Sexual and reproductive health in military settings: A qualitative study.

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.

Referral to Adolescent Weight Management Interventions: Qualitative Perspectives From Providers.

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.

Weight Management Engagement for Teens From Low-Income Backgrounds: Qualitative Perspectives From Adolescents and Caregivers.

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.

From "disappointing" to "fantastic": Women's experiences with labor induction in a U.S. tertiary hospital.

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.

Stakeholder perspectives on adjunctive mHealth services during transitions of care for patients with schizophrenia-spectrum disorders.

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.

Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial.

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.

Personalized feedback improves cardiovascular risk perception and physical activity levels in persons with HIV: results of a pilot randomized clinical trial.

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.

Partner Type and Young Women's Sexual Behavior: A Qualitative Inquiry.

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.

"A Woman in A Man's World": A Pilot Qualitative Study of Challenges Faced by Women Veterans During and After Deployment.

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.

Protective parenting practices among mothers living with HIV and their adolescent children: a qualitative study.

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.

A Brief Clinic-Based Intervention to Reduce Alcohol Misuse and Sexual Risk Behavior in Young Women: Results from an Exploratory Clinical Trial.

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 χ2 = 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.

'I feel like a person has a right to use a product to protect themselves ': a qualitative study of the risk-benefit calculus on women's contraceptive use and choice.

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.

Alcohol Use and Sexual Risk Behavior in Young Women: A Qualitative Study.

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.

Sexual risk behavior and substance use among young, diverse women seeking care at a reproductive health clinic.

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.

Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial.

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.

Perceived barriers to smoking cessation and perceptions of electronic cigarettes among persons living with HIV.

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.

Temporal Fluctuations in Behavior, Perceived HIV Risk, and Willingness to Use Pre-Exposure Prophylaxis (PrEP).

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.

Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of semisoft vaginal suppositories.

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.

Physician Views of Telehealth for Special Populations of Older Adults: Preliminary Findings.

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.