No observed bidirectional effect between tenofovir diphosphate concentrations and gender-affirming hormone concentrations among transgender persons switching from tenofovir disoproxil fumarate/emtricitabine to tenofovir alafenamide/emtricitabine for HIV pre-exposure prophylaxis.

AIMS: Many transgender and gender diverse (TGD) individuals have expressed concerns about the potential for oral pre-exposure prophylaxis to affect hormonal concentrations achieved from taking gender-affirming hormone therapy (GAHT). The purpose of this study was to understand the bidirectional effects between hormone and intraerythrocytic tenofovir diphosphate concentrations when switching from tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) to tenofovir alafenamide/emtricitabine (TAF/FTC) in TGD users/nonusers of GAHT. METHODS: The study evaluated stored blood samples and dried blood spot cards from TGD adults without HIV who took ≥12 weeks of TDF/FTC and then switched to ≥12 weeks of TAF/FTC for pre-exposure prophylaxis. RESULTS: Thirty-nine individuals met the study inclusion criteria. Regardless of sex assigned at birth and the use of GAHT, there were no significant differences in hormone concentrations when individuals taking GAHT were taking TDF/FTC and then switched to TAF/FTC. Further, there was no significant difference in intraerythrocytic tenofovir diphosphate concentrations between users and nonusers of GAHT. CONCLUSION: There are no bidirectional effects between hormone and intraerythocytic tenofovir diphosphate concentrations when switching from TDF/FTC to TAF/FTC in TGD users/nonusers of GAHT.

Exploring the Experiences of Community-Dwelling Older Adults on Using Wearable Monitoring Devices With Regular Support From Community Health Workers, Nurses, and Social Workers: Qualitative Descriptive Study.

BACKGROUND: The use of wearable monitoring devices (WMDs), such as smartwatches, is advancing support and care for community-dwelling older adults across the globe. Despite existing evidence of the importance of WMDs in preventing problems and promoting health, significant concerns remain about the decline in use after a period of time, which warrant an understanding of how older adults experience the devices. OBJECTIVE: This study aims to explore and describe the experiences of community-dwelling older adults after receiving our interventional program, which included the use of a smartwatch with support from a community health workers, nurses, and social workers, including the challenges that they experienced while using the device, the perceived benefits, and strategies to promote their sustained use of the device. METHODS: We used a qualitative descriptive approach in this study. Older adults who had taken part in an interventional study involving the use of smartwatches and who were receiving regular health and social support were invited to participate in focus group discussions at the end of the trial. Purposive sampling was used to recruit potential participants. Older adults who agreed to participate were assigned to focus groups based on their community. The focus group discussions were facilitated and moderated by 2 members of the research team. All discussions were recorded and transcribed verbatim. We used the constant comparison analytical approach to analyze the focus group data. RESULTS: A total of 22 participants assigned to 6 focus groups participated in the study. The experiences of community-dwelling older adults emerged as (1) challenges associated with the use of WMDs, (2) the perceived benefits of using the WMDs, and (3) strategies to promote the use of WMDs. In addition, the findings also demonstrate a hierarchical pattern of health-seeking behaviors by older adults: seeking assistance first from older adult volunteers, then from social workers, and finally from nurses. CONCLUSIONS: Ongoing use of the WMDs is potentially possible, but it is important to ensure the availability of technical support, maintain active professional follow-ups by nurses and social workers, and include older adult volunteers to support other older adults in such programs.

Experiences of receiving an mHealth application with proactive nursing support among community-dwelling older adults: a mixed-methods study.

