 for every 10-year increase in age, 95% CI 1.10-2.78, p=0.02), while higher medical mistrust related to COVID-19 (aOR 0.21, 95% CI 0.093-0.45, p<0.001) and use of social media for COVID-19 information (aOR 0.30, 95% CI 0.11-0.84, p=0.02) were associated with lower willingness to accept vaccination. Conclusions In this cohort of PLWH in South Africa, over half were willing to accept COVID-19 vaccination, although a substantial proportion remained unsure or were not willing to be vaccinated. Public health messaging should emphasize the safety and efficacy of COVID-19 vaccination and address misinformation and medical mistrust among PLWH. Ongoing efforts to ensure access to COVID-19 vaccines for vulnerable populations are crucial.

Daytime Sleep Behaviors and Cognitive Performance in Middle- to Older-Aged Adults Living with and without HIV Infection.

PURPOSE: We investigated whether daytime sleep behaviors (DSBs) such as frequent daytime sleepiness or napping are associated with worse cognitive performance, and whether HIV infection moderates this relationship. METHODS: Among 502,507 participants in the UK Biobank study, we identified 562 people living with HIV infection (PLWH; M age= 50.51±7.81; 25.09% female; 78.83% white) and extracted 562 uninfected controls who matched on age, sex, ethnic background, social-economic status, and comorbidities. DSB burden was assessed based on answers to two questions on DSBs. Participants who answered "sometimes" or "often/usually" to one of them were considered to have poor DSB burden, or otherwise were considered not having any. A composite cognition score was computed by averaging the available standardized individual test results from four neurocognitive tests: ie, a reaction time test for information processing speed, a pairs matching test for visual episodic memory, a fluid intelligence test for reasoning, and a prospective memory test. Mixed-effects models with adjustment for the variables used in extracting matched uninfected controls were performed to test the hypotheses. RESULTS: Having poor DSB burden was associated with a 0.15 - standard deviation (SD) decrease in cognitive performance (p = 0.006). People living with HIV infection (PLWH) also performed worse on the cognitive tasks than uninfected controls, with an effect size similar to that of having poor DSB burden (p = 0.003). HIV infection significantly modified the negative association between DSB burden and cognition (p for interaction: 0.008). Specifically, the association between DSB burden and cognition was not statistically significant in uninfected controls, whereas PLWH who reported having poor DSB burden had a 0.28 - SD decrease in cognitive performance compared to PLWH who did not. CONCLUSION: HIV infection significantly increased the adverse association between DSBs and cognitive performance. Further studies are needed to investigate the potential mechanisms that underlie this interaction effect and whether poor DSBs and worse cognitive performance are causally linked.

Uptake of community- versus clinic-based antiretroviral therapy dispensing in the Central Chronic Medication Dispensing and Distribution program in South Africa.

INTRODUCTION: South Africa's government-led Central Chronic Medication Dispensing and Distribution (CCMDD) program offers people living with HIV the option to collect antiretroviral therapy at their choice of community- or clinic-based pick-up points intended to increase convenience and decongest clinics. To understand CCMDD pick-up point use among people living with HIV, we evaluated factors associated with uptake of a community- versus clinic-based pick-up point at CCMDD enrolment. METHODS: We collected baseline data from October 2018 to March 2020 on adults (≥18 years) who met CCMDD clinical eligibility criteria (non-pregnant, on antiretroviral therapy for ≥1 year and virologically suppressed) as part of an observational cohort in seven public clinics in KwaZulu-Natal. We identified factors associated with community-based pick-up point uptake and fit a multivariable logistic regression model, including age, gender, employment status, self-perceived barriers to care, self-efficacy, HIV-related discrimination, and perceived benefits and challenges of CCMDD. RESULTS AND DISCUSSION: Among 1521 participants, 67% were females, with median age 36 years (IQR 30-44). Uptake of a community-based pick-up point was associated with younger age (aOR 1.18 per 10-year decrease, 95% CI 1.05-1.33), being employed ≥40 hours per week (aOR 1.42, 95% CI 1.10-1.83) versus being unemployed, no self-perceived barriers to care (aOR 1.42, 95% CI 1.09-1.86) and scoring between 36 and 39 (aOR 1.44, 95% CI 1.03-2.01) or 40 (aOR 1.91, 95% CI 1.39-2.63) versus 10-35 on the self-efficacy scale, where higher scores indicate greater self-efficacy. Additional factors included more convenient pick-up point location (aOR 2.32, 95% CI 1.77-3.04) or hours (aOR 5.09, 95% CI 3.71-6.98) as perceived benefits of CCMDD, and lack of in-clinic follow-up after a missed collection date as a perceived challenge of CCMDD (aOR 4.37, 95% CI 2.30-8.31). CONCLUSIONS: Uptake of community-based pick-up was associated with younger age, full-time employment, and systemic and structural factors of living with HIV (no self-perceived barriers to care and high self-efficacy), as well as perceptions of CCMDD (convenient pick-up point location and hours, lack of in-clinic follow-up). Strategies to facilitate community-based pick-up point uptake should be tailored to patients' age, employment, self-perceived barriers to care and self-efficacy to maximize the impact of CCMDD in decongesting clinics.

Curable sexually transmitted infections among women with HIV in sub-Saharan Africa.

