Increasing pre-exposure prophylaxis (PrEP) in primary care: A study protocol for a multi-level intervention using the multiphase optimization strategy (MOST) framework.

BACKGROUND: In the United States, over 1.2 million people are living with HIV. This disease disproportionately affects men who have sex with men (MSM), people of color, youth and young adults, and transgender individuals. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention method. Barriers exist for both primary care providers (PCPs) to prescribe PrEP and prevent patients from initiating PrEP. METHODS: This study, MOST: PrEP, follows the multiphase optimization strategy (MOST) framework. The purpose is to identify a multi-level intervention among patients and PCPs to increase PrEP prescriptions in primary care. First, feedback will be obtained from providers and patients via focus groups, then, suggestions related to the context-specific (provider and individual level) factors of intervention component delivery will be incorporated. Subsequently, a rigorous experiment will be conducted using a 24 factorial design focusing on priority populations for PrEP initiation. Provider components include computer-based simulation training and a best practice alert. Patient components include a tailored PrEP educational video and HIV risk assessment. Finally, the facilitators and barriers to implementing the intervention components will be qualitatively examined. CONCLUSION: In this protocol paper, we describe the one of the first known multilevel MOST optimization trial in healthcare. Intervention components are to be delivered to patients and providers in a large healthcare system, based in an HIV Ending the Epidemic priority jurisdiction. If effective, this multi-level approach could be disseminated to providers and patients in other large healthcare systems to make a significant impact on HIV prevention.

Development of a Conversational Agent for Individuals Ambivalent About Quitting Smoking: Protocol for a Proof-of-Concept Study.

BACKGROUND: Cigarette smoking is the leading preventable cause of disease and death in the United States. Despite the availability of a plethora of evidence-based smoking cessation resources, less than one-third of individuals who smoke seek cessation services, and individuals using these services are often those who are actively contemplating quitting smoking. There is a distinct dearth of low-cost, scalable interventions to support smokers not ready to quit (ambivalent smokers). Such interventions can assist in gradually promoting smoking behavior changes in this target population until motivation to quit arises, at which time they can be navigated to existing evidence-based smoking cessation interventions. Conversational agents or chatbots could provide cessation education and support to ambivalent smokers to build motivation and navigate them to evidence-based resources when ready to quit. OBJECTIVE: The goal of our study is to test the proof-of-concept of the development and preliminary feasibility and acceptability of a smoking cessation support chatbot. METHODS: We will accomplish our study aims in 2 phases. In phase 1, we will survey 300 ambivalent smokers to determine their preferences and priorities for a smoking cessation support chatbot. A "forced-choice experiment" will be administered to understand participants' preferred characteristics (attributes) of the proposed chatbot prototype. The data gathered will be used to program the prototype. In phase 2, we will invite 25 individuals who smoke to use the developed prototype. For this phase, participants will receive an overview of the chatbot and be encouraged to use the chatbot and engage and interact with the programmed attributes and components for a 2-week period. RESULTS: At the end of phase 1, we anticipate identifying key attributes that ambivalent smokers prefer in a smoking cessation support chatbot. At the end of phase 2, chatbot acceptability and feasibility will be assessed. The study was funded in June 2022, and data collection for both phases of the study is currently ongoing. We expect study results to be published by December 2023. CONCLUSIONS: Study results will yield a smoking behavior change chatbot prototype developed for ambivalent smokers that will be ready for efficacy testing in a larger study. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44041.

Key Considerations and Recommended Strategies for Conducting a School-Based Longitudinal RE-AIM Evaluation: Insights From a 28-School Cluster Randomized Trial.