BACKGROUND: As the population ages, a plethora of digital and mobile health applications for assistance with independent living have emerged. Still unknown, however, is how older adults sustain the use of these applications. AIM: This study sought to explore the experiences of older adults following their participation in a programme that combined the use of an mHealth application with proactive telecare nursing support. METHODS: We employed a concurrent mixed-methods design for this study. The quantitative strand included a survey, whereas the qualitative strand included open-ended questions as part of the survey to understand the participants' experiences. Participants for this study were community-dwelling older adults who had taken part in an interventional study that sought to examine the effects of mHealth and nurse support. A convenience sampling approach was employed to recruit potential participants for this study. FINDINGS: Fifty-five older adults participated. The majority expressed positive attitudes and satisfaction with the app and the nurses' support. The app and nurses' support helped participants to understand their health status and obtain health information. Reasons to halt app usage included technical issues and limited social support. CONCLUSION: Mobile apps with professional follow-up support could potentially support older adults in the community, although emerging concerns need to be addressed to sustain long-term usage of these apps.

Impact of (recurrent) bacterial vaginosis on quality of life and the need for accessible alternative treatments.

BACKGROUND: Bacterial vaginosis (BV) is one of the most common vaginal dysbiosis in women aged 15-44 years old. METHODS: We administered a cross-sectional, single timepoint survey to women ages 18 years or older and who have had bacterial vaginosis (BV). Women completed an anonymous online survey evaluating the impact of BV on their quality of life, how effective different types of treatments were and the amount of self-diagnosed vs. provider diagnosed BV episodes they had. RESULTS: 62 participants completed the anonymous online survey. With a self-reported median number of BV episodes in the past year was 4 (IQR 1-7). Among these women 69.8% reported BV had a negative impact on their sexual health, 67.7% on their physical health, 74.6% on their mental health. More than half of the respondents had used probiotics with oral Lactobacillus sp. (53.2%), mainly by oral route, and over a third had used vaginal boric acid (37.1%). Most women were unaware of Lactobacillus crispatus. Lactobacillus probiotics were more likely to be tried by women who were negatively impacted by BV for overall quality of life (p = 0.033), sexual health (p = 0.002), and mental health (p = 0.006) while boric acid use was more likely to be used by women who were negatively impacted by BV for their sexual health (p = 0.008). CONCLUSIONS: BV is associated with negative quality of life and the women most impacted are seeking alternative treatments such as probiotics (Lactobacillus) and boric acid. There needs to be improvements in BV treatment that include alternative therapy options that have demonstrated efficacy with standardized composition, formulation and dosage.

The Synergistic Effect of Nurse Proactive Phone Calls With an mHealth App Program on Sustaining App Usage: 3-Arm Randomized Controlled Trial.

BACKGROUND: Although mobile health application (mHealth app) programs have effectively promoted disease self-management behaviors in the last decade, usage rates have tended to fall over time. OBJECTIVE: We used a case management approach led by a nurse and supported by a health-social partnership team with the aim of sustaining app usage among community-dwelling older adults and evaluated the outcome differences (i.e, self-efficacy, levels of depression, and total health service usages) between those who continued to use the app. METHODS: This was a 3-arm randomized controlled trial. A total of 221 older adults with hypertension, diabetes, or chronic pain were randomized into 3 groups: mHealth (n=71), mHealth with interactivity (mHealth+I; n=74), and the control (n=76). The mHealth application was given to the mHealth and mHealth+I groups. The mHealth+I group also received 8 proactive calls in 3 months from a nurse to encourage use of the app. The control group received no interventions. Data were collected at preintervention (T1), postintervention (T2), and at 3 months' postintervention (T3) to ascertain the sustained effect. RESULTS: A total of 37.8% of mHealth+I and 18.3% of mHealth group participants continued using the mHealth app at least twice per week until the end of the sixth month. The difference in app usage across the 2 groups between T2 and T3 was significant (χ21=6.81, P=.009). Improvements in self-efficacy (ß=4.30, 95% CI 0.25-8.35, P=.04) and depression levels (ß=-1.98, 95% CI -3.78 to -0.19, P=.03) from T1 to T3 were observed in the mHealth group participants who continued using the app. Although self-efficacy and depression scores improved from T1 to T2 in the mHealth+I group, the mean values decreased at T3. Health service usage decreased for all groups from T1 to T2 (ß=-1.38, 95% CI -1.98 to -0.78, P<.001), with a marginal increase at T3. CONCLUSIONS: The relatively low rates of mHealth app usage at follow-up are comparable to those reported in the literature. More work is needed to merge the technology-driven and in-person aspects of mHealth. TRIAL REGISTRATION: ClinicalTrials.gov NCT03878212; https://clinicaltrials.gov/ct2/show/NCT03878212. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1159/000509129.

