Mental Healthcare Practices from Entry to Release across Southeastern Jails.

Background: Individuals with mental illnesses are disproportionately incarcerated in jails, which have become de facto mental health institutions across the US. Yet there is limited research describing mental healthcare practices from entry to release among multiple jails and states. Methods: We conducted 34 semi-structured interviews with jail healthcare personnel across five Southeastern states. Results: We report results on challenges and practices related to mental health staffing, screening, additional evaluations and services, and discharge planning in jails. Initial mental health screenings were often restricted to the detection of suicidality and history of treatment and medications as opposed to current mental health symptoms. Use of validated mental health screening forms was uncommon. We found delays in care between the initial health screening and being evaluated by a mental health professional. Most jails reported primary responsibilities for mental health care as preventing suicides and managing psychiatric medications. Jails reported mental health care as challenging to manage, with high volumes of individuals with mental health needs, yet limited resources, especially regarding staffing. Discharge planning was limited despite reports of poor continuity of mental healthcare. Conclusions: Jails have a constitutional duty and opportunity to provide adequate healthcare to individuals with mental illnesses, yet practices are insufficient and resources are limited across jails. Based on our findings, we recommend 1) greater adoption and revisions of jail health standards 2) system improvement that expands identification of mental illnesses and quicker, less variable follow-up mental health evaluations, 3) improved linkages and supports for community resources that prevent incarceration of this population.

Provision of health care services related to substance use disorder in southern U.S. jails.

INTRODUCTION: The U.S. jail population has more than tripled since the 1980s, and today, one out of every three incarcerated individuals is being held in a county or city jail. Substance use disorders (SUD) are overrepresented in incarcerated populations; however, little recent research has examined the availability and quality of SUD-related health care services in jail settings. Incarcerated individuals may engage with a variety of SUD-related health care services, including: screening and withdrawal management at entry, SUD treatment or other brief health care interventions while they are being held, and overdose prevention education and reentry planning at release. METHODS: We conducted a thematic analysis of qualitative data from 34 interviews conducted with 38 personnel from a purposive sample of jails that varied in size and rurality within a five-state study area. The goals of the analyses were to: 1) describe jail health care services for SUD and barriers to service provision, 2) compare current practices to best practice recommendations, and 3) provide context by describing factors at the jail and community level that influence service provision, such as access to resources. RESULTS: Interviewees described wide variability in both availability and comprehensiveness of SUD-related health care services. Most adhered to federal guidance for supervising withdrawal from alcohol and benzodiazepines, but not opioids. Medication for addiction treatment was most widely available for pregnant women and rarely for other individuals. Roughly one third of the jails in our sample provided behavioral group or individual therapy with a licensed counselor and roughly one quarter offered self-help groups. Very few jails provided comprehensive re-entry planning and support. Jail staff reported specific barriers to providing each type of service, as well as limiting contextual factors. Despite observed increases in case volume, jail health care staff did not necessarily receive any additional funding or staff members. Overall, lack of investment in mental and behavioral health care contributed to recidivism and feelings of hopelessness among staff. CONCLUSIONS: This study identified several areas where jails could improve SUD-related health care services. Many of the barriers to improvement-organizational buy-in, cost/budgeting, staffing, logistics-were not under the control of health care staff. Implementing changes will require support from local governments, jails administrators, private health care companies, and other local health care providers.

Jail Healthcare Staffing in the US Southeast: a Cross-Sectional Survey.

BACKGROUND: Jails annually incarcerate millions of people with health problems, yet jail healthcare services have not been well described. OBJECTIVE: To describe jail healthcare staffing. DESIGN: Phone-administered survey conducted October 2020 to May 2021. SETTING: County jails in North Carolina, South Carolina, Georgia, and Alabama. PARTICIPANTS: Jail personnel "most knowledgeable" about jail healthcare. MAIN MEASURES: Weekly on-site healthcare coverage rate (hours per 100 incarcerated person-weeks [IPWs]) by personnel type; telemedicine rates and detention officers' healthcare duties. KEY RESULTS: Survey response rate was 73% (254/346). Among surveyed jails, 71% had on-site non-psychiatric providers (e.g., physicians, physician assistants) (median of 3.3 h per 100 IPWs); 90% had on-site nursing (median of 57.0 h per 100 IPWs) including 50% with on-site registered nurses (median of 25 h per 100 IPWs) and 70% with on-site licensed practical nurses (median of 52 h per 100 IPWs); 9% had on-site psychiatric providers (median of 1.6 h per 100 PWs). Telemedicine was used for primary care in 13% of jails (median 2.1 h per 100 IPW); for mental healthcare in 55% (median 2.1 h per 100 IPW); and for other specialties in 5% (median 1.0 h per 100 IPW). In 81% of jails, officers conducted medical intake and in 58% assessed urgency of medical requests (i.e., "sick call"). The number of officers' healthcare responsibilities increased inversely with weekly nursing coverage. CONCLUSIONS: Nearly 30% of surveyed jails routinely lacked on-site healthcare providers and in most other jails providers' on-site presence was modest. Jails relied heavily on LPNs and officers for care, resulting in missed opportunities for care and potentially endangering incarcerated persons.

