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Objective. This study explored the reproductive journeys of women with vasculitis, including their conversations with healthcare providers, disease activity, medication changes, and delivery experiences. Methods. Interviews were conducted with women registered in the Vasculitis Pregnancy Registry (VPREG), an online patient-reported registry of pregnant women with vasculitis. A team of physicians, patients, and qualitative researchers developed a qualitative interview guide. Participant responses were evaluated using thematic analysis. Results. Eighteen patients with vasculitis who had experienced pregnancy were interviewed (10 antineutrophil cytoplasmic antibody–associated vasculitis, 4 Takayasu arteritis, 2 Behçet disease, 1 IgA vasculitis, 1 relapsing polychondritis). Thematic analysis revealed common experiences in the decision-making process during pregnancy planning, including accessing information from multiple sources, communicating with medical professionals, and changing treatment for vasculitis. Women sought information about vasculitis and pregnancy from various sources, including social media; however, opinions from their physicians and family members were most influential. Patients were more likely than providers to initiate conversations regarding family planning. Balancing differing opinions from subspecialists was challenging as many patients recalled acting as a liaison between multiple physicians during pregnancy. The need for self-advocacy was a common experience among patients. Most women had pregnancies that resulted in live births with delivery at term. Conclusion. When making decisions about pregnancy, women of reproductive age with vasculitis used multiple resources. Patients consistently valued their medical provider’s opinion over alternative sources of information. To ensure comprehensive medical care, half of women relied on self-advocacy to coordinate communication among subspecialists. Most women had pregnancies that resulted in live births with delivery at term. [ABSTRACT FROM AUTHOR]

Introduction: Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you notes, as well as to refine and expand guidance on participant and family engagement in Pediatric Trials Network's (PTN) pragmatic paediatric clinical research. Methods: Informed by draft PTN guidance, we conducted in‐depth qualitative interviews with adolescent clinical trial participants and caregivers of paediatric participants in four trials conducted by PTN across eight sites. Participants were shown multiple versions of mock lay summaries and thank you notes and asked questions on their preferences for content and layout, and on trial communications. We used applied thematic analysis to analyse the data. Results: We interviewed 27 individuals engaged in PTN research: 24 caregivers and 3 adolescents. During a trial, participants want regular updates on study progress, reminders of the study purpose and reassurances of data confidentiality. After the trial, participants want to learn the aggregated results, particularly medication effectiveness. Participants reported that lay summaries should include a review of the study's purpose, methods and length, and that they expect to learn individual‐level results. Participants stated that thank you notes must be of sufficient length to be meaningful. Conclusions: This is the first study to describe stakeholder preferences for thank you note content and layout. Using these findings, we finalized PTN's trial communication guidance for use in future PTN trials. Research is needed to determine the effect of lay summaries and thank you notes on improving public transparency regarding clinical trials and paediatric trial recruitment and completion. Patient or Public Contribution: By design, stakeholders (adolescent trial participants and caregivers of pediatric trial participants) contributed to PTN's guidance on the content and layout of lay summaries and thank you notes through their participation in the in‐depth interviews. [ABSTRACT FROM AUTHOR]

Our study explores the understanding of vaccine-induced seropositivity (VISP) and its potential impact on US adolescents' and caregivers' willingness to participate in adolescent HIV vaccine clinical trials. Findings from in-depth interviews suggest that addressing concerns about VISP will be essential for future pediatric HIV vaccine trials in the United States. [ABSTRACT FROM AUTHOR]

Black populations in the U.S. South are disproportionally affected by HIV and COVID-19 due to longstanding inequalities. We conducted 20 in-depth interviews—12 with Black same-gender-loving men and 8 with Black cisgender women—to explore the impact of the initial phase of the COVID-19 pandemic on sexual activities and PrEP use. Almost all participants reduced the frequency of sex and number of partners. Women described little interest in sex, whereas men began to connect with some sexual partners after stay-at-home orders were lifted. Both populations were concerned about contracting COVID-19 through sexual partners, and men described selecting partners based on perceived COVID-19 risk. Participants valued PrEP and could access it, although several men who were not having sex stopped taking it. Risk of acquiring HIV during this time was likely limited. Future qualitative research is needed to understand how sexual behaviors and PrEP use changed as the pandemic continued. [ABSTRACT FROM AUTHOR]

