Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi.

BACKGROUND: Assisted index case testing (ICT), in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase status awareness in people living with HIV. While the available evidence from eastern and southern Africa suggests that assisted ICT can be an effective, efficient, cost-effective, acceptable, and low-risk strategy to implement in the region, it reveals that feasibility barriers to implementation exist. This study aims to inform the design of implementation strategies to mitigate these feasibility barriers by examining "assisting" health care workers' experiences of how barriers manifest throughout the assisted ICT process, as well as their perceptions of potential opportunities to facilitate feasibility. METHODS: In-depth interviews were conducted with 26 lay health care workers delivering assisted ICT in Malawian health facilities. Interviews explored health care workers' experiences counseling index clients and tracing these clients' contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted ICT. Analysis included multiple rounds of coding and iteration with the data collection team. RESULTS: Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including sensitivities around discussing ICT with clients, privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, and logistical obstacles to tracing. Participants also reported several health care worker characteristics that facilitate feasibility (knowledge, interpersonal skills, non-stigmatizing attitudes and behaviors, and a sense of purpose), as well as identified process improvements with the potential to mitigate barriers. CONCLUSIONS: Maximizing assisted ICT's potential to increase status awareness in people living with HIV requires equipping health care workers with effective training and support to address and overcome the many feasibility barriers that they face in implementation. Findings demonstrate the need for, as well as inform the development of, implementation strategies to mitigate barriers and promote facilitators to feasibility of assisted ICT. TRIAL REGISTRATION: NCT05343390. Date of registration: April 25, 2022.

"In Their Own Words": Families' Experiences With Tooth Autotransplantation for the Replacement of Maxillary Incisors in Children.

OBJECTIVES: To examine families' experiences, including motivation and barriers to undergoing tooth autotransplantation (AT), and their perceptions of associated esthetic and functional outcomes. METHODS: Semi-structured, in-depth-interviews (IDIs) were conducted in person with families who had children that underwent the AT procedure. Interviews were audio recorded and transcribed. Transcripts were coded and thematically analyzed both deductively and inductively. A facilitators and barriers matrix and journey maps were created to draw inferences on patterns arising from main themes. RESULTS: Twenty families selecting AT as a solution for a missing maxillary incisor were recruited and interviewed. Overall, all families interviewed had a positive experience with the AT procedure. Motivating factors for undergoing the AT procedure included wanting an earlier intervention for the missing incisor, wishing to mitigate negative psychosocial effects, and the anticipated positive outcomes that would last into adulthood. Barriers to uptake of the AT procedure included the lack of dental practitioner awareness of AT as a potential solution and a large number of appointments and travel. Families were also initially concerned over potential complications that could arise from their child undergoing this procedure. The cost of the procedure was both a barrier and a facilitator for treatment. CONCLUSIONS: The study results demonstrate that the overall AT is favorably considered by the families of growing children for the replacement of maxillary incisors and highlight factors that may act as motivators or barriers to its uptake.

"First, Trust Needs to Develop": Hematologists' Perspectives on Factors Influencing Black Persons' Participation in Clinical Trials.

BACKGROUND: Cancer clinical trials are crucial for treatment standards and innovation but lack racial-ethnic diversity. Understanding physician perspectives on recruiting participants is critical due to their role in decision-making about trial candidacy and enrollment. METHODS: From August 2021 to January 2022 we recruited 13 Academic hematologists experienced with treating blood cancers and enrolling clinical trial participants. Each hematologist participated in a 60-75-minute semistructured interview and completed a sociodemographic survey. Using the National Institute on Minority Health and Health Disparities multilevel model as a framework, we characterized hematologists' perceived barriers to clinical trial participation among Black persons. ATLAS.ti v9 and later v 23.2.1 was used for project management and to facilitate data analysis using the Sort and Sift, Think and Shift approach (ResearchTalk Inc). RESULTS: All hematologists were White, with 70% being male. Three factors influenced their perspectives on enrolling Black individuals in clinical trials: individual attitudes and beliefs, such as perceptions that Black or socioeconomically disadvantaged persons will be less willing or less compliant with the requirements for trial participation and follow-up. The need to build trusting relationships between themselves and patients prior to discussing clinical trials and the prevailing legacy of medical mistrust among the Black community. Trust was found to be the underlying factor in determining communication between hematologists and Black persons about clinical trials across all three levels. CONCLUSION: This study highlights how hematologists' attitudes, beliefs, biases, and views on trust in patient relationships influence their communication with Black individuals about clinical trials. It emphasizes the need for further research to develop interventions that address the lack of racial and ethnic diversity in trials.

