Importance: Little is known about whether digital adherence technologies are economical for patients with tuberculosis (TB) in resource-constrained settings. Objective: To test the hypothesis that for patients with TB, a digital medication event reminder monitor (MERM)-observed therapy provides higher health-related quality of life (HRQoL) and lower catastrophic costs compared with standard directly observed therapy (DOT). Design, Setting, and Participants: This study was a secondary analysis of a randomized, 2-arm, open-label trial conducted in 10 health care facilities in Ethiopia. Eligible participants were adults with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who were eligible to start first-line anti-TB therapy. Participants were enrolled between June 2, 2020, and June 15, 2021, with the last participant completing follow-up on August 15, 2021. Interventions: Participants were randomly assigned (1:1) to receive a 15-day TB medication supply dispensed with a MERM device to self-administer and return every 15 days (intervention arm) or the standard in-person DOT (control arm). Both groups were observed throughout the standard 2-month intensive treatment phase. Main Outcomes and Measures: Prespecified secondary end points of the original trial were HRQoL using the EuroQoL 5-dimension 5-level (EQ-5D-5L) tool and catastrophic costs, direct (out-of-pocket) and indirect (guardian and coping) costs from the individual patient perspective using the World Health Organization's Tool to Estimate Patient Costs, and common factors associated with lower HRQoL and higher catastrophic costs. Results: Among 337 patients screened for eligibility, 114 were randomly assigned, and 109 were included in the final complete-case intention-to-treat analysis (57 control and 52 intervention participants). The mean (SD) age was 33.1 (11.1) years; 72 participants (66.1%) were men, and 15 (13.9%) had HIV coinfection. EQ-5D-5L overall median (IQR) index value was 0.964 (0.907-1). The median (IQR) value was significantly higher in intervention (1 [0.974-1]) vs control (.908 [0.891-0.964]) (P <.001). EQ-5D-5L minimum and maximum health state utility values in intervention were 0.906 and 1 vs 0.832 and 1 in control. Patients' overall median (IQR) postdiagnosis cost was Ethiopian birr (ETB) 80 (ETB 16-ETB 480) (US $1.53). The median cost was significantly lower in intervention (ETB 24 [ETB 16-ETB 48]) vs control (ETB 432 [ETB 210-ETB 1980]) (P <.001), with median possible cost savings of ETB 336 (ETB 156-ETB 1339) (US $6.44) vs the control arm. Overall, 42 participants (38.5%; 95% CI, 29.4%-48.3%) faced catastrophic costs, and this was significantly lower in the intervention group (11 participants [21.2%]; 95% CI, 11.1%-34.7%) vs control (31 participants [54.4%]; 95% CI, 40.7%-67.6%) (P <.001). Trial arm was the single most important factor in low HRQoL (adjusted risk ratio [ARR], 1.49; 95% CI, 1.35-1.65; P <.001), while trial arm (ARR, 2.55; 95% CI, 1.58-4.13; P <.001), occupation (ARR, 2.58; 95% CI, 1.68-3.97; P <.001), number of cohabitants (ARR, 0.64; 95% CI, 0.43-0.95; P =.03), and smoking (ARR, 2.71; 95% CI, 1.01-7.28; P =.048) were the most important factors in catastrophic cost. Conclusions and Relevance: In patients with TB, MERM-observed therapy was associated with higher HRQoL and lower catastrophic costs compared with standard DOT. Patient-centered digital health technologies could have the potential overcoming structural barriers to anti-TB therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT04216420.

Assessing pre-exposure prophylaxis (PrEP) coverage and identifying reasons for disproportionate uptake among the varied social and cultural sub-groups of men who have sex with men (MSM) and transgender women who have sex with men (TWSM) are necessary precursors to setting attainable local PrEP. We report on findings of a cross-sectional survey among MSM/TWSM attending Gay pride events in Atlanta, Georgia, in 2018. Associations between PrEP awareness, uptake, and respondent characteristics were assessed using logistic regression. PrEP awareness did not differ by race, but current use was significantly lower among Blacks at substantial risk of HIV (p =.008). In multivariate analysis, clinician encounter in the past year was associated with awareness while age, income, drug use, sero-discordant sex, and multiple male partners were associated with current use. Among PrEP-naïve MSM/TWSM, the most common reasons for nonuse differed by race (poor knowledge of PrEP: Black—45% vs. non-Black—27%, p =.010, low perception of risk: Black—26% vs. non-Black—52%, p =.001). Key racial and socioeconomic disparities in active PrEP use and reasons for nonuse remain despite the recent increases in PrEP awareness and use among MSM/TWSM in Atlanta. Achieving overall improvement in uptake among all MSM/TWSM sub-groups will require tailoring PrEP educational messaging, optimizing communication modalities, expanding provider outreach, and identifying ways to defray costs for high-risk, underserved sub-groups in these populations.

