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Introduction: Sexual and reproductive health is critical for the readiness of the warfighter, as costs of sexually transmitted infections and unintended pregnancy result in added health care costs, lost mission time, and impact on morale. The Multiphase Optimization Strategy (MOST) is an engineering-inspired framework used to optimize biobehavioral interventions. The Military Active-Duty Reproductive and Sexual Health (MARSH) research team applied the MOST framework to develop "Mission Wellness"-an electronic health intervention to promote sexual and reproductive health within the U.S. Military., Materials and Methods: From 2017 to 2022, the MARSH team implemented the first and second phases of MOST to develop and optimize "Mission Wellness." All phases received institutional review board approval. The first phase consisted of expert and literature review, qualitative interviews, and beta testing to identify intervention components and the optimization objective and to inform study design. The second phase consisted of a factorial trial., Results: Figures 1-4 outline the research program approach, demographics of the sample, and format of the app. Service members who used the application found it to be acceptable and, overall, reported that it would be easier to talk to a sexual partner about risk behaviors and history at the post-intervention assessment compared to baseline. This iterative optimization approach using both local and strategic engagement enhanced program development and set the stage for dissemination and implementation efforts., Conclusions: In line with the iterative nature of MOST, the lessons learned during the optimization trial led the MARSH team to return "Mission Wellness" to the preparation phase. The utilization of mixed (i.e., qualitative and quantitative) research methods and engagement with stakeholders at multiple levels of the military enterprise provided the information necessary to further optimize "Mission Wellness." This programmatic approach also provides a blueprint for the development of research design and testing in military health care balancing rigor and agility., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2024. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Background: Suicide and self-injurious behavior (SSIB) in youth 10 to 14 years old has rapidly increased, with suicide rates for youth 10 to 18 years being the second leading cause of death. Youth with SSIB seen in the Emergency Department (ED) are often discharged to the community, yet less than 40% receive subsequent mental health (MH) care within 30 days. This open pilot study examined the feasibility, acceptability, and sample characteristics of a two-component Family Navigator with text messaging intervention, ED REaCH, for caregivers of youth with SSIB discharged from the ED., Methods: Sixteen dyads of youth (M=12.67; SD=1.09) seeking emergency care for SSIB and their caregivers were enrolled from the ED of a pediatric hospital in the northeast US from November 2023 to March 2024. Dyads were enrolled in the ED REaCH intervention consisting of navigation procedures to promote linkage to care, engagement in community-based MH care for youth with SSIB, and a digital platform to extend purported mechanisms underlying the intervention's efficacy (MH literacy, MH communication, and MH engagement). Data was collected on measures of social identities, demographics, functioning, MH services, and intervention satisfaction., Results: All (100%) caregivers accepted the text messages. Most (75%) utilized the Family Navigator and completed the intervention feedback interviews. Overall, caregivers endorsed positive experiences and satisfaction with the two-component intervention. All caregivers who utilized the Family Navigator reported that 100% of youth attended MH care., Conclusion: Preliminary findings suggest that the content and delivery methods of this intervention are perceived by caregivers as feasible and acceptable. As such, next steps include the evaluation of the ED REaCH intervention in a randomized clinical trial design. Future directions need to focus on intervention scalability, adaptability, personalization, and sustainability.

Aim: In this secondary analysis of a pilot randomized controlled trial (RCT), we sought to examine whether mindfulness training (MT) is associated with change in interoceptive awareness in pregnant people at risk for hypertension using quantitative and qualitative methods. Interoceptive awareness is the perception, regulation, and integration of bodily sensations. Interoceptive awareness increases following MT and has been proposed as a psychosomatic process underlying hypertension outside of pregnancy. Methods: Twenty-nine participants (mean age 32 ± 4 years; 67% White) with a history of hypertensive disorders of pregnancy (HDP) were enrolled at 16 weeks' gestation (SD = 3) for a RCT assessing the feasibility and acceptability of an 8-week phone-delivered MT intervention. Fifteen participants were randomized to MT, whereas 14 were randomized to usual prenatal care. Before and after the intervention, all participants completed the Multidimensional Assessment of Interoceptive Awareness (MAIA) measure and participated an individual interview, which queried for mind-body changes noticed across the study period. Results: Adjusting for baseline interoceptive awareness and gestational age, participants randomized to MT reported less worry about physical sensations on the MAIA after the intervention compared to those randomized to usual care. Qualitative data corroborated these results; MT participants described improved awareness of body and breath sensations, ability to notice blood pressure changes, non-judgmental observation of thoughts, and improved responses to interpersonal challenges. Conclusions: MT may improve the ability to notice body sensations that arise in pregnancy in a way that promotes healthy responding rather than worry. Results provide support for interoceptive awareness as a potential mechanism through which mindfulness may modulate blood pressure and potentially reduce the prevalence of HDP. C linical Trial Registration: ClinicalTrials.gov (NCT03679117).

Background: A growing body of research focuses on developing and testing interventions that leverage mental health-related mobile health (mHealth) services for patients with schizophrenia and other schizophrenia-spectrum disorders. Yet, most formative research has focused on patient perspectives, with little attention paid to clinical stakeholders., Aims: This qualitative study aimed to explore clinical stakeholders' (i.e., administrative supervisors, support staff, and clinicians) perspectives on what might help or hinder the use of mHealth, particularly when patients transition from inpatient to outpatient care., Methods: In-depth individual qualitative interviews were conducted with 18 stakeholders from inpatient and outpatient psychiatric settings., Results: Four key themes were identified: (a) adherence challenges; (b) role of mobile technology in patient care; (c) clinical professionals' receptiveness to adjunctive mHealth services; and, (d) costs related to implementation of mHealth services., Conclusions: Overall, stakeholders agree with extant data showing that supportive networks are important in facilitating patients' return to the community following hospitalization. Stakeholders welcome mHealth services but suggest they should be appropriately tailored to the population, both in terms of usability and connection to ongoing traditional treatments. Demonstration of added value will likely facilitate wider implementation of mHealth services in the care of patients with schizophrenia and other schizophrenia-spectrum disorders.

Mission readiness is critical to the operational success of the United States (US) military and includes having a healthy and fit fighting force. Service members and their dependents have access to a wide range of sexual and reproductive health services with no out-of-pocket costs. Despite this access, negative outcomes such as sexually transmitted infections (STIs) and unintended pregnancy persist. Semi-structured, in-depth interviews were conducted with service members and stakeholders (e.g. medical providers). Interviews explored the individual, interpersonal, organizational, and institutional factors that inform sexual norms, behaviors, and healthcare experiences in the US military. Interview transcripts were coded manually; data were summarized for themes related to unique aspects of military culture and healthcare affecting sexual and reproductive health. Twenty-five (25) service members and 15 stakeholders completed interviews. Four themes emerged: 1) despite free access, both general and military-specific barriers to sexual and reproductive healthcare persist; 2) general and military-specific cultural norms apply to sexual behavior and care seeking; 3) sexual and reproductive health-related norms can be perceived as confusing and contradictory within the military; and 4) resources addressing sexual assault are ubiquitous in military settings, but resources addressing prevention of STIs and unintended pregnancy are limited. Both general and military-specific norms, behavior, and healthcare experiences need to be considered in clinical care, public health campaigns, and other efforts to promote sexual and reproductive health in military settings.

Background: Emergency department-based HIV self-testing (ED-HIVST) could increase HIV-testing services to high-risk, under-reached populations., Objectives: This study sought to understand the injury patient acceptability of ED-HIVST., Methods: Injury patients presenting to the Kenyatta National Hospital Accident and Emergency Department were enrolled from March to May 2021. Likert item data on HIVST assessing domains of general acceptability, personal acceptability, and acceptability to distribute to social and/or sexual networks were collected. Ordinal regression was performed yielding adjusted odds ratios (aOR) to identify characteristics associated with high HIVST acceptability across domains., Results: Of 600 participants, 88.7% were male, and the median age was 29. Half reported having primary care providers (PCPs) and 86.2% reported prior HIV testing. For each Likert item, an average of 63.5% of the participants reported they 'Agree Completely' with positive statements about ED-HIVST in general, for themselves, and for others. In adjusted analysis for general acceptability, those <25 (aOR = 1.67, 95%CI:1.36-2.08) and with prior HIV testing (aOR = 1.68, 95%CI:1.27-2.21) had greater odds of agreeing completely. For personal acceptability, those with a PCP (aOR = 3.31, 95%CI:2.72-4.03) and prior HIV testing (aOR = 1.83, 95%CI:1.41-2.38) had greater odds of agreeing completely. For distribution acceptability, participants with a PCP (aOR = 2.42, 95%CI:2.01-2.92) and prior HIV testing (aOR = 1.79, 95%CI: 1.38-2.33) had greater odds of agreeing completely., Conclusions: ED-HIVST is perceived as highly acceptable, and young people with prior testing and PCPs had significantly greater favourability. These data provide a foundation for ED-HIVST programme development in Kenya.

