Preferences and uptake of home-based HIV self-testing for maternal retesting in Kenya.

Objective: To compare preferences, uptake, and cofactors for unassisted home-based oral self-testing (HB-HIVST) versus clinic-based rapid diagnostic blood tests (CB-RDT) for maternal HIV retesting. Design: Prospective cohort. Methods: Between November 2017 and June 2019, HIV-negative pregnant Kenyan women receiving antenatal care were enrolled and given a choice to retest with HB-HIVST or CB-RDT. Women were asked to retest between 36 weeks gestation and 1 week post-delivery if the last HIV test was <24 weeks gestation or at 6 weeks postpartum if ≥24 weeks gestation, and self-report on retesting at a 14 week postpartum. Results: Overall, 994 women enrolled and 33% (n=330) selected HB-HIVST. HB-HIVST was selected because it was private (68%), convenient (63%), and offered flexibility in timing of retesting (63%), whereas CB-RDT was selected due to trust of providers to administer the test (77%) and convenience of clinic testing (64%). Among 905 women who reported retesting at follow-up, 135 (15%) used HB-HIVST. Most (94%) who selected CB-RDT retested with this strategy, compared to 39% who selected HB-HIVST retesting with HB-HIVST. HB-HIVST retesting was more common among women with higher household income and those who may have been unable to test during pregnancy (both retested postpartum and delivered <37 weeks gestation) and less common among women who were depressed. Most women said they would retest in the future using the test selected at enrollment (99% HB-HIVST; 93% CB-RDT-RDT). Conclusions: While most women preferred CB-RDT for maternal retesting, HB-HIVST was acceptable and feasible and may increase retesting coverage and partner testing.

Implementation and Assessment of the HIV Enhanced Access Testing in the Emergency Department (HEATED) Program in Nairobi, Kenya: A Quasi-Experimental Prospective Study.

Background: Persons seeking emergency injury care are often from underserved key populations (KPs) and priority populations (PPs) for HIV programming. While facility-based HIV Testing Services (HTS) in Kenya are effective, emergency department (ED) delivery is limited, despite the potential to reach underserved persons. Methods: This quasi-experimental prospective study evaluated implementation of the HIV Enhanced Access Testing in Emergency Departments (HEATED) at Kenyatta National Hospital ED in Nairobi, Kenya. The HEATED program was designed using setting specific data and utilizes resource reorganization, services integration and HIV sensitization to promote ED-HTS. KPs included sex workers, gay men, men who have sex with men, transgender persons and persons who inject drugs. PPs included young persons (18-24 years), victims of interpersonal violence, persons with hazardous alcohol use and those never previously HIV tested. Data were obtained from systems-level records, enrolled injured patient participants and healthcare providers. Systems and patient-level data were collected during a pre-implementation period (6 March - 16 April 2023) and post-implementation (period 1, 1 May - 26 June 2023). Additional, systems-level data were collected during a second post-implementation (period 2, 27 June - 20 August 2023). Evaluation analyses were completed across reach, effectiveness, adoption, implementation and maintenance framework domains. Results: All 151 clinical staff were reached through trainings and sensitizations on the HEATED program. Systems-level ED-HTS increased from 16.7% pre-implementation to 23.0% post-implementation periods 1 and 2 (RR=1.31, 95% CI:1.21-1.43; p<0.001) with a 62.9% relative increase in HIV self-test kit provision. Among 605 patient participants, facilities-based HTS increased from 5.7% pre-implementation to 62.3% post-implementation period 1 (RR=11.2, 95%CI:6.9-18.1; p<0.001). There were 440 (72.7%) patient participants identified as KPs (5.6%) and/or PPs (65.3%). For enrolled KPs/PPs, HTS increased from 4.6% pre-implementation to 72.3% post-implementation period 1 (RR=13.8, 95%CI:5.5-28.7, p<0.001). Systems and participant level data demonstrated successful adoption and implementation of the HEATED program. Through 16-weeks post-implementation a significant increase in ED-HTS delivery was maintained as compared to pre-implementation. Conclusions: The HEATED program increased ED-HTS and augmented delivery to KPs/PPs, suggesting that broader implementation could improve HIV services for underserved persons, already in contact with health systems.

Behavior Change Among HIV-Negative Men Who Have Sex with Men Not Using PrEP in the United States.

