High Rates of Missed HIV Testing Among Oral PrEP Users in the United States From 2018-2021: A National Assessment on Compliance With HIV Testing Recommendations of the CDC PrEP Guidelines.

Background: The US Centers for Disease Control and Prevention recommends HIV testing every 3 months in oral PrEP users. We performed a national assessment of HIV testing compliance among oral PrEP users. Methods: We analyzed 408 910 PrEP prescriptions issued to 39 809 PrEP users using a national insurance claims database that contained commercial and Medicaid claims. We identified PrEP use based on pharmacy claims and outpatient diagnostic coding. We evaluated the percentage of PrEP prescription refills without HIV testing (identified by CPT codes) within the prior 3, 6, and 12 months using time to event methods. We performed subgroup and multivariate analyses by age, gender, race, insurance type, and geography. Results: Of 39 809 persons, 36 197 were commercially insured, 3612 were Medicaid-insured, and 96% identified as male; the median age (interquartile range) was 34 (29-44) years, and the Medicaid-insured PrEP users were 24% Black/African American, 44% White, and 9% Hispanic/Latinx. Within the prior 3, 6, and 12 months, respectively, the percentage of PrEP prescription fills in individuals without HIV Ag/Ab testing was 34.3% (95% CI, 34.2%-34.5%), 23.8% (95% CI, 23.7%-23.9%), and 16.6% (95% CI, 16.4%-16.7%), and the percentage without any type of HIV test was 25.8% (95% CI, 25.6%-25.9%), 14.6% (95% CI, 14.5%-14.7%), and 7.8% (95% CI, 7.7%-7.9%). Conclusions: Approximately 1 in 3 oral PrEP prescriptions were filled in persons who had not received an HIV Ag/Ab test within the prior 3 months, with evidence of health disparities. These findings inform clinical PrEP monitoring efforts and compliance with national HIV testing guidance to monitor PrEP users.

HIV pre-exposure prophylaxis provision by U.S. health centers in 2021.

OBJECTIVES: The aim of this study was to assess HIV preexposure prophylaxis (PrEP) provision in U.S. health centers. DESIGN: The U.S. Ending the HIV Epidemic (EHE) initiative designated health centers as the main healthcare system through which PrEP scale-up occurs. Health centers offer primary care to over 30 million disproportionately uninsured, racially or ethnically minoritized, and low-income patients. This study is the first to assess PrEP provision across health centers, including characteristics of clinics, patient populations, and policies associated with PrEP prescribing. METHODS: The Health Resources and Services Administration's Uniform Data System contained aggregate data on PrEP prescriptions and patient sociodemographics at health centers from January 1 through December 31, 2021, in 50 U.S. states, the District of Columbia, and eight U.S. territories. We compared patient demographics and availability of Medicaid expansion and PrEP assistance programs at health centers that prescribed vs. those that did not prescribe PrEP. RESULTS: Across 1375 health centers serving 30 193 278 patients, 79 163 patients were prescribed PrEP. Health centers that prescribed any PrEP had higher proportions of sexual, gender, racial, and ethnic minority patient populations compared with health centers that prescribed no PrEP. Compared with health centers that prescribed no PrEP, a higher proportion of health centers that prescribed PrEP were located in designated high-priority jurisdictions of the EHE initiative or states with Medicaid expansion or public PrEP assistance programs. CONCLUSION: Health centers are critical for scaling up PrEP in minoritized populations disproportionately affected by HIV, facilitated through federal and state-level policies. These findings highlight service gaps and inform future interventions to optimize PrEP implementation and support EHE initiative goals.

Decreased Anogenital Gonorrhea and Chlamydia in Transgender and Gender Diverse Primary Care Patients Receiving Gender-Affirming Hormone Therapy.