Feasibility and acceptability of integrating mass distribution of azithromycin to children 1-11 months into a trachoma mass drug administration campaign to reduce child mortality in Côte d'Ivoire.

Evidence suggests that bi-annual mass drug administration (MDA) of single-dose azithromycin to 1-11 month-old children reduces child mortality in high child-mortality settings. Several countries conduct annual MDAs to distribute azithromycin to individuals ages 6 months and older to prevent trachoma infection. This study examined the feasibility and acceptability of reaching 1-11 months-old children during a trachoma MDA in Côte d'Ivoire by extending azithromycin distribution to infants 1-5 months old during the campaign. In November 2020, the study piloted single-dose azithromycin for 1-5 month-olds during a trachoma MDA in one health district. Monitoring data included the number of children reached and occurrences of adverse drug reactions. Feasibility, the extent to which the target population received the intervention (coverage), was assessed through a population-based, household survey with parents/caregivers of eligible children conducted after the MDA. Acceptability was explored through in-depth interviews (IDIs) with parents/caregivers of eligible children, focus group discussions (FGDs) with community drug distributors (CDDs), and IDIs with their supervisors. CDD FGDs and supervisor IDIs also documented implementation challenges and recommendations for scale-up. 1,735 1-5 month-olds received azithromycin during the pilot activity (estimated population coverage of 90.2%). Adverse drug reactions were reported for 1% (n = 18) infants; all were mild and self-limited. The post-MDA coverage survey interviewed 267 parents/caregivers; survey-based intervention coverage was 95.4% of 1-5 month-olds. Qualitative data revealed high intervention acceptability among parents, CDDs, and supervisors. Implementation challenges included the need to weigh babies to calculate dosage for 1-5 month-olds and the need to obtain written informed consent from parents to provide the drug to 1-5 month-olds. CDDs also indicated the need for more information on azithromycin and possible side effects during training. Delivering azithromycin to younger infants appears acceptable to parents and implementers; >90% coverage indicates feasibility to integrate into a trachoma MDA. (Clinicaltrials.gov ID number: NCT04617626).

Does a blended learning implementation package enhance HIV index case testing in Malawi? A protocol for a cluster randomised controlled trial.

INTRODUCTION: Index case testing (ICT) is an evidence-based approach that efficiently identifies persons in need of HIV treatment and prevention services. In Malawi, delivery of ICT has faced challenges due to limited technical capacity of healthcare workers (HCWs) and clinical coordination. Digitisation of training and quality improvement processes presents an opportunity to address these challenges. We developed an implementation package that combines digital and face-to-face modalities (blended learning) to strengthen HCWs ICT skills and enhance quality improvement mechanisms. This cluster randomised controlled trial will assess the impact of the blended learning implementation package compared with the standard of care (SOC) on implementation, effectiveness and cost-effectiveness outcomes. METHODS AND ANALYSIS: The study was conducted in 33 clusters in Machinga and Balaka districts, in Southern Malawi from November 2021 to November 2023. Clusters are randomised in a 2:1 ratio to the SOC versus blended learning implementation package. The SOC is composed of: brief face-to-face HCW ICT training and routine face-to-face facility mentorship for HCWs. The blended learning implementation package consists of blended teaching, role-modelling, practising, and providing feedback, and blended quality improvement processes. The primary implementation outcome is HCW fidelity to ICT over 1 year of follow-up. Primary service uptake outcomes include (a) index clients who participate in ICT, (b) contacts elicited, (c) HIV self-test kits provided for secondary distribution, (d) contacts tested and (e) contacts identified as HIV-positive. Service uptake analyses will use a negative binomial mixed-effects model to account for repeated measures within each cluster. Cost-effectiveness will be assessed through incremental cost-effectiveness ratios examining the incremental cost of each person tested. ETHICS AND DISSEMINATION: The Malawi National Health Science Research Committee, the University of North Carolina and the Baylor College of Medicine Institutional Review Boards approved the trial. Study findings will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT05343390.