RE-AIM is an implementation science framework that provides a structure to promote data collection and analysis in the domains of Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance. The RE-AIM approach promotes more data collection and reporting than typical evaluations so potential adopters can determine the potential program fit for their setting. RE-AIM has been used to evaluate a variety of programs; however, there are few resources that provide strategies for conducting a RE-AIM evaluation in the school setting. The purpose of this article is to inform future studies by elucidating experiences conducting a large, complex, multisite, longitudinal RE-AIM evaluation in schools in partnership with the state's Departments of Education and Health, and to share strategies for overcoming obstacles. With the long-term goal of facilitating the translation of school-based intervention research into practice, we provide key considerations and recommend strategies for school-based RE-AIM evaluation success.

Considerations for partnering with Ryan White Case Managers to create equitable opportunities for people with HIV to participate in research.

Many research studies focus on recruitment from one or few HIV clinics or internet-engaged populations, but this may result in inequitable representation of people with HIV (PWH), across the rural/urban/suburban continuum. Ryan White Case Managers (RWCM) meet regularly with PWH, potentially positioning them as partners in gathering research-related data from diverse groups of low-income, marginalized, PWH. Yet, data collection in partnership with RWCM, particularly over large geographic areas, has been under-explored. We partnered with RWCM and their organizations throughout Florida to administer a 10-item technology use and willingness survey to clients living with HIV; RWCMs provided process-oriented feedback. Among 382 approached RWCM, 71% completed human subjects and survey administration training; 48% gathered data on 10 predetermined survey administration days; and 68% administered at least one survey during the entire period for survey administration. Altogether, 1,268 client surveys were completed, 2.7% by rural participants. Stigma, privacy concerns, and disinterest reportedly inhibited client participation; competing obligations, policies, and narrow recruitment windows prevented some RWCM from offering the survey to clients. Research should further explore strategies and best practices to ensure equitable access to participate in research among PWH.

The State of our Breastfeeding Friendly Childcare Programs: Ten Years After the 2011 Surgeon General's Call to Action to Support Breastfeeding.

BACKGROUND: Ten years ago, the U.S. Surgeon General's Call to Action to Support Breastfeeding made recommendations for childcare settings, including: (1) accommodating and supporting breastfeeding families; and (2) adopting national guidelines on breastfeeding support in childcare settings. RESEARCH AIMS: To (1) describe the existing breastfeeding friendly childcare designation programs in the United States; and (2) describe how states are accommodating breastfeeding families in childcare settings. METHOD: The study design was cross-sectional, prospective thematic description of existing publicly available documents. A search of state breastfeeding coalitions was conducted to assess the number of states with breastfeeding friendly childcare designation programs. A definitive yes-or-no answer regarding whether each state had a program was obtained from all 50 states. For states with programs, designation materials were analyzed using thematic analysis and the framework method to compare designation components. RESULTS: Fifteen states had evidence of breastfeeding friendly childcare designation programs and similarities exist across designation program components. Four standards were common to all 15 programs: written policy on breastfeeding, suitable space within the center where mothers can breastfeed or express their milk, educational materials, and resources on breastfeeding available to parents. Most states required self-assessment to achieve designation status. CONCLUSION: Research is needed to enable evidence-based programs and decision-making regarding components and processes. Federal funding should support these programs' mission, including funding research to assess how and in what circumstances these programs are improving breastfeeding-related outcomes and supporting breastfeeding families.

High levels of mild to moderate depression among men who have sex with men and transgender women in Lima, Peru: implications for integrated depression and HIV care.

ABSTRACTDepression disproportionally affects people at risk of acquiring or living with HIV and is associated with worse health outcomes; however, depression care is not routinely integrated with HIV prevention and treatment services. Selection of the best depression intervention(s) for integration depends both on the prevalence and severity of depression among potential users. To inform depression care integration in a community-based setting in Lima, Peru, we retrospectively analyzed routinely collected depression screening data from men who have sex with men and transgender women seeking HIV prevention and care services (N = 185). Depression was screened for using the Patient Health Questionnaire-9. Prevalence of any depression (PHQ-9 ≥ 5) was 42% and was significantly associated with the last sexual partner being "casual" (p = 0.01). Most (81%) depressive symptoms were mild to moderate (≥5 PHQ-9 ≤ 14). Integrating depression care with HIV prevention and treatment services in Peru should begin by implementing interventions targeting mild to moderate depression.