This study measures changes in condomless anal sex (CAS) among HIV-negative men who have sex with men (MSM) who are not taking pre-exposure prophylaxis (PrEP). It considers the 2014-2019 cycles of the American Men's Internet Survey, a serial, cross-sectional web-based survey of US cisgender MSM aged ≥ 15 years, in which ~ 10% of each year's sample is drawn from the previous year. Among those surveyed for 2 years who remained HIV-negative and off PrEP, reports of having any CAS and of CAS partner number were compared across years. We disaggregated by partner HIV status, and considered demographic predictors. The overall population saw a significant 2.2 percentage-point (pp) increase in reports of any CAS year-over-year. Sub-populations with the largest year-on-year increases were 15-24-year-olds (5.0-pp) and Hispanic respondents (5.1-pp), with interaction (young Hispanic respondents = 12.8-pp). On the relative scale, these numbers correspond to 3.2%, 7.2%, 7.3% and 18.7%, respectively. Absolute increases were concentrated among partners reported as HIV-negative. Multivariable analyses for CAS initiation found effects concentrated among Hispanic and White youth and residents of fringe counties of large metropolitan areas. CAS partner number increases were similarly predicted by Hispanic identity and young age. Although condom use remains more common than PrEP use, increasing CAS among MSM not on PrEP suggests potential new HIV transmission pathways. Concentration of increases among 18-24-year-old MSM portends future increases in the proportion of newly diagnosed HIV that occur among youth. Concentration among young Hispanic MSM will likely expand existing disparities. Although reducing barriers to PrEP remains vital, condom promotion for MSM remains a key public health practice and appears to be missing key audiences. LGBTQ+-inclusive sex education is one avenue for enhancing these efforts.

Reasons for Migration and Their Associations with HIV Risk and Prevention Among Cisgender Sexual Minority Men: A Latent Class Analysis.

The immigrant population in the United States (U.S.) is rapidly growing; yet there is limited knowledge about how reasons for migrating to the U.S. are associated with HIV prevention behaviors. Using data from the American Men's Internet Survey (2018-2020), we performed a Latent Class Analysis (LCA) to identify patterns in reasons for migration among cisgender gay, bisexual, and other sexual minority men (SMM) who born outside the U.S. We used multivariable logistic regression controlling for demographic characteristics to assess class associations with the following in the past 12 months: condomless anal sex (CAS), illicit drug use, marijuana use, HIV testing, and PrEP use. LCA identified six distinct patterns in reasons for migration among the sample (n = 1,657): (1) Family and friends (14%); (2) Financial (17%); (3) Personal freedom related to being gay (10%); (4) Pursuit of opportunities while living openly as SMM (12%); (5) Educational purposes (18%); (6) Not my decision (29%). While HIV testing (range = 57.6-65.4%) and PrEP use (range = 15.6-21.4%) did not vary by class (p > .05 for all), CAS and illicit drug use were significantly different (p < .05). SMM who migrated to pursue opportunities while living openly and whose reasons were not their decision had greater odds of CAS than SMM who migrated for educational purposes (aOR:1.72, 95% confidence interval [95%CI]:1.15-2.59; 1.57, 1.13-2.19, respectively). Reasons for migration among SMM were associated with behaviors that can increase HIV risk, but not testing or PrEP. Push and pull factors related to migration should be considered when developing behavioral HIV interventions for immigrant SMM.