Reframing the Three Delays framework: factors influencing referrals to facilities by matrones in rural Haiti.

In Haiti, there has been limited research on the experiences of traditional birth attendants/matrones when they decide to refer and accompany pregnant women to the facility for giving birth. Understanding this contextualised experience could help to strengthen programming aimed at improving maternal, neonatal, and child health (MNCH) outcomes in rural Haiti. This paper describes the qualitative findings from seven focus group discussions (FGDs) with matrones regarding their experience of referring pregnant women to facilities in Haiti's Central Plateau. Each FGD was conducted in Haitian Kreyol and audio recorded. Recordings were transcribed, translated to English, and thematically analysed. A conceptual model visualising factors influencing matrone decision-making was then developed using an adapted version of the Three Delays framework. Findings from this study show that matrones face a complex, multilayered web of intertwining factors related to attitudes and beliefs around their role, resource availability, and perceptions around quality of care and treatment. Each factor corresponds to a delay in the Three Delays framework. The factors can occur at the same time or each can occur individually at different times, and influence the decision to refer. The complexity of factors identified reflects the need to reassess the Three Delays framework so that it accounts for the intertwining, cyclical complexities faced by those trying to access the facility amidst the backdrop of both time and the community/social contexts. Results further reflect the need for strengthened health systems that better facilitate matrone facility-based referrals, improving outcomes for all parties involved and bridging the gap between homes/ communities and facilities. This calls for better integration of the matrones into the formal health system to systematically strengthen the continuum of MNCH health services provided from home to facility.

Identifying symptomatic adverse events using the patient-reported outcomes version of the common terminology criteria for adverse events in patients with non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.

OBJECTIVE: Tolerability and safety of treatments are important in oncology trials and should be informed by patient assessments. We identified the most relevant patient-reported symptomatic adverse events (AEs) to measure in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. METHODS: This study selected relevant symptomatic AEs from 78 AEs available in the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system. Initially, symptomatic AEs were selected based on literature and product labeling reviews, and then core sets of symptomatic AEs were identified by patient and clinician interviews. Qualitative and descriptive analyses were performed using the data collected from three iterative rounds of patient interviews. RESULTS: During concept elicitation interviews involving 29 patients, 12 symptomatic AEs were identified and were then adapted into a 25-item PRO-CTCAE form for use in future clinical trials along with commonly used PRO measures. Cognitive interviews showed that the PRO-CTCAE items were easy to answer and appropriate for assessing the patients' experience with symptomatic AEs. This study also assessed disease symptoms, impacts, and overall patient experience. CONCLUSIONS: The 25-item PRO-CTCAE form captures the most relevant symptomatic AEs in this patient population, and it is available for future studies. Baseline characterization of AEs associated with this distinct patient group contributes to our broader knowledge about NSCLC and through platforms like Project Patient Voice will expand our understanding of treatment tolerability and safety for NSCLC. Ultimately, this data collection will help inform decision-making for patients, caregivers, healthcare providers, and regulators.

Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi.