Understanding young Black women's socialisation and perceptions of sexual and reproductive health.

Although sexual and reproductive health inequities acutely and disproportionately affect Black women in the USA, there are few studies that consider the sociocultural context in which Black women transition to adulthood and develop their sexuality. The objective of this study was to describe the lived realities of young Black women to elucidate how the sociocultural context informs their current perceptions of sexual and reproductive health. We conducted phenomenological interviews with 22 Black women aged 18-29 years to elicit their life stories. The main categories identified in the findings include how the sociocultural environment informs the self-concept; how the sociocultural environment informs early learning about sexual health; and how together these experiences inform women's development of a sexual self-concept. Three main groupings of experiences were identified relative to women's sexual self-concept: fear-based disease and pregnancy prevention; a deeper understanding of bodies and sexuality beyond disease and pregnancy prevention; and sexual pleasure and fulfilment as a priority. To address ongoing sexual and reproductive health inequities that particularly disadvantage young Black women, health systems and interventions should address the sociocultural contexts in which young Black women develop and manage their sexual health.

A Statewide Evaluation of the Breastfeeding Resource Nurse Model.

OBJECTIVE: To evaluate a statewide initiative to increase the provisioning of human milk in NICUs. DESIGN: A survey of nurses before participation in an educational session, immediately after education, and again 9 months later. SETTING: Nurses from 22 hospitals throughout Florida. PARTICIPANTS: We surveyed 121 participants, including some nurses who had prior breastfeeding education or certification as well as those without specialized breastfeeding training. INTERVENTION: An educational project called the Breastfeeding Resource Nurse Master program was intended to educate NICU nurses to implement the "Ten Steps to Promote and Protect Human Milk and Breastfeeding in Vulnerable Infants." MEASUREMENT: A quantitative needs assessment survey was administered to participants to determine current hospital practices, policies, and perceived areas for improvement. Pre- and immediate posttraining surveys assessed NICU nurses' knowledge, attitudes, and beliefs about human milk feeding of critical care infants and their self-efficacy for implementing the program in their respective NICUs. A follow-up, open-ended survey was administered at 9 months to yield information on program implementation. RESULTS: NICU breastfeeding practices varied widely at baseline. Nurses' scores for knowledge, beliefs, and behavioral intentions improved postsession, but the implementation of practice changes related to the Ten Steps for Vulnerable Infants proved difficult. Nurses identified insufficient time and resources as barriers to educating others and changing practice. CONCLUSIONS: Policies and regulations that make hospitals accountable for increasing human milk provision to vulnerable infants may be necessary to ensure that hospitals devote adequate resources to implementing practice changes in this area.

A tailored telehealth group tobacco cessation treatment program for people with HIV: Study protocol for a randomized controlled trial.

BACKGROUND: Smoking-related illnesses are the leading cause of death among people with HIV (PWH). Yet, there are few effective evidence-based interventions that help PWH quit smoking. The group-based program Positively Smoke Free is a biobehavioral cessation intervention for PWH with a growing evidence base. This study builds on prior work of Positively Smoke Free and addresses numerous weaknesses of prior trials for this population. We describe the Positively Quit Trial, a randomized controlled trial comparing a videoconferencing delivered Positively Smoke Free intervention to an attention-matched condition, assessing cessation over a 1-year period. METHODS: This attention-matched, randomized (1:1) controlled trial compares Positively Smoke Free Video-Groups to an updated version of Healthy Relationship Video-Groups. Participants are PWH, aged 18 years and older, who smoke at least one cigarette per day. All are offered nicotine replacement therapy patches and given brief advice to quit. Participants are enrolled in 12 group sessions focusing on either smoking cessation for PWH or broader topics regarding living healthy with HIV; in both conditions, Social Cognitive Theory is the guiding theoretical framework. Participants complete assessments at baseline, days 42, 90, 180, and 360; self-reported abstinence is verified with a video-observed cheek swab sent to a lab and tested for cotinine. PRIMARY OUTCOMES: Biochemically confirmed 7-day point prevalence smoking abstinence at day 360 is the primary outcome. Cost per quit, sustained abstinence at various timepoints, and biochemical confirmed abstinence at three and six months are secondary outcomes. Effects of smoking cessation on CD4 and virologic suppression are also explored.