BACKGROUND: Transgender and gender diverse (TGD) adults in the U.S. experience health disparities, including in anogenital sexually transmitted infections (STI). Gender-affirming hormone therapy (GAHT) is known to be medically necessary and improve health. Few studies have assessed the effect of GAHT on STI diagnoses. OBJECTIVE: To evaluate the effect of GAHT delivered in primary care as an intervention to improve STI outcomes for TGD adults. DESIGN: LEGACY is a longitudinal, multisite cohort study of adult TGD primary care patients from two federally qualified community health centers in Boston, MA, and New York, NY. PARTICIPANTS: Electronic health record data for eligible adult TGD patients contributed to the LEGACY research data warehouse (RDW). A total of 6330 LEGACY RDW patients were followed from 2016 to 2019, with 2555 patients providing STI testing data. MAIN MEASURES: GAHT exposure was being prescribed hormones, and the clinical outcome was anogenital gonorrhea or chlamydia diagnoses. Log-Poisson generalized estimating equations assessed the effect of prescription GAHT on primary outcomes, adjusting for age, race, ethnicity, gender identity, poverty level, health insurance, clinical site, and cohort years. KEY RESULTS: The median age was 28 years (IQR = 13); the racial breakdown was 20.4% Black, 8.1% Multiracial, 6.9% Asian/Pacific Islander, 1.8% Other; 62.8% White; 21.3% Hispanic/Latinx; 47.0% were assigned female at birth, and 16.0% identified as nonbinary. 86.3% were prescribed hormones. Among those tested, the percentage of patients with a positive anogenital STI diagnosis ranged annually from 10.0 to 12.5% between 2016 and 2019. GAHT prescription was associated with a significant reduction in the risk of anogenital STI diagnosis (aRR = 0.75; 95% CI = 0.59-0.96) over follow-up. CONCLUSIONS: GAHT delivered in primary care was associated with less STI morbidity in this TGD cohort over follow-up. Patients may benefit from individualized and tailored clinical care alongside GAHT to optimize STI outcomes.

The future of HIV pre-exposure prophylaxis adherence: reducing barriers and increasing opportunities.

The effectiveness of HIV pre-exposure prophylaxis (PrEP) hinges on adherence, which has been restricted by multifaceted barriers. Uptake of PrEP has been impeded by poor access resulting from high costs, provider uncertainty, discrimination, stigma, and poor understanding within the health-care community and the public of who can benefit from PrEP. Other important barriers to adherence and persistence over time relate to individuals (eg, depression) and their community, partners, and family (eg, poor support), and their effects vary substantially with each person, population, and setting. Despite these challenges, key opportunities for improving PrEP adherence exist, including novel delivery systems, tailored individual interventions, mobile health and digital health interventions, and long-acting formulations. Objective monitoring strategies will help to improve adherence interventions and alignment of PrEP use with the need for HIV prevention (ie, prevention-effective adherence). The future of PrEP adherence lies in person-centred approaches to service delivery that meet the needs of individuals while creating supportive environments and facilitating health-care access and delivery.

Health Center Leadership Perspectives Regarding Barriers to and Facilitators of Providing Culturally Responsive Care for Sexual and Gender Minority Patients.

Purpose: This study identified barriers and facilitators associated with providing culturally responsive care for sexual and gender minority (SGM) patients at federally qualified health centers (FQHCs) in the United States, from the perspective of clinical leadership. Methods: Between July and December 2018, 23 semistructured, in-depth qualitative interviews were held with clinical leaders representing six FQHCs residing in rural and urban settings. Stakeholders included Chief Executive Officer, Executive Director, Chief Medical Officer, Medical Director, Clinic Site Director, and Nurse Manager positions. Interview transcripts were analyzed using inductive thematic analysis. Results: Barriers included personnel factors related to lack of training and fear, competing priorities, and environments that focused on treating all patients similarly. Facilitators included established partnerships with external organizations, staff with prior SGM training and knowledge, and active initiatives in clinic settings targeting SGM care. Conclusions: Clinical leadership expressed strong support for evolving their FQHCs into organizations that provide culturally responsive care for their SGM patients. FQHC staff across all levels of clinical care would benefit from regularly occurring training sessions on culturally responsive care for SGM patients. To ensure sustainability, improve staff buy-in, and mitigate the impact of staff turnover, improving culturally competent care for SGM patients should be a shared goal and responsibility for leadership, medical providers, and administrative staff. CTN Registration: NCT03554785.

Transgender and gender diverse adults' reflections on alcohol counseling and recommendations for providers.