Gay, bisexual, and other men who have sex with men (MSM) have been disproportionately affected during the 2022 U.S. monkeypox outbreak, with Black or African American (Black) MSM being the most affected demographic group (1). As of September 28, 2022, Georgia had reported 1,784 monkeypox cases; 98% of which occurred in males and 77% among Black persons (2). As of September 13, 2022, 60% of reported cases were among persons with HIV infection, and 50% of persons with monkeypox had a sexually transmitted infection within the past year (3). Because of racial disparities in the incidence of monkeypox cases and a large proportion of cases among MSM in Georgia, early vaccination beginning in July focused on improving equitable access by establishing new and leveraging existing partnerships with community-based organizations that serve affected populations, including persons with HIV infection. Despite these efforts, disparities persisted because of high demand and limited vaccine supply. The Georgia Department of Public Health (DPH) requested CDC support for a vaccine pilot and received an additional allocation of 5,500 doses of JYNNEOS vaccine for administration at events leading up to and throughout a Black gay Pride festival in Atlanta, a multiday event held Labor Day weekend (September 2-5, 2022). The event celebrates lesbian, gay, bisexual, transgender, queer or questioning, intersex, asexual, and other (LGBTQIA+) communities of color and hosts more than 125,000 attendees each year. Before the festival (as of August 24), 17,546 persons had been vaccinated in Georgia, of whom 96% were male, 34% aged 25-36 years, 44% Black, and 8% Hispanic or Latino (Hispanic) (4).

During February 2021-June 2022, the Georgia Department of Public Health (GDPH) detected five clusters of rapid HIV transmission concentrated among Hispanic or Latino (Hispanic) gay, bisexual, and other men who have sex with men (MSM) in metropolitan Atlanta. The clusters were detected through routine analysis of HIV-1 nucleotide sequence data obtained through public health surveillance (1,2). Beginning in spring 2021, GDPH partnered with health districts with jurisdiction in four metropolitan Atlanta counties (Cobb, DeKalb, Fulton, and Gwinnett) and CDC to investigate factors contributing to HIV spread, epidemiologic characteristics, and transmission patterns. Activities included review of surveillance and partner services interview data,† medical chart reviews, and qualitative interviews with service providers and Hispanic MSM community members. By June 2022, these clusters included 75 persons, including 56% who identified as Hispanic, 96% who reported male sex at birth, 81% who reported male-to-male sexual contact, and 84% of whom resided in the four metropolitan Atlanta counties. Qualitative interviews identified barriers to accessing HIV prevention and care services, including language barriers, immigration- and deportation-related concerns, and cultural norms regarding sexuality-related stigma. GDPH and the health districts expanded coordination, initiated culturally concordant HIV prevention marketing and educational activities, developed partnerships with organizations serving Hispanic communities to enhance outreach and services, and obtained funding for a bilingual patient navigation program with academic partners to provide staff members to help persons overcome barriers and understand the health care system. HIV molecular cluster detection can identify rapid HIV transmission among sexual networks involving ethnic and sexual minority groups, draw attention to the needs of affected populations, and advance health equity through tailored responses that address those needs.

Background: US long-term care facilities (LTCFs) have experienced a disproportionate burden of COVID-19 morbidity and mortality. Methods: We examined SARS-CoV-2 transmission among residents and staff in 60 LTCFs in Fulton County, Georgia, from March 2020 to September 2021. Using the Wallinga-Teunis method to estimate the time-varying reproduction number, R(t), and linear-mixed regression models, we examined associations between case characteristics and R(t). Results: Case counts, outbreak size and duration, and R(t) declined rapidly and remained low after vaccines were first distributed to LTCFs in December 2020, despite increases in community incidence in summer 2021. Staff cases were more infectious than resident cases (average individual reproduction number, Ri= 0.6 [95% confidence intervals [CI] = 0.4, 0.7] and 0.1 [95% CI = 0.1, 0.2], respectively). Unvaccinated resident cases were more infectious than vaccinated resident cases (Ri= 0.5 [95% CI = 0.4, 0.6] and 0.2 [95% CI = 0.0, 0.8], respectively), but estimates were imprecise. Conclusions: COVID-19 vaccines slowed transmission and contributed to reduced caseload in LTCFs. However, due to data limitations, we were unable to determine whether breakthrough vaccinated cases were less infectious than unvaccinated cases. Staff cases were six times more infectious than resident cases, consistent with the hypothesis that staff were the primary drivers of SARS-CoV-2 transmission in LTCFs.

