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Type 1 diabetes (T1D) is a chronic condition affecting nearly 1.9 million people in the United States. Young adults (YAs) with T1D face unique challenges in managing their condition, experiencing poorer health and well-being than other age groups. The current study is evaluating the Resilient, Empowered, Active Living (REAL) intervention, previously shown to improve glucose levels and quality of life among YAs with diabetes, using telehealth delivery (REAL-T) to expand reach and accessibility. This paper reports on the methodology and baseline participant characteristics of the REAL-T study. REAL-T is a two-arm randomized controlled trial that recruited 18–30 year olds with T1D via clinics and social media advertising. Data collection, which was adapted to be fully remote due to COVID-19, occurs every three months for one year. Participants receive either usual care or a 6-month telehealth occupational therapy intervention. The primary outcome is glycated hemoglobin (A1c); secondary outcomes include diabetes distress, quality of life, and continuous glucose monitor-derived measures. The study enrolled a diverse sample of 209 YAs with T1D. Analysis of baseline data indicates equivalence between the intervention and control groups. Study participants have notably higher diabetes distress and poorer mental well-being than similar populations. The REAL-T study successfully adapted to remote implementation during the COVID-19 pandemic. By examining long-term outcomes, mediating pathways, and cost-effectiveness, the study will contribute knowledge of the impact of tailored interventions for YAs with T1D, designed to reduce disparities and improve health and well-being in this population. [ABSTRACT FROM AUTHOR]

Although unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in treatment and experience variable responses to treatment. We describe the rationale, aims, and study design for the F inancial I ncentives, R andomization, with S tepped T reatment (FIRST) Trial, a multi-site randomized controlled efficacy trial. PWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20 ng/mL, and were not engaged in formal alcohol treatment were randomized to integrated contingency management with stepped care versus treatment as usual. The intervention involved two steps; Step 1 : Contingency management (n = 5 sessions) with potential rewards based on 1) short-term abstinence; 2) longer-term abstinence; and 3) completion of healthy activities to promote progress in addressing alcohol consumption or conditions potentially impacted by alcohol; Step 2 : Addiction physician management (n = 6 sessions) plus motivational enhancement therapy (n = 4 sessions). Participants' treatment was stepped up at week 12 if they lacked evidence of longer-term abstinence. Primary outcome was abstinence at week 24. Secondary outcomes included alcohol consumption (assessed by TLFB and PEth) and the Veterans Aging Cohort Study (VACS) Index 2.0 scores; exploratory outcomes included progress in addressing medical conditions potentially impacted by alcohol. Protocol adaptations due to the COVID-19 pandemic are described. The FIRST Trial is anticipated to yield insights on the feasibility and preliminary efficacy of integrated contingency management with stepped care to address unhealthy alcohol use among PWH. ClinicalTrials.gov identifier: NCT03089320. • People with HIV (PWH) often are ambivalent about engaging in treatment of unhealthy alcohol use. • Contingency management holds promise for reducing unhealthy alcohol use among PWH. • Stepped care strategies are important given lack of consistent response to alcohol treatments. [ABSTRACT FROM AUTHOR]

Abstract: High consumption of sugar-sweetened beverages (SSB) contributes to a wide range of poor health outcomes. Further, few US adults drink less than the recommended ≤8oz per day; and individuals with low socioeconomic, low health literacy status, and in rural areas are even less likely to meet recommendations. Unfortunately, few SSB behavioral interventions exist targeting adults, and none focus on low health literacy in rural areas. Talking Health, a type 1 effectiveness-implementation hybrid trial targeting adults in rural southwest Virginia, was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore). SIPsmartER was developed based upon the Theory of Planned Behavior and uses health literacy strategies to improve comprehension of the intervention content among participants. MoveMore is based on a research-tested intervention that was adapted to address all theory of planned behavior constructs and health literacy principles. Secondary aims include additional health outcomes (e.g., physical activity, weight) and reach, adoption, implementation, and maintenance indicators. This paper highlights the opportunities and considerations for developing health behavior trials that aim to determine intervention effectiveness, provide all study participants an opportunity to benefit from research participation, and collect key information on reach and the potential for organizational adoption, implementation, and maintenance with the longer-term goal of speeding translation into practice settings. [Copyright &y& Elsevier]

Abstract: Depression affects 20–30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV adherence and clinical outcomes in PLWHA with depression. The Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC) Study is a randomized clinical effectiveness trial funded by the National Institute for Mental Health. The objective of SLAM DUNC is to test whether a depression treatment program integrated into routine HIV clinical care affects ARV adherence. PLWHA with depression (n=390) are randomized to enhanced usual care or a depression treatment model called Measurement-Based Care (MBC). MBC deploys a clinically supervised Depression Care Manager (DCM) to provide evidence-based antidepressant treatment recommendations to a non-psychiatric prescribing provider, guided by systematic and ongoing measures of depressive symptoms and side effects. MBC has limited time requirements and the DCM role can be effectively filled by a range of personnel given appropriate training and supervision, enhancing replicability. In SLAM DUNC, MBC is integrated into HIV care to support HIV providers in antidepressant prescription and management. The primary endpoint is ARV adherence measured by unannounced telephone-based pill counts at 6months with follow-up to 12months and secondary endpoints including viral load, health care utilization, and depressive severity. Important outcomes of this study will be evidence of the effectiveness of MBC in treating depression in PLWHA and improving HIV-related outcomes. [Copyright &y& Elsevier]

Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120–159 mmHg; a diastolic blood pressure of 80–99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875 [ABSTRACT FROM AUTHOR]

Abstract: Obesity prevalence is increasing in the U.S., especially among children and minority populations. This report describes the design and baseline data of the ongoing Girls health Enrichment Multi-site Studies (GEMS) trial (Memphis site), which is testing the efficacy of a 2-year family-based intervention to reduce excessive increase in body mass index (BMI). This randomized, controlled trial conducted at community centers in Memphis, Tennessee requires major measurements at baseline and at 12 and 24 months post-randomization. The participants are healthy African-American girls and one parent/caregiver of each girl. Participating girls are of ages 8–10 years, with BMI≥25th percentile of the CDC 2000 growth charts or with one overweight or obese parent/caregiver (BMI≥25 kg/m2). The active intervention is designed to prevent excessive weight gain by promoting healthy eating habits and increasing physical activity. An alternative intervention (comparison group) promotes general self-esteem and social efficacy. The main outcome measure is the difference between the two treatment groups in the change in BMI at 2 years. Three hundred and three girls have been randomly assigned to receive the test intervention (n =153) or the alternative intervention (n =150). The two groups do not differ in baseline characteristics. At the time of enrollment, the mean age was 9 years, the mean BMI was 22 kg/m2 (mean BMI percentile=77th), and 41% were overweight (BMI≥95th percentile using CDC 2000 growth charts). Participants'' intake of fruits and vegetables (1.3 serving/day) and fats (36% kcal), and their participation in moderate-to-vigorous physical activity (20 min/day), did not meet national recommendations. The GEMS obesity prevention intervention targets improved diet and increased physical activity to reduce excessive weight gain in healthy African-American girls of ages 8–10. [Copyright &y& Elsevier]

By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population. This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH. This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial. • This is the first large-scale prevention trial for older people living with HIV. • Novel methods employed enhance fidelity to treatment delivery. • Features of this RCT blend efficacy and effectiveness designs. [ABSTRACT FROM AUTHOR]