Sexual and reproductive health in military settings: A qualitative study.

Mission readiness is critical to the operational success of the United States (US) military and includes having a healthy and fit fighting force. Service members and their dependents have access to a wide range of sexual and reproductive health services with no out-of-pocket costs. Despite this access, negative outcomes such as sexually transmitted infections (STIs) and unintended pregnancy persist. Semi-structured, in-depth interviews were conducted with service members and stakeholders (e.g. medical providers). Interviews explored the individual, interpersonal, organizational, and institutional factors that inform sexual norms, behaviors, and healthcare experiences in the US military. Interview transcripts were coded manually; data were summarized for themes related to unique aspects of military culture and healthcare affecting sexual and reproductive health. Twenty-five (25) service members and 15 stakeholders completed interviews. Four themes emerged: 1) despite free access, both general and military-specific barriers to sexual and reproductive healthcare persist; 2) general and military-specific cultural norms apply to sexual behavior and care seeking; 3) sexual and reproductive health-related norms can be perceived as confusing and contradictory within the military; and 4) resources addressing sexual assault are ubiquitous in military settings, but resources addressing prevention of STIs and unintended pregnancy are limited. Both general and military-specific norms, behavior, and healthcare experiences need to be considered in clinical care, public health campaigns, and other efforts to promote sexual and reproductive health in military settings.

Increasing Incidence of Gonorrhea at an Urban STI Clinic in the United States.

Medical record data was extracted from a sexually transmitted infection (STI) clinic in Providence, Rhode Island to characterize trends in Neisseria gonorrhoeae (GC) infection and explore risk factors. Of 16,601 clinical encounters, 6% (n=991) tested GC positive: 5.28 GC case rate (per 100 encounters) in the first two years of data collection (2015-2016) and 7.04 in the last two years (2020-2021). Analysis suggested a single linear trend line over time (p<.05). Overall, in more recent years, patients were older and more like to identify as male, Black, and Hispanic/Latino, as well as to have reported a previous STI, current symptoms, and specific risk behaviors. GC-positive patients in 2020-2021 were older and more like to identify as female and Black compared to 2015-2016. Lower rates of condom use were especially salient among female patients. These findings may reflect GC trends in the community.

Facilitators and Barriers to Breastfeeding Among Veterans Using Veterans Affairs Maternity Care Benefits.

INTRODUCTION: U.S. veterans of childbearing age represent one of the fastest growing populations using Veterans Affairs (VA) health care. The VA does not provide obstetric care directly but pays for VA-enrolled veterans to obtain outside obstetric care. The VA also provides maternity care coordination (MCC) services, including lactation support. Breastfeeding benefits mothers and babies; however, previous research shows that veteran mothers quit exclusive breastfeeding earlier than the American Academy of Pediatrics and World Health Organization recommendation of 6 months. This study aimed to understand facilitators and barriers to breastfeeding among a cohort of veterans who used VA maternity care benefits. METHODS: Qualitative data from an open-ended question from a national sample of postpartum veterans using VA pregnancy benefits were coded using deductive and inductive content analysis within a matrix framework. Quantitative data were used to contextualize the responses. RESULTS: Four themes emerged from the data: (1) impacts on health of baby/mother; (2) the ability to breastfeed; (3) early postnatal experiences breastfeeding; and (4) cost/convenience. Among those who responded to the open-ended breastfeeding question (329/669), most participants (n = 316; 96%) attempted breastfeeding their current baby. Respondents who did not initiate breastfeeding or who discontinued breastfeeding earlier than planned cited diverse reasons. These included low milk supply, poor latch, nipple pain, mental health factors, and low confidence in their ability to continue breastfeeding. Participants cited the MCC program as a facilitator to breastfeeding, and non-VA hospital experiences were mentioned as barriers. CONCLUSION: Veterans in this cohort of 329 veterans who responded to an open-ended breastfeeding question wanted and attempted to breastfeed; however, barriers such as lactation challenges and unsupportive health care providers made it difficult to continue the practice. As the MCC program grows to include more lactation professionals, MCCs may address barriers such as lactation challenges and unsupportive non-VA health care providers. Further program development should focus on addressing these challenges prenatally.

Comparative effectiveness and complications of intravenous ceftriaxone compared with oral doxycycline in Lyme meningitis in children: a multicentre prospective cohort study.