Post-earthquake Self-Reported Depressive Symptoms and Post-Traumatic Stress Disorder and their Correlates among College-Youths in Kathmandu, Nepal.

Exposure to earthquake has previously been associated with adverse mental health outcomes, however, evidence is limited among youth in resource-limited settings. This study explored the association of retrospective extent of exposure on current day depressive symptoms and post-traumatic stress disorder (PTSD) symptoms among 125 youth attending a college in Kathmandu, Nepal. A self-administered survey including socio-demographic variables, scale for earthquake exposure and Nepali language validated standardized scales for depressive and PTSD symptoms was used. Prevalence estimates for depressive symptoms was 43.2% and PTSD symptoms was 19.2%. For each increasing unit of the extent of earthquake exposure, the odds of having depressive symptoms increased by a factor of 1.26 (p = 0.001) and PTSD symptoms increased by a factor of 1.26 (p = 0.002). Being in a complicated romantic relationship increased the odds of both depressive symptoms and PTSD symptoms. Exposure to earthquake is an important factor to consider while assessing depressive and PTSD symptoms among youth earthquake survivors in Kathmandu. It is important that programs or policies aimed at youth mental health concurrently address disaster exposures.

Modesty and Security: Attributes Associated with Comfort and Willingness to Engage in Telelactation.

The objectives were to identify conditions under which mothers may be willing to use telelactation and explore associations between participant characteristics, willingness, and beliefs regarding telelactation use. Mothers 2-8 weeks postpartum were recruited from two Florida maternal care sites and surveyed to assess demographics, breastfeeding initiation, and potential telelactation use. Analyses included descriptive statistics and logistic regression models. Of the 88 participants, most were white, married, earned less than USD 50,000 per year, had access to technology, and were willing to use telelactation if it was free (80.7%) or over a secure server (63.6%). Fifty-six percent were willing to use telelactation if it involved feeding the baby without a cover, but only 45.5% were willing if their nipples may be seen. Those with higher odds of willingness to use telelactation under these modesty conditions were experienced using videochat, white, married, and of higher income. Mothers with security concerns had six times the odds of being uncomfortable with telelactation compared to mothers without concerns. While telelactation can improve access to critical services, willingness to use telelactation may depend on conditions of use and sociodemographics. During the COVID-19 pandemic and beyond, these findings offer important insights for lactation professionals implementing virtual consultations.

Understanding Technology Fit Among People with HIV Based on Intersections of Race, Sex, and Sexual Behavior: An Equitable Approach to Analyzing Differences Across Multiple Social Identities.

HIV disproportionately impacts individuals based on intersecting categories (e.g. gender, race/ethnicity, behavior), with groups most at-risk deemed priority populations. Using weighted effects coding to account for differential group sizes, this study used multilevel mixed logistic models to investigate differences in eHealth use and willingness to use eHealth for HIV-related information among priority populations. Compared to the sample average, Black men who had sex with women were less likely to use all technologies except cellphones with text-messaging and less likely to be willing to use computers and tablets. White and Hispanic men who had sex with men were more likely to use all technologies. No significant differences existed for use or willingness to use cellphones with text-messaging. Future research should consider approaches used here to account for equity and multiple intersecting social identities; practitioners may use these findings or similar local data to ensure fit between eHealth programs and priority populations.