Background: The success of a tuberculosis digital adherence technology relies on patients’ satisfaction with and the usability of the technology. This study aimed to evaluate treatment satisfaction and usability of a digital medication event reminder and monitor (MERM) device for patients with tuberculosis to address the prespecified secondary endpoint of the SELFTB trial. Methods: In this multicenter, randomised controlled trial, adults (≥18 years) with new or previously treated, bacteriologically-confirmed, drug-sensitive pulmonary tuberculosis who were eligible to start anti-tuberculosis therapy were recruited from 10 healthcare facilities in Ethiopia. With a computer-generated random number sequence, participants were randomly assigned 1:1 to receive a 15-day tuberculosis medication supply dispensed with an evriMED500® MERM device to self-administer and return every 15 days or the standard in-person DOT. Both arms were followed throughout the standard two-month intensive treatment phase. Treatment was based on the WHO-recommended two-month fixed-dose-combination of first-line anti-tuberculosis drug delivered as a single daily dose (2RHZE). Treatment Satisfaction Questionnaire for Medication version 4 (TSQM 1.4©) was used to measure and compare treatment satisfaction between arms. Adapted System Usability Scale (SUS) was used to assess the usability of the device, with emphasis on ease of use, challenges, benefits, motivation, popularity, and recommendation. The findings were correlated with adherence and clinical endpoints including sputum smear conversion and IsoScreen urine isoniazid test results. This trial is registered with ClinicalTrials.gov, NCT04216420. Findings: Between June 2, 2020, and June 15, 2021, 337 patients were screened for eligibility, of whom 109 participants enrolled and completed the satisfaction [control (n = 57) and intervention (n = 52) arms] and usability [intervention arm (n = 52)] questionnaires. TSQM 1.4© geometric mean scores were: Effectiveness 73.25 [geometric standard deviation (GSD) 1.28], Side Effects 100, Convenience 63.31 (GSD 1.45), and Global Satisfaction 77.29 (GSD 1.25). TSQM score was significantly higher in the intervention vs the control: Effectiveness [85.78 vs 63.43, 95% CI 1.35 (1.26–1.45), p < 0.001], Convenience [85.41 vs 48.18, 95% CI 1.77 (1.63–1.93), p < 0.001], and Global Satisfaction [90.19 vs 67.11, 95% CI 1.34 (1.26–1.43), p < 0.001]. There were significant associations between Global Satisfaction and medication adherence (p = 0.017). Average SUS score was 97.45%, which was close to the best imaginable SUS value of 100%. Likelihood to Recommend (LTR) value was ≥9, on a scale of 0–10, for 90.4% of MERM users, yielding higher net promoters. There was no significant association between usability and medication adherence (p = 0.691). Interpretation: Our findings suggested that treatment satisfaction scores were superior in the intervention vs control arms and across the domains of Effectiveness, Convenience, and Global Satisfaction. There was excellent usability of the MERM device and a significantly higher number of users likely to promote the device. High tuberculosis burden countries may transform patient-centered care through ongoing evaluation and scale-up of digital health innovations. Funding: U.S. National Institute of Health (NIH) Fogarty International Center and National Institute of Allergy and Infectious Diseases ( D43 TW009127) and the Emory Center for AIDS Research ( P30 AI050409).

The gap between how health information is communicated and what people understand and can use to make informed health decisions is called health literacy. This gap was exacerbated by the rapidly changing and excessive volume of information, misinformation, and disinformation during the COVID-19 pandemic. People with lower health literacy may not have understood the importance of COVID-19 vaccination for themselves or for their communities. Our aim was to understand health literacy levels within Fulton County, Georgia, and their relationship to vaccine prevalence. Fulton county residents ages 18 and over (n = 425) completed an on-line Health Literacy Questionnaire. Individual, organizational, functional, interactive, and critical health literacy scales were created. Vaccination prevalence data were collected from the Georgia Vaccine Distribution Dashboard. All data were divided into one of three county areas. There were statistically significant variations in vaccine prevalence χ2(3) = 29.325, p < 0.001 among the three county areas. All levels of health literacy predicted overall county vaccination prevalence F (4,420) = 85.941, p < 0.001, There were significant differences in health literacy levels among two of the three county area pairs; the lowest resourced county area had the lowest vaccination prevalence and health literacy rates. This is the first example of relating direct health literacy measures across a major metropolitan US county with vaccine prevalence data.