INTRODUCTION: Lyme disease is the most common vectorborne disease in the Northern hemisphere with more than 400 000 new cases in the USA annually. Lyme meningitis is an uncommon but potentially serious clinical manifestation of Lyme disease. Intravenous ceftriaxone had been the first-line treatment for Lyme meningitis, but is associated with a high rate of complications. Although efficacy and effectiveness (or real-world evidence) data for oral doxycycline are limited, practice guidelines were recently expanded to recommend either oral doxycycline or ceftriaxone as first-line treatments for Lyme meningitis. Our goal is to compare oral doxycycline with intravenous ceftriaxone for the treatment of Lyme meningitis on short-term recovery and long-term quality of life. METHODS AND ANALYSIS: We are performing a prospective cohort study at 20 US paediatric centres located in diverse geographical range where Lyme disease is endemic. The clinical care team will make all antibiotic treatment decisions for children with Lyme meningitis, as per usual practice. We will follow enrolled children for 6 months to determine time of acute symptom recovery and impact on quality of life. ETHICS AND DISSEMINATION: Boston Children's Hospital, the single Institutional Review Board (sIRB), has approved the study protocol with the other 19 enrolling sites as well as the Utah data coordinating centre relying on the Boston Children's Hospital sIRB. Once the study is completed, we will publish our findings in a peer-reviewed medical journal.

Sexual Health-related Quality of Life in Women with Pulmonary Arterial Hypertension: Compensating for Loss.

Rationale: Health-related quality of life in patients with pulmonary arterial hypertension (PAH) has become increasingly important in disease management as numerous treatment options have improved prognosis and time to clinical worsening. Sexual health-related quality of life (SHRQoL) is poorly understood in patients with PAH, but previous work has shown that patients may face unrecognized challenges, especially related to parenteral prostanoid analogue therapies. Objectives: Using qualitative methods, to describe challenges and perspectives related to SHRQoL among women with PAH. Methods: We conducted 13 semistructured in-depth interviews at the Pulmonary Hypertension Association's International Pulmonary Hypertension Conference and Scientific Sessions among female attendees with World Symposium on Pulmonary Hypertension group 1 PAH. A coding structure using both deductive and inductive coding was developed to organize and analyze data using applied thematic analysis. Salient themes were identified and are presented here using summary and illustrative quotations. Results: Ninety-two percent (12 of 13) of participants reported declines in the frequency of sex after diagnosis of PAH. A significant portion (62% [8 of 13]) experienced fear of having sexual intercourse because of cardiopulmonary symptoms. All participants (100% [13 of 13]) reported compensatory behaviors/strategies during and around sexual intercourse; some participants on subcutaneous prostanoids also reported timing intercourse to coincide with infusion site changes and, as a result, interrupted treatment during this time. Participants reported changing positions during sex to reduce breathlessness, and some reported removing oxygen to avoid interrupting intimacy. Most participants endorsed negative body image related to their medications, external oxygen supplementation, and/or body weight fluctuations (54% [7 of 13]). Many participants revealed that they had never discussed sexual practices with healthcare professionals and desired increased communication and discussion with their providers. Conclusions: Women with PAH face significant burdens and challenges regarding SHRQoL. PAH therapies directly affect SHRQoL. Further targeted qualitative and quantitative studies are needed to better characterize and improve SHRQoL in patients with PAH.

The preparation phase in the multiphase optimization strategy (MOST): a systematic review and introduction of a reporting checklist.

Multicomponent behavioral interventions developed using the multiphase optimization strategy (MOST) framework offer important advantages over alternative intervention development models by focusing on outcomes within constraints relevant for effective dissemination. MOST consists of three phases: preparation, optimization, and evaluation. The preparation phase is critical to establishing the foundation for the optimization and evaluation phases; thus, detailed reporting is critical to enhancing rigor and reproducibility. A systematic review of published research using the MOST framework was conducted. A structured framework was used to describe and summarize the use of MOST terminology (i.e., preparation phase and optimization objective) and the presentation of preparation work, the conceptual model, and the optimization. Fifty-eight articles were reviewed and the majority focused on either describing the methodology or presenting results of an optimization trial (n = 38, 66%). Although almost all articles identified intervention components (96%), there was considerable variability in the degree to which authors fully described other elements of MOST. In particular, there was less consistency in use of MOST terminology. Reporting on the MOST preparation phase is varied, and there is a need for increased focus on explicit articulation of key design elements and rationale of the preparation phase. The proposed checklist for reporting MOST studies would significantly advance the use of this emerging methodology and improve implementation and dissemination of MOST. Accurate reporting is essential to reproducibility and rigor of scientific trials as it ensures future research fully understands not only the methodology, but the rationale for intervention and optimization decisions.

Designing Dual Compartment HIV Prevention Products: Women's Sensory Perceptions and Experiences of Suppositories for Rectal and Vaginal Use.