RESUMEN: La población inmigrante en los Estados Unidos (EE. UU.) está creciendo rápidamente; sin embargo, hay un conocimiento limitado acerca de cómo las razones para migrar a los EE. UU. se asocian con comportamientos de prevención del VIH. Utilizando datos del American Men's Internet Survey (2018­2020), realizamos un Análisis de Clases Latentes (ACL) para identificar patrones en las razones de migración entre hombres cisgénero gays, bisexuales y otros hombres de minorías sexuales (HMS) que reportaron haber nacido fuera de los EE. UU. Utilizamos regresión logística multivariable controlando las características demográficas para evaluar las asociaciones de clases con los siguientes comportamientos en los últimos 12 meses: sexo anal sin condón (SAC), consumo de drogas ilícitas, uso de marihuana, prueba del VIH y uso de PrEP. El ACL identificó seis patrones distintos en las razones de migración en la muestra (n = 1,657): (1) Familia y amigos (14%); (2) Motivos financieros (17%); (3) Libertad personal relacionada con ser gay (10%); (4) Búsqueda de oportunidades mientras viven abiertamente como HMS (12%); (5) Propósitos educativos (18%); (6) No fue decisión propia (29%). Mientras que las pruebas del VIH (rango = 57.6­65.4%) y el uso de PrEP (rango = 15.6­21.4%) no variaron según la clase (p > .05 para todos), el SAC y el consumo de drogas ilícitas fueron significativamente diferentes (p < .05). Los HMS que emigraron para perseguir oportunidades mientras vivían abiertamente, y aquellos cuyas razones no fueron decisión propia, tuvieron mayores probabilidades de tener SAC que los HMS que emigraron con propósitos educativos (razón de probabilidades ajustada [aOR]: 1.72, intervalo de confianza del 95% [IC 95%]: 1.15­2.59; 1.57, 1.13­2.19, respectivamente). Las razones de migración a los EE. UU. entre los HMS estuvieron asociadas con comportamientos que pueden aumentar el riesgo de VIH, pero no con pruebas o PrEP. Los factores que impulsan y atraen relacionados con la migración deben considerarse al desarrollar intervenciones de prevención del VIH para HMS inmigrantes.

A smoking cessation intervention for rural veterans tailored to individual risk factors: A multicenter randomized clinical trial.

INTRODUCTION: Rates of cigarette use remain elevated among those living in rural areas. Depressive symptoms, risky alcohol use, and weight concerns frequently accompany cigarette smoking and may adversely affect quitting. Whether treatment for tobacco use that simultaneously addresses these issues affects cessation outcomes is uncertain. METHODS: The study was a multicenter, two-group, randomized controlled trial involving mostly rural veterans who smoke (N = 358) receiving treatment at one of five Veterans Affairs Medical Centers. The study randomly assigned participants to a tailored telephone counseling intervention or referral to their state tobacco quitline. Both groups received guideline-recommended smoking cessation pharmacotherapy, selected using a shared decision-making approach. The primary outcome was self-reported seven-day point prevalence abstinence (PPA) at three and six months. The study used salivary cotinine to verify self-reported quitting at six months. RESULTS: Self-reported PPA was significantly greater in participants assigned to Tailored Counseling at three (OR = 1.66; 95 % CI: 1.07-2.58) but not six (OR = 1.35; 95 % CI: 0.85-2.15) months. Post hoc subgroup analyses examining treatment group differences based on whether participants had a positive screen for elevated depressive symptoms, risky alcohol use, and/or concerns about weight gain indicated that the cessation benefit of Tailored Counseling at three months was limited to those with ≥1 accompanying concern (OR = 2.02, 95 % CI: 1.20-3.42). Biochemical verification suggested low rates of misreporting. CONCLUSIONS: A tailored smoking cessation intervention addressing concomitant risk factors enhanced short-term abstinence but did not significantly improve long-term quitting. Extending the duration of treatment may be necessary to sustain treatment effects.

Consensus of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic and musculoskeletal diseases.

BACKGROUND: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight, fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise definitions of all mandatory domains within the core domain set. METHODS: OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain.  The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of 'what' is to be measured. RESULTS: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of 'truth' before moving on to feasibility and discrimination. CONCLUSION: The OMERACT GC Impact Working Group has developed and agreed upon detailed domain definitions for core domains. Future steps of the working group are to select instruments and develop the core outcome measurement set for clinical trials measuring the impact of GC on patients with rheumatic and musculoskeletal diseases.

Modeling the impact of changing sexual behaviors with opposite-sex partners and STI testing among women and men ages 15-44 on STI diagnosis rates in the United States 2012-2019.

