The Impact of Providing Free HIV Self-testing on Sexual Risk Behaviors Among Men who have Sex with Men in Hunan, China: A Randomized Controlled Trial.

HIV self-testing (HIVST) increases testing frequency among men who have sex with men (MSM). However, its impact on sexual risk behaviors is unclear. In a randomized controlled trial conducted in Hunan Province, China, HIV-negative MSM were randomized to receive one of two interventions for one year: (1) facility-based HIV testing, or (2) facility-based HIV testing augmented with free HIVST. From April to June 2018, 230 MSM were enrolled. They self-reported sexual behaviors every 3 months for 12 months. Among 216 MSM with follow-ups (intervention: 110; control: 106), adjusting for potential confounders in Generalized Estimating Equation models, there were no statistically significant differences in consistent condom use with male partners (regular/casual) or female partners, nor on number of male or female sexual partners. Provision of free HIVST kits does not increase risky sex and should be included in comprehensive HIV prevention packages, particularly for sexual minority men in China.

Reframing the meaning of life and professional values: A theoretical framework of facilitating professional care for terminally ill patients.

Professional values reflect nurses' understanding of how to deliver professional care, which might influence nurses' attitudes and caring behaviors during end-of-life care. However, limited research has been conducted to explore nurses' experiences of professional development during end-of-life care, and theoretical explanations are scarce about how nurses enact their professional values during the caring process. This study explored the social process of professional values involved in end-of-life care in the Chinese cultural context by adopting a constructivist grounded theory approach. Twenty semi-structured in-depth interviews with 15 nurses from three hospitals in southeastern China were conducted. A theoretical framework emerged when focusing on the social process of "reframing the meaning of life and professional values" to facilitate professional care for terminally ill patients. Three main categories were sequentially identified as "recognizing the dilemmas when caring for terminally ill patients," "applying strategies to deal with values conflict," and "reconstructing values." This theoretical framework may be applied as a practical framework for equipping nurses with effective strategies to cultivate professional values, including the provision of adequate end-of-life knowledge, and a supportive workplace environment.

Impact of providing free HIV self-testing kits on frequency of testing among men who have sex with men and their sexual partners in China: A randomized controlled trial.

BACKGROUND: The HIV epidemic is rapidly growing among men who have sex with men (MSM) in China, yet HIV testing remains suboptimal. We aimed to determine the impact of HIV self-testing (HIVST) interventions on frequency of HIV testing among Chinese MSM and their sexual partners. METHODS AND FINDINGS: This randomized controlled trial was conducted in 4 cities in Hunan Province, China. Sexually active and HIV-negative MSM were recruited from communities and randomly assigned (1:1) to intervention or control arms. Participants in the control arm had access to site-based HIV testing (SBHT); those in the intervention arm were provided with 2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT. They were encouraged to distribute HIVST kits to their sexual partners. The primary outcome was the number of HIV tests taken by MSM participants, and the secondary outcome was the number of HIV tests taken by their sexual partners during 12 months of follow-up. The effect size for the primary and secondary outcomes was evaluated as the standardized mean difference (SMD) in testing frequency between intervention and control arms. Between April 14, 2018, and June 30, 2018, 230 MSM were recruited. Mean age was 29 years; 77% attended college; 75% were single. The analysis population who completed at least one follow-up questionnaire included 110 (93%, 110/118) in the intervention and 106 (95%, 106/112) in the control arm. The average frequency of HIV tests per participant in the intervention arm (3.75) was higher than that in the control arm (1.80; SMD 1.26; 95% CI 0.97-1.55; P < 0.001). This difference was mainly due to the difference in HIVST between the 2 arms (intervention 2.18 versus control 0.41; SMD 1.30; 95% CI 1.01-1.59; P < 0.001), whereas the average frequency of SBHT was comparable (1.57 versus 1.40, SMD 0.14; 95% CI -0.13 to 0.40; P = 0.519). The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055). Zero-inflated Poisson regression analyses showed that the likelihood of taking HIV testing among intervention participants were 2.1 times greater than that of control participants (adjusted rate ratio [RR] 2.10; 95% CI 1.75-2.53, P < 0.001), and their sexual partners were 1.55 times more likely to take HIV tests in the intervention arm compared with the control arm (1.55, 1.23-1.95, P < 0.001). During the study period, 3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive. No other adverse events were reported. Limitations in this study included the data on number of SBHT were solely based on self-report by the participants, but self-reported number of HIVST in the intervention arm was validated; the number of partner HIV testing was indirectly reported by participants because of difficulties in accessing each of their partners. CONCLUSIONS: In this study, we found that providing free HIVST kits significantly increased testing frequency among Chinese MSM and effectively enlarged HIV testing coverage by enhancing partner HIV testing through distribution of kits within their sexual networks. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800015584.