"What Is the Benefit?": Perceptions and Preferences for Long-Acting Injectable Antiretroviral Therapy Among People Living With HIV.

Long-acting injectable antiretroviral therapy (LA-ART) expands treatment options for people living with HIV (PLWH). This qualitative study characterizes LA-ART awareness, perceptions, and preferences among PLWH engaged in HIV care. From 2019 through 2021, we conducted semistructured in-depth interviews with 71 PLWH sampled from three clinics in three U.S. settings (North Carolina, Washington, DC, Massachusetts). Transcripts were analyzed using narrative and thematic techniques. Participant mean age was 46 years (range 24-72); most were cisgender men (55%) and virally suppressed (73%). Most participants had not heard of LA-ART and reacted with a mix of excitement and cautiousness. Potential LA-ART benefits included easier adherence, privacy, and effectiveness; concerns included effectiveness, side effects, costs, and increased clinic visits. Participants appreciated that LA-ART could support achieving and sustaining viral suppression. To inform their decision, participants wanted more information and convenient access and administration. Findings indicated that a shared decision-making approach and economic and logistical support for PLWH could facilitate LA-ART uptake.

"We don't wanna birth it here": A qualitative study of Southern jail personnel approaches to pregnancy.

Each year, approximately 55,000 pregnant people are incarcerated in US jails. To learn about pregnancy and postpartum care in jails, we analyzed 34 qualitative interviews with jail personnel from facilities in five Southeastern US states. Themes included jail processes unique to pregnancy and burden on jails produced by liability and limited resources. Societal attitudes such as stigma, distrust of pregnant people, and a focus on fetal well-being were also important themes. Jail-community partnerships may mitigate the effects of scarce resources and improve jail perinatal care. Better community safety nets that decrease contact with jails are needed to improve pregnancy outcomes.

The role of detention officers in the provision of jail healthcare in the Southeastern United States.

Jailed individuals have considerable healthcare needs, yet jail healthcare resources are often limited. We interviewed staff from 34 Southeastern jails about strategies that jails use to deliver healthcare. One of the most prominent strategies was the use of detention officers to provide or facilitate the provision of healthcare. Officers' roles included assessing the need for medical clearance, conducting medical intake screenings, monitoring for suicide/withdrawal, transporting patients to medical appointments, medication administration, monitoring blood glucose and blood pressure, responding to medical emergencies, and communication with healthcare personnel. Several participants reported that due to officer shortages, conflicting priorities, and lack of adequate training, officers' healthcare roles can compromise privacy, delay access to care, and result in inadequate monitoring and safety. Findings suggest the need for training and standardized guidelines for officers' involvement in jail healthcare delivery and reassessment of the scope of officers' healthcare responsibilities.

"You can get a couple of ramen noodle packs for a BusparⓇ": A qualitative examination of medication access, policy, and procedures in southern jails.

BACKGROUND: Jails in the United States are required to provide health care to the over 10 million people entering jails each year, a significant portion of whom need medications. Yet little is known about the processes by which medications are prescribed, obtained, and administered to incarcerated persons in jails. OBJECTIVE: To describe medication access, policy, and procedures in jails. METHODS: Semi-structured interviews were conducted with administrators and health workers from 34 jails (of 125 contacted) across 5 states in the southeastern United States. The interview guide covered all aspects of healthcare in jails from entry to release; however, the present study focused on responses relating to medications. Interviews were thematically coded using a combination of deductive and inductive coding guided by the research objective. RESULTS: Four processes described medication use chronologically from intake to release: jail entry and health screening, pharmacy and medication protocols, protocols specific to medication dispensing and administration, and medications at release. Many jails had procedures for using medications brought from home, though some declined to use these medications. Medication decision-making in jails was primarily performed by contracted healthcare providers, and most medications were obtained from contract pharmacies. Almost all jails banned narcotics; however, other medication restrictions varied by jail. Most jails charged a copay for medications. Participants discussed various privacy practices related to medication distribution, as well as approaches to diversion prevention including "crushing and floating" medications. Finally, the pre-release medication management process included transition planning that ranged from no planning to sending additional prescriptions to the patient's pharmacy. CONCLUSIONS: Medication access, protocols, and procedures in jails varies considerably, and there is a need for further adoption of existing standards and guidelines for the use of medications in jails, such as the Assess, Plan, Identify, and Coordinate (APIC) model of community re-entry.