Objective: The series of interventions that comprise labor induction shape patient experiences; however, patient perceptions are not always considered when structuring the process of care. Through qualitative interviews, we elucidated women's expectations and experiences regarding labor induction., Methods: Labor induction patients were recruited from a United States tertiary care hospital's postpartum mother-baby unit and invited to participate in semi-structured qualitative interviews. Interview questions included expectations and experiences of the labor induction process, side effects and health outcomes of concern, reflections on personal tolerance of different interventions, and thoughts about an ideal process., Results: Between April and September 2018, 36 women were interviewed. The labor induction process involved a wide range of experiences; when asked to characterize labor induction in one word, responses ranged from horrible, frustrating, and terrifying to simple, fast, and smooth. Inductions were often described as longer than what was expected. The most polarizing induction method was the Foley balloon catheter. Women's concerns regarding side effects largely centered on the health of their baby, and an ideal induction involved fewer interventions., Conclusions: Experiences with labor induction vary greatly and are related to expectations. The way interventions are introduced influences women's perceptions of control and their ultimate level of contentment with the birthing process. Attention to experiences and preferences has the potential to improve quality of care through communication, shared decision-making, and education., (© 2023 Wiley Periodicals LLC.)

Objective: Current guidelines for treatment of obesity in adolescence include screening and referring youth with obesity to appropriate weight management (WM) care. However, prior work has not explored the referral process to adolescent WM programs, especially for youth from lower-income backgrounds, who are at increased risk of obesity and related negative health outcomes. This qualitative study sought to understand pediatricians' current practices regarding referrals to adolescent WM interventions with a focus on adolescents from lower-income backgrounds., Methods: Individual interviews were conducted with 11 medical providers that had referred at least 5 adolescents from low-income backgrounds to WM interventions. Applied thematic analysis was used for data analysis., Results: Identified themes included weight-related discussions with adolescents as potentially fraught, as providers want to address weight-related health concerns while being thoughtful about potential harm. Providers also noted varied factors affecting their decision to refer to WM programs, including health implications, perceived motivation of the patient and family, and availability of programs. Providers identified that many families experience shame or guilt around referral to WM. Few themes were identified regarding impact of income on weight-related conversations with adolescents., Conclusion: Findings were novel in regard to discussions of weight in adolescents with obesity leading to WM referral. Despite being a primary focus of the present study, few themes were identified regarding specific considerations for adolescents from low-income backgrounds. Future clinical research should focus on provider-focused interventions to increase sensitivity regarding weight-related discussions and attention to diversity, equity, and inclusion., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: Adolescents from low-income backgrounds are at increased risk for obesity and related negative health outcomes. Furthermore, these adolescents have less access to, and success in, weight management (WM) programs. This qualitative study sought to better understand engagement in a hospital-based WM program from the perspective of adolescents and caregivers at different levels of program initiation and engagement., Methods: Qualitative interviews were conducted with 55 participants (29 adolescents and 26 caregivers). This included: (a) those that were referred to, but never initiated, WM treatment (non-initiators); (b) those that prematurely disengaged from treatment (drop-outs); and (c) those that had ongoing participation in treatment (engaged). Data were analyzed using applied thematic analysis., Results: Related to program initiation, participants across all groups (including adolescents and caregivers) noted that they did not have a full understanding of the scope or goals of the WM program following initial referral. In addition, many participants identified misperceptions of the program (e.g., perceptions of a screening visit as compared to an intensive program). Both caregivers and adolescents identified caregivers as drivers of engagement, with adolescents often hesitant about participation in the program. However, engaged adolescents found the program valuable and sought ongoing participation following caregiver initiation., Conclusions: When considering initiation and engagement in WM services for adolescents at highest risk, healthcare providers should provide more detailed information concerning WM referrals. Future research is needed to improve adolescent perception of WM, especially for adolescents from low-income backgrounds, which could increase initiation and engagement for this population., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Women need multipurpose prevention technologies (MPTs) to simultaneously prevent sexually transmitted infections (STIs), including HIV, with or without contraception. User feedback early in product development is critical for maximizing uptake and continuation. Our global online survey (April 2017-December 2018) explored women's opinions about MPT formulations in development (e.g., fast-dissolving vaginal inserts, vaginal films, intravaginal rings, injectables, implants), preferences for long-acting or "on-demand" methods, and interest in a contraceptive MPT versus products for HIV/STI prevention alone. Of the 630 women in our final analysis (mean 30 years old; range 18-49), 68% were monogamous, 79% completed secondary education, 58% had ≥ 1 child, 56% were from sub-Saharan Africa and 82% preferred a cMPT versus HIV/STI prevention alone. There were no clear preferences for any specific product or product type (long-acting, on-demand, daily). No single product will appeal everyone, however, adding contraception is likely to increase uptake of HIV/STI prevention methods for most women., (© 2023. The Author(s).)

This study's objective was to determine how frontline physicians perceived telehealth for older adults with sensory impairments, cognitive impairments, mobility challenges, or those receiving end-of-life care. We conducted a multiple-methods study of US emergency, geriatric, and primary care physicians. Phase 1 involved semi-structured interviews with 48 physicians on their experiences using telehealth with older adults. In phase 2, we used those qualitative findings to generate a web-based survey administered to 74 physicians. In phase 3, we reintegrated qualitative data to enrich survey results. We identified 3 key findings: (1) 50% of emergency physicians, 33% of geriatricians, and 18% of primary care physicians considered telehealth to be a poor substitute for providing end-of-life care ( p  = .68); (2) for hearing, vision, and cognitive impairments, 61%, 58%, and 54%, respectively, saw telehealth as a good or fair substitute for providing care ( p  = .14); and (3) 98% indicated that telehealth was a good or fair substitute for in-person care for those with mobility impairment ( p  < .001). Preferences and comfort using telehealth with older adults vary by clinical context, patient population, and physician specialty, requiring tailored adaptations., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)

Objectives: Our objective was to interview primary care physicians (PCPs) and geriatricians on their experiences using telemedicine during the COVID-19 pandemic to examine strategies used to maintain continuity of care with their patients, ages 65 and older. Methods: Using purposive sampling, we selected physicians based on community size (metro/suburban/rural) and practice setting (academic/community) and conducted semi-structured interviews via Zoom (mean: 30 minutes). Interviews were recorded, transcribed, coded, and analyzed using framework analysis. Results: We enrolled 33 physicians (15 PCPs and 18 geriatricians) from July to November 2020. Findings indicate that many physicians successfully bridged the digital divide by: assessing patients' technological readiness in advance, being flexible with telehealth modes, using available home or facility-based staff, educating patients on telehealth privacy and usefulness, making accommodations for disabilities, and involving caregivers. Discussion: These findings can inform future policy and practice and assist physicians in resolving addressable barriers to telehealth use among older patients.