Background: Methamphetamine use is a contributor to HIV risk and poor health outcomes among gay, bisexual and other men who have sex with men (GBMSM). There is a paucity of research examining methamphetamine use and its social context specifically among Black GBMSM. We therefore sought to: (1) describe trends in methamphetamine use among Black GBMSM in Atlanta, Georgia, and (2) examine the risk environment (micro-, meso‑ and macro-level factors operating in the political, social, physical, economic, and healthcare environments) that might elevate risk for methamphetamine use in this population. Methods: We conducted a qualitative study consisting of eight focus groups with 54 key informants between December 2019 and March 2020. Participants represented community-based and healthcare organizations that work closely with Black GBMSM. Our thematic analysis included an iterative, team coding approach combining deductive and inductive elements. Results: Participants unanimously agreed that methamphetamine use was increasingly prevalent among Black GBMSM in Atlanta, with many describing a historical arc in which methamphetamine use – previously associated with predominantly white, affluent GBMSM – was now common among younger, lower socioeconomic status Black GBMSM. At the micro-level, participants described contributors to increasing methamphetamine use including use as a sex drug, and the interrelated burdens of stress and mental illness, housing instability, geographic mobility and poverty. At the meso‑level, participants described virtual and physical sex scenes including use of geosocial networking apps that facilitated the spread of methamphetamine use in the Black GBMSM community. At the macro-level, participants described how policies prioritizing other concerns (e.g., HIV, opioids) seemed to limit resources available for methamphetamine prevention and treatment programming. Conclusion: Multi-level environmental influences are working together to elevate risk for methamphetamine use among Black GBMSM in Atlanta, with potential to adversely impact health and well-being and undermine HIV prevention and treatment efforts.

BACKGROUND: Shorter treatment regimens for tuberculosis (TB) are deemed vital for advancing TB control. Murine studies have suggested potential new regimens; however, Phase II human studies of these drug combinations have not shown clear improvement in 2-month culture conversion over current therapy. Nevertheless, drugs such as rifapentine (RPT) may have additional sterilizing effects after 2 months that are difficult to measure in current Phase II studies. OBJECTIVES : To model potential bactericidal effects of RPT in a Phase III trial of a 4-month anti-tuberculosis regimen. METHODS : We developed a Markov model of antituberculosis treatment to compare two regimens for treating TB: a 6-month standard (rifampin-based) treatment and a 4-month regimen using high-dose RPT. The primary outcome was the number of relapses. RESULT S : In the base-case scenario, standard therapy resulted in fewer relapses; improvement in 2-month culture conversion rates in the RPT arm did not change this result. However, while RPT has better sterilizing ability during months 3 and 4 (as observed in the mouse model), the 4-month regimen results in fewer relapses. CONCLUS IONS : Higher 2-month culture conversion rates are neither sufficient nor necessary for making a theoretical 4-month anti-tuberculosis treatment regimen advantageous.

Background: Black men who have sex with men (BMSM) suffer from alarmingly high rates of HIV in the United States. Pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 99% among men who have sex with men, yet profound racial disparities in the uptake of PrEP persist. Low PrEP uptake in BMSM is driven by poor access to PrEP, including inconvenient locations of PrEP-prescribing physicians, distrust of physicians, and stigma, which limit communication about PrEP and its side effects. Previous work indicates that offering HIV prevention services in pharmacies located in low-income, underserved neighborhoods is feasible and can reduce stigma because pharmacies offer a host of less stigmatized health services (eg, vaccinations). We present a protocol for a pharmacy PrEP model that seeks to address challenges and barriers to pharmacy-based PrEP specifically for BMSM. Objective: We aim to develop a sustainable pharmacy PrEP delivery model for BMSM that can be implemented to increase PrEP access in low-income, underserved neighborhoods. Methods: This study design is a pilot intervention to test a pharmacy PrEP delivery model among pharmacy staff and BMSM. We will examine the PrEP delivery model’s feasibility, acceptability, and safety and gather early evidence of its impact and cost with respect to PrEP uptake. A mixed-methods approach will be performed, including three study phases: (1) a completed formative phase with qualitative interviews from key stakeholders; (2) a completed transitional pilot phase to assess customer eligibility and willingness to receive PrEP in pharmacies during COVID-19; and (3) a planned pilot intervention phase which will test the delivery model in 2 Atlanta pharmacies in low-income, underserved neighborhoods. Results: Data from the formative phase showed strong support of pharmacy-based PrEP delivery among BMSM, pharmacists, and pharmacy staff. Important factors were identified to facilitate the implementation of PrEP screening and dissemination in pharmacies. During the transitional pilot phase, we identified 81 individuals who would have been eligible for the pilot phase. Conclusions: Pharmacies have proven to be a feasible source for offering PrEP for White men who have sex with men but have failed to reach the most at-risk, vulnerable population (ie, BMSM). Increasing PrEP access and uptake will reduce HIV incidence and racial inequities in HIV. Translational studies are required to build further evidence and scale pharmacy-based PrEP services specifically for populations that are disconnected from HIV prevention resources.