Qualitative evaluation of barriers and facilitators to hepatocellular carcinoma care in North Carolina.

BACKGROUND: Many patients with hepatocellular carcinoma (HCC) never receive cancer-directed therapy. In order to tailor interventions to increase access to appropriate therapy, we sought to understand the barriers and facilitators to HCC care. METHODS: Patients with recently diagnosed HCC were identified through the University of North Carolina (UNC) HCC clinic or local hospital cancer registrars (rapid case ascertainment, RCA). Two qualitative researchers conducted in-depth, semi-structured interviews. Interviews were audiotaped, transcribed, and coded. RESULTS: Nineteen interviews were conducted (10 UNC, 9 RCA). Key facilitators of care were: physician knowledge; effective communication regarding test results, plan of care, and prognosis; social support; and financial support. Barriers included: lack of transportation; cost of care; provider lack of knowledge about HCC; delays in scheduling; or poor communication with the medical team. Participants suggested better coordination of appointments and having a primary contact within the healthcare team. LIMITATIONS: We primarily captured the perspectives of those HCC patients who, despite the challenges they describe, were ultimately able to receive HCC care. CONCLUSIONS: This study identifies key facilitators and barriers to accessing care for HCC in North Carolina. Use of the RCA system to identify patients from a variety of settings, treated and untreated, enabled us to capture a broad range of perspectives. Reducing barriers through improving communication and care coordination, assisting with out-of-pocket costs, and engaging caregivers and other medical providers may improve access. This study should serve as the basis for tailored interventions aimed at improving access to appropriate, life-prolonging care for patients with HCC.

Barriers and facilitators to the engagement of physical activity among Black and African American cancer survivors during and after treatments.

PURPOSE: To identify physical activity (PA) barriers and facilitators among Black and African American (Black/AA) cancer survivors that should be considered in future PA intervention development for this population. METHODS: A community advisory board (CAB) of Black/AA cancer survivors and patient advocates guided in-depth qualitative interviews (n = 19) that were completed via telephone using a semi-structured interview guide. Interviews were transcribed verbatim, and data were analyzed using directed content analysis to detail a report of PA barriers and facilitators during and after cancer treatment. The CAB reviewed and interpreted these barriers and facilitators to identify the final results. RESULTS: Survivors (n = 19) of nine different types of cancer completed interviews. PA barriers during cancer treatments included physical and psychological suffering. PA barriers after cancer treatments included social and environmental constraints (e.g., lack of access needed for PA, safety concerns, and competing priorities). PA facilitators both during and after cancer treatments included family support, faith, and support from other survivors. PA facilitators during treatment also included feeling better after doing PA, setting realistic and flexible goals, and gaining a sense of control of one's health by striving for PA goals. CONCLUSIONS: To increase PA among Black/AA cancer survivors, PA interventions are needed that address structural barriers, include the role of faith, leverage family support, highlight the psychological benefits of PA, and use goal setting.

Evaluation of early de-escalation of empiric antimicrobial therapy in acute leukemia patients with febrile neutropenia at a large academic medical center.