Emergency departments (EDs) in Africa are contact points for key groups for HIV testing services (HTS) but understanding of ED-testing delivery is limited which may impeded program impacts. This study evaluated the offering and uptake of standard HTS among injured persons seeking ED care at Kenyatta National Hospital (KNH) in Nairobi, Kenya. An ED population of adult injured persons was prospectively enrolled (1 March-25 May 2021) and followed through ED disposition. Participants requiring admission were followed through hospital discharge and willing participants were contacted at 28-days for follow up. Data on population characteristics and HTS were collected by personnel distinct from clinicians responsible for standard HTS. Descriptive analyses were performed and prevalence values with 95% confidence intervals (CI) were calculated for HIV parameters. The study enrolled 646 participants. The median age was 29 years with the majority male (87.8%). Most ED patients were discharged (58.9%). A prior HIV diagnosis was reported by 2.3% of participants and 52.7% reported their last testing as >6 months prior. Standard ED-HTS were offered to 49 or 8.6% of participants (95% CI: 5.8-9.9%), among which 89.8% accepted. For ED-tested participants 11.4% were newly diagnosed with HIV (95% CI: 5.0-24.0%). Among 243 participants admitted, testing was offered to 6.2% (95% CI: 3.9-9.9%), with 93.8% accepting. For admitted participants tested 13.3% (95% CI: 4.0-35.1%) were newly diagnosed (all distinct from ED cases). At 28-day follow up an additional 22 participants reported completing testing since ED visitation, with three newly diagnosed. During the full follow-up period the HIV prevalence in the population tested was 10.3% (95% CI: 5.3-19.0%); all being previously undiagnosed. Offering of standard HTS was infrequent, however, when offered, uptake and identification of new HIV diagnoses were high. These data suggest that opportunities exist to improve ED-HTS which could enhance identification of undiagnosed HIV., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Aluisio et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Siblings describe positive and negative aspects of autism and often assume lifelong support roles. Less is known about cultural influences on sibling relationships. This qualitative study characterizes processes linking siblings' autism conceptualizations, sibling relationships, and self-concept using a multicultural framework. Siblings (12 Latino/a/x, 9 non-Latino/a/x white) participated. Data were stratified by ethnicity and analyzed using applied thematic analysis. Latino/a/x and non-Latino/a/x siblings described processes linking autism, relationships, and self-concept differently. Latino/a/x siblings emphasized family roles and identified as caregivers and protectors. Non-Latino/a/x siblings emphasized general sensitivity toward individuals who differed from themselves. Findings may reflect cultural differences in familism, caregiving expectations, and autism conceptualizations, thereby illuminating foundations of siblings' lifelong caregiving roles and highlighting the importance of culturally-sensitive, family-centered care., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Rationale: Health-related quality of life in patients with pulmonary arterial hypertension (PAH) has become increasingly important in disease management as numerous treatment options have improved prognosis and time to clinical worsening. Sexual health-related quality of life (SHRQoL) is poorly understood in patients with PAH, but previous work has shown that patients may face unrecognized challenges, especially related to parenteral prostanoid analogue therapies. Objectives: Using qualitative methods, to describe challenges and perspectives related to SHRQoL among women with PAH. Methods: We conducted 13 semistructured in-depth interviews at the Pulmonary Hypertension Association's International Pulmonary Hypertension Conference and Scientific Sessions among female attendees with World Symposium on Pulmonary Hypertension group 1 PAH. A coding structure using both deductive and inductive coding was developed to organize and analyze data using applied thematic analysis. Salient themes were identified and are presented here using summary and illustrative quotations. Results: Ninety-two percent (12 of 13) of participants reported declines in the frequency of sex after diagnosis of PAH. A significant portion (62% [8 of 13]) experienced fear of having sexual intercourse because of cardiopulmonary symptoms. All participants (100% [13 of 13]) reported compensatory behaviors/strategies during and around sexual intercourse; some participants on subcutaneous prostanoids also reported timing intercourse to coincide with infusion site changes and, as a result, interrupted treatment during this time. Participants reported changing positions during sex to reduce breathlessness, and some reported removing oxygen to avoid interrupting intimacy. Most participants endorsed negative body image related to their medications, external oxygen supplementation, and/or body weight fluctuations (54% [7 of 13]). Many participants revealed that they had never discussed sexual practices with healthcare professionals and desired increased communication and discussion with their providers. Conclusions: Women with PAH face significant burdens and challenges regarding SHRQoL. PAH therapies directly affect SHRQoL. Further targeted qualitative and quantitative studies are needed to better characterize and improve SHRQoL in patients with PAH.

Dual compartment suppositories are being developed to prevent HIV and other sexually transmitted infections. Such products, for use in the rectum, the vagina, or both, could have a significant public health impact by decreasing global incidence of these diseases. In this study, 16 women each used two rheologically distinct suppositories in their vagina and rectum. User Sensory Perception and Experience (USPE) scales assessed sensory experiences during sexual activity to understand whether, and how, women perceive formulation properties in the vagina and rectum. Qualitative data from individual in-depth interviews captured women's descriptions and comparisons of the experiences. Significant differences and large Cohen's d effect sizes between vaginal and rectal experiences of suppository-A were found for three scales: Application (APP): Product Awareness , SEX: Initial Penetration ; and SEX: Effortful . Qualitative data provided user experience details that credibly align with these score differences. Near significant differences and large effect sizes were found for two additional scales: SEX: Perceived Wetness with suppository-A and SEX: Messiness with suppository-B. In addition, other scale scores showed medium-to-large effect sizes that correspond to hypothesized sensations associated with biophysical properties of the suppositories. Statistical significance combined with large effect sizes and qualitative data accurately represent the hypothesized perceptibility of suppository properties and identifies performance characteristics relevant to acceptability and adherence; together these data provide discernment of factors that can guide the development of dual compartment products. The Clinical Trial Registration number: NCT02744261.

Background: Emergency departments (ED) interface with large numbers of patients that are often missed by conventional HIV testing approaches. ED-based HIV self-testing (HIVST) is an innovative engagement approach which has potential for testing gains among populations that have failed to be reached. This systematic review and meta-analysis evaluated acceptability and uptake of HIVST, as compared to standard provider-delivered testing approaches, among patients seeking care in ED settings., Methods: Six electronic databases were systematically searched (Dates: January 1990-May 2021). Reports with data on HIVST acceptability and/or testing uptake in ED settings were included. Two reviewers identified eligible records (κ= 0.84); quality was assessed using formalized criteria. Acceptability and testing uptake metrics were summarized, and pooled estimates were calculated using random-effects models with assessments of heterogeneity., Results: Of 5773 records identified, seven met inclusion criteria. The cumulative sample was 1942 subjects, drawn from three randomized control trials (RCTs) and four cross-sectional studies. Four reports assessed HIVST acceptability. Pooled acceptability of self-testing was 92.6% (95% confidence interval [CI]: 88.0%-97.1%). Data from two RCTs demonstrated that HIVST significantly increased testing uptake as compared to standard programs (risk ratio [RR] = 4.41, 95% CI: 1.95-10.10, I 2  = 25.8%). Overall, the quality of evidence was low (42.9%) or very low (42.9%), with one report of moderate quality (14.2%)., Conclusions: Available data indicate that HIVST may be acceptable and may increase testing among patients seeking emergency care, suggesting that expanding ED-based HIVST programs could enhance HIV diagnosis. However, given the limitations of the reports, additional research is needed to better inform the evidence base., (© 2021 Society for Academic Emergency Medicine.)

Objective: To determine usability of the Apple Watch in older adult emergency department (ED) patients after a fall., Methods: We recruited older adults who fell and visited two urban EDs. They participated in an Apple Watch orientation and interviews on their experiences using the watch to complete varied tasks for 30 days. Interviews were recorded, transcribed, coded, and analyzed using framework analyses., Results: Eight participants (mean age 77.6 years) enrolled from November 2019 to March 2020. Participants reported being able to apply and charge the watch but struggled with navigating screens, monitoring charging status, and responding with de novo text messages. Many cited difficulties with advanced tasks, such as the study's app-based movement and memory activities. Experience with smartphones and caregiver assistance enhanced users' ability to complete tasks., Conclusions: Older adults successfully performed basic Apple Watch functions. Family and community members may be necessary to assist with complex tasks.

People with HIV (PWH) have an elevated risk for cardiovascular disease (CVD) compared with the general population. This study examined the feasibility, acceptability and preliminary efficacy of a tailored intervention aimed at increasing CVD risk perception and the adoption of heart-healthy behaviors in PWH. Forty adults were randomized to receive personalized feedback on CVD risk and discussion of risk reduction or health education. Participants were issued pedometers and seen for two treatment sessions. Participants were 60% male and had a mean age of 51.5 years. Ninety percent of participants completed all study sessions indicating good feasibility and acceptability. A medium effect size for the difference between treatment and control groups was found on both the Perceived Risk for Heart Disease ( d  = .38) and the Rapid Eating and Activity for Patients scales ( d  = .56) at 12 weeks. Atherosclerotic cardiovascular disease (ASCVD) risk score moderated the effect of treatment, such that at high (but not low) ASCVD risk, active intervention, compared to control, was associated with a greater increase in steps between baseline and both 8 ( d  = .38) and 12 weeks ( d  = .55). Findings provide preliminary evidence that tailored interventions delivered by nurses may be effective for primary prevention of CVD in PWH.