Transgender and gender diverse (TGD) populations experience health disparities due to societal stigma that increases TGD individuals' sources of stress and decreases access to health protective resources. Research has linked experiences of stigma to risky alcohol use, yet there remains a dearth of culturally sensitive alcohol use interventions that meet the needs of TGD people. The present study was conducted to inform modifications to the content and delivery of an existing brief, telehealth, motivational intervention to decrease at-risk alcohol use among TGD adults. Individual semi-structured in-depth qualitative interviews were conducted with TGD adults who reported recent alcohol use (n = 18) to explore factors that facilitate positive interactions with health care providers and identify relevant information for alcohol use disorder treatment. Participants were recruited from an LGBTQ +-focused health center in Los Angeles, California. Two major themes and recommendations emerged: (a) A multicultural orientation of humility is important to develop productive therapeutic relationships with TGD clients when delivering motivational interviewing; (b) Due to insufficient appropriate data on alcohol use and health in TGD populations, feedback used in motivational alcohol counseling needs to be modified to better serve TGD clients. These findings show that counselors' philosophy and behavior, as well as session content, need to be considered when working with TGD populations within the context of alcohol counseling. These findings also have implications for intervention development, clinical treatment, and future research. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Suicidal Ideation Disparities Among Transgender and Gender Diverse Compared to Cisgender Community Health Patients.

BACKGROUND: Transgender and gender diverse (TGD) individuals experience more severe psychological distress and may be at higher risk for suicide compared to cisgender individuals. The existing literature largely consists of small-sample studies that do not assess subgroup differences. OBJECTIVE: To examine rates of self-reported suicidal ideation among four TGD groups compared to cisgender individuals. DESIGN: Data were extracted from the electronic health records of patients receiving primary care at a community health center specializing in sexual and gender minority health. A logistic regression was used to examine the relationship between sociodemographic variables and the presence of current suicidal ideation. PARTICIPANTS: 29,988 patients receiving care at a community health center in Northeastern US between 2015 and 2018. MAIN MEASURES: Demographic questionnaire, 9-item Patient Health Questionnaire KEY RESULTS: Younger age, sexual and gender minority identity, and public/grants-based insurance were associated with significantly higher odds of suicidal ideation. Relative to cisgender men, transgender men (OR=2.08; 95% CI=1.29-3.36; p=.003), transgender women (OR=3.08; 95% CI=2.05-4.63; p<.001), nonbinary (NB) individuals assigned male at birth (AMAB; OR=3.55; 95% CI=1.86-6.77; p<001), and NB individuals assigned female at birth (AFAB; OR=2.49; 95% CI=1.52-4.07; p<001) all endorsed significantly higher odds of current suicidal ideation, controlling for age, race, ethnicity, sexual orientation, and insurance status. Larger proportions of transgender women (23.6%) and NB AMAB individuals (26.7%) reported suicidal ideation not only compared to cisgender men (6.1%) and women (6.6%), but also compared to transgender men (17.4%; χ2[5, n=25,959]=906.454, p<0.001). CONCLUSIONS: TGD patients were at significantly increased risk of suicidal ideation, even after accounting for age, race, ethnicity, sexual orientation, and insurance status. Findings suggest distinct risk profiles by assigned sex at birth. Consistent assessment of and intervention for suicidal ideation should be prioritized in settings that serve TGD patients.

Implementation of Client-Centered Care Coordination for HIV Prevention with Black Men Who Have Sex with Men: Activities, Personnel Costs, and Outcomes-HPTN 073.

BACKGROUND: Black men who have sex with men (MSM) experience disproportionate rates of HIV infection in the USA, despite being no more likely to engage in sexual risk behaviors than other MSM racial/ethnic groups. HIV pre-exposure prophylaxis (PrEP) has been shown to reduce risk of HIV acquisition; however, rates of PrEP use among Black MSM remain low. Clinical, psychosocial, and structural factors have been shown to impact PrEP use and adherence among Black MSM. Care coordination of HIV prevention services has the potential to improve PrEP use and adherence for Black MSM, as it has been shown to improve HIV-related care outcomes among people living with HIV. METHODS: Client-centered care coordination (C4) is a multi-level intervention designed to address clinical, psychosocial, and structural barriers to HIV prevention services for Black MSM within HPTN 073, a PrEP demonstration project among Black MSM in three cities in the USA. The current study examined the implementation process of C4, specifically investigating the activities, cost, time, and outcomes associated with the C4 intervention. RESULTS: On average, participants engaged in five care coordination encounters. The vast majority of care coordination activities were conducted by counselors, averaging 30 min per encounter. The cost of care coordination was relatively low with a mean cost of $8.70 per client encounter. CONCLUSION: Although client-centered care coordination was initially implemented in well-resourced communities with robust HIV research and service infrastructure, our findings suggest that C4 can be successfully implemented in resource constrained communities.

