Evaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial.

Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We conducted an inductive thematic analysis and aligned the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as required enabled acceptance for patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, and collaboration among HCPs enabled, whereas initial concerns about 3HP safety among HCPs delayed 3HP adoption and implementation. SAT was maintained post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up.

Comparison of 3 optimized delivery strategies for completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV in Uganda: A single-center randomized trial.

BACKGROUND: Expanding access to shorter regimens for tuberculosis (TB) prevention, such as once-weekly isoniazid and rifapentine taken for 3 months (3HP), is critical for reducing global TB burden among people living with HIV (PLHIV). Our coprimary hypotheses were that high levels of acceptance and completion of 3HP could be achieved with delivery strategies optimized to overcome well-contextualized barriers and that 3HP acceptance and completion would be highest when PLHIV were provided an informed choice between delivery strategies. METHODS AND FINDINGS: In a pragmatic, single-center, 3-arm, parallel-group randomized trial, PLHIV receiving care at a large urban HIV clinic in Kampala, Uganda, were randomly assigned (1:1:1) to receive 3HP by facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between facilitated DOT and facilitated SAT using a shared decision-making aid. We assessed the primary outcome of acceptance and completion (≥11 of 12 doses of 3HP) within 16 weeks of treatment initiation using proportions with exact binomial confidence intervals (CIs). We compared proportions between arms using Fisher's exact test (two-sided α = 0.025). Trial investigators were blinded to primary and secondary outcomes by study arm. Between July 13, 2020, and July 8, 2022, 1,656 PLHIV underwent randomization, with equal numbers allocated to each study arm. One participant was erroneously enrolled a second time and was excluded in the primary intention-to-treat analysis. Among the remaining 1,655 participants, the proportion who accepted and completed 3HP exceeded the prespecified 80% target in the DOT (0.94; 97.5% CI [0.91, 0.96] p < 0.001), SAT (0.92; 97.5% CI [0.89, 0.94] p < 0.001), and Choice (0.93; 97.5% CI [0.91, 0.96] p < 0.001) arms. There was no difference in acceptance and completion between any 2 arms overall or in prespecified subgroup analyses based on sex, age, time on antiretroviral therapy, and history of prior treatment for TB or TB infection. Only 14 (0.8%) participants experienced an adverse event prompting discontinuation of 3HP. The main limitation of the study is that it was conducted in a single center. Multicenter studies are now needed to confirm the feasibility and generalizability of the facilitated 3HP delivery strategies in other settings. CONCLUSIONS: Short-course TB preventive treatment was widely accepted by PLHIV in Uganda, and very high levels of treatment completion were achieved in a programmatic setting with delivery strategies tailored to address known barriers. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934931.

The Impact of a Student-Led Health Education Clinic on the Health Literacy and Behaviors of a Rural Community in the State of Pennsylvania, USA.

Rural populations experience a number of disparities that place them at increased risk of morbidity and mortality related to chronic disease, including lower health literacy and greater distance to medical care. Community-based free healthcare education can offer targeted preventive care to these vulnerable populations; however, limited quantitative research exists measuring their impact, specifically on health literacy and likelihood for behavior change. To investigate this, a student-led health education clinic was held in January 2023 in the rural community of Lykens, Pennsylvania by the Student-run and Collaborative Outreach Program for Health Equity (SCOPE). Fifty-five pre- and post-clinic surveys using Likert-style questions measured the knowledge and likelihood of behavioral change for several preventive health topics, including hypertension, diabetes mellitus, cancer screenings, childhood vaccinations, skin cancer, mental health, addiction, and nutrition. From pre- to post-clinic, there was a significant increase in knowledge of hypertension (p = 0.023) and diabetes (p = 0.014), likelihood of attending cancer screenings (p = 0.038), and confidence in identifying cancerous moles (p = < 0.001). There was a non-significant increase in understanding of mental health and nutrition, and no change in understanding of addiction or childhood vaccinations. It is likely that the level of interaction in education provided and relevance of information to participants contributed to effective uptake of information. The results demonstrate an immediate impact on health literacy and likelihood of behavioral change for several important preventive health topics, and advocate for the use of student-run healthcare interventions in addressing the prevalence of chronic disease in rural communities.