Dual compartment suppositories are being developed to prevent HIV and other sexually transmitted infections. Such products, for use in the rectum, the vagina, or both, could have a significant public health impact by decreasing global incidence of these diseases. In this study, 16 women each used two rheologically distinct suppositories in their vagina and rectum. User Sensory Perception and Experience (USPE) scales assessed sensory experiences during sexual activity to understand whether, and how, women perceive formulation properties in the vagina and rectum. Qualitative data from individual in-depth interviews captured women's descriptions and comparisons of the experiences. Significant differences and large Cohen's d effect sizes between vaginal and rectal experiences of suppository-A were found for three scales: Application (APP): Product Awareness, SEX: Initial Penetration; and SEX: Effortful. Qualitative data provided user experience details that credibly align with these score differences. Near significant differences and large effect sizes were found for two additional scales: SEX: Perceived Wetness with suppository-A and SEX: Messiness with suppository-B. In addition, other scale scores showed medium-to-large effect sizes that correspond to hypothesized sensations associated with biophysical properties of the suppositories. Statistical significance combined with large effect sizes and qualitative data accurately represent the hypothesized perceptibility of suppository properties and identifies performance characteristics relevant to acceptability and adherence; together these data provide discernment of factors that can guide the development of dual compartment products. The Clinical Trial Registration number: NCT02744261.

Characterizing Post-treatment Lyme Disease Syndrome: A Mixed Methods Study of Patients at a Lyme Disease Clinic in Rhode Island.

BACKGROUND: Mixed quantitative and qualitative research methods may be useful for characterizing the experiences of patients with post-treatment Lyme disease syndrome. METHODS: 15 participants completed demographic and screening questions, surveys assessing quality of life, fatigue, pain, cognitive functioning, and other patient- reported outcomes, a semi-structured in-depth interview, and consented to a Lyme-related medical chart review. RESULTS: Participants reported mild to moderate symptoms and functional impairments on patient-reported outcome surveys and in-depth interviews. Participants reported on a number of management strategies that they found more or less effective in managing their symptoms. Participants endorsed the need for better clinical assessment of symptom patterns over time, greater Lyme-related education for providers, more holistic approaches to diagnosis and care, and the desire to participate in Lyme-focused support groups. CONCLUSIONS: Overall, participants desired a more holistic approach to diagnosis, symptom assessment, and symptom management. Recommendations for future research and clinical considerations are discussed.

Characterizing the Symptoms of Patients with Persistent Post-Treatment Lyme Symptoms: A Survey of Patients at a Lyme Disease Clinic in Rhode Island.

BACKGROUND: 10-20% of individuals diagnosed with Lyme disease develop chronic symptoms after antibiotic treatment. METHODS: A convenience sample of adults with self- reported, persistent post-Lyme treatment symptoms seeking treatment at the Lifespan Lyme Disease Center in Rhode Island completed a demographic and medical survey, the Patient Reported Outcomes Measurement Information System (PROMIS)-29 v2.0, and other short-form PROMIS measures of cognitive function, sleep disturbance, and fatigue. RESULTS: Compared to average standardized scale scores (T=50; SD=10), participants had mild impairments in physical (T=41) and social (T=42) functioning, mild symptoms of depression (T=56), anxiety (T=60), and sleep disturbance (T=57), and moderate pain interference (T=62), and fatigue (T=65). Participants reported greater symptoms than some other clinical samples including those with cancer and chronic pain. Post-hoc analyses revealed that women reported higher levels of fatigue than men. CONCLUSIONS: People with persistent post-Lyme treatment symptoms report debilitating symptoms and functional impairments which must be considered in clinical care.

Lessons Learned from a Rhode Island Academic Out-Patient Lyme and Tick-Borne Disease Clinic.

Although the prevalence of Lyme and tick-borne diseases (TBDs) continues to rise, there is conflicting information regarding the best approach to management. The Lifespan Lyme Disease Clinic (LDC) is an academic out- patient clinic for Lyme and other TBDs. A chart review of 218 new patients between March and November 2018 was conducted. Symptoms most commonly reported included fatigue (66.5%), joint pain (58.2%), cognitive difficulty (32.1%), and headaches (27.9%). Most (87.1%) patients had received TBD-directed antibiotic treatment prior to their first appointment. Of the 136 patients who had experienced more than 6 months of symptoms attributed to Lyme, 55.1% had positive two-tiered serologies. Many patients characterized themselves as having "chronic Lyme" or had a diagnosis of "post-treatment Lyme disease syndrome," a condition for which there is no clear consensus on pathophysiology or treatment. Outlined here are some lessons learned and practical approaches used by LDC physicians in caring for this patient population.