INTRODUCTION: Recent trials have shown early de-escalation of empiric antimicrobial therapy (EAT) in febrile neutropenia has led to less adverse effects with no difference in patient mortality. In 2019, our institution adjusted internal guidelines to de-escalate EAT after 7 days of intravenous anti-pseudomonal therapy in patients with signs of clinical recovery from febrile neutropenia and no evidence of infection. METHODS: This was a retrospective, single-center, observational, cohort study. Eligible patients were adults with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) who received induction chemotherapy and developed febrile neutropenia without documented infection. Patients were separated based on EAT duration: ≤ 9 days and > 9 days. Empiric antimicrobial therapy was defined as the initiation of an anti-pseudomonal beta-lactam. The primary outcome was the difference in number of EAT-free days. Secondary outcomes included fever recurrence, ICU admissions, fever duration, infections post de-escalation, and Clostridioides difficile infection (CDI). RESULTS: Forty-four encounters met inclusion. The EAT ≤ 9 days group had 7 more EAT-free days compared to the EAT > 9 days group (p < 0.001). No between-group differences were identified in terms of fever after EAT discontinuation (p = 0.335), ICU admission (p = 0.498), or CDI (p = 0.498). The EAT > 9 days group experienced longer initial fever (p < 0.001) and received addition of resistant Gram-positive coverage (p = 0.014). More patients receiving EAT > 9 days had a diagnosis of AML (p = 0.001). CONCLUSIONS: Shorter EAT duration did not lead to worse outcomes in patients with AML or ALL who received induction chemotherapy and developed febrile neutropenia without a documented infection source.

Patient and Provider Perception of Transurethral Resection of Bladder Tumor vs Chemoablation for Nonmuscle-invasive Bladder Cancer Treatment.

PURPOSE: The aim of this mixed methods study was to investigate patient and provider perceptions of repeat transurethral resection of bladder tumors to improve counseling as new nonsurgical treatment modalities for nonmuscle-invasive bladder cancer emerge. MATERIALS AND METHODS: Quantitative data were collected via a web-based survey through the Bladder Cancer Advocacy Network of patients with nonmuscle-invasive bladder cancer who had undergone at least 1 transurethral resection of bladder tumor. Bivariable and multivariable analyses were performed to evaluate associations of patient demographics and clinical variables with treatment preference. Qualitative data were collected with 60 in-depth telephone interviews with patients (n=40) and urologists (n=20) to understand experiences with bladder cancer and transurethral resection of bladder tumor. Telephone interviews were conducted by trained qualitative experts. Transcripts were imported into Dedoose to facilitate analysis. RESULTS: Survey data of 352 patients showed 210 respondents (60%) preferred repeat transurethral resection of bladder tumor while 142 (40%) preferred intravesical chemoablation. Patients who preferred repeat transurethral resection of bladder tumor were more likely to prioritize initial treatment effectiveness (63%), whereas those who preferred chemoablation prioritized risk of recurrence (55%). Variables associated with a preference for intravesical chemoablation included U.S. residence (OR=2; 95% CI 1.1, 3.8), or if they expressed their reason for treatment preference as priority of recurrence risk over effectiveness (OR=14.6; 95% CI 7.4, 28.5). Predominant interview themes varied across participants, with patients but not urologists emphasizing the emotional toll of the procedure along with the need for improved counseling regarding recurrence, terminology, and cancer-related signs and symptoms. CONCLUSIONS: Differences exist in the way patients and urologists perceive repeat transurethral resection of bladder tumor for bladder cancer. Understanding transurethral resection of bladder tumor perception will aid in shared decision making as novel treatments emerge for nonmuscle-invasive bladder cancer.

SARS-CoV-2 Mitigation Strategies, Testing, and Cases at 254 Jails in the US Southeast, October 2020 to May 2021.

Objectives. To characterize severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mitigation strategies, testing, and cases across county jails in the Southeastern United States, examining variability by jail characteristics. Methods. We administered a 1-time telephone survey to personnel of 254 jails in Alabama, Georgia, North Carolina, and South Carolina between October 2020 and May 2021. Results. Some SARS-CoV-2 mitigation strategies (e.g., screening at intake, isolation and masking for symptomatic persons) were commonly reported (≥ 75% of jails). Other measures, such as masking regardless of symptoms (52%) and screening at release (26%), were less common and varied by jail state or population size. Overall, 41% of jails reported no SARS-CoV-2 testing in the past 30 days. Jails with testing (59%) tested a median of 6 per 100 incarcerated persons; of those jails, one third reported 1 or more cases of positive tests. Although most jails detected no cases, in the 20% of all jails with 1 or more case in the past 30 days, 1 in 5 tests was positive. Conclusions. There was low testing coverage and variable implementation of SARS-CoV-2 mitigation strategies in Southeastern US jails during the first year of the COVID-19 pandemic. (Am J Public Health. 2022;112(11):1589-1598. https://doi.org/10.2105/AJPH.2022.307012).

Solving coagulation conundrums: comparing prophylaxis strategies in adult patients receiving PEG-asparaginase.