Objective: To estimate the potential contributions of reported changes in frequency of penile-vaginal sex (PVS), condom use and STI screening to changes in gonorrhea and chlamydial diagnoses from 2012 to 2019. Methods: An agent-based model of the heterosexual population in the U.S. simulated the STI epidemics. Baseline was calibrated to 2012 diagnosis rates, testing, condom use, and frequency of PVS. Counterfactuals used behaviors from the 2017-2019 NSFG, and we evaluated changes in diagnosis and incidence rates in 2019. Results: Higher testing rates increased gonorrhea and chlamydia diagnosis by 14% and 13%, respectively, but did not reduce incidence. Declining frequency of PVS reduced the diagnosis rate for gonorrhea and chlamydia 6% and 3% respectively while reducing incidence by 10% and 9% respectively. Declining condom use had negligible impact on diagnosis and incidence. Conclusion: Understanding how changing behavior drives STI incidence is essential to addressing the growing epidemics. Changes in testing and frequency of PVS likely contributed to some, but not all, of the changes in diagnoses. More research is needed to understand the context within which changing sexual behavior and testing are occurring.

"It Is A Carrot-Stick Model": A Qualitative Study of Rural-Serving Clinician and Rural-Residing Veteran Perceptions of Requirements to Quit Smoking prior to Elective Surgery.

Introduction: Some medical centers and surgeons require patients to stop smoking cigarettes prior to elective orthopaedic surgeries in an effort to decrease surgical complications. Given higher rates of smoking among rural individuals, rural patients may be disproportionately impacted by these requirements. We assessed the perceptions and experiences of rural-residing Veterans and clinicians related to this requirement. Methods: We conducted qualitative semistructured one-on-one interviews of 26 rural-residing veterans, 10 VA orthopaedic surgery staff (from two Veterans Integrated Services Networks), 24 PCPs who serve rural veterans (14 VA; 10 non-VA), and 4 VA pharmacists. Using the knowledge, attitudes, and behavior framework, we performed conventional content analysis. Results: We found three primary themes across respondents: (1) knowledge of and the evidence base for the requirement varied widely; (2) strong personal attitudes toward the requirement; and (3) implementation and possible implications of this requirement. All surgery staff reported knowledge of requirements at their institution. VA PCPs reported knowledge of requirements but typically could not recall specifics. Most patients were unaware. The majority of respondents felt this requirement could increase motivation to quit smoking. Some PCPs felt a more thorough explanation of smoking-related complications would result in increased quit attempts. About half of all patients reported belief that the requirement was reasonable regardless of initial awareness. Respondents expressed little concern that the requirement might increase rural-urban disparities. Most PCPs and patients felt that there should be exceptions for allowing surgery, while surgical staff disagreed. Discussion. Most respondents thought elective surgery was a good motivator to quit smoking; but patients, PCPs, and surgical staff differed on whether there should be exceptions to the requirement that patients quit preoperatively. Future efforts to augment perioperative smoking cessation may benefit from improving coordination across services and educating patients more about the benefits of quitting.

Dexamethasone Suppression Testing in a Contemporary Cohort with Adrenal Incidentalomas in Two U.S. Integrated Healthcare Systems.

Autonomous cortisol secretion (ACS) from an adrenal adenoma can increase the risk for comorbidities and mortality. The dexamethasone suppression test (DST) is the standard method to diagnose ACS. A multi-site, retrospective cohort of adults with diagnosed adrenal tumors was used to understand patient characteristics associated with DST completion and ACS. Time to DST completion was defined using the lab value and result date; follow-up time was from the adrenal adenoma diagnosis to the time of completion or censoring. ACS was defined by a DST > 1.8 µg/dL (50 nmol/L). The Cox proportional hazards regression model assessed associations between DST completion and patient characteristics. In patients completing a DST, a logistic regression model evaluated relationships between elevated ACS and covariates. We included 24,259 adults, with a mean age of 63.1 years, 48.1% obese, and 28.7% with a Charlson comorbidity index ≥ 4. Approximately 7% (n = 1768) completed a DST with a completion rate of 2.36 (95% CI 2.35, 2.37) per 100 person-years. Fully adjusted models reported that male sex and an increased Charlson comorbidity index were associated with a lower likelihood of DST completion. Current or former smoking status and an increased Charlson comorbidity index had higher odds of a DST > 1.8 µg/dL. In conclusion, clinical policies are needed to improve DST completion and the management of adrenal adenomas.

Changes in Oral and Anal Sex With Opposite-Sex Partners Among Sexually Active Females and Males Aged 15 to 44 Years in the United States: National Survey of Family Growth, 2011-2019.