"When Is Health Care Actually Going to Be Care?" The Lived Experience of Family Planning Care Among Young Black Women.

While family planning care (FPC) visits may serve as opportunities to address gaps in knowledge and access to limited resources, young Black women may also face structural barriers (i.e., racism, discrimination, bias) to engaging in care due to the intersections of racial identity, age, and socioeconomic status. Findings from interviews with 22 Black women, ages 18 to 29 years, about the lived experience of FPC highlighted dynamic patient-provider encounters. Women's narratives uncovered the following essences: silence around sex impedes engagement in care, patient-provider racial concordance as protection from harm, providers as a source of discouragement and misinformation, frustration as a normative experience, decision making excludes discussion and deliberation, medical mistrust is pervasive and a part of Black consciousness, and meaningful and empathic patient-provider encounters are elusive. Health systems should prioritize developing and enhancing young Black women's relationship with FPC providers to help mitigate persistent inequities that perpetuate disadvantage among this population.

Examining the Factors Affecting PrEP Implementation Within Community-Based HIV Testing Sites in Florida: A Mixed Methods Study Applying the Consolidated Framework for Implementation Research.

HIV testing/counseling is a critical point during which non-clinical staff could intervene, discuss and/or refer clients for pre-exposure prophylaxis (PrEP). This analysis investigated the contextual factors affecting PrEP implementation within HIV testing sites. Two generalized linear mixed models were conducted to estimate PrEP implementation as a function of constructs from the Consolidated Framework for Implementation Research (CFIR). Qualitative interviews were analyzed thematically. Data integration occurred via joint analysis and triangulation. Constructs from the CFIR domain Characteristics of Individuals did not predict PrEP implementation when controlling for demographic characteristics; qualitative data signaled divergent findings in PrEP knowledge. Within the CFIR domains Inner and Outer Settings, relevant priority and available resources predicted PrEP implementation; qualitative data confirmed the importance of available resources and provided insight into the impact of cosmopolitanism and leadership. Addressing the contextual factors that affect PrEP implementation may help HIV testing staff to better implement PrEP programs.

Opportunities for and Perceptions of Integrating Community Health Workers Via the Affordable Care Act: Medicaid Health Homes.

CONTEXT: The Affordable Care Act created opportunities for innovative, cost-saving measures to improve health care access. Community health workers (CHWs) are frontline public health workers who have a close understanding of the communities they serve. States that expanded Medicaid coverage could also create Medicaid Health Homes (MHHs)-virtual health care networks-to coordinate care for people with chronic conditions. New York was the second state to implement MHHs and gave the option to include CHWs as part of the health care team. OBJECTIVE: To understand the perceptions of MHH administrators regarding CHW engagement in MHHs, as well as the facilitators and barriers to adoption in MHHs that are unknown. DESIGN, SETTING, AND PARTICIPANTS: Semistructured qualitative interviews (n = 18) were conducted with MHH administrators throughout New York State guided by the Diffusion of Innovations (DOI) framework. Qualitative thematic analysis was used to explore the domains and themes. RESULTS: Most MHH administrators believed that CHWs fit within MHHs. The DOI constructs of compatibility and complexity and the Consolidated Framework for Implementation Research construct of external policies helped explain CHW integration. CHWs were compatible with MHHs by enrolling patients, helping coordinate patient care, and providing social support. The complexities of CHW integration into MHHs included barriers to CHW integration, no direct reimbursement for their services, lack of clarity for CHW roles and responsibilities, and no explicit external policy for their use in MHHs. CONCLUSIONS: CHWs can, and have, been integrated into the relatively novel Health Home system. While some barriers have prevented their integration into all MHHs, lessons learned could provide guidance for CHW integration into other health care systems in the United States.

"Breast Is Best, But " According to Childcare Administrators, Not Best for the Childcare Environment.