The cost-effectiveness of a resilience-based psychosocial intervention for HIV prevention among MSM in India.

OBJECTIVE: MSM in India are at a high risk for HIV infection given psychosocial challenges, sexual orientation stress, and stigma. We examined the cost-effectiveness of a novel resilience-based psychosocial intervention for MSM in India. DESIGN: We parameterized a validated microsimulation model (CEPAC) with India-specific data and results from a randomized trial and examined two strategies for MSM: status quo HIV care ( SQ ), and a trial-based psychosocial intervention ( INT ) focused on building resilience to stress, improving mental health, and reducing condomless anal sex (CAS). METHODS: We projected lifetime clinical and economic outcomes for MSM without HIV initially. Intervention effectiveness, defined as reduction in self-reported CAS, was estimated at 38%; cost was $49.37/participant. We used a willingness-to-pay threshold of US$2100 (2019 Indian per capita GDP) per year of life saved (YLS) to define cost-effectiveness. We also assessed the 5-year budget impact of offering this intervention to 20% of Indian MSM. RESULTS: Model projections showed the intervention would avert 2940 HIV infections among MSM over 10 years. Over a lifetime horizon, the intervention was cost-effective (ICER = $900/YLS). Results were most sensitive to intervention effectiveness and cost; the intervention remained cost-effective under plausible ranges of these parameters. Offering this intervention in the public sector would require an additional US$28 M over 5 years compared with SQ . CONCLUSION: A resilience-based psychosocial intervention integrated with HIV risk reduction counseling among MSM in India would reduce HIV infections and be cost-effective. Programs using this approach should be expanded as a part of comprehensive HIV prevention in India.

Preferences for Conditional Economic Incentives to Improve Pre-exposure Prophylaxis Adherence: A Discrete Choice Experiment Among Male Sex Workers in Mexico.

Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV but requires sustained adherence. Conditional economic incentives (CEIs) can improve medication-taking behaviors, yet preferences for programs that employ CEIs to increase PrEP use among male sex workers (MSWs) have not been investigated. We conducted a discrete choice experiment in Mexico City to elicit stated preferences for a CEI-based PrEP adherence program among MSWs. Respondents expressed their preferences for different program characteristics: incentive amount; incentive format; incentive type; and adherence-verification method. We used a random utility logit model to estimate the relative importance of each attribute and estimated willingness-to-pay. MSWs preferred a higher, fixed incentive, with PrEP adherence measured via hair sampling. MSWs were willing to forego up to 21% of their potential maximum CEI amount to ensure receipt of a fixed payment. MSWs are highly willing to accept a CEI-based intervention for PrEP adherence, if offered along with fixed payments.

RESUMEN: La profilaxis previa a la exposición (PrEP) es muy eficaz para prevenir el VIH, pero requiere una adherencia sostenida. Los incentivos económicos condicionales (IEC) pueden mejorar los comportamientos de toma de medicamentos, sin embargo, no se han investigado las preferencias por los programas que emplean IEC para aumentar el uso de PrEP entre los trabajadores sexuales masculinos (TSM). Realizamos un experimento de elección discreta con TSM en la Ciudad de México para obtener preferencias declaradas para un programa de adherencia a la PrEP basado en IEC. Los participantes expresaron sus preferencias en cuanto a diferentes características: monto del incentivo; formato del incentivo; tipo de incentivo; y método de verificación de la adherencia. Utilizamos un modelo logit de utilidad aleatoria para estimar la importancia relativa de cada atributo y la disposición a pagar estimada (DAP). Los TSM prefirieron un incentivo fijo más alto, con la adherencia a la PrEP medida a través de muestras de cabello. Los TSM estaban dispuestos a renunciar hasta el 21% de su monto máximo potencial de IEC para garantizar la recepción de un pago fijo. Los TSM están muy dispuestos a aceptar una intervención basada en IEC para la adherencia a la PrEP, si se ofrece junto con pagos fijos.

"PrEP's just to secure you like insurance": a qualitative study on HIV pre-exposure prophylaxis (PrEP) adherence and retention among black cisgender women in Mississippi.