BACKGROUND: Oral and anal sex with opposite-sex partners is common and associated with sexually transmitted infection (STI) transmission. Trends in these behaviors over the last decade, during which bacterial STI diagnoses have reached historic highs while HIV diagnoses have decreased, are not well understood. We examined recent trends in oral and anal sex and associated condom use with opposite-sex partners among females and males. METHODS: We analyzed data from 16,926 female and 13,533 male respondents aged 15 to 44 years who reported sex with an opposite-sex partner in the past 12 months from the National Survey of Family Growth, 2011-2019. We used survey-weighted linear or logistic regression to evaluate linear temporal trends in oral and anal sex behaviors. RESULTS: From 2011-2013 to 2017-2019, reports of oral sex and number of oral sex partners in the past 12 months increased among females (85.4% in 2011-2013 to 89.4% in 2017-2019; odds ratio [OR], 1.05 [95% confidence interval {CI}, 1.02-1.09], and ß = 0.014 [95% CI, 0.005-0.023]; respectively) but not males (ranges, 87.9%-89.1%; 1.27-1.31). Condom use at last oral sex decreased among both females and males (6.3%-4.3%: OR, 0.93 [95% CI, 0.88-0.99]; 5.9%-4.4%: OR, 0.95 [95% CI, 0.91-1.00]). Anal sex (ranges, 21.0%-23.3% [females] and 23.3%-24.6% [males]), number of anal sex partners (females, 0.22-0.25; males, 0.26-0.30), and condom use at last anal sex (females, 15.3%-18.2%; males, 27.0%-28.7%) remained stable. CONCLUSIONS: The frequency of oral and anal sex with opposite-sex partners among U.S. 15- to 44-year-olds, paired with limited and-for oral sex-decreasing condom use, demonstrates the need to understand the role of these behaviors in increasing STI diagnosis rates and the potential role of extragenital screening and condoms in reducing STI transmission.

Population Target-Mediated Pharmacokinetic/Pharmacodynamic Modeling to Evaluate SPI-62 Exposure and Hepatic 11ß-Hydroxysteroid Dehydrogenase Type 1 (HSD-1) Inhibition in Healthy Adults.

INTRODUCTION: SPI-62 is a small-molecule 11ß-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor exhibiting complicated nonlinear pharmacokinetics (PK) in human. Previously, we developed a target-mediated drug disposition (TMDD) model to characterize the substantial nonlinear PK of SPI-62. OBJECTIVE: The aim of the current analysis was to perform population PK/PD analysis to further link SPI-62 exposure (i.e., PK) with its response (i.e., inhibition of hepatic HSD-1 activity) to gain a quantitative understanding of the SPI-62 dose-exposure-response relationship. METHODS: PK and PD data from the first-in-human (FIH) clinical trials, including single ascending dose (SAD) and multiple ascending dose (MAD) studies, were used for model development. During the model development process, the final model selection was based on biological and physiological plausibility, goodness-of-fit plots, stability of parameter estimates, and objective function value. The nonlinear-mixed effect modeling (NONMEM) software was used for both the implementation of the PK/PD model and model simulation. SPI-62 plasma levels and hepatic HSD-1 inhibition over time following various dose regimens were simulated. RESULTS: The final model was a two-compartment TMDD model component for SPI-62 and an inhibitory Imax model component for hepatic HSD-1 activity. The TMDD-hepatic PD model that we established adequately characterized all remarkable PK and PD behaviors of SPI-62, such as extremely low plasma exposures following the first low doses, nonlinear PK turned into linear PK after repeated low doses, and substantial and long-lasting hepatic HSD-1 inhibition following low doses. SPI-62 was estimated to bind to the target with a second-order association rate constant (Kon) of 8.43 nM-1 h-1 and first-order dissociation rate constant (Koff) value of 0.229 h-1, indicating that SPI-62 binds rapidly to, and dissociates slowly from, its pharmacological target. The estimated target capacity (Rtot) of 5460 nmol corresponds to approximately 2.2 mg of SPI-62, which comports well with the dose range in which PK nonlinearity is prominent. Model simulation results reveal that a 6 mg once-daily regimen can lead to long-lasting and substantial hepatic HSD-1 inhibition. CONCLUSIONS: A population TMDD-PD model that explains SPI-62 nonlinear PK and hepatic HSD-1 inhibition following different dose regimens in healthy adults was successfully established. Our simulation results provide a solid foundation for model-informed development of SPI-62.