Women Veterans face gender-specific challenges to military life and post-deployment readjustment, including gender-based discrimination and military sexual trauma. Despite recent military initiatives to address these issues, women still experience unique challenges during military service. This study examines spontaneous comments about gender-specific challenges to military life that were made by participants in a qualitative study of women's transitions to civilian life after deployment to Iraq or Afghanistan., Methods: Women Veterans who were enrolled at a New England VA hospital and who had deployed to the U.S. conflicts in Iraq and Afghanistan participated in this qualitative study (N = 22). Interview queries and initial coding structure were developed through an extensive literature review. An iterative coding process generated additional themes identified in the data. For this project, codes regarding self-initiated reports of gender-specific challenges that fell outside the scope of the study's initial interview agenda were reviewed for thematic analysis., Results: The following three self-initiated themes emerged among 12 respondents: 1) gender-based scrutiny and discrimination; 2) the military's inadequate position and response to military sexual trauma; and 3) disadvantages to women service members living in a male-dominated environment. Across all three themes emerged a sub-theme in which women perceived their unique needs to be inconvenient and/or disregarded. Respondents described how these challenges disrupted their lives during and after military service., Conclusion: Results imply gender-specific challenges and military sexual trauma remain critical concerns for women Veterans well after deployment had ended, and that improved policy may have long-term health implications.

Background: MB66 film is a multipurpose prevention technology (MPT) product with monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). The mAbs were produced by transient expression in Nicotiana benthamiana (N). We conducted a Phase I clinical trial to assess the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66 when used intravaginally., Methods and Findings: The clinical trial enrolled healthy reproductive-aged, sexually abstinent women. In Segment A, 9 women received a single MB66 film which was inserted into the vaginal posterior fornix by a clinician. In Segment B, 29 women were randomly assigned to MB66 (Active) or Placebo film groups and were instructed to insert 1 film vaginally for 7 consecutive days. Visits and clinical sampling occurred predose and at various time points after single and repeated film doses. The primary endpoint was number of adverse events (AEs) Grade 2 or higher related to product use. Secondary endpoints included film dissolution rate, Nugent score (a Gram stain scoring system to diagnose bacterial vaginosis), vaginal pH, post-use survey results, cytokine concentrations in cervicovaginal lavage (CVL) specimens (assessed by Luminex assay), mAb concentrations in vaginal fluid collected from 4 sites (assessed by ELISA), and HIV and HSV neutralization activity of CVL samples ex vivo (assessed by TZM-bl and plaque reduction assay, respectively). The product was generally safe and well tolerated, with no serious AEs recorded in either segment. The AEs in this study were primarily genitourinary in nature with the most commonly reported AE being asymptomatic microscopic hematuria. There were no differences in vaginal pH or Nugent scores or significant increases in levels of proinflammatory cytokines for up to 7 days after film insertion in either segment or between Active and Placebo groups. Acceptability and willingness to use the product were judged to be high by post-use surveys. Concentrations of VRC01-N and HSV8-N in vaginal secretions were assessed over time to generate pharmacokinetic curves. Antibody levels peaked 1 hour postdosing with Active film (median: 35 μg/mL) and remained significantly elevated at 24 hours post first and seventh film (median: 1.8 μg/mL). Correcting for sample dilution (1:20), VRC01-N concentrations ranged from 36 to 700 μg/mL at the 24-hour time point, greater than 100-fold the IC50 for VRC01 (0.32 μg/mL); HSV8-N concentrations ranged from 80 to 601 μg/mL, well above the IC50 of 0.1 μg/m. CVL samples collected 24 hours after MB66 insertion significantly neutralized both HIV-1 and HSV-2 ex vivo. Study limitations include the small size of the study cohort, and the fact that no samples were collected between 24 hours and 7 days for pharmacokinetic evaluation., Conclusions: Single and repeated intravaginal applications of MB66 film were safe, well tolerated, and acceptable. Concentrations and ex vivo bioactivity of both mAbs in vaginal secretions were significantly elevated and thus could provide protection for at least 24 hours postdose. However, further research is needed to evaluate the efficacy of MB66 film in women at risk for HIV and HSV infection. Additional antibodies could be added to this platform to provide protection against other sexually transmitted infections (STIs) and contraception., Trial Registration: ClinicalTrials.gov NCT02579083., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: KJW and LZ own Mapp Biopharmaceutical Inc., a company that intends to commercialize antibody-based products. TRM, TN and MB work for Mapp Biopharmaceutical Inc. The other authors have declared that no competing interests exist.

The incidence of sexually transmitted infections (STIs) has increased over recent years, particularly among young women. Partner type is believed to influence women's STI risk. However, researchers often restrict partner type to "casual" versus "committed," labels that can mask risk variability. Therefore, in this study, we identified and explored a range of sexual partner types in order to understand how young women's perceived risk and condom use intentions vary by partner type. Data were obtained during six focus groups of young women (N =25) who were recruited from a community reproductive healthcare clinic. Women described a range of monogamous and non-monogamous partner types that were distinguished based on partner regularity (i.e., whether the sexual partnership was ongoing) and personal relationship (i.e., degree of involvement outside of the sexual relationship). Women's perceived STI risk was higher and condom use intentions stronger with new partners, particularly unfamiliar partners (i.e., "one-night stand," "fuck boy"). Women identified potential harm from condom negotiation with all but the "friends with benefits" partners. However, the nature of this harm differed by partner type. Clinicians and researchers should consider how to support women in advocating for safer sexual behaviors across these partner types by understanding how partner regularity, degree of personal relationship, and emotional attachment differentially impact couples' condom use decisions.

Users' sensory perceptions and experiences (USPEs; perceptibility) of drug formulations can critically impact product adoption and adherence, especially when products rely on appropriate user behaviors (timing of administration, dosing measurement) for effectiveness. The use of topical gel formulations for effective antihuman immunodeficiency virus/sexually transmitted infection (HIV/STI) vaginal microbicides has been associated with messiness and other use-associated challenges, resulting in low adherence. Nonetheless, such formulations remain attractive due to good pharmacokinetics and resulting pharmacodynamics through their volume and surface contact for drug delivery into luminal fluids and mucosa. Consequently, advocates and scientists continue to pursue topical forms [semisolid (e.g., gel, suppository); solid (e.g., film)] to deliver select drugs and offer user choice in HIV/STI prevention. The current data build on previously validated USPE scales evaluating perceptibility of gels with various biophysical/rheological properties. Specifically, increased formulation parameter space adds a new set of properties inherent in quick-dissolving film. We compared film, a product adding no discernable volume to the vaginal environment, to 2 and 3.5 mL hydroxyethyl cellulose gel to consider the impact of volume on user experience. We also examined the USPE scales for evaluation of male sexual partners' experiences. The original USPE scales functioned as expected. Additionally, six new USPE scales were identified in this enhanced parameter space. Significant differences were noted between USPEs in pairwise comparisons, with largest differences between film and high-volume gel. Product developers and behavioral scientists can use these scales to design products, optimizing user experience and maximizing adherence and delivery of efficacious anti-HIV/STI pharmaceuticals. They can be extended to evaluation of additional formulations, devices, and compartments, as well as single- and multipurpose pharmaceuticals. In broader contexts, USPEs could be of value in evaluating formulations and devices to prevent/treat other diseases (e.g., ophthalmologic, dermatologic). Steadfast attention should be given to patient experience, and, where applicable, experiences of partners and/or caregivers.

Growing up with a mother living with HIV (MLH) is a unique experience for adolescents. Children in these families often thrive; however, many also exhibit behavioral health problems including HIV risk behaviors. Under a lens of youth risk reduction, we examined the role of protective parenting practices in their lives including parent-child communication about sex, parent-child relationship quality, parental monitoring, and mother-to-child HIV disclosure. For this exploratory study, we conducted four focus groups with MLH ( n  = 15) and 13 in-depth interviews with HIV-negative adolescent children of MLH. Participants were primarily African American and recruited from clinics and non-profit organizations in the southeastern United States. A thematic analysis of focus group and in-depth interview data revealed that mothers' prior experiences with HIV and HIV-related risks often underlie their strengths as parents - for example, confidence in their ability to discuss sexual risk topics with their children as well as enhanced motivation to monitor their children's whereabouts and exposure to risky environments. Nonetheless, many MLH face challenges, including problems with mother-to-child HIV disclosure and relationship disruptions, which likely hinder protective parenting. Implications of our findings include specific recommendations for adapting effective and culturally-informed prevention interventions for families affected by maternal HIV infection.