BACKGROUND: Pre-exposure prophylaxis (PrEP) has the potential to reduce transmission of HIV among Black cisgender women in the Southern United States (U.S.); however, national data suggests that PrEP initiation is lowest in the South and among Black women compared to other U.S. regions and white women. This study applied intersectionality and PrEP multilevel resilience frameworks to assess how socio-structural and clinical contexts shaped PrEP persistence among Black cisgender women in Mississippi. METHODS: Semi-structured interviews were conducted with eight Black cisgender women in Jackson, Mississippi. This sample was purposively recruited to include PrEP-initiated Black cisgender women. RESULTS: Six themes identified that shaped PrEP care among Black cisgender women: (1) internal assets, (2) sole responsibility to HIV prevention, (3) added protection in HIV serodifferent relationships, (4) financial issues, (5) trust and distrust in the medical system, and (6) side effects. Black cisgender women reported that PrEP persistence increased control over their sexual health, reduced anxiety about HIV, and promoted self-care. Black cisgender women also indicated that medication assistance programs increased PrEP affordability resulting in continued persistence. CONCLUSIONS: In addition to preventing HIV, PrEP may yield secondary positive impacts on the health and relationships of Black cisgender women. However, very few Black cisgender women in the South are using PrEP given intersectional barriers and thus necessitates adaptive strategies to support PrEP initiation and persistence. Efforts aimed at increasing the coverage of PrEP among Black cisgender women should consider implementation strategies responsive to lived realities of Black women.

COVID-19 Vaccine Acceptance among an Online Sample of Sexual and Gender Minority Men and Transgender Women.

Sexual and gender minority (SGM) populations are particularly vulnerable to poor COVID-19 outcomes and are more likely to experience stigma and medical mistrust that may impact COVID-19 vaccine acceptance. This study examined the prevalence of COVID testing and diagnosis and assessed COVID-19 vaccine acceptance among a large sample of SGM. Participants were recruited as part of an online cross-sectional study focused on an HIV biomedical prevention technology willingness in the United States at increased risk for HIV sero-conversion. Multivariate linear analysis was conducted to examine COVID-19 vaccine acceptance. The study sample included 1350 predominately gay (61.6%), Black (57.9%), cis-gender (95.7%) males with a mean age of 32.9 years. Medical mistrust and social concern regarding COVID-19 vaccine stigma were significantly associated with decreased COVID-19 vaccine acceptance, and altruism was significantly associated with increased vaccine acceptance. Black participants were significantly less likely to accept a COVID-19 vaccine, and Asian participants were significantly more likely to accept a vaccine, compared to White peers. As the planning of COVID-19 vaccine rollout efforts is conceptualized and designed, these data may inform equitable implementation strategies and prevent worsening health inequities among SGM populations.

Call to action: how can the US Ending the HIV Epidemic initiative succeed?

With more than 1·2 million people living with HIV in the USA, a complex epidemic across the large and diverse country, and a fragmented health-care system marked by widening health disparities, the US HIV epidemic requires sustained scientific and public health attention. The epidemic has been stubbornly persistent; high incidence densities have been sustained over decades and the epidemic is increasingly concentrated among racial, ethnic, and sexual and gender minority communities. This fact remains true despite extraordinary scientific advances in prevention, treatment, and care-advances that have been led, to a substantial degree, by US-supported science and researchers. In this watershed year of 2021 and in the face of the COVID-19 pandemic, it is clear that the USA will not meet the stated goals of the National HIV/AIDS Strategy, particularly those goals relating to reductions in new infections, decreases in morbidity, and reductions in HIV stigma. The six papers in the Lancet Series on HIV in the USA have each examined the underlying causes of these challenges and laid out paths forward for an invigorated, sustained, and more equitable response to the US HIV epidemic than has been seen to date. The sciences of HIV surveillance, prevention, treatment, and implementation all suggest that the visionary goals of the Ending the HIV Epidemic initiative in the USA might be achievable. However, fundamental barriers and challenges need to be addressed and the research effort sustained if we are to succeed.

Epidemiology of HIV in the USA: epidemic burden, inequities, contexts, and responses.