The Role of Volume in the Perceptibility of Topical Vaginal Formulations: User Sensory Perceptions and Experiences of Heterosexual Couples During Vaginal Sex.

Users' sensory perceptions and experiences (USPEs; perceptibility) of drug formulations can critically impact product adoption and adherence, especially when products rely on appropriate user behaviors (timing of administration, dosing measurement) for effectiveness. The use of topical gel formulations for effective antihuman immunodeficiency virus/sexually transmitted infection (HIV/STI) vaginal microbicides has been associated with messiness and other use-associated challenges, resulting in low adherence. Nonetheless, such formulations remain attractive due to good pharmacokinetics and resulting pharmacodynamics through their volume and surface contact for drug delivery into luminal fluids and mucosa. Consequently, advocates and scientists continue to pursue topical forms [semisolid (e.g., gel, suppository); solid (e.g., film)] to deliver select drugs and offer user choice in HIV/STI prevention. The current data build on previously validated USPE scales evaluating perceptibility of gels with various biophysical/rheological properties. Specifically, increased formulation parameter space adds a new set of properties inherent in quick-dissolving film. We compared film, a product adding no discernable volume to the vaginal environment, to 2 and 3.5 mL hydroxyethyl cellulose gel to consider the impact of volume on user experience. We also examined the USPE scales for evaluation of male sexual partners' experiences. The original USPE scales functioned as expected. Additionally, six new USPE scales were identified in this enhanced parameter space. Significant differences were noted between USPEs in pairwise comparisons, with largest differences between film and high-volume gel. Product developers and behavioral scientists can use these scales to design products, optimizing user experience and maximizing adherence and delivery of efficacious anti-HIV/STI pharmaceuticals. They can be extended to evaluation of additional formulations, devices, and compartments, as well as single- and multipurpose pharmaceuticals. In broader contexts, USPEs could be of value in evaluating formulations and devices to prevent/treat other diseases (e.g., ophthalmologic, dermatologic). Steadfast attention should be given to patient experience, and, where applicable, experiences of partners and/or caregivers.

'I feel like a person has a right to use a product to protect themselves ': a qualitative study of the risk-benefit calculus on women's contraceptive use and choice.

Background Reducing pregnancy risk requires a multidimensional approach to sexual and reproductive health product development. The purpose of this analysis is to identify, compare, and contrast women's pre-use beliefs and attitudes about three different forms of contraceptives: intravaginal rings; spermicide in conjunction with condoms; and oral contraceptive pills - and explore how those attitudes and beliefs, along with actual method-use experience, may affect potential choices in contraceptive method moving forward. The relationship of beliefs and attitudes to their risk-benefit calculations when using these methods was also considered.? METHODS: Women used one or more contraceptive methods, each for 3-6 months. Qualitative data from individual in-depth interviews completed after each 3-month use period were analysed using a summary matrix framework. Data were extracted and summarised into themes. Each woman's experiences were compared among the methods she used; comparisons were also made across participants. RESULTS: The data consist of 33 90-120 min in-depth qualitative interviews from 16 women aged 20-34 years, in which they discussed various elements of their method use experience. One prominent theme was identified: the influence of attitudes and beliefs on the risk-benefit calculus. There were six key elements within the theme: pregnancy prevention; dosing and the potential for user error; side-effects; familiarity; disclosure; and sexual partnerships. CONCLUSIONS: Women weighed perceived risks and benefits in their decision-making and, ultimately, their contraception choices. Understanding women's beliefs and attitudes that contribute to a calculation of risk-benefit can inform the development of sexual and reproductive health products.

Interventions to Improve Sexual and Reproductive Health in US Active Duty Military Service Members: A Systematic Review.

OBJECTIVE: To identify and describe behavioral interventions to promote sexual and reproductive health among US active duty military service members. DATA SOURCES: Systematic searches of PubMed, CINAHL, and PsychINFO (N = 1609 records). INCLUSION CRITERIA: English-language articles published between 1991 and 2018 and retrieved using search terms related to military service, interventions, and sexual and reproductive health. EXCLUSION CRITERIA: Articles excluded if not empirically based, not published in peer-reviewed journals, did not sample active duty US military personnel, and did not examine the effectiveness of specified preventive sexual or reproductive health intervention(s). DATA EXTRACTION: Teams of paired authors extracted study rationale; aims; design; setting; description of the intervention; measures; sample demographics; clinical, behavioral, and psychosocial outcomes; and conclusions. DATA SYNTHESIS: Given the heterogeneity of studies, narrative synthesis was performed. RESULTS: Fifteen articles met inclusion criteria: 10 focused on sexually transmitted infection (STI) acquisition and/or unintended pregnancy and 5 on sexual assault. Studies that assessed clinical outcomes found that interventions were associated with lower rates of STIs and/or unintended pregnancy. Significant effects were found on knowledge-related outcomes, while mixed effects were found on attitudes, intentions, and behaviors. CONCLUSIONS: Current evidence on the effectiveness of sexual and reproductive health interventions in the US military is limited in quality and scope. Promoting sexual and reproductive health in this population is critical to maintaining well-being among servicemembers, their families, and the communities surrounding military installations.