Effects of a Video-Based mHealth Program for Homebound Older Adults: Study Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Although homebound older adults are among the highest users of hospital services, the existing health and social services that are provided to them in the community are limited and fragmented. This study attempts to bring this group of older adults to providers' attention by designing a health-social-oriented self-care mobile Health (mHealth) program and subjecting it to empirical testing. The aim of this study is to shift the current reactive, cure-oriented approach to a preventive and health-promoting model, empowering homebound older adults to take an active role in their health, be responsive to their care needs, and subsequently improve their holistic health. METHODS: This is a pilot randomized controlled trial. The study is supported by 5 community centers with an estimated sample size of 68 subjects. The subjects will be randomly assigned to video-based mHealth or control groups when they (1) are aged 60 or over, (2) go outdoors less than once a week in the current 6 months, (3) live within the service areas, and (4) use a smartphone. Subjects in the video-based mHealth group will receive a 3-month program comprising 2 main interventions: nurse case management supported by a social service team and video messages covering self-care topics, delivered via smartphone. The control group will receive usual care. Data will be collected at 2 time points - pre-intervention (T1) and post-intervention (T2). The primary outcome will be self-efficacy, and secondary outcomes will include health outcomes (activities of daily living, instrumental activities of daily living, and medication adherence), perceived well-being outcomes (quality of life and depression), and health service utilization outcomes (outpatient clinic, emergency room, and hospital admission). DISCUSSION: The current study will add to the knowledge gap in using mHealth supported by a health-social team to enhance quality of life and self-care and meet the needs of these particularly vulnerable older adults.

A community-based health-social partnership program for community-dwelling older adults: a hybrid effectiveness-implementation pilot study.

BACKGROUND: A growing body of literature supports the efficacy of the health-social approach for the implementation of complex interventions to enhance self-care health management among community-dwelling older adults. However, there is little research on how interventions with this approach are implemented and disseminated in a real community setting. METHODS: This pilot study adopted an effectiveness-implementation hybrid design to 1) evaluate the effectiveness of a community-based Health-Social Partnership Program (HSPP) and 2) explore the reach, adoption, implementation, and maintenance of the HSPP in the community. Potential participants were recruited if they were aged 60 or above, owned a smartphone, and were cognitively competent. The participants received nurse-led case management with support from a social service team. Factors that hindered or facilitated the program delivery were examined to determine the implementation outcomes and sustained effects of the program. Data were collected at pre-intervention (T1), immediately post-intervention (T2), and 3 months post-intervention (T3). RESULTS: Ninety-two older adults joined and completed the program. The recruitment rate was 76.7%. A significant interaction effect was found for the mean self-efficacy scores from T1 to T2 (Wald χ2 = 12.28, p ≤ .001). Barriers to widespread program implementation included manpower shortage, lack of experienced staff, and unpredictable environment, whereas facilitators, as suggested by the older adults, providers, and community staff members, included regular communication between the research and service teams, recruitment of participants through community centers with the support of the research team, and seamless partnership among the health-social partnership team members. Strong implementation fidelity was achieved with zero attrition rate. CONCLUSION: Most conventional randomized controlled trials investigating the effects of community-based programs have tended to control the contextual factors rather than incorporate the program in a real setting. This pilot study was the first to use a hybrid model to test the effectiveness and outcomes of HSPP implementation. The results imply that the program has a high potential sustainability in the real-life context. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (NCT04442867; date of first registration 23/06/2020).

Results from a Pre-exposure Prophylaxis Demonstration Project for At-risk Cisgender Women in the United States.

BACKGROUND: Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women. METHODS: Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence. RESULTS: From June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections. CONCLUSION: Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.

Generalization of novel sensorimotor associations among pianists and non-pianists: more evidence that musical training effects are constrained.