Objective: Falls are a leading cause of injury-related emergency department (ED) visits and may serve as a sentinel event for older adults, leading to physical and psychological injury. Our primary objective was to characterize patient- and caregiver-specific perspectives about care transitions after a fall., Methods: Using a semistructured interview guide, we conducted in-depth, qualitative interviews using grounded theory methodology. We included patients enrolled in the Geriatric Acute and Post-acute Fall Prevention Intervention (GAPcare) trial aged 65 years and older who had an ED visit for a fall and their caregivers. Patients with cognitive impairment (CI) were interviewed in patient-caregiver dyads. Domains assessed included the postfall recovery period, the skilled nursing facility (SNF) placement decision-making process, and the ease of obtaining outpatient follow-up. Interviews were audio-recorded, transcribed verbatim, and coded and analyzed for a priori and emergent themes., Results: A total of 22 interviews were completed with 10 patients, eight caregivers, and four patient-caregiver dyads within the 6-month period after initial ED visits. Patients were on average 83 years old, nine of 14 were female, and two of 14 had CI. Six of 12 caregivers were interviewed in reference to a patient with CI. We identified four overarching themes: 1) the fall as a trigger for psychological and physiological change, 2) SNF placement decision-making process, 3) direct effect of fall on caregivers, and 4) barriers to receipt of recommended follow-up., Conclusions: Older adults presenting to the ED after a fall report physical limitations and a prominent fear of falling after their injury. Caregivers play a vital role in securing the home environment; the SNF placement decision-making process; and navigating the transition of care between the ED, SNF, and outpatient visits after a fall. Clinicians should anticipate and address feelings of isolation, changes in mobility, and fear of falling in older adults seeking ED care after a fall., (© 2020 by the Society for Academic Emergency Medicine.)

Objective: To identify and describe behavioral interventions to promote sexual and reproductive health among US active duty military service members., Data Sources: Systematic searches of PubMed, CINAHL, and PsychINFO (N = 1609 records)., Inclusion Criteria: English-language articles published between 1991 and 2018 and retrieved using search terms related to military service, interventions, and sexual and reproductive health., Exclusion Criteria: Articles excluded if not empirically based, not published in peer-reviewed journals, did not sample active duty US military personnel, and did not examine the effectiveness of specified preventive sexual or reproductive health intervention(s)., Data Extraction: Teams of paired authors extracted study rationale; aims; design; setting; description of the intervention; measures; sample demographics; clinical, behavioral, and psychosocial outcomes; and conclusions., Data Synthesis: Given the heterogeneity of studies, narrative synthesis was performed., Results: Fifteen articles met inclusion criteria: 10 focused on sexually transmitted infection (STI) acquisition and/or unintended pregnancy and 5 on sexual assault. Studies that assessed clinical outcomes found that interventions were associated with lower rates of STIs and/or unintended pregnancy. Significant effects were found on knowledge-related outcomes, while mixed effects were found on attitudes, intentions, and behaviors., Conclusions: Current evidence on the effectiveness of sexual and reproductive health interventions in the US military is limited in quality and scope. Promoting sexual and reproductive health in this population is critical to maintaining well-being among servicemembers, their families, and the communities surrounding military installations.

Background Reducing pregnancy risk requires a multidimensional approach to sexual and reproductive health product development. The purpose of this analysis is to identify, compare, and contrast women's pre-use beliefs and attitudes about three different forms of contraceptives: intravaginal rings; spermicide in conjunction with condoms; and oral contraceptive pills - and explore how those attitudes and beliefs, along with actual method-use experience, may affect potential choices in contraceptive method moving forward. The relationship of beliefs and attitudes to their risk-benefit calculations when using these methods was also considered.?, Methods: Women used one or more contraceptive methods, each for 3-6 months. Qualitative data from individual in-depth interviews completed after each 3-month use period were analysed using a summary matrix framework. Data were extracted and summarised into themes. Each woman's experiences were compared among the methods she used; comparisons were also made across participants., Results: The data consist of 33 90-120 min in-depth qualitative interviews from 16 women aged 20-34 years, in which they discussed various elements of their method use experience. One prominent theme was identified: the influence of attitudes and beliefs on the risk-benefit calculus. There were six key elements within the theme: pregnancy prevention; dosing and the potential for user error; side-effects; familiarity; disclosure; and sexual partnerships., Conclusions: Women weighed perceived risks and benefits in their decision-making and, ultimately, their contraception choices. Understanding women's beliefs and attitudes that contribute to a calculation of risk-benefit can inform the development of sexual and reproductive health products.

This exploratory trial determined the feasibility, acceptability, and preliminary efficacy of a brief intervention (BI), supplemented with text messaging and a curated Web site, on alcohol use and sexual risk behavior among young women. Young women seeking care at a reproductive health clinic were screened for alcohol misuse and sexual risk behavior. Those who screened positive and who agreed to participate (N = 48; M = 22.67 years) were randomized to either (a) a brief in-person session during which personalized feedback regarding alcohol use and sexual risk taking was provided and discussed, or (b) a control condition. Feasibility was assessed by recruitment and retention rates. Acceptability was assessed with participant ratings of their intervention. Efficacy was measured using self-reported alcohol use and sexual behavior at baseline and during a 3-month follow-up. We supplemented the quantitative data with qualitative data from semi-structured interviews. Feasibility data indicated that 64% of eligible women agreed to participate, 74% of eligible women were enrolled, and 86% of enrolled women were retained through follow-up. Acceptability data showed that women who received the BI reported strong satisfaction with their intervention (M = 4.65 vs. 3.98 on a five-point scale) and also reported that text messaging was helpful (M = 4.73 on a seven-point scale) and acceptable (M = 5.27 on a seven-point scale). Qualitative data provided additional support for BI feasibility and acceptability. Efficacy data showed that women in both conditions reduced alcohol use and sexual risk behavior over time; women who received the BI reduced their maximum daily alcohol intake more than controls (BI from 7.68 to 4.82 standard drinks vs. control from 6.48 to 5.65; Wald χ 2  = 4.93, p < .05). Women in the BI reported fewer occasions of condomless sex (median = 2.50) than controls (median = 5.00) at the follow-up, but this difference was not statistically significant (OR = 0.61, 95% CI [0.32, 1.15]). A brief intervention, supplemented with text messaging and a Web site, that targeted alcohol use and sexual behavior was feasible and acceptable to young women and led to lower levels of alcohol misuse and sexual risk behavior.

Context: Vaginal rings are available for contraception and hormone replacement, and are being developed as HIV/STD or multipurpose prevention technologies. A comprehensive understanding of women's expectations of and experiences with rings is urgently needed to inform product development and to optimize ring use., Methods: Three databases (PubMed, Global Health and CINAHL) were searched for English-language, peer-reviewed articles published between January 1996 and November 2017 that reported qualitative data on barriers to and facilitators of use of female-controlled contraceptive methods. Data on study methods, findings and conclusions pertaining to contraceptive rings were extracted, organized and analyzed., Results: Twenty-six articles, all published since 2008, met the inclusion criteria. Seven studies focused largely or entirely on rings (and involved current, former or potential users), while the others focused on other contraceptive methods but included ring-specific data. Familiarity with the ring was low, and women commonly had initial concerns about the method-often related to insertion and removal, cleanliness and discomfort with touching their vagina-that were typically overcome over time. Other major themes were issues related to ring use and discontinuation, the importance of ring-related properties and characteristics, and considerations related to sexual partners and health care providers., Conclusions: Qualitative data have the potential to inform ring design and promotion. Future research should further explore women's expectations and experiences with the ring, the value of involving male partners in ring evaluation, and evaluation of interventions to improve patient-provider communication concerning ring choice and use.

Objective: To elucidate the effects of the intravaginal ring, oral contraceptive pill (OCP), and spermicide plus condom on women's sexual experiences through an in-depth understanding of the physical characteristics of these contraceptive methods., Methods: We conducted qualitative in-depth interviews with women (aged 18-45 years) who used up to three contraceptive methods (intravaginal ring, OCP, and spermicide plus condom). Women completed in-depth interviews after each 3-month use period. We used a summarized matrix framework and thematic content analysis to explore how each method affected participants' sexual experiences., Results: Sixteen women completed interviews, yielding 33 transcripts. Women reported physical effects on their sexual experiences while using the intravaginal ring and spermicide plus condom. The OCP was often discussed as lacking these physical effects. Discussion themes included product administration (eg, navigating intravaginal ring removal) and physical product awareness (eg, spermicide as a lubricant). From these experiences, women often altered and individualized their use and subsequent opinions of the contraceptive method., Conclusion: The range of contraceptive effects on women's sexual experiences shape their use and opinions of the product, leading to either increased motivation and consistent use or poor adherence and discontinuation. Awareness of these individualized experiences can help providers better understand and guide their patients towards successful contraceptive use.