PEG-asparaginase is a key component in treatment regimens for acute lymphoblastic leukemia (ALL). Major side effects include thrombosis and bleeding; however, there is currently no consensus on methods to prevent these complications. In this multi-center retrospective cohort study of 101 adults, we compared two prophylaxis strategies: cryoprecipitate and fresh frozen plasma (Cryo/FFP) versus cryoprecipitate and antithrombin (ATIII). The overall incidence of venous thromboembolism (VTE) was not significantly different between the two groups (19.7% for Cryo/FFP and 8.6% in Cryo/ATIII, p = 0.17), and neither was grade ≥3 bleeding (3% for Cryo/FFP and 11.4% for Cryo/ATIII, p = 0.18). Given the significant cost associated with ATIII without a clear benefit, a careful benefit and risk analysis should be considered before utilizing ATIII as a prophylaxis strategy to prevent thrombosis or bleeding following asparaginase administration.

Jail Health Care in the Southeastern United States From Entry to Release.

Policy Points As a consequence of mass incarceration and related social inequities in the United States, jails annually incarcerate millions of people who have profound and expensive health care needs. Resources allocated for jail health care are scarce, likely resulting in treatment delays, limited access to care, lower-quality care, unnecessary use of emergency medical services (EMS) and emergency departments (EDs), and limited services to support continuity of care upon release. Potential policy solutions include alternative models for jail health care oversight and financing, and providing alternatives to incarceration, particularly for those with mental illness and substance use disorders. CONTEXT: Millions of people are incarcerated in US jails annually. These individuals commonly have ongoing medical needs, and most are released back to their communities within days or weeks. Jails are required to provide health care but have substantial discretion in how they provide care, and a thorough overview of jail health care is lacking. In response, we sought to generate a comprehensive description of jails' health care structures, resources, and delivery across the entire incarceration experience from jail entry to release. METHODS: We conducted in-depth interviews with jail personnel in five southeastern states from August 2018 to February 2019. We purposefully targeted recruitment from 34 jails reflecting a diversity of sizes, rurality, and locations, and we interviewed personnel most knowledgeable about health care delivery within each facility. We coded transcripts for salient themes and summarized content by and across participants. Domains included staffing, prebooking clearance, intake screening and care initiation, withdrawal management, history and physicals, sick calls, urgent care, external health care resources, and transitional care at release. FINDINGS: Ninety percent of jails contracted with private companies to provide health care. We identified two broad staffing models and four variations of the medical intake process. Detention officers often had medical duties, and jails routinely used community resources (e.g., emergency departments) to fill gaps in on-site care. Reentry transitional services were uncommon. CONCLUSIONS: Jails' strategies for delivering health care were often influenced by a scarcity of on-site resources, particularly in the smaller facilities. Some strategies (e.g., officers performing medical duties) have not been well documented previously and raise immediate questions about safety and effectiveness, and broader questions about the adequacy of jail funding and impact of contracting with private health care companies. Beyond these findings, our description of jail health care newly provides researchers and policymakers a common foundation from which to understand and study the delivery of jail health care.

"If I Get Cured, My Whole Quality of Life Will Change": Patients' Anticipated and Actualized Benefits Following Cure from Chronic Hepatitis C.

BACKGROUND: Patients' motivations for undergoing direct-acting antiviral (DAA) therapy for chronic hepatitis C may include anticipation of treatment benefits not well described in the literature. AIMS: Evaluate patients' anticipated and actualized improvements in several domains of functioning before and after viral cure. METHODS: Pre-post-study utilizing in-depth interviews with 28 patients prior to, and several months after, DAA therapy. Interviews were audio-recorded, transcribed, coded, and analyzed by two qualitative experts. RESULTS: Patients had a median age of 54 years, 43% were male, 57% white, 25% had cirrhosis, and 71% were treated with sofosbuvir/ledipasvir. Pre-treatment, patients hoped for improvements in several domains including psychological, emotional, physical, social, and occupational functioning. After viral cure, increased energy and less fear of transmission were pathways to better quality of life. Psychological and emotional improvements positively affected physical, social, and occupational functioning. Social improvements were due to better mood and motivation, fewer symptoms, and reduced fear of stigma and transmission. Occupational benefits were linked to increased stamina, self-confidence, and less pain, anxiety, and stigma. Reduced fear of stigma had a pervasive impact on all life improvements after cure. Patient characteristics such as the presence of cirrhosis or psychiatric issues influence treatment motivations. Qualitative data correspond with change in pre-post-survey scores. CONCLUSIONS: Tremendous hope is placed on the ability of DAA therapy to bring about substantial improvements in life functioning after viral cure. Highly interconnected effects on quality of life worked synergistically through improved physical and psychological well-being. Stakeholders should appreciate the multi-dimensional benefits that viral eradication bestows upon individuals and society.

