Integrating an online weight management program with population health management in primary care: Design,methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies)

BackgroundScalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.MethodsWe adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m², and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.ResultsWe enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m²; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.ConclusionIt is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings.ClinicalTrials.gov registration number: NCT02656693     

Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial)

BackgroundLow back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP.Methods and study designThe TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently.DiscussionThe TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT.Trial Registration: ClinicalTrials.gov NCT02647658 Registered Jan. 6, 2016.     

Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City)

IntroductionType 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.MethodsThe “Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento” [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30–65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.DiscussionFindings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an ‘at-risk’ population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.Trial registrationThis trial is registered at Clinicaltrials.gov (NCT03194009).     

Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study

BackgroundTobacco, alcohol and opioid misuse are associated with substantial morbidity and mortality among people with HIV (PWH). Despite existence of evidence-based counseling and medications for addiction, these treatments are infrequently offered in HIV clinics. The Working with HIV clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study was conducted to address this implementation challenge. The study's goals were to conduct a formative evaluation of barriers to and facilitators of implementing addiction treatment for PWH followed by an evaluation of the impact of Implementation Facilitation (IF) on promoting adoption of addiction treatments and clinical outcomes.MethodsThe study was conducted at four HIV clinics in the northeast United States, using a hybrid type 3 effectiveness-implementation stepped wedge design and guided by the Promoting Action on Research Implementation in Health Services Research (PARiHS) framework. A mixed-methods approach was used to identify evidence, context, and facilitation-related barriers to and facilitators of integration of addiction treatments into HIV clinics and to help tailor IF for each clinic. An evaluation was then conducted of the impact of IF on implementation outcomes, including provision of addiction treatment (primary outcome), organizational and clinician and staff readiness to adopt addiction treatment, and changes in organizational models of care used to deliver addiction treatment. The evaluation also included IF's impact on effectiveness outcomes, specifically HIV-related outcomes among patients eligible for addiction treatment.ConclusionsResults will generate important information regarding the impact of IF as a reproducible strategy to promote addiction treatment in HIV clinics.     

Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol

BackgroundFunctional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders.MethodsThe “MANTRA” (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist (‘biofeedback’) and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures.DiscussionThere have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders.TRIAL REGISTRATION Number: Clinicaltrials.gov NCT03078634Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017.Ethics and Dissemination:Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences.Protocol version 1.2     

Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness

BackgroundCardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk.Methods/Design78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications.DiscussionThis cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020.Trial registrationClinicalTrials.gov Identifier: NCT02451670     

Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study

BackgroundDespite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities. TACTICS combines a needs assessment, a rubric for selecting implementation strategies based on local barriers, an implementation toolkit, and external facilitation to support local champions and their implementation teams in enacting changes. This paper describes the rationale for and design of a study that will evaluate whether TACTICS can increase implementation of PE for PTSD and improve patient outcomes in military BH clinics relative to provider training in PE alone.MethodsThe study is a multi-site, cluster randomized, stepped-wedge trial, with the military treatment facility as the unit of analysis. Eight facilities undergo a provider-training phase, followed by 5 months of TACTICS implementation. The timing of TACTICS at each facility is randomly assigned to begin 9, 14, or 19 months after beginning the provider-training phase. Primary analyses will compare the proportion of PTSD patients receiving PE and patients' mean improvement in PTSD symptoms before and after the onset of TACTICS.DiscussionTACTICS endeavors to balance standardization of empirically-supported implementation strategies with the flexibility of application necessary for success across varied clinical settings. If successful, TACTICS may represent a systematic and scalable method of promoting and supporting EBP implementation.Trial registrationClinicaltrials.gov Identifier: NCT03663452     

Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol

IntroductionMost smokers see a physician each year, but few use any assistance when they try to quit. Text messaging programs improve smoking cessation in community and school settings; however, their efficacy in a primary care setting is unclear. The current trial assesses the feasibility and preliminary clinical outcomes of text messaging and mailed nicotine replacement therapy (NRT) among smokers in primary care.MethodsIn this single-center pilot randomized trial, eligible smokers in primary care are offered brief advice by phone and randomly assigned to one of four interventions: (1) Brief advice only, (2) text messages targeted to primary care patients and tailored to quit readiness, (3) a 2-week supply of nicotine patches and/or lozenges (NRT), and (4) both text messaging and NRT. Randomization is stratified by practice and intention to quit. The text messages (up to 5/day) encourage those not ready to quit to practice a quit attempt, assist those with a quit date through a quit attempt, and promote NRT use. The 2-week supply of NRT is mailed to patients' homes.ResultsFeasibility outcomes include recruitment rates, study retention, and treatment adherence. Clinical outcomes are assessed at 1, 2, 6, and 12-weeks post-enrollment. The primary outcome is ≥1self-reported quit attempt(s). Secondary clinical outcomes include self-reported past 7- and 30-day abstinence, days not smoked, NRT adherence, and exhaled carbon monoxide.ConclusionsThis pilot assesses text messaging plus NRT, as a proactively offered intervention for smoking cessation support in smokers receiving primary care and will inform full-scale randomized trial planning.Trial registrationClinicalTrials.govNCT03174158.     

Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes

BackgroundAdolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.MethodsThis research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).DiscussionAYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.Trial registrationThe study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).     

A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial

BackgroundDespite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance.MethodsForty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study.DiscussionThis study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing.Trial registrationClinicalTrials.gov identifier: NCT03891368Registered 25 March 2019, retrospectively registered.https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1     

Rationale,design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial

BackgroundElevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients.MethodsThe Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2–12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months.ResultsA total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms.ConclusionsUsing a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients.Trial registration: ClinicalTrials.gov (NCT 01993017).     

Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic,feasibility, online randomized trial protocol

BackgroundHigh attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap.PurposeTo describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business.MethodsThis study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m², and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program.DiscussionThis study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.     

A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol

Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.MethodsThe Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16–29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity.DiscussionBehavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population.Trial registration: ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.     

A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings

IntroductionEquitable delivery of advance care planning and symptom management among patients is crucial to improving cancer care. Existing interventions to improve the uptake of these services have predominantly occurred in clinic settings and are limited in their effectiveness, particularly among low-income and minority populations.MethodsThe “Lay health worker Educates Engages and Activates Patients to Share (LEAPS)” intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings. The intervention provides a lay health worker to all patients newly diagnosed with cancer and aims to educate and activate patients to engage in advance care planning and symptom management with their oncology providers. In this randomized clinical trial, we will evaluate the effect on quality of life (primary outcome) using the validated Functional Assessment of Cancer Therapy – General Survey, at enrollment, 4- and 12- months post-enrollment. We will examine between-group differences on our secondary outcomes of patient activation, patient satisfaction with healthcare decision-making, and symptom burden (at enrollment, 4- and 12-months post-enrollment), and total healthcare use and healthcare costs (at 12-months post-enrollment).DiscussionMultilevel approaches are urgently needed to improve cancer care delivery among low-income and minority patients diagnosed with cancer in community settings. The current study describes the LEAPS intervention, the study design, and baseline characteristics of the community centers participating in the study.ClinicalTrials.gov Registration #NCT03699748.     

Design and sample characteristics of COordinated Oral health Promotion (CO-OP) Chicago: A cluster-randomized controlled trial

COordinated Oral health Promotion (CO-OP) Chicago is a two-arm cluster-randomized trial with a wait-list control. The primary aim is to evaluate the efficacy of an oral health community health worker (CHW) intervention to improve oral health behaviors in low-income, urban children under the age of three years. Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting. This paper describes progress toward achieving these aims. Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois. Sites were cluster-randomized to CHW intervention or usual services (a wait-list control). The intervention is oral health support from CHWs delivered in four visits to individual families over one year. The trial sample consists of 420 child/caregiver dyads enrolled at the 20 participating sites over 11 months. Participant demographics varied across the sites, but primary outcomes values at baseline did not. Data on brushing frequency, plaque, and other oral health behaviors are collected at three timepoints: baseline, 6-, and 12-months. The primary analysis will assess differences in caregiver-reported child brushing frequency and observed plaque score between the two arms at 12-months. The trial is currently in the active intervention phase. The trial's cluster-randomized controlled design takes a real-world approach by integrating into existing health and social service agencies and collecting data in participant homes. Results will address an important child health disparity. ClinicalTrials.gov identifier: NCT03397589.Clinical trial registrationUniversity of Illinois at Chicago Protocol Record 2017–1090. National Institutes of Dental & Craniofacial Research of the National Institutes of Health (NIDCR) Protocol Number: 17–074-E. NCT03397589     

Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV

PurposeBy 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.MethodsThis 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.ConclusionThis 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.     

Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life,the baby-act trial: Rationale and design

Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs.Objectives1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.MethodsThe lifestyle intervention focuses on age-appropriate infant physical activation, healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling. It is being tested among caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12 months of age. The main outcome is infant rate of weight gain at 12 months; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors. We are also recording fees, time and personnel involved in the intervention development, maintenance and dissemination.ConclusionsIf successful, the intervention could be incorporated as a ‘best practice’ through WIC policy as a means to strengthen obesity prevention efforts to improve minority health and eliminate health disparities among Hispanics and possibly other at-risk groups beyond the childhood period.Clinicaltrials.gov registration: NCT03517891.