OBJECTIVES: Sexually transmitted infections (STIs) cause significant morbidity among women with HIV and increase HIV transmission. We estimated the prevalence of four STIs among women with HIV in sub-Saharan Africa (SSA) and compared prevalence among women with and without HIV. DESIGN: Systematic review and meta-analysis. METHODS: We searched for studies published 1 January 1999 to 19 December 2019 reporting prevalence of gonorrhea, chlamydia, trichomoniasis, or Mycoplasma genitalium among women with HIV in SSA. We excluded studies conducted in high-risk groups (e.g. female sex workers). We extracted data on laboratory-confirmed STIs among women with HIV, and when included, among women without HIV. We estimated pooled prevalence for each STI among women with HIV using inverse variance heterogeneity meta-analysis, compared prevalence to women without HIV, and examined the influences of region, clinical setting, and pregnancy status in subgroup analyses. RESULTS: We identified 3756 unique records; 67 studies were included in the meta-analysis. Prevalence of gonorrhea, chlamydia, trichomoniasis, and M. genitalium was 3.5, 4, 15.6, and 10.2%, respectively. Chlamydia prevalence was lower in Eastern (2.8%) than in Southern (12.5%) and West/Central (19.1%) Africa combined. Prevalence of chlamydia and trichomoniasis was higher among pregnant (8.1%, 17.6%) than nonpregnant (1.7%, 12.3%) women. All STIs were more prevalent among women with than without HIV (relative risks ranging 1.54-1.89). CONCLUSION: STIs are common among women with HIV in SSA, and more common among women with than without HIV. Integrated STI and HIV care could substantially impact STI burden among women with HIV, with potential downstream impacts on HIV transmission.

A REDCap-based model for online interventional research: Parent sleep education in autism.

INTRODUCTION: The use of online platforms for pediatric healthcare research is timely, given the current pandemic. These platforms facilitate trial efficiency integration including electronic consent, randomization, collection of patient/family survey data, delivery of an intervention, and basic data analysis. METHODS: We created an online digital platform for a multicenter study that delivered an intervention for sleep disorders to parents of children with autism spectrum disorder (ASD). An advisory parent group provided input. Participants were randomized to receive either a sleep education pamphlet only or the sleep education pamphlet plus three quick-tips sheets and two videos that reinforced the material in the pamphlet (multimedia materials). Three measures - Family Inventory of Sleep Habits (FISH), Children's Sleep Habits Questionnaire modified for ASD (CSHQ-ASD), and Parenting Sense of Competence (PSOC) - were completed before and after 12 weeks of sleep education. RESULTS: Enrollment exceeded recruitment goals. Trial efficiency was improved, especially in data entry and automatic notification of participants related to survey completion. Most families commented favorably on the study. While study measures did not improve with treatment in either group (pamphlet or multimedia materials), parents reporting an improvement of ≥3 points in the FISH score showed a significantly improved change in the total CSHQ (P = 0.038). CONCLUSION: Our study demonstrates the feasibility of using online research delivery platforms to support studies in ASD, and more broadly, pediatric clinical and translational research. Online platforms may increase participant inclusion in enrollment and increase convenience and safety for participants and study personnel.

Medical Mistrust and Stigma Associated with COVID-19 Among People Living with HIV in South Africa.

We evaluated COVID-19 stigma and medical mistrust among people living with HIV in South Africa. We conducted telephone interviews with participants in a prospective study of a decentralized antiretroviral therapy program. Scales assessing medical mistrust, conspiracy beliefs, anticipated and internalized stigma, and stereotypes specific to COVID-19 were adapted primarily from the HIV literature, with higher scores indicating more stigma or mistrust. Among 303 participants, the median stigma summary score was 4 [interquartile range (IQR) 0-8; possible range 0-24] and 6 (IQR 2-9) for mistrust (possible range 0-28). A substantial proportion of participants agreed or strongly agreed with at least one item assessing stigma (54%) or mistrust (43%). Higher COVID-19 stigma was associated with female gender and antecedent HIV stigma, and lower stigma with reporting television as a source of information on COVID-19. Further efforts should focus on effects of stigma and mistrust on protective health behaviors and vaccine hesitancy.

A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study.

BACKGROUND: Every year, approximately 42 million people sustain a mild traumatic brain injury (mTBI, also known as concussion), with particularly high rates among college-aged individuals. A substantial proportion of these people (44%-64%) develop persistent symptoms that are challenging to treat, costly, and associated with significant disability. Anxiety has emerged as a risk factor for progression from acute to persistent mTBI symptoms. OBJECTIVE: This study aims to develop, adapt, and establish the feasibility of the Toolkit for Optimal Recovery after Concussions (TOR-C), an innovative mind-body program aimed at preventing persistent symptoms among young adults with mTBI and comorbid anxiety. Here, we describe the proposed study design, methodology, measurement, and treatment manuals. METHODS: In phase 1, we will conduct individual, live video qualitative interviews (up to n=20) with college-aged individuals with mTBI and comorbid anxiety to inform adaptation of the intervention and study procedures. In phase 2, an open pilot of the live video TOR-C (n=5) with exit interviews will be conducted to explore the initial feasibility, acceptability, and credibility of the program and to refine the study procedures. Phase 3 will involve conducting a feasibility randomized controlled trial (N=50) of the TOR-C versus a health education control (Health Enhancement for Concussions; HE-C), both delivered via live video, to establish feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection; feasibility, credibility, and acceptability of the live video TOR-C and HE-C (adherence, retention, fidelity, and satisfaction) following prespecified benchmarks; and a signal of improvement in outcomes. RESULTS: Phase 1 of the study has been approved by the Massachusetts General Hospital Institutional Review Board. Study completion is anticipated by early 2025. CONCLUSIONS: We will develop and test the first mind-body intervention focused on prevention of persistent symptoms following mTBI in young adults with comorbid anxiety problems. This will allow us to establish feasibility markers in postconcussive symptoms, anxiety, disability, and fear avoidance to inform a future efficacy trial of the TOR-C versus HE-C. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25746.