Implementation, feasibility, and acceptability of 99DOTS-based supervision of treatment for drug-susceptible TB in Uganda.

99DOTS is a low-cost digital adherence technology that allows people with tuberculosis (TB) to self-report treatment adherence. There are limited data on its implementation, feasibility, and acceptability from sub-Saharan Africa. We conducted a longitudinal analysis and cross-sectional surveys nested within a stepped-wedge randomized trial at 18 health facilities in Uganda between December 2018 and January 2020. The longitudinal analysis assessed implementation of key components of a 99DOTS-based intervention, including self-reporting of TB medication adherence via toll-free phone calls, automated text message reminders and support actions by health workers monitoring adherence data. Cross-sectional surveys administered to a subset of people with TB and health workers assessed 99DOTS feasibility and acceptability. Composite scores for capability, opportunity, and motivation to use 99DOTS were estimated as mean Likert scale responses. Among 462 people with pulmonary TB enrolled on 99DOTS, median adherence was 58.4% (inter-quartile range [IQR] 38.7-75.6) as confirmed by self-reporting dosing via phone calls and 99.4% (IQR 96.4-100) when also including doses confirmed by health workers. Phone call-confirmed adherence declined over the treatment period and was lower among people with HIV (median 50.6% vs. 63.7%, p<0.001). People with TB received SMS dosing reminders on 90.5% of treatment days. Health worker support actions were documented for 261/409 (63.8%) people with TB who missed >3 consecutive doses. Surveys were completed by 83 people with TB and 22 health workers. Composite scores for capability, opportunity, and motivation were high; among people with TB, composite scores did not differ by gender or HIV status. Barriers to using 99DOTS included technical issues (phone access, charging, and network connection) and concerns regarding disclosure. 99DOTS was feasible to implement and highly acceptable to people with TB and their health workers. National TB Programs should offer 99DOTS as an option for TB treatment supervision.

Facilitating Integrated Perinatal Care for Families Affected by Substance Use.

Families of newborns are frequently referred to child protection systems because of parental substance use, yet many families face barriers to accessing prenatal care and substance use treatment services. Although federal legislation requires states to develop Plans of Safe Care to address families' health and substance use treatment needs, few have developed comprehensive and systematic approaches to provide perinatal support to parents and infants. In this commentary, we describe the development and initial testing of a Plan of Safe Care that engages patients and their providers in perinatal care coordination. Developed out of an in-depth analysis of current care workflows at an urban safety net health system, the Plan of Safe Care facilitates conversations with clients around delivery planning and aligns resources to support families with substance use disorders.

Using a human-centered, mixed methods approach to understand the patient waiting experience and its impact on medically underserved Populations.

PURPOSE: To use a mixed methods approach to investigate the patient waiting experience for a medically underserved population at an outpatient surgical clinic. METHODS: We used lean methodology to perform 96 time-tracked observations of the patient journey in clinic, documenting the duration of activities from arrival to departure. We also used human-centered design (HCD) to perform and analyze 43 semi-structured interviews to understand patients' unmet needs. RESULTS: Patients spent an average of 68.5% of their total clinic visit waiting to be seen. While the average visit was 95.8 minutes, over a quarter of visits (27%) were over 2 hours. Patients waited an average of 24.4 minutes in the waiting room and 41.2 minutes in the exam room; and only spent 19.7% of their visit with an attending provider and 11.8% with a medical assistant. Interviews revealed that patients arrive to their visit already frustrated due to difficulties related to scheduling and attending their appointment. This is exacerbated during the visit due to long wait times, perceived information opacity, and an uncomfortable waiting room, resulting in frustration and anxiety. CONCLUSIONS: While time tracking demonstrated that patients spend a majority of their visit waiting to be seen, HCD revealed that patient frustrations span the waiting experience from accessing the appointment to visit completion. These combined findings are crucial for intervention design and implementation for medically underserved populations to improve the quality and experience with healthcare and also address system inefficiencies such as long wait times.