Alcohol use and sexual behavior co-occur frequently in young women, increasing risk for HIV and other sexually transmitted infections. To inform preventive interventions, we used qualitative methods to better understand how women think about the contribution of alcohol use to sexual risk-taking. Young women (N = 25; M = 22.8 years; 64% White) were recruited from a community-based reproductive health clinic to attend focus groups; a semi-structured agenda was used to investigate both a priori explanatory mechanisms as well as participant-driven explanations for the alcohol-sex association. Women reported that alcohol reduced their social anxiety, helped them to feel outgoing and confident, and lowered inhibitions and other barriers to sexual encounters (consistent with alcohol expectancies). During drinking events, women described being less concerned with risks, less discriminating regarding sexual partners, and less likely to insist on safer sex practices (consistent with alcohol myopia). These empirical findings support previous theory-based guidance for tailoring preventive programs for alcohol use and sexual risk reduction for young women.

The ability to regulate emotions has been linked to a variety of adolescent health risk behaviors, including sexual risk behaviors, especially for adolescents who are experiencing mental health symptoms. However, there is limited information available on intuitive emotion regulation strategies for early adolescents with mental health symptoms to facilitate the adaptation of emotion regulation interventions for psychopathology to health risk behavior prevention. For example, interventions to prevent sexual risk behaviors in early adolescence have yet to specifically target emotion regulation. This paper describes the use of focus groups to identify emotion regulation strategies that were understood by and acceptable to early adolescents with mental health symptoms who are also more likely to engage in risky health behaviors. Qualitative data were collected through focus groups (k=5 groups) with 15 early adolescents with mental health symptoms. The most commonly generated emotion regulation strategies were leaving the situation, distraction, physical release, expressing oneself to someone, positive thinking, and considering other options. Translation of these findings for use in preventive health-risk behavior interventions (including for sexual risk) is discussed., Competing Interests: Conflict of Interest: The authors declare that they have no conflict of interest.

Objectives: This study:Healthy Active and in Control (HA1C), examined the feasibility and acceptability of yoga as a complementary therapy for adults with Type-2 Diabetes (T2DM)., Design: A 2-arm randomized clinical trial comparing Iyengar yoga with a supervised walking program., Setting: Hospital based gym-type facility and conference rooms., Interventions: Participants were randomized to a 12-week program of either; (1) a twice weekly Iyengar yoga, or (2) a twice-weekly program of standard exercise (SE)., Main Outcome Measures: Primary outcomes assessed feasibility and acceptability, including enrollment rates, attendance, study completion, and participant satisfaction. Secondary outcomes included HbA1c, physical activity, and measures of diabetes-related emotional distress, self-care and quality of life (QOL). Assessments were conducted at baseline, end of treatment, 6-months and 9-months post-enrollment., Results: Of 175 adults screened for eligibility, 48 (30 women, 18 men) were eligible and enrolled. The most common reasons for ineligibility were orthopedic restrictions, HbA1c levels <6.5 and BMI > 42. Session attendance was high (82% of sessions attended), as was follow-up completion rates (92%). Program satisfaction rated on a 5-point scale, was high among both Yoga (M = 4.63, SD = 0.57) and SE (M = 4.77, SD = 0.52) participants. Overall 44 adverse events (26 Yoga, 18 SE) were reported. Of these, six were deemed "possibly related" (e.g., neck strain, back pain), and 1 "probably related" (ankle pain after treadmill) to the study. Yoga produced significant reductions in HbA1c. Median HbA1c at 6 months was 1.25 units lower for Yoga compared to SE (95% CI: -2.54 -0.04). Greater improvements in diabetes self-care, quality of life, and emotional distress were seen among Yoga participants than among SE participants. Increases in mindfulness were seen in Yoga but not in SE., Conclusions: The yoga intervention was highly feasible and acceptable, and produced improvements in blood glucose and psychosocial measures of diabetes management., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: To describe sexual risk behavior, alcohol (and other substance) use, and perceived health promotion needs among young adult women seeking care from an urban reproductive health care clinic in the Northeastern United States, and to examine if these needs differ by race and ethnicity., Methods: Women 18-29 years old presenting for a routine medical visit were invited to participate. Of 486 eligible women, 466 (96%) agreed to participate and completed a brief survey on a tablet computer. Most of the sample (53%) identified as non-Hispanic White. One-quarter (25%) identified as Hispanic/Latina. A smaller proportion of women identified as African American (19%)., Results: One-third (31%) of women reported a history of sexually transmitted infection (STI), and women reported infrequent condom use with recent sexual partners. Regarding behavioral health needs, nearly three-quarters of women (72%) reported regular alcohol use, approximately one-third had used marijuana (37%) or tobacco (33%) in the last month, and 19% reported clinically significant depressive symptoms in the last two weeks. Women reported moderate-to-strong interest in receiving information about relationships and sexual health; however, the majority were not interested in information about their substance use. Hispanic and African-American women were more likely to report STI history despite reporting fewer sexual partners than non-Hispanic White women. Minority women also reported significantly less alcohol and cigarette use, but more water pipe tobacco use, and reported significantly greater interest in interventions to promote sexual health. Hispanic women also evidenced significantly elevated rates of depressive symptoms, with 26% of Hispanic women reporting a clinically significant level of depressive symptoms., Conclusions: Reproductive health centers are opportune settings to address a broad range of healthcare needs, including sexual health, substance use, and mental health. These centers engage a diverse group of women, which is important given observed disparities in health outcomes based on race/ethnicity. Young women, particularly racial and ethnic minority women, report the most interest in services addressing sexual and relationship health.

Background: Three million US emergency department (ED) visits occur for falls each year. The mortality of falls is increasing and only one fourth of older adults report their fall to their primary care provider, suggesting that valuable preventative opportunities are missed. A fall prevention intervention initiated in the ED immediately after a fall has the potential to reduce subsequent falls, but ED providers lack the time and resources to complete fall risk assessments on their patients. GAPcare, the Geriatric Acute and Post-Acute Fall Prevention Intervention, was developed to address this need., Methods: GAPcare combines a pharmacist-led medication therapy management intervention with a physical therapist (PT)-administered fall risk assessment and disposition planning. A key objective of this pilot randomized controlled trial (RCT) was to create a patient and caregiver-centric intervention. This manuscript reports on the results of the qualitative companion study in which we conducted in-depth interviews with patients and caregivers to determine their lived experience with the intervention, barriers and perceived impact of the intervention, and to obtain their recommendations for the improvement of GAPcare. We recruited patients and their caregivers from the RCT into 30 minutes interviews in the participants' home singularly or in dyads (patient and caregiver together). Interviews were audio-recorded, transcribed, and double-coded. We used applied thematic analysis to guide the data analysis., Results: We conducted 20 interviews; patients (n=12), caregivers (n=11). Patients were on average 83 years old, 7/12 were female, and 2/14 had cognitive impairment. 6/11 caregiver interviews were in reference to a patient with dementia. Patients and caregivers reported they embraced the experience of motivational interviewing elements, citing its collaborative and inclusive nature. Caregivers in particular said they felt that PT helped their loved one recognize and overcome functional limitations. Barriers included lack of time, the burden of coordinating multiple service providers once home, and concerns that PT would be ineffective or increase pain. Areas for improvement included better screening for those who would benefit from the individual components (pharmacy vs. PT consultation), improving identification of GAPcare pharmacists and PTs vs. other hospital staff in the ED, and expanding the role of GAPcare personnel to provide culturally competent, comprehensive care to improve adherence and medication education., Conclusions: We found that GAPcare, a new team-based intervention for fall prevention in the ED, was welcomed by patients and their caregivers. Several suggestions to improve the intervention were made that will inform the screening, content, and communication with patients in GAPcare., Competing Interests: Competing Interests The authors have declared that no competing interests exist.

Smoking is more prevalent in persons living with HIV than the general population and is linked to increased morbidity and mortality. Some have suggested that based on current knowledge of harms and benefits, it may be feasible to advise smokers who are unable or unwilling to quit to switch to electronic cigarettes (ECs) as a less harmful alternative. We conducted 25 qualitative interviews with HIV-positive current or former smokers to explore perceived barriers to smoking cessation and perceptions of ECs. A high level of nicotine dependence, smoking as a form of stress management, motivational factors (including lack of readiness, low self-efficacy, ambivalence toward quitting), and having a social network of smokers were identified as cessation barriers. Low knowledge of ECs and uncertainty about EC safety and efficacy were barriers to EC uptake. However, current smokers indicated a willingness to try ECs. This study provides evidence that HIV-positive smokers face significant individual and environmental barriers to cessation. ECs may have potential as a harm reduction strategy in this population; however, there is a significant need for education regarding use and relative safety.