In the process of acquiring musical skills, such as playing the piano, we develop sensorimotor associations between motor movements and perception of pitch. Previous research suggests that these acquired associations are relatively inflexible and show limited generalizability to performance under novel conditions. The current study investigated whether piano training constrains the ability to generalize learning based on an unfamiliar (inverted) pitch mapping, using a transfer-of-training paradigm (Palmer and Meyer in Psychol Sci 11:63-68, 2000). Pianists and non-pianists learned a training melody by ear with normal (higher pitches to the right) or inverted (higher pitches to the left) pitch mapping. After training, participants completed a generalization test in which they listened to and then immediately reproduced four types of melodies that varied in their similarity to the melody used during training and were based on the same, a similar, an inverted, or a different pitch pattern. The feedback mapping during the generalization test matched training. Overall, pianists produced fewer errors and required fewer training trials than non-pianists. However, benefits of training were absent for pianists who trained with inverted feedback when they attempted to reproduce a melody with a different structure than the melody used for training. This suggests that piano experience may constrain one's ability to generalize learning that is based on novel sensorimotor associations.

Performance anxiety and the plasticity of emotional responses.

Current psychological theories of performance anxiety focus heavily on relating performers' physiological and mental states to their abilities to maintain focus and execute learned skills. How task-specific expertise and past experiences moderate the degree to which individuals become anxious in a given performance context are not well accounted for within these theories. This review considers how individual differences arising from learning may shape the psychobiological, emotional, and cognitive processes that modulate anxious states associated with the performance of highly trained skills. Current approaches to understanding performance anxiety are presented, followed by a critique of these approaches. A connectionist model is proposed as an alternative approach to characterising performance anxiety by viewing performers' anxious states at a specific time point as jointly determined by experience-dependent plasticity, competition between motivational systems, and ongoing cognitive and somatic states. Clarifying how experience-dependent plasticity contributes to the emergence of socio-evaluative anxiety in challenging situations can not only help performers avoid developing maladaptive emotional responses, but may also provide new clues about how memories of past events and imagined future states interact with motivational processes to drive changes in emotional states and cognitive processing.

The Effects of the Connecting all Generations Through the Gerontech (CARETech) Program on Motivating Young People to Enter the Elderly Care Sector.

PURPOSE: This study aims to organize an intergenerational program to provide unemployed young people with operational skills related to gerontechnology and the experience required to deliver digital outreach rehabilitation services to community-dwelling older people. METHODS: A quasi-experimental research design was adopted. The young participants received a 12-session training program on the management of common chronic diseases, communication with older people, the functions and use of interactive games, and techniques to teach and match interactive games with older people. The perception of elderly outcomes (i.e., knowledge and attitude toward elderly care, willingness to care for the elderly), personal outcomes (i.e., life satisfaction, self-efficacy), and desired vocational outcomes (i.e., hours worked in the nongovernmental organization's center, hours spent with older people) were evaluated preprogram and postprogram. RESULTS: Fifty-one young people joined the program. A statistically significant improvement was seen from preprogram to postprogram in their willingness to care for the elderly (p = .016) and life satisfaction (p = .005), as well as in the number of hours that they spent in the community center volunteering or engaged in social services for older people. DISCUSSION: The findings proved that the program could improve the willingness of young people to care for older people, as well as improve their own life satisfaction. Using gerontechnology can serve to bridge the intergenerational gap and bring benefits to both young adults and older people. It may provide policy makers with a way to address the manpower shortage in elderly care services and help frail older people to age in place.

A health-social service partnership programme for improving the health self-management of community-dwelling older adults: a hybrid effectiveness-implementation pilot study protocol.