The HIV epidemic in the USA began as a bicoastal epidemic focused in large cities but, over nearly four decades, the epidemiology of HIV has changed. Public health surveillance data can inform an understanding of the evolution of the HIV epidemic in terms of the populations and geographical areas most affected. We analysed publicly available HIV surveillance data and census data to describe: current HIV prevalence and new HIV diagnoses by region, race or ethnicity, and age; trends in HIV diagnoses over time by HIV acquisition risk and age; and the distribution of HIV prevalence by geographical area. We reviewed published literature to explore the reasons for the current distribution of HIV cases and important disparities in HIV prevalence. We identified opportunities to improve public health surveillance systems and uses of data for planning and monitoring public health responses. The current US HIV epidemic is marked by geographical concentration in the US South and profound disparities between regions and by race or ethnicity. Rural areas vary in HIV prevalence; rural areas in the South are more likely to have a high HIV prevalence than rural areas in other US Census regions. Ongoing disparities in HIV in the South are probably driven by the restricted expansion of Medicaid, health-care provider shortages, low health literacy, and HIV stigma. HIV diagnoses overall declined in 2009-18, but HIV diagnoses among individuals aged 25-34 years increased during the same period. HIV diagnoses decreased for all risk groups in 2009-18; among men who have sex with men (MSM), new diagnoses decreased overall and for White MSM, remained stable for Black MSM, and increased for Hispanic or Latino MSM. Surveillance data indicate profound and ongoing disparities in HIV cases, with disproportionate impact among people in the South, racial or ethnic minorities, and MSM.

Differences in mental health symptom severity and care engagement among transgender and gender diverse individuals: Findings from a large community health center.

Mental health disparities among transgender and gender diverse (TGD) populations have been documented. However, few studies have assessed differences in mental health symptom severity, substance use behavior severity, and engagement in care across TGD subgroups. Using data from the electronic health record of a community health center specializing in sexual and gender minority health, we compared the (1) severity of self-reported depression, anxiety, alcohol use, and other substance use symptoms; (2) likelihood of meeting clinical thresholds for these disorders; and (3) number of behavioral health and substance use appointments attended among cisgender, transgender, and non-binary patients. Participants were 29,988 patients aged ≥18 who attended a medical appointment between 2015 and 2018. Depression symptom severity (F = 200.6, p < .001), anxiety symptom severity (F = 102.8, p < .001), alcohol use (F = 58.8, p < .001), and substance use (F = 49.6, p < .001) differed significantly by gender. Relative to cisgender and transgender individuals, non-binary individuals are at elevated risk for depression, anxiety, and substance use disorders. Gender was also associated with differences in the number of behavioral health (χ2 = 51.5, p < .001) and substance use appointments (χ2 = 39.3, p < .001) attended. Engagement in treatment among certain gender groups is poor; cisgender women and non-binary patients assigned male at birth were the least likely to have attended a behavioral health appointment, whereas transgender men and cisgender women had attended the lowest number of substance use appointments. These data demonstrate the importance of (1) assessing gender diversity and (2) addressing the barriers that prevent TGD patients from receiving affirming care.

Economic vulnerability and non-initiation of antiretroviral therapy in India: a qualitative study.

In India, many people living with HIV (PLHIV) do not successfully initiate antiretroviral therapy (ART) after diagnosis. We conducted a clinic-based qualitative study at the Y.R. Gaitonde Centre for AIDS Research in Chennai, Tamil Nadu to explore factors that influence ART non-initiation. We interviewed 22 men and 15 women; median age was 42 (IQR, 36-48) and median CD4+ was 395 (IQR, 227-601). Participants were distrustful of HIV care freely available at nearby government facilities. Faced with the perceived need to access the private sector and therefore pay for medications and transportation costs, non-initiators with high CD4+ counts often decided to postpone ART until they experienced symptoms whereas non-initiators with low CD4+ counts often started ART but defaulted quickly after experiencing financial stressors or side effects. Improving perceptions of quality of care in the public sector, encouraging safe serostatus disclosure to facilitate stronger social support, and alleviating economic hardship may be important in encouraging ART initiation in India.

The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design.

OBJECTIVES: To determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts. METHODS: We report the rationale and design of a planned pragmatic, cluster randomized, double-blinded trial (N = 2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts), randomized to either vitamin D3 (loading dose, then 3200 IU/day) or placebo in a 1:1 ratio and a household cluster design. The study duration is 4 weeks. The primary outcome for newly diagnosed individuals is the occurrence of hospitalization and/or mortality. Key secondary outcomes include symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts. Changes in vitamin D 25(OH)D levels will be assessed and their relation to study outcomes will be explored. CONCLUSIONS: The proposed pragmatic trial will allow parallel testing of vitamin D3 supplementation for early treatment and post-exposure prophylaxis of COVID-19. The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.

Explaining Differences in the Acceptability of 99DOTS, a Cell Phone-Based Strategy for Monitoring Adherence to Tuberculosis Medications: Qualitative Study of Patients and Health Care Providers.