Background: Assisted index case testing, in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase PLHIV status awareness. Promising evidence for the approach has led to several attempts to scale assisted index case testing throughout eastern and southern Africa in recent years. However, despite effective implementation being at the heart of any assisted index case testing strategy, there is limited implementation science research from the perspective of the HCWs who are doing the "assisting". This study examines the feasibility of assisted index case testing from the perspective of health care workers implementing the approach in Malawi. Methods: In-depth interviews were conducted with 26 lay health care workers delivering assisted index case testing in Malawian health facilities. Interviews explored health care workers' experiences counselling index clients and tracing these clients' contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted index case testing. Analysis included multiple rounds of coding and iteration with the data collection team. Results: Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, logistical obstacles to tracing, and challenges of discussing sexual behavior with clients. Participants also reported several health care worker characteristics that facilitate feasibility: robust understanding of assisted index case testing's rationale and knowledge of procedures, strong interpersonal skills, positive attitudes towards clients, and sense of purpose in their work. Conclusions: Findings demonstrate that maximizing assisted index case testing's potential to increase HIV status awareness requires adequately equipping health care workers with appropriate knowledge, skills, and support to address and overcome the many feasibility challenges that they face in implementation. Trial Registration Number: NCT05343390 Date of registration: April 25, 2022.

The symptom experience of hereditary angioedema (HAE) patients beyond HAE attacks: literature review and clinician interviews.

BACKGROUND: Hereditary angioedema (HAE) is a genetic disorder characterized by re-occurring swelling episodes called "attacks," usually in the limbs, face, airways, and intestinal tract. New prophylactic therapies have reduced the frequency of these attacks. This study describes results from a literature review and clinician interviews assessing patient HAE symptom experiences and timing, and then evaluates whether existing patient-reported outcome (PRO) tools adequately reflect this experience. METHODS: A targeted literature review as well as interviews with key opinion leaders (KOLs), were conducted to capture information about the patient experience and their symptoms. An assessment of various PROs was then conducted to determine how well they each covered HAE symptoms and impacts. RESULTS: Nineteen HAE symptoms were identified. KOLs reported that patients on prophylactic therapy experienced some symptoms indicating an attack was imminent, but then never experienced an attack. The comparison of the different PROs found that the Hereditary Angioedema Patient-Reported Outcome was the instrument that most thoroughly examined the symptoms of patients with HAE. CONCLUSIONS: Given the introduction of new prophylactic therapies, further research is needed to determine the effect of being attack-free for longer periods of time on health-related quality of life.

Symptom burden and health-related quality of life impacts of smoldering multiple myeloma: the patient perspective.

BACKGROUND: Smoldering multiple myeloma (SMM) is an early form of multiple myeloma (MM). SMM is typically considered asymptomatic, and research on how it affects health-related quality of life (HRQoL) is limited. This study assessed the symptoms and HRQoL of patients with SMM and those who progressed from SMM to MM and evaluated the content validity of two patient-reported outcome instruments (EORTC QLQ-C30 and nine items from the EORTC QLQ-MY20) for use in SMM clinical trials. To address these objectives, concept elicitation and cognitive interviews were conducted with SMM patients and recently diagnosed MM patients. RESULTS: Fifteen adult SMM and six adult MM participants with a prior SMM diagnosis were interviewed. On average, SMM study participants were 61 years old (46.0-78.0), 11 (73%) were female, and diagnosed 2.6 (±2.0) years ago. Each participant had experienced at least one symptom, most commonly tiredness/fatigue, weakness, and pain. The most common HRQoL impacts were emotional and physical. SMM study participants demonstrated good understanding of both the EORTC QLQ-C30 and EORTC QLQ-MY20 subscales and found them relevant to their SMM health state. The average age of MM participants was 53 years old (39.0-62.0); 5 (83%) were female and diagnosed 1.9 years ago (±2.1). MM participants most commonly reported tiredness, weakness, constipation, shortness of breath, and dry mouth as occurring when they progressed from SMM to MM. CONCLUSIONS: Although previously described as asymptomatic, these SMM participants reported experiencing symptoms that affected their lives. Additionally, the EORTC subscales measured symptoms SMM patients experienced. The participants with MM reported that the symptom burden and HRQoL impacts increased when diagnosed with MM. These findings suggest the need for increased surveillance of symptoms within the SMM population and further suggest that the EORTC subscales can be used to assess symptoms and impacts in both the SMM and MM populations.