BACKGROUND: The ageing population requires seamless, integrated health and social care services in the community to promote the health of older adults. However, inadequate financial resources, a lack of clear operational guidelines, and various organisational work cultures may affect the implementation quality and sustainability of these services. As a unique approach, this study seeks to examine the preliminary effects of a health-social partnership programme on the health self-management of community-dwelling older adults in Hong Kong. Additionally, the study seeks to ascertain key insights into the mechanisms and processes required to implement and sustain a self-care management programme in broader practice in community settings. METHODS: This study will use a hybrid effectiveness-implementation design. During the 3-month programme, subjects in the intervention group will receive four Zoom video conference sessions and four telephone calls conducted by a health-social service team that will include a nurse case manager, community workers, general practitioners, a Chinese medicine practitioner, and social workers. Subjects in the control group will receive a monthly social telephone call from a trained research assistant to rule out the possible social effect of the intervention. The reach, effectiveness, adoption, implementation, and maintenance framework (i.e. RE-AIM framework) will be used to evaluate the implementation and effectiveness outcomes. Of the five dimensions included in the RE-AIM framework, only effectiveness and maintenance outcomes will be collected from both the intervention and control groups. The outcomes of the other three dimensions-reach, adoption, and implementation-will only be collected from subjects in the intervention group. Data will be collected pre-intervention, immediately post-intervention, and 3 months after the intervention is completed to evaluate the maintenance effect of the programme. DISCUSSION: This programme will aim to enhance health-promoting self-care management behaviours in older adults dwelling in the community. This will be the first study in Hong Kong to use the hybrid effectiveness-implementation design and involve key stakeholders in the evaluation and implementation of a health self-management programme using a health-social service partnership approach. The programme, which will be rooted in the community, may be used as a model, if proven successful, for similar types of services. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04442867. Submitted 19 June 2020.

Effectiveness of support from community health workers on the sustained use of a wearable monitoring device among community-dwelling older adults: A randomized trial protocol.

BACKGROUND: Wearable monitoring devices, such as smartwatches and fitness bands, are health technologies for enhancing self-care management among community-dwelling older adults. While the evidence suggests that these devices can promote health, older adults often struggle to use them over the long term. Community health workers can effectively motivate older adults to change their health behaviors. This study proposes an intervention involving community health workers as peer supporters to promote sustained daily use of wearable monitoring devices among community-dwelling older adults. METHODS: The intervention group in this randomized controlled trial will receive the Live with Wearable Monitoring Device program from trained community health workers with the support of a nurse and social workers through a one-time home visit and regular phone calls. The control group will receive only the wearable monitoring device. Data will be collected at baseline, 1 month, 3 months, and 6 months. DISCUSSION: Merely providing older adults with wearable monitoring devices may not lead to the realization of the potential health benefits of these devices, as long-term usage can be challenging. The results of this trial can provide evidence for a new approach to enhancing self-management and community healthcare among community-dwelling older adults, ultimately improving their health outcomes. IMPACT: Wearable monitoring devices not only enable real-time monitoring of vital signs, but can also support tailored messaging and facilitate virtual communication between users and healthcare professionals. Despite considerable health benefits, there is evidence showing that older adults largely stop using them after a few months. This study is the first to use a peer support approach to help older adults incorporate a wearable monitoring device in their daily routines in conjunction with goal setting and regular reminders. This will boost the self-care ability of the older adults, allowing them to continue physically functioning in the community. TRIAL REGISTRATION: This study was prospectively registered at clinicaltrials.gov (identifier: NCT05269303). Registration date: 24/2/2022.

Patient and Physician Preferences Regarding Long-Acting Pre-Exposure Prophylaxis and Antiretroviral Therapy: A Mixed-Methods Study in Southern California, USA.

Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are key strategies in ending the HIV epidemic. However, poor adherence to daily ART and PrEP increases the risk of HIV transmission and acquisition. Long-acting ART and PrEP formulations attempt to improve adherence through providing long-lasting forms of the medication delivered through different routes of administration: oral (potentially monthly), injection (1-6 months), and subdermal implant (up to annually). This study explored patient and physician preferences for long-acting ART and PrEP as well as adherence support strategies. Adult patients (n = 42) with experience taking ART or PrEP participated in individual interviews or focus groups. Physicians (n = 13) currently prescribing ART and/or PrEP completed an online questionnaire. Rapid qualitative analysis systematically synthesized qualitative data, and descriptive statistics examined survey responses. Patients supported improved adherence as a top potential advantage of long-acting ART and PrEP, and reduced internal stigma as a strong benefit specific to long-acting ART. Annual coverage offered through subdermal implants had strong appeal; however, oral was the preferred modality for long-acting ART and PrEP. Patients preferred injectable ART and PrEP if concurrently receiving hormone therapy injections. Side effects, medication cost, and treatment accessibility were potential barriers. Patients preferred calendar tracking and text messages/phone reminders for adherence supports. Physicians reported that they would reduce clinic visits and HIV testing for all patients on long-acting PrEP, except men who have sex with men who would continue to complete HIV testing every 3 months. Physicians were mixed on whether they believed long-acting ART and PrEP would improve patient adherence. Overall, findings demonstrate the potential benefits of long-acting ART and PrEP, while highlighting the need to obtain additional information to address treatment concerns.

A randomized controlled trial of an mHealth application with nursing interaction to promote quality of life among community-dwelling older adults.

Significance: Using mHealth apps alone at home without the support of healthcare experts could mean that older adults might not fully utilize the functions of the apps, recognize their benefits, and sustain their use. Incorporating an integrated health-social partnership model to support the app usage when further help is needed by the older adults might maximize the apps' benefits in the long term. Objectives: This study aimed to examine the benefits of adding nursing interaction supported by a health-social partnership model in the use of mHealth, and the sustained beneficial effects on psychological outcomes, including quality of life, self-efficacy, and depression, among older adults after the completion of the program. Methods: A three-arm, randomized controlled trial design was adopted. Community-dwelling older adults with chronic pain, hypertension, or diabetes, were randomly assigned to either the mHealth, mHealth with interactivity, or control group. Subjects in both the mHealth and the mHealth with interactivity groups received the mHealth application. In addition, the mHealth with interactivity group received support from a nurse case manager, who was supported by a health-social partnership team. mHealth apps and services from a nurse case manager were not provided to the control group. The primary outcome measure was quality of life, and secondary outcomes were self-efficacy and depression. Data were collected at pre-intervention (T1), post-intervention (T2), and at 3 months post-intervention to measure the sustained effect of the program. Results: There were 74 mHealth+I, 71 mHealth, and 76 control group subjects enrolled in the program. No statistically significant between-group, within-group, and interaction effects between group and time in both physical component summary (PCS) and mental component summary (MCS) scores were found among the three groups. The mHealth group showed an improvement in PCS and depression scores from T1 to T2, sustained at T3; while the mHealth+I group demonstrated improved self-efficacy from T1 to T2, with a decrease at T3. Conclusion: Adding nurse-directed telephone calls may be of little to no benefit at all in the long term. Future studies may consider a longer intervention period to build and sustain quality of life and self-efficacy levels among community-dwelling older adults. Clinical trial registration: www.ClinicalTrials.gov, identifier: NCT03878212.

Effect of a Mobile Health Application With Nurse Support on Quality of Life Among Community-Dwelling Older Adults in Hong Kong: A Randomized Clinical Trial.