"You Only Teach PE and It Doesn't Really Matter": Middle School PE Teachers' Perspectives on Intervention Efforts to Increase Physical Activity.

Physical education (PE) is a frequent site of public health intervention to promote physical activity (PA); however, intervention research frequently overlooks the perspective of PE teachers. The purpose of this qualitative study was to explore teachers' experiences with and perceptions of a PA curriculum intervention. Six findings within three categories were identified and described in detail. In-depth one-on-one semistructured interviews were conducted with nine PE teachers from eight middle schools in Los Angeles. Feeling underappreciated and having a "muddled mission" within PE were driving factors in teacher morale and practice. Teachers had positive experiences with the curriculum, but significant barriers remained and limited the potential for PA during PE classes. PE teachers are pulled in multiple directions and perceive a lack of necessary support systems to achieve student health goals. Interventions aimed at leveraging PE as a site of PA promotion must incorporate the perspectives of PE teachers.

Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon.

Cellular & Gene Therapies (CGTs) are complex products, which have been key foci of the International Society for Cell & Gene Therapy (ISCT). For this ISCT North American Legal & Regulatory Affairs Committee review publication, CGTs include but are not limited to somatic cell-based therapies, pluripotent cell-derived cell-based therapies, gene- or non-gene-modified or gene edited versions of these cell-based therapies, in vivo gene therapies, organ/tissue engineered products, and relevant combination products. These products are regulated by the Food and Drug Administration (FDA) in the United States. This publication reviews selected laws, regulations, guidance, definitions, processes, types of meetings and submissions, and other key factors that the FDA follows and implements to regulate and support development of these types of products. These factors may be considered in order to help current and potential product developers/sponsors/applicants navigate through FDA regulatory pathways. We also review expedited programs including types of Designations available at the FDA, and their specific eligibility criteria. We include FDA and other stakeholder resources to consider regarding CGT regulation, to help prepare for CGT development and subsequent FDA approval.

Physical Activity Correlates in Middle School Adolescents: Perceived Benefits and Barriers and Their Determinants.

The purpose of this study was to examine the determinants of benefits and barriers and their relationship with physical activity (PA) among predominantly Latino middle school students. Data were collected in a cross-sectional survey of 4,773 seventh-grade students recruited from a large, urban school district in Los Angeles. Hierarchical logistic regression models were used to assess determinants of benefits and barriers as well as their association with self-reported PA. Differences in benefits and barriers were observed by gender, ethnicity, and body size. Barriers were negatively correlated with all three PA outcomes while benefits were positively associated with exercising at least 60 min daily. A deeper understanding of benefits and barriers can facilitate the development of interventions and collaborative efforts among physical education teachers, school nurses, and administrators to implement comprehensive approaches that encourage students' participation in PA inside and outside of the classroom.

Review: Partner Support and Physical Activity among Mexican American Women.

Objective: Global recommendations on physical activity for noncommunicable disease prevention can be promoted using partner support strategies among women of Mexican descent and other ethnicities. Design/Methods: This systematic review utilized a multifaceted ecological approach by focusing comprehensively on community, individual, and social factors influencing physical activity. PubMed, SAGE Publications, EBSCO, ResearchGate, the Cochrane Library and Google Scholar search engines were used to find research on physical activity, with inclusion criteria of Mexican American women, aged ≥ 18 years, comprising at least 50% of study population sizes. Main Outcome Measures: An initial search of 232 articles with subsequent searches from reference lists led to selection of a mixture of qualitative (3), mixed methods (3), and intervention (1) studies reporting partner support for physical activity as perceived by women. Results: Primarily, studies have conceptualized physical activity as leisure time activities. Few studies have considered multiple ecological factors in examining influences of physical activity among women. Importantly, how women perceive support for physical activity received from partners has been shown to influence their levels of activity. Conclusions: Conceptualization of physical activity restricted only to leisure time eliminates other domains that a broader definition of the term encompasses. Future studies are needed to investigate partner support influences on the overall physical activity of Mexican American women within a larger ecological context. Careful attention to partner support for physical activity engagement can help ameliorate and prevent chronic diseases both nationally and around the world.