As an occupational group, clergy exhibit numerous physical health problems. Given the physical health problems faced by clergy, understanding where physical health falls within the priorities of seminary students, the ways students conceptualize physical health, and how seminary students do or do not attend to their physical health in the years immediately prior to becoming clergy, can inform intervention development for both seminary students and clergy. Moreover, understanding and shaping the health practices of aspiring clergy may be particularly impactful, with cascading effects, as clergy serve as important role models for their congregants. Drawing on 36 in-depth, qualitative interviews with first-year seminary students, this study examines the complex dynamics between religious frameworks related to physical health, explicit intentions to maintain healthy practices, and reported physical health behaviors. Our findings suggest that even students who deploy religious frameworks in relation to their physical health—and who, as a result, possess positive intentions to implement and maintain healthy behaviors—often report being unable to live up to their aspirations, especially in the face of barriers to health practices posed by the seminary program itself. After reviewing these findings, we offer suggestions for physical health focused interventions, including action and coping planning, which could be implemented at seminaries to reduce the intention–behavior gap and improve clergy health. [ABSTRACT FROM AUTHOR]

Introduction: Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities. Methods: We conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n = 14) and patient groups (n = 14) to determine: (1) how representatives define benefits and investments of patient group engagement in medical product development, and (2) to refine a list of 31 predefined patient group engagement activities. Results: Patient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. Discussion: Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool (https://prioritizationtool.ctti-clinicaltrials.org/) to help clinical research sponsors and patient groups identify high-priority engagement activities. Use of this tool can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development. [ABSTRACT FROM AUTHOR]

Many women’s decisions about whether and how to participate in sex work are driven by financial considerations. Despite the recognized importance of economic factors in HIV risk among female sex workers (FSWs), many HIV prevention programs focus narrowly on sexual risk behaviors. We collected data on the financial practices of FSWs in Abidjan, Côte d’Ivoire, to better inform economic strengthening programs for HIV risk reduction with this population. We conducted “walk-along” participant observations (N = 74) during FSWs’ daily non-working routines and analyzed resultant notes using qualitative thematic analysis. We used a financial diary methodology to collect detailed quantitative data on income, spending, savings and lending from a sub-sample of participants (n = 33) over six weeks; these data were analyzed using descriptive statistics. All women in our sample reported sex work as their primary source of earned income. Median weekly income was roughly US $114, with a wide range across the sample and from week to week. Cash expenses related primarily to routine needs (e.g., food, housing, transportation) and accounted, on average, for approximately 90% of weekly spending. Around one-quarter of weekly expenses were directly associated with sex work (e.g., clothing, beauty products, and alcohol). FSWs held “savings” in boxes, mobile money platforms, informal savings groups, or banks, though most withdrew cash from these funds frequently. These findings suggest that this group of FSWs in Abidjan, Côte d’Ivoire, are not cash-poor: median weekly income is greater than the estimated Ivoirian weekly per capita gross national income. Yet the erratic nature of income alongside routine spending needs suggests that effective economic strengthening programs in this context should include financial management education, group-based savings and lending, and links to formal financial institutions. These economic strengthening activities hold promise to empower FSWs financially for downstream HIV-risk reduction benefits by building economic resilience to reduce financially-driven sexual risk decisions. [ABSTRACT FROM AUTHOR]