Associations Between Characteristics of Individuals With Fontan Circulation With Blood and Urine Biomarkers of Kidney Injury and Dysfunction.

Background Fontan circulation is associated with kidney injury and dysfunction, often unappreciated until Fontan circulatory failure. We hypothesized that cystatin C-estimated glomerular filtration rate (eGFR) would identify chronic kidney disease more frequently and that urine kidney injury biomarkers would be higher with declining Fontan physiological features. Methods and Results We enrolled 100 ambulatory individuals. Blood and urinary laboratory measurements were compared with demographics and clinically obtained data. Different eGFR equations were used for individuals aged ≥19 years and <19 years. Chronic kidney disease was defined as eGFR <90 mL/min per 1.73 m2. Median (25th-75th percentile) age was 19 (14-26) years, and 43% were female patients. Cystatin C eGFR detected chronic kidney disease (37%) in more patients than creatinine eGFR (11%). Cystatin C eGFR was positively associated, and skeletal muscle mass was negatively associated, with creatinine eGFR in both univariate (cystatin C eGFR ß=0.44±0.12, P=0.0006; skeletal muscle mass ß=-0.72±0.32, P=0.03) and multivariable analysis (cystatin C eGFR ß=0.43±0.12, P=0.0005; skeletal muscle mass ß=-0.69±0.29, P=0.02). Urine neutrophil gelatinase-associated lipocalin concentration correlated with Fontan pressure (r=0.28; P=0.04), ventricular end-diastolic pressure (r=0.28; P=0.04), and body fat mass (r=0.26; P=0.03). Conclusions Cystatin C eGFR identified more kidney dysfunction, likely attributable to creatinine eGFR being confounded by skeletal muscle mass. Elevated urine neutrophil gelatinase-associated lipocalin was associated with worse Fontan hemodynamics and higher percentage body fat, suggesting that higher venous pressure and higher adiposity are associated with ongoing kidney injury.

"I feel good because I have saved their lives": Acceptability of assisted partner services among female index clients and male sexual partners in Kenya.

INTRODUCTION: Assisted partner services (APS), or notification for sexual partners of people diagnosed with HIV, is an efficient, effective, and high yield strategy to identify people living with HIV and is recommended by the World Health Organization (WHO). However, there remains a need to further understand the acceptability of APS qualitatively from a client lens, particularly when APS is integrated into the national health system. We investigated acceptability of APS when integrated into HIV services in Kenya. METHODS: Starting in May 2018, APS was implemented in 31 health facilities in Kisumu and Homa Bay counties in western Kenya. From January to December 2019, we conducted in-depth interviews (IDIs) with female index clients (n = 16) and male sexual partners (n = 17) in 10 facilities participating in an APS scale up study. Interviews assessed APS satisfaction, perceived benefits of the intervention, and challenges that may affect delivery or uptake. We applied the Theoretical Framework of Acceptability by Sekhon et al. (2017) as a guide to organize our findings. RESULTS: We find that views of APS are often guided by an individual's trust in the intervention's design and implementation, and an interest to preserve one's health and that of one's family and children. There were strong and consistent acceptable views of APS as "doing good" and "saving a life" and as a means of showing love towards one's partner(s). The initial acceptability framing of individuals engaging with APS was predicated either on a feeling of comfort with the intervention, or a wariness of divulging sex partner personal information. Health care workers (HCWs) were seen to play an important role in mitigating participant fears linked with the intervention, particularly around the sensitive nature of HIV disclosure and sexual partners. Clients noted considerable challenges that affected acceptability, including the risk to the relationship of disclosing one's HIV status, and the risk of intimate partner violence. DISCUSSION: We found that APS is acceptable as a strategy to reach male sexual partners of females diagnosed with HIV, and these findings provide opportunities to inform recommendations for further scale-up. Opportunities such as focusing on intervention confidentiality and appropriate counseling, excluding female clients at risk of IPV from this intervention, and highlighting the altruistic benefits of APS to potential clients. Understanding the perspectives of clients receiving APS in a real-world setting may be valuable to policy-makers and stakeholders interested in scaling up or enhancing APS within health systems.