Background: Nearly 74% of U.S. mothers work full-time and employment is a cited reason for stopping breastfeeding. In the effort to increase breastfeeding duration, childcare providers could facilitate continuation of human milk feeding when mothers return to work. Yet, mothers report receiving little support when transitioning infants into childcare. Objective: Explore the themes of comfort with human milk and formula feeding among childcare administrators near Tampa, Florida. Material and Methods: Twenty-eight childcare administrators participated in semistructured interviews regarding policies and perceptions about infant feeding practices at their center. Using Applied Thematic Analysis, interview themes were identified. Results: Most administrators agreed "breastfeeding is best." However, they expressed discomfort with mothers breastfeeding at the center and perceived risk with handling and feeding human milk. These perceptions are illustrated through the theme "Formula feeding is normative" and four emergent subthemes: "Human milk is potentially harmful," "People are uncomfortable with breastfeeding in public," "I'm not the expert," and "'Breastfeeding is best', in theory." Conclusion: While breastfeeding may be best for health, from the childcare administrators' perspectives, it may not be best for the childcare environment. A cultural shift may be needed to change norms and perceptions in the childcare environment to support mothers in their effort to provide human milk. Perhaps it is time for a new message, such as "We can help you."

The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV.

The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. IMPLICATIONS: This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

Achieve Research Continuity During Social Distancing by Rapidly Implementing Individual and Group Videoconferencing with Participants: Key Considerations, Best Practices, and Protocols.

The novel coronavirus has upended many traditional research procedures as universities and other research entities have closed to activate social distancing. Some social and behavioral research activities (e.g. data analysis, manuscript preparation) can be continued from other environments with appropriate security protocols in place. For studies involving in-person interactions, continuity may be more difficult. Phone-based interactions provide a low-tech solution that may suffice in some cases. Yet, videoconferencing platforms can nearly replicate in-person interactions, activating both auditory and visual senses and potentially resulting in more substantial engagement. Staff can meet with participants individually or in groups, each seeing and hearing one another in real time. This paper provides guidance for researchers transitioning in-person assessments and interventions to a synchronous videoconferencing platform. Best practices, key considerations, examples from the field, and sample protocols are presented to ease transition for ongoing studies and maximize the potential of videoconferencing-and social distancing.

Latino STYLE: Preliminary Findings From an HIV Prevention RCT Among Latino Youth.

OBJECTIVE: Latino STYLE is a family-centered, HIV-focused intervention (HIV) emphasizing cultural factors and parent-adolescent communication. We hypothesized that, compared with a general health promotion (HP) intervention, the HIV arm would improve caregiver and adolescent HIV knowledge, attitudes, parental monitoring, sexual communication, and family relationships after a 3-month postintervention period. This article reports on the short-term findings of the longer trial. METHODS: A single-site, two-arm, parallel, family-based, randomized, controlled trial was conducted; eligible participants were Latino adolescents aged 14-17 and their primary caregiver. The study was conducted at the University of South Florida with 227 adolescent-caregiver dyads allocated to the HIV (n = 117) or HP (n = 110) intervention after completing a baseline assessment. Interim measures at 3-month follow-up included demographics, HIV knowledge, self-efficacy, parental monitoring, sexual communication, family relationships, and adolescent sexual behavior. RESULTS: Adolescents in the HIV group reported small effects in parental permissiveness and the HP group reported small effects for family support. Caregivers in both groups reported decreases in all outcomes. Incidence of past 90-day sexual intercourse decreased in both treatment arms. Among those who were sexually active over the past 90 days, the number of sex acts decreased from baseline, particularly in the HIV group. The percentage of condom-protected sex acts increased in the HIV group and decreased in the HP group, but did not reach statistical significance. CONCLUSIONS: The HIV Latino STYLE intervention was not efficacious in improving hypothesized outcomes over a 3-month period. However, exploratory analyses revealed moderate effects for decreases in adolescent sexual risk behavior, particularly in the HIV group.