Importance: Mobile health (mHealth) smartphone apps are becoming increasingly popular among older adults, although the reactive care approach of these apps has limited their usability. Objective: To evaluate the effects of an interactive mHealth program supported by a health-social partnership team on quality of life (QOL) among community-dwelling older adults in Hong Kong. Design, Setting, and Participants: This was a 3-group, randomized clinical trial conducted in 5 community centers in Hong Kong from December 1, 2020, to April 30, 2022, with a last follow-up date of January 31, 2022. Participants included older adults aged at least 60 years who were living within the service area, used a smartphone, and had at least 1 of the following problems: chronic pain, hypertension, or diabetes. Data were analyzed from May 1 to 10, 2022. Interventions: Participants were randomly assigned to the mHealth with interactivity (mHealth+I) group, mHealth group, or control group. Participants in the mHealth+I group received the mHealth app and nurse case management supported by a health-social partnership team. The mHealth group received the mHealth app only. The control group received no mHealth app or health-social care services. Main Outcomes and Measures: The primary outcome was the change in QOL from baseline to 3 months after completion of the intervention. Results: Among 221 participants (mean [SD] age 76.6 [8.0] years; 185 [83.7%] women), 76 were randomized to the control group, 71 were randomized to the mHealth group, and 74 were randomized to the mHealth+I group. The most common chronic diseases or problems were hypertension (147 participants [66.5%]), pain (144 participants [65.2%]), cataracts (72 participants [32.6%]), and diabetes (61 participants [27.6%]). At 3 months after the intervention and compared with the intervention group, there were no statistically significant differences in either the physical component summary (mHealth+I: ß = -1.01 [95% CI, -4.13 to 2.11]; P = .53; mHealth: ß = 0.22 [95% CI, -3.07 to 3.50]; P = .90) or the mental component summary (mHealth+I: ß = -0.87 [95% CI, -4.42 to 2.69]; P = .63; mHealth: ß = 1.73 [95% CI, -1.89 to 5.34]; P = .35) QOL scores. Only secondary outcomes, including self-efficacy (ß = -2.31 [95% CI, -4.26 to -0.36]; P = .02), systolic blood pressure (ß = -2.30 [95% CI, -5.00 to -0.13]; P = .04), pain levels (ß = 1.18 [95% CI, 0.52 to 2.00]; P = .02), and health services utilization (ß = 0.98 [95% CI, 0.32 to 2.09]; P = .048) improved in the mHealth+I group compared with the control group. Conclusions and Relevance: This randomized clinical trial found no difference in the primary outcome between the mHealth+I group and the control group confirming that there were no incremental benefits to adding interactivity in mHealth programs for older adults with chronic diseases. Trial Registration: Clinicaltrials.gov Identifier: NCT03878212.

Sexually transmitted infections among participants in an HIV PrEP adherence trial.

BACKGROUND: HIV PrEP effectiveness is highly dependent on adherence. High STI incidence has been reported among PrEP users. We assessed the relationship between STI incidence (CT, NG, and syphilis) and PrEP adherence. METHODS: We performed a subanalysis of a controlled, open-label, two-arm, randomized clinical demonstration project of a text-message based adherence intervention. Participants had 48 weeks of follow-up and had STI testing every 12 or 24 weeks. PrEP adherence was measured at week 48 using intracellular tenofovir-diphosphate drug concentrations. We calculated incidence rate ratios for STIs among those adherent as compared with those not adherent to PrEP. RESULTS: Of the 381 assessed for CT, NG and syphilis at one or more follow-up visits, there were 16 cases of syphilis or 5.0 per 100 person years (95% CI: 2.6, 7.5); 63 cases of NG or 26.3 per 100 person years (95% CI: 19.8, 32.8); and 81 cases of CT or 36.3 per 100 person years (95% CI: 28.4, 44.2). We found no association between adequate PrEP adherence and STI incidence (aIRR: 0.97 95% CI: 0.67, 1.40). CONCLUSIONS: We found that the incidence of STIs was not significantly different between those adherent to PrEP and those non-adherent. Further research is needed to assess how PrEP use may impact STIs over time.

Randomized Trial of Individualized Texting for Adherence Building (iTAB) Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals: The iM-PrEPT Study.