Real-world impact of integrating HIV assisted partner services into 31 facilities in Kenya: a single-arm, hybrid type 2 implementation-effectiveness study.

BACKGROUND: Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of individuals diagnosed with HIV (index clients), have been shown to be safe and effective in clinical trials. We assessed the real-world effectiveness of APS when integrated into HIV clinics in western Kenya. METHODS: In this single-arm, hybrid type 2 implementation science study, we facilitated APS implementation in 31 health facilities in Kenya by training existing health-care staff. We focused on male partner outcomes to assess the impact of APS in reaching male individuals in sub-Saharan Africa, who have lower rates of HIV testing than female individuals. Female individuals (aged ≥18 years or emancipated minor) who tested positive for HIV at participating facilities in Kenya were offered APS; consenting female participants provided contact information for all male sexual partners in the past 3 years. Male partners were notified of their potential HIV exposure and offered a choice of community-based or facility-based HIV testing services (HTS). Female index clients and male partners with HIV were followed up at 6 weeks, 6 months, and 12 months after enrolment, to assess linkage to antiretroviral treatment. Viral load was assessed at 12 months. FINDINGS: Between May 1, 2018, and March 31, 2020, 32 722 female individuals received HTS; 1910 (6%) tested positive for HIV, of whom 1724 (90%) received APS. Female index clients named 5137 male partners (median 3 per index [IQR 2-4]), of whom 4422 (86%) were reached with exposure notification and HTS. 524 (12%) of the male partners tested were newly diagnosed with HIV and 1292 (29%) reported a previous HIV diagnosis. At 12 months follow-up, 1512 (88%) female index clients and 1621 (89%) male partners with HIV were taking ART, with few adverse events: 25 (2%) female index clients and seven (<1%) male partners reported intimate partner violence, and 60 (3%) female index clients and ten (<1%) male partners reported relationship dissolution. INTERPRETATION: Evidence from this real-world APS scale-up project shows that APS is a safe, acceptable, and effective strategy to identify males with HIV and retain them in care. FUNDING: The US National Institutes of Health.

Regionalization or Access to Care? A Joint Pediatric Heart Care Program That Achieves Both: One Program-Two Sites.

Background: Regionalization of care for children with congenital heart disease has been proposed as a method to improve outcomes. This has raised concerns about limiting access to care. We present the details of a joint pediatric heart care program (JPHCP) which utilized regionalization and actually improved access to care. Methods: In 2017, Kentucky Children's Hospital (KCH) launched the JPHCP with Cincinnati Children's Hospital Medical Center (CCHMC). This unique satellite model was the product of several years of planning, leading to a comprehensive strategy with shared personnel, conferences, and a robust transfer system; "one program-two sites." Results: Between March 2017 and the end of June 2022, 355 operations were performed at KCH under the auspices of the JPHCP. As of the most recent published Society of Thoracic Surgeons (STS) outcome report (through the end of June 2021), for all STAT categories, the JPHCP at KCH outperformed the STS overall in postoperative length of stay, and the mortality rate was lower than expected for the case mix. Of the 355 operations, there were 131 STAT 1, 148 STAT 2, 40 STAT 3, and 36 STAT 4 operations, with two operative mortalities: an adult undergoing surgery for Ebstein anomaly, and a premature infant who died from severe lung disease many months after aortopexy. Conclusions: With a select case mix, and by affiliating with a large volume congenital heart center, the creation of the JPHCP at KCH was able to achieve excellent congenital heart surgery results. Importantly, access to care was improved for those children at the more remote location utilizing this one program-two sites model.

Integration of assisted partner services within Kenya's national HIV testing services program: A qualitative study.

