Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol.

BACKGROUND: As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411-93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1-3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside 'one-stop-shop' approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic's current practice of usual care, which includes comprehensive patient navigation. METHODS: A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the "simplified care" pathway (intervention group) or the "usual care" pathway (control group). Block randomization will be performed with a 1:1 randomization. DISCUSSION: Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. TRIAL REGISTRATION: We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

Tools for Supporting the MCH Workforce in Addressing Complex Challenges: A Scoping Review of System Dynamics Modeling in Maternal and Child Health.

OBJECTIVES: System Dynamics (SD) is a promising decision support modeling approach for growing shared understanding of complex maternal and child health (MCH) trends. We sought to inventory published applications of SD to MCH topics and introduce the MCH workforce to these approaches through examples to support further iteration and use. METHODS: We conducted a systematic search (1958-2018) for applications of SD to MCH topics and characterized identified articles, following PRISMA guidelines. Pairs of experts abstracted information on SD approach and MCH relevance. RESULTS: We identified 101 articles describing applications of SD to MCH topics. APPROACH: 27 articles present qualitative diagrams, 10 introduce concept models that begin to quantify dynamics, and 67 present more fully tested/analyzed models. PURPOSE: The most common purposes described were to increase understanding (n = 55) and support strategic planning (n = 26). While the majority of studies (n = 53) did not involve stakeholders, 40 included what we considered to be a high level of stakeholder engagement - a strength of SD for MCH. TOPICS: The two Healthy People 2020 topics addressed most frequently were early and middle childhood (n = 30) and access to health services (n = 26). The most commonly addressed SDG goals were "End disease epidemics" (n = 26) and "End preventable deaths" (n = 26). CONCLUSIONS FOR PRACTICE: While several excellent examples of the application of SD in MCH were found, SD is still underutilized in MCH. Because SD is particularly well-suited to studying and addressing complex challenges with stakeholders, its expanded use by the MCH workforce could inform an understanding of contemporary MCH challenges.

Response to the Coronavirus Disease 2019 Pandemic Among People Experiencing Homelessness in Congregant Living Settings in San Diego, California.

During April 2020-August 2020, a preemptive testing strategy combined with accessible isolation and symptom screening among people experiencing homelessness in congregant living settings in San Diego, California, contributed to a low incidence proportion of coronavirus disease 2019 (0.9%). Proactively addressing challenges specific to a vulnerable population may prove impactful.

Personal health records for people living with HIV: a review.

Personal health records have the potential to improve patient outcomes, but the state of the literature on personal health record usage by people living with the human immunodeficiency virus (HIV) is unclear. The purpose of this review is to examine the impact of personal health records on HIV-related health beliefs and behaviors. We used the Health Belief Model to guide a review of studies examining the impact of electronic personal health records on the health beliefs and behaviors among people living with HIV. The search yielded 434 results. Following abstract review, 19 papers were selected for full-text review, and 12 were included in the review. A limited number of studies in this review found a positive impact of personal health records on HIV-related beliefs and behaviors. Additional research is needed to identify which personal health record features are most influential in changing health behaviors and why adoption rates remain low, particularly for groups at greatest risk for poor HIV outcomes. Theory-informed interventions are needed to identify which patients are likely to benefit from using personal health records and how to reduce barriers to personal health record adoption for people living with HIV.

Prevalence of Perinatal Depression in the Military: A Systematic Review of the Literature.

Objectives Perinatal depression (PND) has been widely studied in the general population, but has been under studied in military populations. This literature review evaluates studies of PND in military service women and spouses of military servicemen. Methods Articles from peer-reviewed journals published from January 2005 to September 2015 were included if they reported on US military women and/or spouses of military servicemen who were screened for PND symptoms during the prenatal and/or postpartum periods; and were available in English. Qualitative studies were excluded. Studies were compared and contrasted by screening instrument, screening time-period, study population, deployment status as a unique risk factor, and results. Results Ten articles were included. Studies varied greatly in methodology and use of screening instruments and screening time-period, but collectively indicate a wide prevalence range of PND symptoms in military populations. Studies also indicate deployment status as a unique risk factor associated with PND symptoms. Common methodological issues include excluding women at high risk for PND, and not reporting if adequate clinical resources were readily available to ensure appropriate diagnostic and therapeutic services treatment for women who screened positive for PND. Conclusions for Practice PND is receiving increasing attention and military populations should be studied more closely to identify this condition, and understand the complex interactions of unique risk factors associated with a military way of life in order to implement more rigorous screening and early, appropriate intervention strategies.

Bridging the Chasm between Pregnancy and Health over the Life Course: A National Agenda for Research and Action.