This study's purpose was to evaluate feasibility and acceptability, obtain preliminary efficacy data, and evaluate predictors of improvement with iDOVE, a technology-augmented violence and depression prevention intervention for high-risk adolescents seen in the emergency department (ED). We conducted a pilot randomized controlled trial (RCT) with 116 English-speaking adolescents (ages 13-17 years), presenting to the ED for any reason, who reported past-year physical peer violence and current depressive symptoms. The cognitive-behavioral therapy- and motivational interviewing-based intervention consisted of a brief in-ED intervention session and 8 weeks of automated text-message daily mood queries and tailored responses. The control was a brief in-ED presentation and twice-weekly text messages on healthy behaviors. Follow-up was conducted at 8 and 16 weeks. Descriptive statistics, bivariate comparisons, mixed-effects longitudinal regression models, and latent class models (LCMs) were calculated. iDOVE had high acceptability and feasibility, with 86% of eligible youth consenting (n = 116), 95% completing 8-week follow-up, and 91% completing 16-week follow-up. High quantitative and qualitative satisfaction were reported by intervention and control participants. Comparing intervention to control, improved depressive symptoms (p = .07) and physical peer violence (p = .01) were observed among the more symptomatic youth in the intervention group (but no difference in symptoms between full intervention and control groups). LCMs showed that intervention responsiveness correlated with lower mood (measured through daily text messages) at Day 7 of the intervention. This RCT of a technology-augmented intervention shows high feasibility and acceptability and a promising signal of reduced violence among the highest-risk participants. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Diabetes is the seventh leading cause of death in the United States. For most patients, medication alone is not sufficient to achieve glycemic control; attention must also be paid to multiple healthy behaviors including diet, regular physical activity, and stress management. Yoga, a mindfulness practice with emphasis on relaxation, meditation, and deep breathing, may have special relevance to people with type 2 diabetes mellitus (T2DM). Yoga practice may positively affect stress and other self-care tasks that will contribute to improved glycemic control. The Healthy, Active, and in Control (HA1C) study is designed to examine the feasibility and acceptability of yoga among adult patients with T2DM. In this pilot randomized controlled trial, adults with T2DM were randomly assigned to either a 12-week Iyengar Yoga intervention given twice weekly, or a twice-weekly 12-week program of traditional exercise (e.g., walking, stationary cycling). Assessments are conducted at the end of treatment (12 weeks) and at 3 and 6 months postintervention. The HA1C study will assess feasibility and acceptability (e.g., attendance/retention rates, satisfaction with program), glycemic outcomes (e.g., HbA1c, fasting blood glucose, postprandial blood glucose), and changes in physiological (e.g., salivary cortisol) and behavioral factors (e.g., physical activity, diet) relevant to the management of T2DM. Focus groups are conducted at the end of the intervention to explore participants' experience with the program and their perception of the potential utility of yoga for diabetes management.

Background: Vaginal microbicides are a promising means to prevent the transmission of HIV and other sexually transmitted infections, by empowering women to initiate use prophylactically when they perceive themselves to be at risk. However, in clinical trials, microbicides have shown mixed results, with the consistent finding that effectiveness varies substantially as a function of user adherence., Methods: Based on the assumption that adherence is driven, at least in part, by product properties that influence acceptability, we used softgel technology to develop vaginal drug delivery systems in the intermediate texture space between solids and liquids to overcome potential shortcomings of current dosage forms. Here, we used focus groups and surveys to determine women's initial reactions (i.e., acceptance and willingness-to-try) for semisoft vaginal suppositories intended for HIV and STI prevention, with a specific focus on how perception of and preferences for vaginal suppositories may be influenced by product characteristics such as size, shape, and firmness., Results: Via focus groups, we identified intrinsic and extrinsic factors relevant to acceptability of semisoft suppository prototypes. Willingness-to-try depended on factors like intended functionality, anticipated leakage, type of sex, recommended frequency of use, type of sexual partner, and perceived risk. When handled ex vivo, shape, size, and firmness of suppositories communicated information about ease of imagined insertion and handling, perceived effectiveness, anticipated awareness and comfort of the product in the body. These impressions were partly based on prior experience with vaginal products., Conclusions: Sensory attributes appear to play a substantial role in women's preferences and willingness to try the semisoft suppositories. Using these methods during preclinical development should help efficiently optimize a final product that is both biologically efficacious and preferred by women, toward a goal of enhancing adherence and effectiveness.

Pulmonary arterial hypertension (PAH) is characterized by progressive limitations in physical activity and health-related quality of life (HRQoL). HRQoL deficits may extend beyond the traditional domains of physical activity, psychological health, and emotional wellbeing to sexual health and function. Sexual HRQoL has not been studied in PAH, nor has the impact of PAH therapies themselves on sexual health and intimacy. In this initial investigation, we sought to explore HRQoL among women diagnosed with PAH and to determine if PAH treatment type (intravenous or subcutaneous prostanoids versus oral medications) was associated with levels of self-reported HRQoL assessed by validated measures for PAH-specific, general, and sexual HRQoL. We administered the emPHasis-10, Short Form (SF)-36, Female Sexual Dysfunction Scale-Revised (FSDS-R), and the Arizona Sexual Experience Scale (ASEX) to 35 women with self-reported World Health Organization Group 1 PAH at the 2016 Pulmonary Hypertension Association International Conference and Scientific Sessions. HRQoL instruments demonstrated excellent internal reliability. Women with PAH had high levels of sexual distress captured with the FSDS-R scale. The FSDS-R (but not ASEX) was significantly correlated to emPHasis-10 ( r = 0.64, p < 0.01) and most SF-36 domains ( r = - 0.36 to - 0.64, p < 0.05). Participants treated with intravenous or subcutaneous prostanoids had higher (worse) FSDS-R scores than those on oral therapies while ASEX, emPHasis-10, and SF-36 scores were similar across treatment types. Sexual HRQoL may impact overall quality of life in PAH and specific assessment of sexual health and functioning within intimate relationships may detect deficits in wellbeing not addressed by established HRQoL metrics. Further study to address all aspects of HRQoL in PAH is required.

Individual perceptions of HIV risk influence willingness to use pre-exposure prophylaxis (PrEP) for HIV prevention. Among men who have sex with men (MSM) and male sex workers (MSWs), temporal or episodic changes in risk behavior may influence perceived risk and PrEP acceptability over time. We investigated fluctuations in perceived HIV risk and PrEP acceptability, comparing MSWs against MSM who do not engage in sex work. We conducted 8 focus groups (n = 38) and 56 individual interviews among MSM and MSWs in Providence, RI. Perceived HIV risk shaped willingness to use PrEP among both MSWs and MSM who did not engage in sex work, and risk perceptions changed over time depending on behavior. For MSWs, perceived risk cycled according to patterns of substance use and sex work activity. These cycles yielded an "access-interest paradox": an inverse relationship between willingness to use and ability to access PrEP. MSM who did not engage in sex work also reported temporal shifts in risk behavior, perceived risk, and willingness to use PrEP, but changes were unrelated to access. MSM attributed fluctuations to seasonal changes, vacations, partnerships, behavioral "phases," and episodic alcohol or drug use. Efforts to implement PrEP among MSM and street-based MSWs should address temporal changes in willingness to use PrEP, which are linked to perceived risk. Among MSWs, confronting the access-interest paradox may require intensive outreach during high-risk times and efforts to address low perceived risk during times of reduced sex work.