Knowledge, Behaviors, and Attitudes About Human Papilloma Virus Among Nursing Students in Izmir, Turkey.

Human papillomavirus (HPV) is transmitted through sexual contact and can cause cervical cancer. The aim of this study was to determine knowledge, behaviors, and attitudes about human papillomavirus (HPV) in nursing students in a baccalaureate program. This study was conducted with a sample of 624 students. Data were collected via questionnaires administered during the first class time. Students' knowledge about HPV was high; 90.5% knew HPV can cause cervical cancer; 94.6% recognized it as a sexually transmitted disease. Although; 87.7% stated a vaccine is available to protect women from HPV, nearly all participants (98.1%) had not received HPV vaccination. Findings show students' level of knowledge about HPV's risk factors and modes of transmission were high. However, this knowledge did not translate into engagement in health related behaviors such as being vaccinated against HPV.

Consistency of Moderate to Vigorous Physical Activity in Middle School Physical Education.

This study assessed the consistency of moderate to vigorous physical activity (MVPA) in a sample of middle school physical education lessons. Random intercept hierarchical linear regressions were employed to model the relationship between consistency of MVPA and independent variables, including lesson and teacher characteristics. Larger classes spent significantly more time in consistent MVPA in the absence of controlling for teacher characteristics. A significant interaction between class size and teacher experience suggests that experience may play a beneficial role in larger classes, and overall class size does not have to be a barrier to achieving high levels of MVPA.

Awareness of Cardiovascular Disease and Preventive Behaviors Among Overweight Immigrant Latinas.

BACKGROUND AND OBJECTIVES: Low-income Latina women face increased risk for cardiovascular disease (CVD) due to high rates of obesity, diabetes, and other comorbidities. Language barriers, lack of health insurance, and lack of access to preventive health messages may further increase their risk. The purpose of this study was to evaluate knowledge about CVD of overweight, immigrant Latinas who spoke little or no English and participated in an educational intervention. METHODS: Ninety participants completed a CVD knowledge questionnaire before and after 8 educational sessions based upon Su Corazón, Su Vida. The curriculum focused on understanding risk factors of CVD and prevention through heart-healthy diets, physical activity, and weight control. The questionnaire evaluated general CVD knowledge (eg, heart disease is the leading cause of death in women) and prevention measures (eg, physical activity can lower a woman's risk for getting heart disease). Data were analyzed using generalized estimating equations and correlational statistics. RESULTS: Participants were middle-aged, overweight Latinas, predominantly of Mexican descent, with low education and acculturation. Baseline knowledge that heart disease is the leading cause of death in women was low. A comparison of preintervention and postintervention scores on the questionnaire showed a significant change (P < 0.001), with means of 7.9 and 9.4, respectively. Scores for individual items correctly answered significantly improved for 9 of the 11 items, including questions about portion control to lose weight, physical activity, overweight, and risk for heart disease. Most participants did not recognize that men and women may experience different symptoms of a heart attack. Knowledge was not significantly related to background characteristics, body mass index, or lifestyle behaviors. CONCLUSIONS: Despite campaigns to increase CVD awareness, many Spanish-speaking, immigrant Latinas remain unaware that heart disease is the leading cause of death. Educational interventions may significantly improve their CVD knowledge; nonetheless, continued cardiovascular health promotion efforts are needed for this population.

Promotoras as facilitators of change: Latinas' perspectives after participating in a lifestyle behaviour intervention program.