Assisted partner service (aPS) augments HIV case-finding among sex partners to individuals newly diagnosed with HIV. In 2016, aPS was incorporated into the national HIV testing services (HTS) program in Kenya. We evaluated the extent of, barriers to, and facilitators of aPS integration into HTS. We conducted semi-structured in-depth interviews (IDIs) with 32 stakeholders selected using purposive sampling at national, county, facility, and community levels. IDIs were conducted at two timepoints, at baseline from August-September 2018 in Kisumu and January-June 2019 in Homa Bay, and at follow-up from May-August 2020 to understand changes in aPS integration over time. We defined integration as the creation of linkages between the new intervention (aPS) and the existing HTS program. Data were analyzed using thematic content analysis. We found varying degrees of aPS integration, highest in procurement/logistics and lowest in HTS provider recruitment/training. At baseline, aPS integration was low and activities were at an introductory phase. At follow-up, aPS was integrated in almost the entire HTS program with the exception of low community awareness, which was noted at both baseline and follow-up. There was increasing routinization with establishment of clear aPS cycles, e.g., quarterly data review meetings, annual budget cycles and work-plans. Major barriers included limited government funding, staff constraints, and inadequate community-level sensitization, while key facilitators included increased resources for aPS, and community health volunteer (CHV) facilitated awareness of aPS. Varying degrees of aPS integration across different units of the national HTS program highlights challenges in funding, human resource, and public awareness. Policymakers will need to address these barriers to ensure optimal provision of aPS.

The Pre-exposure Prophylaxis (PrEP) Care Continuum Among English-Speaking Latino Sexual Minority Men in the United States (2014-2020).

BACKGROUND: There is limited understanding of the pre-exposure prophylaxis (PrEP) care continuum specific to Latino/x gay, bisexual, and other sexual minority men (SMM) that encompasses the population residing outside of large metropolitan or urban areas. SETTING: We examined trends and characteristics associated with the PrEP care continuum with data from the 2014-2020 cycles of the American Men's Internet Survey, an annual online cross-sectional behavioral survey of cisgender SMM in the United States. METHODS: We calculated PrEP continuum outcomes overall and by year among Hispanic/Latino SMM (n = 9010). We used generalized estimating equations with Poisson links to examine (1) temporal trends (2014-2020) in each step of the PrEP continuum and PrEP use in the past year stratified by PrEP eligibility and (2) correlates of each step of the PrEP continuum in 2020 using multivariable models. RESULTS: Among 2283 Latino SMM in 2020, 84% reported PrEP awareness, 30% discussed PrEP with a provider, 15% used PrEP in the past year, and 12% were currently using PrEP. PrEP awareness increased from 52% in 2014 to 84% in 2020; and PrEP use in the past year increased from 4% in 2014 to 15% in 2020. In the multivariable models, age and PrEP eligibility were associated with PrEP use in the past year, and urban-rural classification was associated with current PrEP use. CONCLUSIONS: While most of the Latino SMM are aware of PrEP, significant gaps remain in this population in discussing PrEP with a provider and using PrEP that require tailored strategies to enhance access to HIV prevention services.

HIV self-testing acceptability among injured persons seeking emergency care in Nairobi, Kenya.

BACKGROUND: Emergency department-based HIV self-testing (ED-HIVST) could increase HIV-testing services to high-risk, under-reached populations. OBJECTIVES: This study sought to understand the injury patient acceptability of ED-HIVST. METHODS: Injury patients presenting to the Kenyatta National Hospital Accident and Emergency Department were enrolled from March to May 2021. Likert item data on HIVST assessing domains of general acceptability, personal acceptability, and acceptability to distribute to social and/or sexual networks were collected. Ordinal regression was performed yielding adjusted odds ratios (aOR) to identify characteristics associated with high HIVST acceptability across domains. RESULTS: Of 600 participants, 88.7% were male, and the median age was 29. Half reported having primary care providers (PCPs) and 86.2% reported prior HIV testing. For each Likert item, an average of 63.5% of the participants reported they 'Agree Completely' with positive statements about ED-HIVST in general, for themselves, and for others. In adjusted analysis for general acceptability, those <25 (aOR = 1.67, 95%CI:1.36-2.08) and with prior HIV testing (aOR = 1.68, 95%CI:1.27-2.21) had greater odds of agreeing completely. For personal acceptability, those with a PCP (aOR = 3.31, 95%CI:2.72-4.03) and prior HIV testing (aOR = 1.83, 95%CI:1.41-2.38) had greater odds of agreeing completely. For distribution acceptability, participants with a PCP (aOR = 2.42, 95%CI:2.01-2.92) and prior HIV testing (aOR = 1.79, 95%CI: 1.38-2.33) had greater odds of agreeing completely. CONCLUSIONS: ED-HIVST is perceived as highly acceptable, and young people with prior testing and PCPs had significantly greater favourability. These data provide a foundation for ED-HIVST programme development in Kenya.