BACKGROUND: 99DOTS is a cell phone-based strategy for monitoring tuberculosis (TB) medication adherence that has been rolled out to more than 150,000 patients in India's public health sector. A considerable proportion of patients stop using 99DOTS during therapy. OBJECTIVE: This study aims to understand reasons for variability in the acceptance and use of 99DOTS by TB patients and health care providers (HCPs). METHODS: We conducted qualitative interviews with individuals taking TB therapy in the government program in Chennai and Vellore (HIV-coinfected patients) and Mumbai (HIV-uninfected patients) across intensive and continuation treatment phases. We conducted interviews with HCPs who provide TB care, all of whom were involved in implementing 99DOTS. Interviews were transcribed, coded using a deductive approach, and analyzed with Dedoose 8.0.35 software (SocioCultural Research Consultants, LLC). The findings of the study were interpreted using the unified theory of acceptance and use of technology, which highlights 4 constructs associated with technology acceptance: performance expectancy, effort expectancy, social influences, and facilitating conditions. RESULTS: We conducted 62 interviews with patients with TB, of whom 30 (48%) were HIV coinfected, and 31 interviews with HCPs. Acceptance of 99DOTS by patients was variable. Greater patient acceptance was related to perceptions of improved patient-HCP relationships from increased phone communication, TB pill-taking habit formation due to SMS text messaging reminders, and reduced need to visit health facilities (performance expectancy); improved family involvement in TB care (social influences); and from 99DOTS leading HCPs to engage positively in patients' care through increased outreach (facilitating conditions). Lower patient acceptance was related to perceptions of reduced face-to-face contact with HCPs (performance expectancy); problems with cell phone access, literacy, cellular signal, or technology fatigue (effort expectancy); high TB- and HIV-related stigma within the family (social influences); and poor counseling in 99DOTS by HCPs or perceptions that HCPs were not acting upon adherence data (facilitating conditions). Acceptance of 99DOTS by HCPs was generally high and related to perceptions that the 99DOTS adherence dashboard and patient-related SMS text messaging alerts improve quality of care, the efficiency of care, and the patient-HCP relationship (performance expectancy); that the dashboard is easy to use (effort expectancy); and that 99DOTS leads to better coordination among HCPs (social influences). However, HCPs described suboptimal facilitating conditions, including inadequate training of HCPs in 99DOTS, unequal changes in workload, and shortages of 99DOTS medication envelopes. CONCLUSIONS: In India's government TB program, 99DOTS had high acceptance by HCPs but variable acceptance by patients. Although some factors contributing to suboptimal patient acceptance are modifiable, other factors such as TB- and HIV-related stigma and poor cell phone accessibility, cellular signal, and literacy are more difficult to address. Screening for these barriers may facilitate targeting of 99DOTS to patients more likely to use this technology.

Hepatitis C Management at Federally Qualified Health Centers during the Opioid Epidemic: A Cost-Effectiveness Study.

BACKGROUND: The opioid epidemic has been associated with an increase in hepatitis C virus (HCV) infections. Federally qualified health centers (FQHCs) have a high burden of hepatitis C disease and could serve as venues to enhance testing and treatment. METHODS: We estimated clinical outcomes and the cost-effectiveness of hepatitis C testing and treatment at US FQHCs using individual-based simulation modeling. We used individual-level data from 57 FQHCs to model 9 strategies, including permutations of HCV antibody testing modality, person initiating testing, and testing approach. Outcomes included life expectancy, quality-adjusted life-years (QALY), hepatitis C cases identified, treated and cured; and incremental cost-effectiveness ratios. RESULTS: Compared with current practice (risk-based with laboratory-based testing), routine rapid point-of-care testing initiated and performed by a counselor identified 68% more cases after (nonreflex) RNA testing in the first month of the intervention and led to a 17% reduction in cirrhosis cases and a 22% reduction in liver deaths among those with cirrhosis over a lifetime. Routine rapid testing initiated by a counselor or a clinician provided better outcomes at either lower total cost or at lower cost per QALY gained, when compared with all other strategies. Findings were most influenced by the proportion of patients informed of their anti-HCV test results. CONCLUSIONS: Routine anti-HCV testing followed by prompt RNA testing for positives is recommended at FQHCs to identify infections. If using dedicated staff or point-of-care testing is not feasible, then measures to improve immediate patient knowledge of antibody status should be considered.