A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies.

CONTEXT: Vaginal rings are available for contraception and hormone replacement, and are being developed as HIV/STD or multipurpose prevention technologies. A comprehensive understanding of women's expectations of and experiences with rings is urgently needed to inform product development and to optimize ring use. METHODS: Three databases (PubMed, Global Health and CINAHL) were searched for English-language, peer-reviewed articles published between January 1996 and November 2017 that reported qualitative data on barriers to and facilitators of use of female-controlled contraceptive methods. Data on study methods, findings and conclusions pertaining to contraceptive rings were extracted, organized and analyzed. RESULTS: Twenty-six articles, all published since 2008, met the inclusion criteria. Seven studies focused largely or entirely on rings (and involved current, former or potential users), while the others focused on other contraceptive methods but included ring-specific data. Familiarity with the ring was low, and women commonly had initial concerns about the method-often related to insertion and removal, cleanliness and discomfort with touching their vagina-that were typically overcome over time. Other major themes were issues related to ring use and discontinuation, the importance of ring-related properties and characteristics, and considerations related to sexual partners and health care providers. CONCLUSIONS: Qualitative data have the potential to inform ring design and promotion. Future research should further explore women's expectations and experiences with the ring, the value of involving male partners in ring evaluation, and evaluation of interventions to improve patient-provider communication concerning ring choice and use.

RESUMEN Contexto: Los anillos vaginales están disponibles para la anticoncepción y el reemplazo hormonal, y se están desarrollando como tecnologías de prevención del VIH/ETS o de propósitos múltiples. Se necesita con urgencia una comprensión integral de las expectativas y experiencias de las mujeres con los anillos para fundamentar el desarrollo del producto y optimizar el uso del anillo. Métodos: Entre enero de 1996 y noviembre de 2017, se realizaron búsquedas en tres bases de datos (PubMed, Global Health y CINAHL) sobre artículos en idioma inglés sometidos a revisión por pares, que aportaron datos cualitativos sobre barreras y facilitadores del uso de métodos anticonceptivos controlados por mujeres. Los datos sobre los métodos de estudio, hallazgos y conclusiones relacionados con los anillos anticonceptivos se extrajeron, organizaron y analizaron. Resultados: Veintiséis artículos, todos publicados desde 2008, cumplieron con los criterios de inclusión en el análisis. Siete estudios se centraron en gran medida o completamente en los anillos (e involucraron usuarias actuales, anteriores o potenciales), mientras que los otros estudios se centraron en otros métodos anticonceptivos, pero incluyeron datos específicos sobre el anillo. La familiaridad con el anillo era baja y las mujeres generalmente expresaron preocupaciones iniciales sobre el método ­muchas veces en relación con la inserción y extracción, la limpieza y la incomodidad al tocar su vagina­ que típicamente se superaban con el tiempo. Otros temas importantes fueron aspectos relacionados con el uso y la interrupción del uso del anillo, la importancia de las propiedades y características relacionadas con el anillo y consideraciones relacionadas con parejas sexuales y proveedores de servicios médicos. Conclusiones: Los datos cualitativos tienen potencial para fundamentar el diseño y la promoción de los anillos vaginales. Las investigaciones futuras deben explorar más a fondo las expectativas y experiencias de las mujeres con respecto al anillo, el valor de involucrar a los compañeros masculinos en la evaluación del anillo y la evaluación de las intervenciones para mejorar la comunicación entre paciente y proveedor con respecto a la elección y el uso del anillo.