Using Architectural Mapping to Understand Behavior and Space Utilization in a Surgical Waiting Room of a Safety Net Hospital.

OBJECTIVE: To use architectural mapping to understand how patients and families utilize the waiting space at an outpatient surgery clinic in a safety-net hospital. BACKGROUND: The waiting period is an important component of patient experience and satisfaction. Studies have found that patients value privacy, information transparency and comfort. However, approaches common in the architecture field have rarely been used to investigate interactions between patients and the built environment in a safety-net healthcare setting. METHODS: This was a prospective observational study in a general surgery outpatient clinic at a safety-net hospital and level 1 trauma center. We used a web-based application generated from the design and architecture industry, to quantitatively track waiting space utilization over 2 months. RESULTS: A total of 728 observations were recorded across 5 variables: time, location, chair selection, person/object, and activity. There were 536 (74%) observations involving people and 179 (25%) involving personal items. People most frequently occupied chairs facing the door (43%, n = 211), and least frequently occupied seats in the hallway (5%, n = 23), regardless of the time of their appointment (p-value = 0.92). Most common activities included interacting with personal phone, gazing into space, and talking face to face. Thirteen percent of people brought mobility devices, and 64% of objects were placed on an adjacent chair, indicating the desire for increased personal space. CONCLUSION: Architectural behavioral mapping is an effective information gathering tool to help design waiting space improvement in the safety-net healthcare setting.

Completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV: Interim analysis of a hybrid type 3 effectiveness-implementation randomized trial.

BACKGROUND: Scaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid-rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization's (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa. METHODS AND FINDINGS: The 3HP Options Trial is a pragmatic, parallel type 3 effectiveness-implementation randomized trial comparing 3 optimized strategies for delivering 3HP-facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid-to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (≥11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes. CONCLUSIONS: 3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934931.

Using human centered design to identify opportunities for reducing inequities in perinatal care.

BACKGROUND: Extreme disparities in access, experience, and outcomes highlight the need to transform how pregnancy care is designed and delivered in the United States, especially for low-income individuals and people of color. METHODS: We used human-centered design (HCD) to understand the challenges facing Medicaid-insured pregnant people and design interventions to address these challenges. The HCD method has three phases: Inspiration, Ideation, and Implementation. This study focused on the first and second. In the Inspiration phase we conducted semi-structured interviews with a purposeful sample of stakeholders who had either received or participated in the care of Medicaid-insured pregnant people within our community, with a specific emphasis on representation from marginalized communities. Using a general inductive approach to thematic analysis, we identified themes, which were then framed into design opportunities. In the Ideation phase, we conducted structured brainstorming sessions to generate potential prototypes of solutions, which were tested and iterated upon through a series of community events and engagement with a diverse community advisory group. RESULTS: We engaged a total of 171 stakeholders across both phases of the HCD methodology. In the Inspiration phase, interviews with 23 community members and an eight-person focus group revealed seven insights centered around two main themes: (1) racism and discrimination create major barriers to access, experience, and the ability to deliver high-value pregnancy care; (2) pregnancy care is overmedicalized and does not treat the pregnant person as an equal and informed partner. In the Ideation phase, 162 ideas were produced and translated into eight solution prototypes. Community scoring and feedback events with 140 stakeholders led to the progressive refinement and selection of three final prototypes: (1) implementing telemedicine (video visits) within the safety-net system, (2) integrating community-based peer support workers into healthcare teams, and (3) delivering co-located pregnancy-related care and services into high-need neighborhoods as a one-stop shop. CONCLUSIONS: Using HCD methodology and a collaborative community-health system approach, we identified gaps, opportunities, and solutions to address perinatal care inequities within our urban community. Given the urgent need for implementable and effective solutions, the design process was particularly well-suited because it focuses on understanding and centering the needs and values of stakeholders, is multi-disciplinary through all phases, and results in prototyping and iteration of real-world solutions.