Impact of Oncology Pharmacists on the Knowledge, Attitude, and Practices of Clinicians to Enhance Patient Engagement of Self-Administered Oral Oncolytics.

Oncology clinical pharmacists are uniquely positioned to make interventions to impact the knowledge, attitudes, and practices of clinicians as well as patient activation and engagement. To accomplish this goal, pharmacists can target health system-related, provider-related, and patient-related factors to enhance patient-centered care and drive behavioral health changes. Interventions that pharmacists must tackle include educating team members and patients on the medication acquisition process, communicating urgency of treatment, optimizing workflows, facilitating guideline recommendations, preventing, and managing treatment toxicities, and promoting patient self-advocacy through education and shared decision-making. As crucial members of the healthcare team, oncology pharmacists can simplify highly complex treatment regimens to facilitate and optimize patients' ownership of their care. This narrative review will focus on the example of venetoclax treatment in acute myeloid leukemia to demonstrate the impact that pharmacists provide that leads to behavioral change of patients and clinicians.

Evaluation and optimization of a clinical pharmacist driven transitions of care model for malignant hematology.

PURPOSE: To implement and optimize a pilot transitions of care model for scheduled chemotherapy admissions in patients with hematologic malignancies at our institution.Methodology: We utilized the plan-do-study-act (PDSA) quality improvement technique to prospectively measure success of interventions related to improving transitions of care processes that occurred in multiple stages including development of standardized operating procedures, electronic medical record documentation, and education to the malignant hematology multidisciplinary group. Chart review was performed retrospectively for at least nine patients per PDSA cycle. Areas of intervention addressed and measured regarding communication between the ambulatory care and acute care settings included: admission purpose, processes related to insurance benefits investigations for specialty medications required in the post-discharge setting, and plan for growth factors, prophylactic antimicrobials, and follow-up.Results and conclusions: We included 28 patients and performed a total of three PDSA cycles demonstrating specific improvements in: communication regarding status of benefits investigations performed for specialty medications prior to admission, resolution of these benefits investigations at various time points, improvement in efficient use of the electronic medical record for chemotherapy orders, and patient instructions for appropriate use of prophylactic antimicrobials. Although improvement was noted initially with prescribing of discharge antiemetics and antimicrobials, regression to baseline was noted with the third PDSA cycle.

Safety of Intravenous Bisphosphonates for the Treatment of Hypercalcemia in Patients With Preexisting Renal Dysfunction.

BACKGROUND: Although intravenous (IV) bisphosphonates are first-line medications for the management of hypercalcemia, studies examining their use in patients with preexisting renal dysfunction are limited. OBJECTIVE: The objective of this study is to describe the safety and efficacy of pamidronate and zoledronic acid in the treatment of hypercalcemia in patients with baseline renal dysfunction. METHODS: A retrospective analysis was conducted of IV pamidronate and zoledronic acid in adult patients with hypercalcemia and creatinine clearance (CrCl) <60 mL/min. The primary endpoint was incidence of all-grade serum creatinine (SCr) elevations. Secondary endpoints included refractory hypercalcemia, hypocalcemia, osteonecrosis of the jaw (ONJ), corrected serum calcium (CSC) decrease ≥1.0 mg/dL by day 7 of bisphosphonate administration, and normalization of CSC ≤10.5 mg/dL by days 10 and 30. RESULTS: A total of 113 patients were included (n = 55 pamidronate, n = 58 zoledronic acid). The primary endpoint of all-grade SCr elevation occurred in 28 (24.8%) patients. Grades 3/4 SCr elevations occurred in 10.9% of patients treated with pamidronate and 1.7% of patients receiving zoledronic acid. Approximately 16% and 14% of patients developed grades 1 and 2 hypocalcemia, respectively, and there were no cases of ONJ. Overall, 64.6% of patients achieved normalization of CSC by day 10, and there were no statistical differences between bisphosphonate type and renal function. CONCLUSIONS AND RELEVANCE: The analysis suggests an association between IV bisphosphonates and increased rates of SCr elevations among patients with preexisting renal dysfunction. Future prospective studies are necessary to elucidate these findings.

Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study.

Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.