BACKGROUND: Many pregnant people find no bridge to ongoing specialty or primary care after giving birth, even when clinical and social complications of pregnancy signal need. Black, indigenous, and all other women of color are especially harmed by fragmented care and access disparities, coupled with impacts of racism over the life course and in health care. METHODS: We launched the initiative "Bridging the Chasm between Pregnancy and Health across the Life Course" in 2018, bringing together patients, advocates, providers, researchers, policymakers, and systems innovators to create a National Agenda for Research and Action. We held a 2-day conference that blended storytelling, evidence analysis, and consensus building to identify key themes related to gaps in care and root causes of inequities. In 2019, more than 70 stakeholders joined six working groups to reach consensus on strategic priorities based on equity, innovation, effectiveness, and feasibility. FINDINGS: Working groups identified six key strategic areas for bridging the chasm. These include: 1) progress toward eliminating institutional and interpersonal racism and bias as a requirement for accreditation of health care institutions, 2) infrastructure support for community-based organizations, 3) extension of holistic team-based care to the postpartum year and beyond, with integration of doulas and community health workers on the team, 4) extension of Medicaid coverage and new quality and pay-for-performance metrics to link maternity care and primary care, 5) systems to preserve maternal narratives and data across providers, and 6) alignment of research with women's lived experiences. CONCLUSIONS: The resulting agenda presents a path forward to remedy the structural chasms in women's health care, with key roles for advocates, policymakers, researchers, health care leaders, educators, and the media.

Integrating Reproductive and Sexual Health Education and Services Into Opioid Use Disorder Treatment Programs: A Qualitative Study.

OBJECTIVES: Women with opioid use disorder (OUD) in the USA are at risk for poor reproductive and sexual health (RSH) outcomes. The qualitative research presented here is part of a larger mixed methods study. The qualitative component used an implementation science framework to investigate provider and staff perspectives regarding the integration of RSH education and services for reproductive-age women in opioid treatment programs (OTPs) in North Carolina. METHODS: Thirty-one semistructured interviews were conducted with providers and staff at 9 OTPs between November and December, 2017. The Consolidated Framework for Implementation Research (CFIR) was used to assess multilevel implementation contexts (eg, patient, provider, organizational) to identify barriers and facilitators that might influence effective intervention implementation. Interviews were audio-recorded, transcribed, coded, and analyzed to identify key themes. Deductive and inductive approaches were used. RESULTS: Barriers included transportation, childcare, and time constraints (patient-level), lack of communication between providers (provider-level), lack of political will, competing priorities, and shortages of available resources (organizational-level). Facilitators included a group education approach (patient-level), strong communication (provider-level), and a culture of collaboration (organizational-level). CONCLUSIONS: Assessing determinants of implementation is important to the development of RSH interventions. CFIR constructs were found to be important influences that could facilitate or hinder effective implementation. Integration of RSH education and services is a process, and, when addressed in stages, might be feasible. A broad range of RSH education and services has the potential to have a profound impact on the health of women with OUD and their children, their families, and their communities.

Evaluation of an Innovative, Hospital-Based Volunteer Doula Program.

OBJECTIVE: To evaluate program growth, doula characteristics, patient satisfaction, and characteristics and perceptions of labor and delivery nurses who work with volunteer doulas in a hospital-based volunteer doula program. DESIGN: Descriptive quantitative. SETTING: An academic health center in the southeastern United States with approximately 4,000 births per year. PARTICIPANTS: Participants (N = 519) included volunteer doulas (n = 80), labor and delivery nurses (n = 24), and women who were supported by doulas (n = 415). METHODS: We evaluated program growth by the number of doulas and women supported over time. We developed surveys to evaluate doula characteristics, patient satisfaction, and characteristics and perceptions of labor and delivery nurses who work with volunteer doulas. RESULTS: From 2012 to 2018, the number of Birth Partners doulas increased from 25 to 80. The annual number of women who received intrapartum care from doulas increased from 88 in 2012 to 477 in 2018. Doula characteristics included race, ethnicity, age, student or nonstudent status, and ability to speak Spanish. Of the 1,185 women who received doula support from 2015 to 2018, 415 (35%) responded to the patient satisfaction survey. Most were satisfied with the physical support (n = 379, 97.63%), emotional support (n = 384, 96.88%), doula care (n = 410, 96.34%), and support for family/friends (n = 346, 95.38%). All of the labor and delivery nurses who responded (n = 24, 100%) agreed or strongly agreed that doulas were important members of the maternity care team. CONCLUSION: In this evaluation, we highlight rapid program growth, expansion of services, and demographic characteristics of volunteer doulas; patient satisfaction with doula care; and acceptance of volunteer doulas among nursing staff. The data provided herein can be used to inform future development and guide the implementation of similar volunteer doula programs at other institutions.

Provision of and Barriers to Integrating Reproductive and Sexual Health Services for Reproductive-age Women in Opioid Treatment Programs.