AIM: To describe immigrant Latinas' perspectives of a lifestyle behaviour intervention, focusing on their interactions with and perceptions of the promotoras who delivered the program in the USA. BACKGROUND: Immigrant Latinas in the USA have high obesity rates, which contribute to increased risk for cardiovascular disease and other long-term diseases. Interventions using the promotora model appear to be effective in reducing cardiovascular disease risk by improving dietary habits, physical activity and selected clinical variables among Latinas. However, there has been very limited enquiry into what it is about these interventions and promotoras that facilitates behaviour change, from the perspective of participants. DESIGN: Grounded theory methodology guided the data collection and analysis. METHODS: This qualitative study was completed in 2012 in California, after the end of a lifestyle behaviour intervention. Four focus groups and seven one-on-one interviews were conducted with a total of 18 immigrant Latina intervention participants. RESULTS: Women described promotoras as helping them change by motivating them through three interconnected elements: tools, support and knowledge. Latinas viewed their ability to make lifestyle changes as connected with their emotional and psychological health and saw promotoras as counsellors who gave emotional and social support. In this respect, the intervention was emotionally therapeutic for this sample of Latinas, although this was not the original intention of the program. CONCLUSION: Promotoras gave the backbone of the intervention and were crucial in motivating Latinas to implement lifestyle changes. Future lifestyle behaviour interventions should include a strong component of mental and emotional well-being.

Blood donation: comparing individual characteristics, attitudes, and feelings of donors and nondonors.

The shortage of blood donors and increased demand for blood is an important health issue. Finding ways to increase donor recruitment and retention is a priority and, thus, an important area for research. This article aims to better understand donors and nondonors on the basis of their social responsibility, susceptibility to interpersonal influence, involvement in and attitude towards the blood donation issue, and their aroused feelings. The data from 345 completed surveys were collected via a web-based, self-administered method. Mean differences were examined and the conceptual model was tested via structural equation modeling. The findings provide important clarification of donation and nondonation behavior.

Using qualitative inquiry and participatory research approaches to develop prevention research: validating a life course perspective.

Application of life course theory (LCT) holds promise for advancing knowledge toward the elimination of health disparities. This article validates the usefulness of employing a life course perspective when conducting health disparities research. We provide an overview of LCT as it applies to our research program in prevention of human immunodeficiency virus (HIV) among Latino teen parents. We illustrate the goodness-of-fit of our research with the basic premises of LCT. Though early adverse life experiences impact health over the lifespan, strength-based HIV prevention programs designed for Latino teen parents that recognize the reality of their lives may alter their health trajectory.

Invincibility fable: tool development to measure invincibility.

UNLABELLED: Invincibility is a phase of social-cognitive development of the adolescent and has been associated with risk behavior involvement. OBJECTIVE: To determine psychometric properties of the Adolescent Invincibility Tool (AIT). METHODS: Reliability was assessed and validity was examined using principal components analysis. RESULTS: Internal consistency was demonstrated with a Cronbach's alpha of .88; factor analysis led to the confirmation of subscales. Criterion validity was validated with similar and opposing measures of invincibility. DISCUSSION: Initial testing suggests that the AIT is a valid and reliable tool for screening invincibility. Further testing is recommended to determine relevance for other populations of youth.

Ethical Decision-making of Health Professionals Caring for People Living with HIV/AIDS in Hunan, China: A Qualitative Study.

Numerous ethical issues surged the moment acquired immunodeficiency syndrome (AIDS) was discovered. As advocates of people living with HIV/AIDS (PLWHA), health professionals encounter many ethical dilemmas in clinical practice. However, it remains unclear how health professionals solve these issues. The descriptive qualitative research was conducted through semi-structured interviews with 22 health professionals from May to August 2018. Three themes emerged from data analyses of the interviews: (1) real ethical dilemma experienced by health professionals, (2) factors influencing ethical judgment, (3) ethical motivations. About two-thirds of participants failed to recall ethical dilemmas experienced in their clinical practice. Emotions, gender, occupation, and difficulty balancing different roles may influence the ethical judgments of health professionals. In the ethical decision-making (EDM) process, most participants took other people's interests into consideration and conformed to law and professional codes of conduct. However, the fear of medical disputes (conflicts with families and others) was experienced by many participants, influencing their ethical behaviors.