Three randomised controlled trials in Africa indicated that voluntary medical male circumcision (VMMC) is an effective method to reduce a man's risk of becoming infected through sex with an HIV-positive female partner. The success of recent public health initiatives to increase numbers of circumcised men in Malawi has been very limited. We conducted in-depth interviews and focus group discussions (FGDs) with men, women and male adolescents from non-circumcising and circumcising communities in southern Malawi to better understand their beliefs about male circumcision and the promotion of VMMC for HIV prevention. Results revealed that beliefs about male circumcision, in general, are strongly mediated by Malawian culture and history. Participants have attempted to develop a new meaning for circumcision in light of the threat of HIV infection and the publicised risk reduction benefits of VMMC. Several study participants found it difficult to distinguish VMMC from traditional circumcision practices (jandoandlupanda), despite awareness that the new form of circumcision was an expression of (western) modern medicine performed largely for public health purposes. Greater recognition of background cultural beliefs and practices could inform future efforts to promote medical male circumcision as an HIV prevention strategy in this context. [ABSTRACT FROM PUBLISHER]

Introduction: FEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up study to identify, among other topics, participants’ reasons for taking the study pill. Methods: Qualitative, semi-structured interviews (SSIs) were conducted with 88 FEM-PrEP participants. Participants were purposefully selected based on their adherence drug concentrations collected during FEM-PrEP and placed into three adherence interview groups: “high,” “moderate,” and “none/scarce.” Participants in the high and moderate groups described reasons why they adhered most or some of the time, including factors that facilitated their adherence. Participants in all groups described what they believed made it possible for other FEM-PrEP participants to adhere. In addition, 224 FEM-PrEP participants reported on their reasons for taking the study pills through a quantitative, audio computer-assisted self-interview (ACASI). Thematic analysis and descriptive statistics were used to analyze the qualitative and quantitative data, respectively. Results: Five themes were identified from the SSIs as facilitating factors of adherence: 1) participants’ support for the research, 2) HIV risk reduction, 3) routine formation and use of tools, 4) adherence counseling, and 5) partner awareness and support. Participants described similar facilitators when they spoke about other participants’ adherence. Among the 172 participants who reported in ACASI that they had taken a study pill, wanting to help answer the research question was the most frequently stated reason for taking the pills (94%, n = 161). We also found evidence of preventive misconception. Conclusions: Adherence was facilitated by personal motivations, such as risk reduction and interest in the research outcome, and by adherence strategies consisting of external cues, reminders, and support. These findings can inform future HIV prevention clinical trials and the rollout of effective antiretroviral-based HIV prevention technologies for women. [ABSTRACT FROM AUTHOR]

Background: The successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical investigators; however, little information is known about the perspectives of investigators using mobile technologies in clinical trials. Objective: The aim of this study was to seek investigators' insights on the advantages and challenges of mobile clinical trials (MCTs); site-level budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and the advantages and disadvantages for trial participants using mobile technologies in clinical trials. Methods: Using a qualitative descriptive study design, we conducted in-depth interviews with investigators involved in the conduct of MCTs. Data were analyzed using applied thematic analysis. Results: We interviewed 12 investigators who represented a wide variety of clinical specialties and reported using a wide range of mobile technologies. Investigators most commonly cited 3 advantages of MCTs over traditional clinical trials: more streamlined study operations, remote data capture, and improvement in the quality of studies and data collected. Investigators also reported that MCTs can be designed around the convenience of trial participants, and individuals may be more willing to participate in MCTs because they can take part from their homes. In addition, investigators recognized that MCTs can also involve additional burden for participants and described that operational challenges, technology adoption barriers, uncertainties about data quality, and time burden made MCTs more challenging than traditional clinical trials. Investigators stressed that additional training and dedicated staff effort may be needed to select a particular technology for use in a trial, helping trial participants learn and use the technology, and for staff troubleshooting the technology. Investigators also expressed that sharing data collected in real time with investigators and trial participants is an important aspect of MCTs that warrants consideration and potentially additional training and education. Conclusions: Investigator perspectives can inform the use of mobile technologies in future clinical trials by proactively identifying and addressing potential challenges. JMIR Mhealth Uhealth 2021;9(2):e19242 doi:10.2196/19242 [ABSTRACT FROM AUTHOR]