RÉSUMÉ Contexte: L'anneau vaginal, déjà proposé à des fins de contraception et de traitement hormonal de substitution, fait aujourd'hui l'objet d'une mise au point parmi les technologies de prévention du VIH/sida ou polyvalente. Il est impératif de bien comprendre les attentes et le vécu des utilisatrices pour éclairer la mise au point du produit et en optimiser l'usage. Méthodes: Trois bases de données (PubMed, Global Health et CINAHL) ont été consultées à la recherche d'articles en langue anglaise évalués par les pairs et publiés entre janvier 1996 et novembre 2017, faisant état de données qualitatives sur les obstacles et les facteurs propices à l'usage des méthodes contraceptives contrôlées par les femmes. Les données relatives aux méthodes d'étude, aux observations et aux conclusions pertinentes à l'anneau contraceptif en ont été extraites, puis organisées et analysées. Résultats: Vingt-six articles publiés, tous depuis 2018, ont répondu aux critères d'inclusion. Sept études concernaient largement ou exclusivement l'anneau (avec participation des utilisatrices actuelles, passées ou potentielles); les autres examinaient d'autres méthodes contraceptives mais présentaient des données spécifiques à l'anneau. L'anneau n'était guère familier aux femmes, dont les préoccupations initiales à l'égard de la méthode ­ souvent liées aux questions d'insertion et de retrait, d'hygiène et de gêne au contact du vagin ­ se dissipaient toutefois au fil du temps. Les autres grands thèmes touchaient à l'utilisation de l'anneau et à l'arrêt de la méthode, à l'importance de ses propriétés et caractéristiques et à des considérations relatives aux partenaires sexuels et aux prestataires de soins de santé. Conclusions: Les données qualitatives offrent un potentiel utile à la conception et à la promotion de l'anneau. La recherche future devra examiner davantage les attentes et le vécu des femmes à son égard, l'importance de la participation des partenaires masculins à son évaluation et l'évaluation des interventions entreprises pour améliorer la communication entre patientes et prestataires quant au choix et à l'utilisation de la méthode.

A Qualitative Study of the Contraceptive Effect on Women's Sexual Experiences: Beyond Hormonal Effects.

OBJECTIVE: To elucidate the effects of the intravaginal ring, oral contraceptive pill (OCP), and spermicide plus condom on women's sexual experiences through an in-depth understanding of the physical characteristics of these contraceptive methods. METHODS: We conducted qualitative in-depth interviews with women (aged 18-45 years) who used up to three contraceptive methods (intravaginal ring, OCP, and spermicide plus condom). Women completed in-depth interviews after each 3-month use period. We used a summarized matrix framework and thematic content analysis to explore how each method affected participants' sexual experiences. RESULTS: Sixteen women completed interviews, yielding 33 transcripts. Women reported physical effects on their sexual experiences while using the intravaginal ring and spermicide plus condom. The OCP was often discussed as lacking these physical effects. Discussion themes included product administration (eg, navigating intravaginal ring removal) and physical product awareness (eg, spermicide as a lubricant). From these experiences, women often altered and individualized their use and subsequent opinions of the contraceptive method. CONCLUSION: The range of contraceptive effects on women's sexual experiences shape their use and opinions of the product, leading to either increased motivation and consistent use or poor adherence and discontinuation. Awareness of these individualized experiences can help providers better understand and guide their patients towards successful contraceptive use.

A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies.

CONTEXT: Vaginal rings are available for contraception and hormone replacement, and are being developed as HIV/STD or multipurpose prevention technologies. A comprehensive understanding of women's expectations of and experiences with rings is urgently needed to inform product development and to optimize ring use. METHODS: Three databases (PubMed, Global Health and CINAHL) were searched for English-language, peer-reviewed articles published between January 1996 and November 2017 that reported qualitative data on barriers to and facilitators of use of female-controlled contraceptive methods. Data on study methods, findings and conclusions pertaining to contraceptive rings were extracted, organized and analyzed. RESULTS: Twenty-six articles, all published since 2008, met the inclusion criteria. Seven studies focused largely or entirely on rings (and involved current, former or potential users), while the others focused on other contraceptive methods but included ring-specific data. Familiarity with the ring was low, and women commonly had initial concerns about the method-often related to insertion and removal, cleanliness and discomfort with touching their vagina-that were typically overcome over time. Other major themes were issues related to ring use and discontinuation, the importance of ring-related properties and characteristics, and considerations related to sexual partners and health care providers. CONCLUSIONS: Qualitative data have the potential to inform ring design and promotion. Future research should further explore women's expectations and experiences with the ring, the value of involving male partners in ring evaluation, and evaluation of interventions to improve patient-provider communication concerning ring choice and use.

Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial.