Stress and Coping in Nurses Taking Care of People Living with HIV in Hunan, China: A Descriptive Qualitative Study.

BACKGROUND/PURPOSE: Nurses engaged in the care of people living with HIV (PLWH) are commonly exposed to workplace stress. This study aimed to explore the stress experiences and coping strategies among nurses taking care of PLWH in China. METHODS: Nurses were recruited from the AIDS department of a public, general, third-grade class-A hospital, which has the largest HIV care department in the Hunan Province of China. Thirty-three nurses working in the AIDS Department were recruited in this qualitative study. Eight nurses participated in a focus group and 25 nurses underwent in-depth individual interviews aimed at characterizing the nurse's feelings and struggles with stress during caregiving for PLWH. The interviews were audio-recorded, transcribed verbatim, anonymized, and imported into NVivo 8.0 software. The data were coded and subjected to thematic analysis. RESULTS: Concerns about occupational exposure, heavy workload, mental health problems and risk behaviors of patients, and discrimination towards nurses caring for PLWH were the four main sources of stress. The negative impact of stress included problems with emotion regulation, somatic health and sleep, and work performance. Some participants also reported a positive impact of work stress on their mental health. Using personality strengths, problem-solving, help-seeking, concealing and avoiding/suppression were common coping strategies employed by nurses caring for PLWH. CONCLUSION: Our findings help characterize the stress experienced by nurses caring for PLWH in the Chinese cultural context, and may inform specific interventions to help manage stress and promote mental health of nurses.

Intra-operative preparation of autologous bone marrow-derived CD34-enriched cellular products for cardiac therapy.

BACKGROUND AND AIMS: With the advent of regenerative therapy, there is renewed interest in the use of bone marrow as a source of adult stem and progenitor cells, including cell subsets prepared by immunomagnetic selection. Cell selection must be rapid, efficient and performed according to current good manufacturing practices. In this report we present a methodology for intra-operative preparation of CD34(+) selected autologous bone marrow for autologous use in patients receiving coronary artery bypass grafts or left ventricular assist devices. METHODS AND RESULTS: We developed a rapid erythrocyte depletion method using hydroxyethyl starch and low-speed centrifugation to prepare large-scale (mean 359 mL) bone marrow aspirates for separation on a Baxter Isolex 300i immunomagnetic cell separation device. CD34 recovery after erythrocyte depletion was 68.3 ± 20.2%, with an average depletion of 91.2 ± 2.8% and an average CD34 content of 0.58 ± 0.27%. After separation, CD34 purity was 64.1 ± 17.2%, with 44.3 ± 26.1% recovery and an average dose of 5.0 ± 2.7 × 10(6) CD34(+) cells/product. In uncomplicated cases CD34-enriched cellular products could be accessioned, prepared, tested for release and administered within 6 h. Further analysis of CD34(+) bone marrow cells revealed a significant proportion of CD45(-) CD34(+) cells. CONCLUSIONS: Intra-operative immunomagnetic separation of CD34-enriched bone marrow is feasible using rapid low-speed Hetastarch sedimentation for erythrocyte depletion. The resulting CD34-enriched product contains CD45(-) cells that may represent non-hematopoietic or very early hematopoietic stem cells that participate in tissue regeneration.

Shipping of therapeutic somatic cell products.

BACKGROUND AIMS: Shipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products. METHODS: Comparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions. The data were analyzed at the University of Pittsburgh Biostatistics Facility. RESULTS: No consistent shipping effects on cell viability, phenotype or functions were detected for cryopreserved and shipped peripheral blood mononuclear cells (PBMC), monocytes, immature dendritic cells (iDC), NK-92 or cytotoxic T cells (CTL). Cryopreserved mesenchymal stromal cells (MSC) had a significantly decreased viability after shipment, but this effect was in part because of inter-laboratory variability in the viable cell counts. Shipments of fresh peripheral blood and apheresis products for the generation of CTL and dendritic cells (DC), respectively, had no significant effects on cell product quality. MSC were successfully generated from fresh bone marrow samples shipped overnight. CONCLUSIONS: This validation study provides a useful set of data for guiding shipments of therapeutic somatic cells in multi-institutional clinical trials.