Background: Intravaginal rings (IVRs) for HIV pre-exposure prophylaxis (PrEP) theoretically overcome some adherence concerns associated with frequent dosing that can occur with oral or vaginal film/gel regimens. An innovative pod-IVR, composed of an elastomer scaffold that can hold up to 10 polymer-coated drug cores (or "pods"), is distinct from other IVR designs as drug release from each pod can be controlled independently. A pod-IVR has been developed for the delivery of tenofovir (TFV) disoproxil fumarate (TDF) in combination with emtricitabine (FTC), as daily oral TDF-FTC is the only Food and Drug Administration (FDA)-approved regimen for HIV PrEP. A triple combination IVR building on this platform and delivering TDF-FTC along with the antiretroviral (ARV) agent maraviroc (MVC) also is under development., Methodology and Findings: This pilot Phase I trial conducted between June 23, 2015, and July 15, 2016, evaluated the safety, pharmacokinetics (PKs), and acceptability of pod-IVRs delivering 3 different ARV regimens: 1) TDF only, 2) TDF-FTC, and 3) TDF-FTC-MVC over 7 d. The crossover, open-label portion of the trial (N = 6) consisted of 7 d of continuous TDF pod-IVR use, a wash-out phase, and 7 d of continuous TDF-FTC pod-IVR use. After a 3-mo pause to evaluate safety and PK of the TDF and TDF-FTC pod-IVRs, TDF-FTC-MVC pod-IVRs (N = 6) were evaluated over 7 d of continuous use. Safety was assessed by adverse events (AEs), colposcopy, and culture-independent analysis of the vaginal microbiome (VMB). Drug and drug metabolite concentrations in plasma, cervicovaginal fluids (CVFs), cervicovaginal lavages (CVLs), and vaginal tissue (VT) biopsies were determined via liquid chromatographic-tandem mass spectrometry (LC-MS/MS). Perceptibility and acceptability were assessed by surveys and interviews. Median participant age was as follows: TDF/TDF-FTC group, 26 y (range 24-35 y), 2 White, 2 Hispanic, and 2 African American; TDF-FTC-MVC group, 24.5 y (range 21-41 y), 3 White, 1 Hispanic, and 2 African American. Reported acceptability was high for all 3 products, and pod-IVR use was confirmed by residual drug levels in used IVRs. There were no serious adverse events (SAEs) during the study. There were 26 AEs reported during TDF/TDF-FTC IVR use (itching, discharge, discomfort), with no differences between TDF alone or in combination with FTC observed. In the TDF-FTC-MVC IVR group, there were 12 AEs (itching, discharge, discomfort) during IVR use regardless of attribution to study product. No epithelial disruption/thinning was seen by colposcopy, and no systematic VMB shifts were observed. Median (IQR) tenofovir diphosphate (TFV-DP) tissue concentrations of 303 (277-938) fmol/10(6) cells (TDF), 289 (110-603) fmol/10(6) cells (TDF-FTC), and 302 (177.1-823.8) fmol/10(6) cells (TDF-FTC-MVC) were sustained for 7 d, exceeding theoretical target concentrations for vaginal HIV prevention. The study's main limitations include the small sample size, short duration (7 d versus 28 d), and the lack of FTC triphosphate measurements in VT biopsies., Conclusions: An innovative pod-IVR delivery device with 3 different formulations delivering different regimens of ARV drugs vaginally appeared to be safe and acceptable and provided drug concentrations in CVFs and tissues exceeding concentrations achieved by highly protective oral dosing, suggesting that efficacy for vaginal HIV PrEP is achievable. These results show that an alternate, more adherence-independent, longer-acting prevention device based on the only FDA-approved PrEP combination regimen can be advanced to safety and efficacy testing., Trial Registration: ClinicalTrials.gov NCT02431273., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: During part of the time of the study, IB, SAC, and JMC were employees of Auritec and participated in manufacturing the vaginal rings; they were no longer employees at the time of sample collection, data analysis, and manuscript preparation. Prior to August 2016, MG was a 50% shared employee of Auritec and participated in the residual drug measurements and coordinating sample distribution. JAM and MMB are co-inventors on patent applications that include aspects of the intravaginal ring device that was used in the clinical trial described in this manuscript and have received funding for preclinical research relevant to HIV (but not vaginal rings) from ViiV/GSK. They also have received funding from the International Partnership for Microbicides, CONRAD, and the Population Council. JAM, MMB, and MG are co-inventors on the following patent applications relevant to HIV: https://patents.google.com/patent/WO2016149561A1/en and https://patents.google.com/patent/WO2017161136A1/en. KLV and RBP are paid consultants to ABL, Inc. CWH has received funding for clinical research from ViiV/GSK managed via Johns Hopkins University and was a consultant for 1-2 days in 2017 to ViiV/GSK.

HIV treatment retention remains a significant public health concern. Our qualitative analysis used emergent data from a larger HIV treatment study to explore clinician perspectives on prescribing opioids to incentivize retention in HIV care. Data from individual interviews with 29 HIV and substance use clinicians were analyzed using thematic analysis. Prescribing opioids as a retention strategy emerged as a theme. Nine of 11 HIV clinicians reported prior knowledge of this practice; only one of 12 substance use clinicians indicated prior knowledge. Positive perceptions included: harm reduction approach, increased appointment attendance, and sustained engagement in HIV care. Negative perceptions included: addiction potential, increased engagement not leading to better health outcomes, and prescriptions becoming the appointment focus. Some clinicians used prescriptions as a strategy to improve treatment retention, which may be particularly problematic in light of the current opioid epidemic. Understanding motives, outcomes, and clinical decision-making processes is needed., (Copyright © 2018 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.)

Background: Effective HIV prevention requires efficient delivery of safe and efficacious drugs and optimization of user adherence. The user's experiences with the drug, delivery system, and use parameters are critical to product acceptability and adherence. Prevention product developers have the opportunity to directly control a drug delivery system and its impact on acceptability and adherence, as well as product efficacy. Involvement of potential users during preclinical design and development can facilitate this process. We embedded a mixed methods user evaluation study into a safety and pharmacokinetics (PK) trial of a pod-intravaginal ring delivering antiretroviral agents., Methodology: Women enrolled in two cohorts, ultimately evaluating the safety/PK of a pod-IVRs delivering TDF-alone, TDF-FTC, and/or TDF-FTC-MVC. A 7-day use period was targeted for each pod-IVR, regardless of drug or drug combination. During the clinical study, participants provided both quantitative (i.e., survey) and qualitative (i.e., in-depth interview) data capturing acceptability, perceptibility, and adherence behaviors. Initial sexual and reproductive health history surveys, daily diaries, a final acceptability and willingness to use survey, and a qualitative in-depth interview comprised the user evaluation data for each pod-IVR experienced by the participants., Findings: Overall, the majority of participants (N = 10) reported being willing to use the pod-IVR platform for HIV prevention should it advance to market. Confidence to use the pod-IVR (e.g., insertion, removal) was high. There were no differences noted in the user experience of the pod-IVR platform; that is, whether the ring delivered TDF-alone, TDF-FTC, or TDF-FTC-MVC, users' experiences of the ring were similar and acceptable. Participants did report specific experiences, both sensory and behavioral, that impacted their use behaviors with respect to the ring, and which could ultimately impact acceptability and adherence. These experiences, and user evaluations elicited by them, could both challenge use or be used to leverage use in future trials and product rollout once fully articulated., Conclusions: High willingness-to-use data and lack of salient differences in user experiences related to use of the pod-IVR platform (regardless of agents delivered) suggests that the pod-IVR is a feasible and acceptable drug delivery device in and of itself. This finding holds promise both for an anti-HIV pod-IVR and, potentially, a multipurpose prevention pod-IVR that could deliver both prevention for sexually transmitted infections (STIs) including HIV and contraception. Given the very early clinical trial context, further acceptability, perceptibility, and adherence data should continue to be explored, in the context of longer use periods (e.g., 28-day ring use), and in the contexts of sexual activity and menses. Using early design and development contexts to gain insights into potential challenges and facilitators of drug delivery systems such as the pod-IVR could save valuable resources and time as a potential biomedical technology moves through the clinical trial pipeline and into real-world use.

Background: Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms. Scales are composed of multiple items in the form of questions or statements that, when combined, measure a more complex construct that may not be directly observable. When psychometrically validated, such measures may better assess the multiple factors contributing to adherence/non-adherence. This study aimed to develop and psychometrically evaluate tools to screen and monitor trial participants' adherence to HIV prevention products within the context of clinical trial research., Methods and Findings: Based on an extensive literature review and conceptual framework, we identified and refined 86 items assessing potential predictors of adherence and 48 items assessing adherence experience. A structured survey, including adherence items and other variables, was administered to former ASPIRE and Ring Study participants and similar non-trial participants (n = 709). We conducted exploratory factor analyses (EFA) to identify a reduced set of constructs and items that could be used at screening to predict potential adherence, and at follow-up to monitor and intervene on adherence. We examined associations with other variables to assess content and construct validity. The EFA of screener items resulted in a 6-factor solution with acceptable to very good internal reliability (α: .62-.84). Similar to our conceptual framework, factors represent trial-related commitment (Distrust of Research and Commitment to Research); alignment with trial requirements (Visit Adherence and Trial Incompatibility); Belief in Trial Benefits and Partner Disclosure. The EFA on monitoring items resulted in 4 Product-specific factors that represent Vaginal Ring Doubts, Vaginal Ring Benefits, Ring Removal, and Side Effects with good to very good internal reliability (α = .71-.82). Evidence of content and construct validity was found; relationship to social desirability bias was examined., Conclusions: These scales are easy and inexpensive to administer, available in several languages, and are applicable regardless of randomization. Once validated prospectively, they could (1) screen for propensity to adhere, (2) target adherence support/counselling, and (3) complement biomarker measures in determining true efficacy of the experimental product.