BACKGROUND: Intravaginal rings (IVRs) for HIV pre-exposure prophylaxis (PrEP) theoretically overcome some adherence concerns associated with frequent dosing that can occur with oral or vaginal film/gel regimens. An innovative pod-IVR, composed of an elastomer scaffold that can hold up to 10 polymer-coated drug cores (or "pods"), is distinct from other IVR designs as drug release from each pod can be controlled independently. A pod-IVR has been developed for the delivery of tenofovir (TFV) disoproxil fumarate (TDF) in combination with emtricitabine (FTC), as daily oral TDF-FTC is the only Food and Drug Administration (FDA)-approved regimen for HIV PrEP. A triple combination IVR building on this platform and delivering TDF-FTC along with the antiretroviral (ARV) agent maraviroc (MVC) also is under development. METHODOLOGY AND FINDINGS: This pilot Phase I trial conducted between June 23, 2015, and July 15, 2016, evaluated the safety, pharmacokinetics (PKs), and acceptability of pod-IVRs delivering 3 different ARV regimens: 1) TDF only, 2) TDF-FTC, and 3) TDF-FTC-MVC over 7 d. The crossover, open-label portion of the trial (N = 6) consisted of 7 d of continuous TDF pod-IVR use, a wash-out phase, and 7 d of continuous TDF-FTC pod-IVR use. After a 3-mo pause to evaluate safety and PK of the TDF and TDF-FTC pod-IVRs, TDF-FTC-MVC pod-IVRs (N = 6) were evaluated over 7 d of continuous use. Safety was assessed by adverse events (AEs), colposcopy, and culture-independent analysis of the vaginal microbiome (VMB). Drug and drug metabolite concentrations in plasma, cervicovaginal fluids (CVFs), cervicovaginal lavages (CVLs), and vaginal tissue (VT) biopsies were determined via liquid chromatographic-tandem mass spectrometry (LC-MS/MS). Perceptibility and acceptability were assessed by surveys and interviews. Median participant age was as follows: TDF/TDF-FTC group, 26 y (range 24-35 y), 2 White, 2 Hispanic, and 2 African American; TDF-FTC-MVC group, 24.5 y (range 21-41 y), 3 White, 1 Hispanic, and 2 African American. Reported acceptability was high for all 3 products, and pod-IVR use was confirmed by residual drug levels in used IVRs. There were no serious adverse events (SAEs) during the study. There were 26 AEs reported during TDF/TDF-FTC IVR use (itching, discharge, discomfort), with no differences between TDF alone or in combination with FTC observed. In the TDF-FTC-MVC IVR group, there were 12 AEs (itching, discharge, discomfort) during IVR use regardless of attribution to study product. No epithelial disruption/thinning was seen by colposcopy, and no systematic VMB shifts were observed. Median (IQR) tenofovir diphosphate (TFV-DP) tissue concentrations of 303 (277-938) fmol/10(6) cells (TDF), 289 (110-603) fmol/10(6) cells (TDF-FTC), and 302 (177.1-823.8) fmol/10(6) cells (TDF-FTC-MVC) were sustained for 7 d, exceeding theoretical target concentrations for vaginal HIV prevention. The study's main limitations include the small sample size, short duration (7 d versus 28 d), and the lack of FTC triphosphate measurements in VT biopsies. CONCLUSIONS: An innovative pod-IVR delivery device with 3 different formulations delivering different regimens of ARV drugs vaginally appeared to be safe and acceptable and provided drug concentrations in CVFs and tissues exceeding concentrations achieved by highly protective oral dosing, suggesting that efficacy for vaginal HIV PrEP is achievable. These results show that an alternate, more adherence-independent, longer-acting prevention device based on the only FDA-approved PrEP combination regimen can be advanced to safety and efficacy testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT02431273.

Sexual health and health-related quality of life among women with pulmonary arterial hypertension.

Pulmonary arterial hypertension (PAH) is characterized by progressive limitations in physical activity and health-related quality of life (HRQoL). HRQoL deficits may extend beyond the traditional domains of physical activity, psychological health, and emotional wellbeing to sexual health and function. Sexual HRQoL has not been studied in PAH, nor has the impact of PAH therapies themselves on sexual health and intimacy. In this initial investigation, we sought to explore HRQoL among women diagnosed with PAH and to determine if PAH treatment type (intravenous or subcutaneous prostanoids versus oral medications) was associated with levels of self-reported HRQoL assessed by validated measures for PAH-specific, general, and sexual HRQoL. We administered the emPHasis-10, Short Form (SF)-36, Female Sexual Dysfunction Scale-Revised (FSDS-R), and the Arizona Sexual Experience Scale (ASEX) to 35 women with self-reported World Health Organization Group 1 PAH at the 2016 Pulmonary Hypertension Association International Conference and Scientific Sessions. HRQoL instruments demonstrated excellent internal reliability. Women with PAH had high levels of sexual distress captured with the FSDS-R scale. The FSDS-R (but not ASEX) was significantly correlated to emPHasis-10 ( r = 0.64, p < 0.01) and most SF-36 domains ( r = - 0.36 to - 0.64, p < 0.05). Participants treated with intravenous or subcutaneous prostanoids had higher (worse) FSDS-R scores than those on oral therapies while ASEX, emPHasis-10, and SF-36 scores were similar across treatment types. Sexual HRQoL may impact overall quality of life in PAH and specific assessment of sexual health and functioning within intimate relationships may detect deficits in wellbeing not addressed by established HRQoL metrics. Further study to address all aspects of HRQoL in PAH is required.