BACKGROUND: Transgender and nonbinary individuals at risk for HIV may benefit from adherence support for pre-exposure prophylaxis. METHODS: Between June 2017 and September 2020, 255 transgender and nonbinary individuals received daily oral tenofovir disoproxil fumarate/emtricitabine for 48 weeks randomized 1:1 to receive individualized Texting for Adherence Building (iTAB) or iTAB plus motivational interviewing (iTAB + MI) through phone for nonadherence. The primary end point was dried blood spot tenofovir diphosphate concentrations at weeks 12 and 48 (or last on-drug study visit) ≥1246 fmol/punch consistent with ≥7 doses/week (ie, near-perfect adherence). Secondary outcomes included dried blood spot tenofovir diphosphate concentrations ≥719 fmol/punch consistent with ≥4 doses/week (ie, adequate adherence) and self-reported adherence by daily text messages. RESULTS: Adherence for the outcome ≥1246 fmol/punch and ≥719 fmol/punch, respectively, was 49.1% and 57.9% for transgender men, 37.7% and 47.2% for nonbinary individuals, and 31.0% and 44.1% for transgender women. No difference was seen in iTAB + MI compared with iTAB alone by drug levels except where it approached significance in transgender women for the outcome of ≥719 fmol/punch in the iTAB + MI group compared with iTAB only (52% versus 35.7%, P = 0.065). There was a significant difference in self-reported daily dose adherence in the iTAB + MI group compared with iTAB alone (57.9% of days versus 46.4%, P = 0.009). In transgender women, the mean percentage of daily doses taken was 58.5% with iTAB + MI and 37.3% with iTAB alone ( P < 0.001). CONCLUSIONS: In addition to automated approaches to adherence promotion, phone-based MI triggered by repeatedly missing doses may improve pre-exposure prophylaxis adherence among transgender women.

Genital Inflammation Is Not Associated With Decreased Vaginal Tenofovir Concentrations in Women Taking Oral PrEP.

BACKGROUND: We evaluated the association of inflammation and dysbosis on cervicovaginal fluid (CVF) tenofovir (TFV) concentrations in women taking oral tenofovir disoproxil fumarate/emtricitable for HIV pre-exposure prophylaxis (PrEP) in the United States. SETTING: Thirty-five women in a HIV PrEP implementation study attended their week 24 visit at a San Diego research clinic and provided CVF specimens. METHODS: Women in the Adherence Enhancement Guided by Individualized Texting and Drug Levels study had their CVF specimens evaluated for (1) sexually transmitted bacterial (Neisseria gonorrhoeae, Chlamydia trachomatis, Gardnerella, and Trichomonas vaginalis), viral (human papillomavirus, cytomegalovirus and herpes simplex virus-1/2) and fungal (Candida) infections; (2) microbiome composition by 16 S sequencing (V3-V4 region); and (3) cytokine profiles by enzyme-linked immunoassay (Interleukin-8, macrophage Inflammatory protein-1a, macrophage Inflammatory Protein-1b and interferon-γ-inducible protein-10). Univariate statistical analysis was used to determine factors associated with CVF TFV concentrations. CVF TFV of 100-1000 ng/mL benchmarked typical genital concentrations and TFV-diphosphate in dried blood spots of 700 fmol/punch was considered adequate adherence. RESULTS: Thirty-five women had CVF specimens collected. No factor was associated with CVF TFV concentrations or discordance of blood and vaginal concentrations. Among 27 participants assessed for vaginosis (Candida, Gardnerella or Trichomonas), women with Gardnerella (n = 11) were more likely to have high (>1000 ng/mL) CVF TFV concentrations (82% versus 33%, P = 0.02). CONCLUSIONS: Presence of genital viruses, cytokines, or vaginal community state types were not associated with low CVF TFV concentrations in cisgender women taking oral tenofovir disoproxil fumarate/emtricitable for PrEP. The surprising association observed between presence of Gardnerella and higher vaginal TFV concentrations needs further evaluation.

Evaluation of videophone communication for families of hospitalized children.

This study evaluated videophones as a means of support among families who had limited access to their hospitalized children due to geographic separation. These videophones facilitated video-mediated communication between the hospital and the family home. Qualitative interviews explored the outcomes and processes related to videophone use for a subsample of 14 participants. Content analysis identified six themes: being in hospital far from home is "draining," vicarious growth and the recalibration of priorities, "it's like you're right there," source of happiness in a hard place, ease of videophone use, and limitations of the videophone. Participants reported that family separation during pediatric hospitalization was very difficult, and use of the videophones mitigated these effects through decreasing feelings of isolation and anxiety, and increasing feelings of connection between family members.