OBJECTIVES: To identify the level of provision of reproductive and sexual health (RSH) services to reproductive-age women enrolled in opioid treatment programs (OTPs) in 2017, and to understand provider-perceived barriers to integration of services. METHODS: A web-based survey was sent to medical or program directors at all OTPs (n = 48) in North Carolina (NC). Data were collected regarding program characteristics, demographic information about female patient populations, provision of RSH services, and provider-perceived barriers to service integration into OTPs. Survey results were aggregated for descriptive analysis. RESULTS: The survey response rate was 79%, representing 38 out of the 48 OTPs. Among OTPs, 95% serve pregnant and parenting women, 21% have female-specific programs, and together they serve a total of about 5000 women annually. Medical and program directors reported that approximately 53% of women have 1 or more children, and 6.5% are, at present, pregnant. Nearly 90% of programs provide pregnancy testing, but only about 50% provide contraception. Although more than half offer hepatitis C virus (HCV) testing, less than half offer human immunodeficiency virus (HIV) testing and sexually transmitted infection (STI) testing. Half of the programs provide education about STI prevention and safer sex practices. Most medical and program directors (84%) perceive female patients could benefit from RSH education and more than two-thirds (68%) perceive female patients need increased access to RSH services. Provider-perceived barriers to service integration include lack of facility equipment and supplies, trained staff, and childcare. CONCLUSIONS: NC OTPs are a logical setting for integrating RSH services to meet the needs of reproductive-age women in treatment for OUD.

Concurrent Opioid and Alcohol Use Among Women Who Become Pregnant: Historical, Current, and Future Perspectives.

The numbers of women using opioids who become pregnant have captured the attention of media, research, policy, and community. At the same time, there is an ever-growing use of alcohol among women who continue drinking during pregnancy that has received less focus. Although both untreated opioid use disorder and alcohol misuse pose risks for maternal, fetal, and child morbidities, alcohol is the substance with the most significant documentation of harms. As we focus on the opioid epidemic in the United States, it is critical that we do not overlook alcohol use during pregnancy. Both opioid use and alcohol use during pregnancy are important public health challenges and often happen concurrently. Thus, this commentary aims to (1) highlight the historical and current context of opioid and alcohol use during pregnancy; (2) summarize the current knowledge of opioids and alcohol use during pregnancy; and (3) detail future directions in how health care providers can help identify and therapeutically respond to women with concurrent opioid and alcohol use disorder.

Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance.

OBJECTIVES: The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children. METHODS: Three separate search methods were employed to identify peer-reviewed journal articles providing evidence on treatment methods for women with OUD who are pregnant or parenting, and for their children. Identified articles were reviewed for inclusion per study guidelines and relevant information was abstracted and summarized. RESULTS: Of the 1697 articles identified, 75 were included in the literature review. The perinatal use of medication for addiction treatment (MAT, also known as medication-assisted treatment), either methadone or buprenorphine, within comprehensive treatment is the most accepted clinical practice, as withdrawal or detoxification risks relapse and treatment dropout. Medication increases may be needed with advancing pregnancy, and are not associated with more severe neonatal abstinence syndrome (NAS). Switching medication prenatally is usually not recommended as it can destabilize opioid abstinence. Postnatally, breastfeeding is seen as beneficial for the infant for women who are maintained on a stable dose of opioid agonist medication. Less is known about ideal pain management and postpartum dosing regimens. NAS appears generally less severe following prenatal exposure to buprenorphine versus methadone. Frontline NAS medication treatments include protocol-driven methadone and morphine dosing in the context of nonpharmacological supports. CONCLUSIONS: Women with OUD can be treated with methadone or buprenorphine during pregnancy. NAS is an expected and manageable condition. Although research has substantially advanced, opportunities to guide future research to improve maternal and infant outcomes are provided.

Organizational theory for dissemination and implementation research.

BACKGROUND: Even under optimal internal organizational conditions, implementation can be undermined by changes in organizations' external environments, such as fluctuations in funding, adjustments in contracting practices, new technology, new legislation, changes in clinical practice guidelines and recommendations, or other environmental shifts. Internal organizational conditions are increasingly reflected in implementation frameworks, but nuanced explanations of how organizations' external environments influence implementation success are lacking in implementation research. Organizational theories offer implementation researchers a host of existing, highly relevant, and heretofore largely untapped explanations of the complex interaction between organizations and their environment. In this paper, we demonstrate the utility of organizational theories for implementation research. DISCUSSION: We applied four well-known organizational theories (institutional theory, transaction cost economics, contingency theories, and resource dependency theory) to published descriptions of efforts to implement SafeCare, an evidence-based practice for preventing child abuse and neglect. Transaction cost economics theory explained how frequent, uncertain processes for contracting for SafeCare may have generated inefficiencies and thus compromised implementation among private child welfare organizations. Institutional theory explained how child welfare systems may have been motivated to implement SafeCare because doing so aligned with expectations of key stakeholders within child welfare systems' professional communities. Contingency theories explained how efforts such as interagency collaborative teams promoted SafeCare implementation by facilitating adaptation to child welfare agencies' internal and external contexts. Resource dependency theory (RDT) explained how interagency relationships, supported by contracts, memoranda of understanding, and negotiations, facilitated SafeCare implementation by balancing autonomy and dependence on funding agencies and SafeCare developers. In addition to the retrospective application of organizational theories demonstrated above, we advocate for the proactive use of organizational theories to design implementation research. For example, implementation strategies should be selected to minimize transaction costs, promote and maintain congruence between organizations' dynamic internal and external contexts over time, and simultaneously attend to organizations' financial needs while preserving their autonomy. We describe implications of applying organizational theory in implementation research for implementation strategies, the evaluation of implementation efforts, measurement, research design, theory, and practice. We also offer guidance to implementation researchers for applying organizational theory.