User evaluations offer promise for pod-intravaginal ring as a drug delivery platform: A mixed methods study of acceptability and use experiences.

BACKGROUND: Effective HIV prevention requires efficient delivery of safe and efficacious drugs and optimization of user adherence. The user's experiences with the drug, delivery system, and use parameters are critical to product acceptability and adherence. Prevention product developers have the opportunity to directly control a drug delivery system and its impact on acceptability and adherence, as well as product efficacy. Involvement of potential users during preclinical design and development can facilitate this process. We embedded a mixed methods user evaluation study into a safety and pharmacokinetics (PK) trial of a pod-intravaginal ring delivering antiretroviral agents. METHODOLOGY: Women enrolled in two cohorts, ultimately evaluating the safety/PK of a pod-IVRs delivering TDF-alone, TDF-FTC, and/or TDF-FTC-MVC. A 7-day use period was targeted for each pod-IVR, regardless of drug or drug combination. During the clinical study, participants provided both quantitative (i.e., survey) and qualitative (i.e., in-depth interview) data capturing acceptability, perceptibility, and adherence behaviors. Initial sexual and reproductive health history surveys, daily diaries, a final acceptability and willingness to use survey, and a qualitative in-depth interview comprised the user evaluation data for each pod-IVR experienced by the participants. FINDINGS: Overall, the majority of participants (N = 10) reported being willing to use the pod-IVR platform for HIV prevention should it advance to market. Confidence to use the pod-IVR (e.g., insertion, removal) was high. There were no differences noted in the user experience of the pod-IVR platform; that is, whether the ring delivered TDF-alone, TDF-FTC, or TDF-FTC-MVC, users' experiences of the ring were similar and acceptable. Participants did report specific experiences, both sensory and behavioral, that impacted their use behaviors with respect to the ring, and which could ultimately impact acceptability and adherence. These experiences, and user evaluations elicited by them, could both challenge use or be used to leverage use in future trials and product rollout once fully articulated. CONCLUSIONS: High willingness-to-use data and lack of salient differences in user experiences related to use of the pod-IVR platform (regardless of agents delivered) suggests that the pod-IVR is a feasible and acceptable drug delivery device in and of itself. This finding holds promise both for an anti-HIV pod-IVR and, potentially, a multipurpose prevention pod-IVR that could deliver both prevention for sexually transmitted infections (STIs) including HIV and contraception. Given the very early clinical trial context, further acceptability, perceptibility, and adherence data should continue to be explored, in the context of longer use periods (e.g., 28-day ring use), and in the contexts of sexual activity and menses. Using early design and development contexts to gain insights into potential challenges and facilitators of drug delivery systems such as the pod-IVR could save valuable resources and time as a potential biomedical technology moves through the clinical trial pipeline and into real-world use.

User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness.

The development of HIV-preventive topical vaginal microbicides has been challenged by a lack of sufficient adherence in later stage clinical trials to confidently evaluate effectiveness. This dilemma has highlighted the need to integrate translational research earlier in the drug development process, essentially applying behavioral science to facilitate the advances of basic science with respect to the uptake and use of biomedical prevention technologies. In the last several years, there has been an increasing recognition that the user experience, specifically the sensory experience, as well as the role of meaning-making elicited by those sensations, may play a more substantive role than previously thought. Importantly, the role of the user-their sensory perceptions, their judgements of those experiences, and their willingness to use a product-is critical in product uptake and consistent use post-marketing, ultimately realizing gains in global public health. Specifically, a successful prevention product requires an efficacious drug, an efficient drug delivery system, and an effective user. We present an integrated iterative drug development and user experience evaluation method to illustrate how user-centered formulation design can be iterated from the early stages of preclinical development to leverage the user experience. Integrating the user and their product experiences into the formulation design process may help optimize both the efficiency of drug delivery and the effectiveness of the user.